Situation analysis of R & d activities: an empirical study in Iranian pharmaceutical companies.

PubMed

Rasekh, Hamid Reza; Mehralian, Gholamhossein; Vatankhah-Mohammadabadi, Abbas Ali

2012-01-01

As global competition intensifies, research and development (R & D) organizations need to enhance their strategic management in order to become goal-directed communities for innovation and allocate their resources consistent with their overall R & D strategy. The world pharmaceutical market has undergone fast, unprecedented, tremendous and complex changes in the last several years. The pharmaceutical industry is today still one of the most inventive, innovative and lucrative of the so-called "high-tech" industries. This industry serves a dual role in modern society. On one hand, it is a growing industry, and its output makes a direct contribution to gross domestic product (GDP). On the other side, drugs, this industry's major output, are an input in the production of good health. The purpose of this study is to evaluate R & D activities of pharmaceutical companies, and also to highlight critical factors which have influential effect on results of these activities. To run this study a valid questionnaire based on literature review and experts' opinion was designed and delivered to 11 pharmaceutical companies. Empirical data show there is not acceptable situations considering of the factors that should be taken in to account by managers including; management commitment, human resource management, information technology and financial management. Furthermore, we concluded some interesting results related to different aspects of R & D management. In conclusion, managers must be aware about their performance in R & D activities, accordingly they will able to take a comprehensive policy in both national and within the company.

[The attractive position of France in international clinical research: 2006 survey assessed by Leem (French pharmaceutical companies)].

PubMed

Courcier, Soizic; Sibenaler, Claire; Couderc, Monique; Trinquet, Françoise; Plétan, Yannick; Lassale, Catherine

2006-01-01

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Initiated in 2006, the current survey was much more representative than the previous ones with 20 companies accounting for 61% of the French market. This survey included 352 international phase II and III clinical studies carried out in 2004 and 2005, 74 countries, 17 345 centres and 137 989 patients. France has participated to half of the overall number of international clinical trials. France ranked among the best European recruiters (0,19 patient/1000 inhabitants) at the second position behind Scandinavian countries, taking in account numbers of inhabitants. Protocols are now to be given the go-ahead by Ethics Committee (CCPPRB) within 60 days. With a high productivity in phase IIb and in oncology, France is still an attractive place to locate clinical research.

[Research in the pharmaceutical industry cannot be objective].

PubMed

Becker-Brüser, Wolfgang

2010-01-01

In the face of tight public budgets more and more studies are being funded by the pharmaceutical industry. At the same time responsibility for conducting company-funded trials is increasingly being shifted to contract research organisations. Pharmaceutical manufacturers sponsor trials that primarily pursue company interests. The dominance of company-funded research does not only have a bearing on the choice of study priorities, though. Company sponsorship also has an influence on the results of trials. Company-funded trials are four times more likely to find evidence in favour of the trial drug than studies funded by other sponsors. There are several contributory factors, from study design (design bias) to data manipulation. And non-publication (publication bias) can distort knowledge. As a result, it is largely impossible to reliably assess the benefit and harm of medical drugs on the basis of published trials. This will have repercussions for the reliability of meta-analyses, guidelines and patient information leaflets. One consequence may be treatment errors.

Practicing Research Ethics: Private-Sector Physicians & Pharmaceutical Clinical Trials

PubMed Central

2008-01-01

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first upon historical studies of physicians as investigators and then upon 12 months of qualitative fieldwork in the South Western US, this paper analyzes the shifting, contextualized ethics that shape physicians’ relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities. PMID:18353515

Practicing research ethics: private-sector physicians & pharmaceutical clinical trials.

PubMed

Fisher, Jill A

2008-06-01

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first on historical studies of physicians as investigators and then on 12 months of qualitative fieldwork in the Southwestern US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.

Pharmaceutical company internet sites as sources of information about antidepressant medications.

PubMed

Graber, Mark A; Weckmann, Michelle

2002-01-01

To determine the informational content of nine pharmaceutical company websites about the antidepressant medication marketed by the company. A structured, explicit review of materials found on pharmaceutical company websites about nine antidepressants for which no generic drug is available was conducted using eight popular search engines. The accessibility of these websites was also determined using these search engines. Of 72 searches (one for each drug using each search engine), 46 yielded the pharmaceutical company website within the top 10 links. When outliers were removed, the company website was found in the top 10 links for 45 of 56 searches. All of the websites contain information of an advertising and emotive nature. Of the nine company websites, three contain anecdotal information; only two mention electroconvulsive therapy and four mention other types of drug therapy; and only one mentions the tradenames of other drugs. None of the websites mention drug costs, only one has efficacy statistics for the company's drug and, although all of the websites mention at least one adverse effect of the company's drug, only one lists percentages for adverse effects. The information about drugs for treating depression on pharmaceutical company websites aimed at consumers is limited and makes it difficult for consumers to compare drugs.

Value of pharmaceuticals: ensuring the future of research and development.

PubMed

Serajuddin, Hamida K; Serajuddin, Abu T M

2006-01-01

To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after

Who has used internal company documents for biomedical and public health research and where did they find them?

PubMed

Wieland, L Susan; Rutkow, Lainie; Vedula, S Swaroop; Kaufmann, Christopher N; Rosman, Lori M; Twose, Claire; Mahendraratnam, Nirosha; Dickersin, Kay

2014-01-01

To describe the sources of internal company documents used in public health and healthcare research. We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source. Our searches identified 9,305 citations of which 357 were eligible. Scanning of reference lists and consultation with colleagues identified 4 additional articles, resulting in 361 included articles. Most articles examined internal tobacco company documents (325/361; 90%). Articles using documents from pharmaceutical companies (20/361; 6%) were the next most common. Tobacco articles used documents from repositories; pharmaceutical documents were from a range of sources. Most included articles relied upon internal company documents obtained through litigation (350/361; 97%). The research questions posed were primarily about company strategies to promote or position the company and its products (326/361; 90%). Most articles (346/361; 96%) used information from miscellaneous documents such as memos or letters, or from unspecified types of documents. When explicit information about study funding was provided (290/361 articles), the most common source was the US-based National Cancer Institute. We developed an alternative and more sensitive search targeted at identifying additional research articles using internal pharmaceutical company documents, but the search retrieved an impractical number of citations for review. Internal company documents provide an excellent source of information on health topics (e.g., corporate behavior, study data) exemplified by articles based on tobacco industry documents. Pharmaceutical and other industry documents appear to have been less used for research, indicating a need for funding for

Gore offers to help drug companies pursue research.

PubMed

1996-03-08

A meeting convened between Vice President Al Gore and executives of leading pharmaceutical companies to determine means of accelerating efforts to develop vaccines, therapeutics, and microbicides for people with HIV. Gore explained that the administration will work with pharmaceutical companies to determine the long-term effectiveness of drugs approved by the Food and Drug Administration (FDA), work with international groups to increase investment in vaccine development, help develop new microbicides for women with HIV, and identify promising areas of AIDS research. According to advocates, the Clinton Administration has made great strides in improving and accelerating the FDA's drug approval process. The next goal of the pharmaceutical research agenda should be to include consumer advocates in the decision-making process.

Micro factors bringing the pharmaceutical industry to a seismic shaking a qualitative research.

PubMed

Dierks, Raphaela Marie Louisa; Bruyère, Olivier; Reginster, Jean-Yves

2017-06-01

Due to changing macro and micro factors, expiring patents and falling net income, pharmaceutical companies need to rethink their vertical business model. The trend shows cross-sectorial partnerships and consolidation to remain and compete on the market. Areas covered: Quantitative research interviewing a target group of 25 key executives from small, mid and large global pharmaceutical companies rounded with qualitative literature research completing the analysis. Expert commentary: Uncertainty in the industry due to changing external factors i.e. pricing pressures, regulations or an economic slowdown, slowing down innovations and new drug outcomes. Pharmaceutical companies understand the existing hurdles, and are critically optimistic implementing new business models. Also, various stakeholders are included in the value chain due to their growing importance. During the next years, the industry will be restructured from volume towards value, and only pharmaceutical companies' clairaudient and reciprocate to the changes with an out-off the box thinking will be able to resist on the market. Small biotech companies should focus on research, and big pharmaceutical companies entering at development focusing on the process until the distribution. This execution business recommendation would enable the best know-how at the right point, mitigating the risk and enhancing the patient outcomes.

Situation Analysis of R & D Activities: An Empirical Study in Iranian Pharmaceutical Companies

PubMed Central

Rasekh, Hamid Reza; Mehralian, Gholamhossein; Vatankhah-Mohammadabadi, Abbas Ali

2012-01-01

As global competition intensifies, research and development (R & D) organizations need to enhance their strategic management in order to become goal-directed communities for innovation and allocate their resources consistent with their overall R & D strategy. The world pharmaceutical market has undergone fast, unprecedented, tremendous and complex changes in the last several years. The pharmaceutical industry is today still one of the most inventive, innovative and lucrative of the so-called “high-tech” industries. This industry serves a dual role in modern society. On one hand, it is a growing industry, and its output makes a direct contribution to gross domestic product (GDP). On the other side, drugs, this industry’s major output, are an input in the production of good health. The purpose of this study is to evaluate R & D activities of pharmaceutical companies, and also to highlight critical factors which have influential effect on results of these activities. To run this study a valid questionnaire based on literature review and experts’ opinion was designed and delivered to 11 pharmaceutical companies. Empirical data show there is not acceptable situations considering of the factors that should be taken in to account by managers including; management commitment, human resource management, information technology and financial management. Furthermore, we concluded some interesting results related to different aspects of R & D management. In conclusion, managers must be aware about their performance in R & D activities, accordingly they will able to take a comprehensive policy in both national and within the company. PMID:24250532

A survey of reimbursement practices of private health insurance companies for pharmaceuticals not covered under the Pharmaceutical Benefits Scheme 2008.

PubMed

Lingaratnam, Senthil M; Kirsa, Sue W; Mellor, James D; Jackson, John; Crellin, Wallace; Fitzsimons, Michael; Zalcberg, John R

2011-05-01

To describe the current practices and policy of Australian private health insurance (PHI) companies with respect to cover for pharmaceuticals not subsidised under the Pharmaceutical Benefits Scheme (PBS). A 2008 review of web-published policy statements for top-level hospital and comprehensive general treatment insurance, and survey of reimbursement practices by way of questionnaire, of 31 Australian-registered, open-membership PHI companies. Description of the level of pharmaceutical cover and important considerations identified by PHI companies for funding non-PBS pharmaceuticals through benefit entitlements or ex-gratia payments. Nine of thirty-one PHI companies (29%) provided responses accounting for ~60% market share of PHI. The majority of smaller PHI firms either declined participation or did not respond. The maximum limits offered for non-PBS pharmaceuticals, under comprehensive general treatment insurance, varied significantly and typically did not adequately cover high-cost pharmaceuticals. Some companies occasionally offered ex-gratia payments (or discretionary payments in excess of the policyholder's entitlement benefits) for high cost-pharmaceuticals. Factors considered important in their decision to approve or reject ex-gratia requests were provided. All results were de-identified. There is little consistency across PHI companies in the manner in which they handle requests for high-cost pharmaceuticals in excess of the defined benefit limits. Such information and processes are not transparent to consumers.

The impact of generic substitution on the activities of pharmaceutical companies - a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland

PubMed Central

2010-01-01

Background Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals. Methods A cross-sectional postal survey was conducted among pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market one year (2004) and five years (2008) after the introduction of GS. Completed questionnaires were returned by 16 original and 7 generic product companies in 2004 (response rate 56%, n = 41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n = 39). Descriptive statistical analyses were performed. Results The number of employees (2004: n = 6/16, 2008: n = 7/16) and the amount of prescription medicine marketing (2004: n = 7/16, 2008: n = 8/16) decreased in many of the original product companies after the introduction of GS. GS resulted in problems related to the storage of pharmaceuticals in the original product companies shortly after GS was introduced (p = 0.032 between 2004 and 2008). In the generic product companies, the prescription medicine representatives' visits to pharmacies increased at the beginning of GS (p = 0.021 between 2004 and 2008). In addition, GS caused problems with the storage of pharmaceuticals one year and five years after the reform (2004: n = 4/7, 2008: n = 3/6). The differences between original and generic product companies regarding the impacts of GS were not, however, statistically significant. GS did not affect on the range of sales packages on the market or the research

The impact of generic substitution on the activities of pharmaceutical companies - a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland.

PubMed

Timonen, Johanna; Bengtström, Marina; Karttunen, Pekka; Ahonen, Riitta

2010-10-22

Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals. A cross-sectional postal survey was conducted among pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market one year (2004) and five years (2008) after the introduction of GS. Completed questionnaires were returned by 16 original and 7 generic product companies in 2004 (response rate 56%, n = 41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n = 39). Descriptive statistical analyses were performed. The number of employees (2004: n = 6/16, 2008: n = 7/16) and the amount of prescription medicine marketing (2004: n = 7/16, 2008: n = 8/16) decreased in many of the original product companies after the introduction of GS. GS resulted in problems related to the storage of pharmaceuticals in the original product companies shortly after GS was introduced (p = 0.032 between 2004 and 2008). In the generic product companies, the prescription medicine representatives' visits to pharmacies increased at the beginning of GS (p = 0.021 between 2004 and 2008). In addition, GS caused problems with the storage of pharmaceuticals one year and five years after the reform (2004: n = 4/7, 2008: n = 3/6). The differences between original and generic product companies regarding the impacts of GS were not, however, statistically significant. GS did not affect on the range of sales packages on the market or the research activities of the majority of

Pharmaceutical policies used by private health insurance companies in Saudi Arabia

PubMed Central

Bawazir, Saleh A.; Alkudsi, Mohammed A.; Al Humaidan, Abdullah S.; Al Jaser, Maher A.; Sasich, Larry D.

2012-01-01

Background Currently, the Council of Cooperative Health Insurance (CCHI) is the body responsible for regulating health insurance in the KSA. While the cooperative health insurance schedule (i.e., model policy for health insurance) is available on the CCHI web site, policies related to pharmaceuticals are ambiguous. Aims The primary objective of this study was to assess the impact of health insurance policies provided by health insurance companies in KSA on access to medication and its use. Settings and Design This study was descriptive in design and used a survey, which was conducted through face-to-face interviews with the medical managers of health insurance companies. Methods and Material The survey took place between March and June, 2011. All 25 insurance companies accredited by CCHI were eligible to be included in the study. Out of these 25 companies, three were excluded from this survey as no response was received. Results All the 16 companies responded “Yes” that they had a prior authorization policy; however, their reasons varied. Eight (50%) of the companies were concerned about the duration of treatment. While 10 (62.5%) did not offer additional coverage over the CCHI model policy, the other 6 (37.5%) reported that they could reconcile certain conditions. The survey also demonstrated that 10 insurance companies allowed refilling of medication but with certain limitations. Six out of the 10 permitted refilling within a maximum time of three months, whereas the other four companies did not have any time-based limits for refilling. The other six companies did not allow refilling without prescription. Conclusions Although this paper was primarily descriptive, the findings revealed a substantial scope for improvement in terms of pharmaceutical policy standards and regulation in the health insurance companies in KSA. Additionally, the study highlighted such areas to augment the overall quality use of medication, over-prescribing and irrational use of

Impact of regulatory requirements on medicine registration in African countries – perceptions and experiences of pharmaceutical companies in South Africa

PubMed Central

Narsai, Kirti; Williams, Abeda; Mantel-Teeuwisse, Aukje Kaija

2012-01-01

Objective: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. Methods: This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). Results: A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource

The Role of Entrepreneurial Activities in Academic Pharmaceutical Science Research

PubMed Central

Stinchcomb, Audra L.

2010-01-01

Academic pharmaceutical science research is expanding further and further from the University setting to encompass the for-profit private company setting. This parallels the National Institutes of Health momentum to include multiple funding opportunities for University and private company collaboration. It has been recognized that the non-profit and for-profit combination research model can accelerate the commercialization of pharmaceutical products, and therefore more efficiently improve human health. Entrepreneurial activities require unique considerations in the University environment, but can be modeled after the commercialization expansion of the academic healthcare enterprise. Challenges and barriers exist to starting a company as an entrepreneurial faculty member, but the rewards to one's personal and professional lives are incomparable. PMID:20017206

Assessing stakeholder opinion on relations between cancer patient groups and pharmaceutical companies in Europe.

PubMed

Leto di Priolo, Susanna; Fehervary, Andras; Riggins, Phil; Redmond, Kathy

2012-01-01

The relationship between the pharmaceutical industry and cancer patient groups has been the subject of much scrutiny and skepticism, and some high-profile negative media coverage has focused attention on some of the problematic aspects of the relationship. Both the pharmaceutical industry and cancer patient groups have made an effort in recent years to improve the transparency and openness of their relations, specifically with regard to the financial support offered by pharmaceutical companies to patient groups. The objectives of this survey were to benchmark perceptions held by different stakeholder groups about current relationships between cancer patient groups and pharmaceutical companies in Europe, and to explore opinions about ways in which partnerships between patient groups and pharmaceutical companies could evolve to the benefit of cancer patients. The survey was conducted using a structured questionnaire that contained a combination of matrix, scaled, and open-ended questions. The questionnaire was developed based on a literature search and the findings from ten in-depth interviews conducted with policy makers and advocates working at an EU level. Telephone interviews were carried out using a structured questionnaire with a convenience sample of 161 policy makers, cancer healthcare group representatives, and cancer patient group leaders from France, Germany, Hungary, Italy, Latvia, the Netherlands, Poland, Portugal, Romania, Spain, Sweden, and the UK. The interviews took place in the relevant language of the country. The current relationship between the pharmaceutical industry and cancer patient groups in Europe is generally viewed as positive, but it is also viewed as being unequal, not transparent enough, and not sufficiently patient-centric. There is broad agreement that cancer patient groups can help companies identify unmet needs and contribute to the development of innovative medicines; however, there is some concern about cancer patients

Who Has Used Internal Company Documents for Biomedical and Public Health Research and Where Did They Find Them?

PubMed Central

Wieland, L. Susan; Rutkow, Lainie; Vedula, S. Swaroop; Kaufmann, Christopher N.; Rosman, Lori M.; Twose, Claire; Mahendraratnam, Nirosha; Dickersin, Kay

2014-01-01

Objective To describe the sources of internal company documents used in public health and healthcare research. Methods We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source. Results Our searches identified 9,305 citations of which 357 were eligible. Scanning of reference lists and consultation with colleagues identified 4 additional articles, resulting in 361 included articles. Most articles examined internal tobacco company documents (325/361; 90%). Articles using documents from pharmaceutical companies (20/361; 6%) were the next most common. Tobacco articles used documents from repositories; pharmaceutical documents were from a range of sources. Most included articles relied upon internal company documents obtained through litigation (350/361; 97%). The research questions posed were primarily about company strategies to promote or position the company and its products (326/361; 90%). Most articles (346/361; 96%) used information from miscellaneous documents such as memos or letters, or from unspecified types of documents. When explicit information about study funding was provided (290/361 articles), the most common source was the US-based National Cancer Institute. We developed an alternative and more sensitive search targeted at identifying additional research articles using internal pharmaceutical company documents, but the search retrieved an impractical number of citations for review. Conclusions Internal company documents provide an excellent source of information on health topics (e.g., corporate behavior, study data) exemplified by articles based on tobacco industry documents. Pharmaceutical and other industry documents appear to have been less used for

Pharmaceutical companies vs. the State: who is responsible for post-trial provision of drugs in Brazil?

PubMed

Wang, Daniel Wei L; Ferraz, Octavio Luiz Motta

2012-01-01

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. © 2012 American Society of Law, Medicine & Ethics, Inc.

Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

PubMed

Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten

2017-01-01

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight's evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.

The role of entrepreneurial activities in academic pharmaceutical science research.

PubMed

Stinchcomb, Audra L

2010-06-01

Academic pharmaceutical science research is expanding further and further from the University setting to encompass the for-profit private company setting. This parallels the National Institutes of Health momentum to include multiple funding opportunities for University and private company collaboration. It has been recognized that the nonprofit and for-profit combination research model can accelerate the commercialization of pharmaceutical products, and therefore more efficiently improve human health. Entrepreneurial activities require unique considerations in the University environment, but can be modeled after the commercialization expansion of the academic healthcare enterprise. Challenges and barriers exist to starting a company as an entrepreneurial faculty member, but the rewards to one's personal and professional lives are incomparable. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association

What patients think about promotional activities of pharmaceutical companies in Turkey.

PubMed

Semin, Semih; Güldal, Dilek; Ozçakar, Nilgün; Mevsim, Vildan

2006-08-01

Drugs, as commercial products, are subject to diverse marketing methods including promotional activities. Although the legal/ethical aspects of promotional activities have been discussed in a limited manner, the patient has remained the neglected variable of this equation. The goal of our study, therefore, is to investigate the patients' opinion on the promotional activities of pharmaceutical companies. A descriptive study was conducted at 44 primary health care centers in Turkey and 584 volunteers who applied to these centers were included. A questionnaire consisting of 42 questions was developed with demographic information in the first section, and drug ads and promotions included in the second section. Chi-square test and logistic regression analysis were used for statistical analysis. The awareness and ethical evaluation of patients of the promotional activities. Nearly 83% of the participants were aware of the promotion issue. Eighty percent found it unethical, 82% suggested that promotional activities should be forbidden, restricted or regulated. 1/3 of the participants believed that physicians made their drug choices based on the gifts and ads of pharmaceutical companies. Half of them had low confidence in the prescriptions of physicians who accepted gifts from the pharmaceutical companies. 54.5% of patients also considered promotional activities as a factor which increased drug prices. In our study, a considerable number of patients were aware of promotions and the effects of promotion on prescriptions. The findings of our study may contribute to the development of effective regulations on this issue. Very strict measures controlling drug companies' promotion activities must be formulated. Further, these regulations must incorporate and take into consideration the patients' opinion. Today, the basic need for the proper use of drugs does not rest in pharmaceutical promotion, but in providing adequate health services and effective education for both people

How do the top 12 pharmaceutical companies operate safety pharmacology?

PubMed

Ewart, Lorna; Gallacher, David J; Gintant, Gary; Guillon, Jean-Michel; Leishman, Derek; Levesque, Paul; McMahon, Nick; Mylecraine, Lou; Sanders, Martin; Suter, Willi; Wallis, Rob; Valentin, Jean-Pierre

2012-09-01

How does safety pharmacology operate in large pharmaceutical companies today? By understanding our current position, can we prepare safety pharmacology to successfully navigate the complex process of drug discovery and development? A short anonymous survey was conducted, by invitation, to safety pharmacology representatives of the top 12 pharmaceutical companies, as defined by 2009 revenue figures. A series of multiple choice questions was designed to explore group size, accountabilities, roles and responsibilities of group members, outsourcing policy and publication record. A 92% response rate was obtained. Six out of 11 companies have 10 to 30 full time equivalents in safety pharmacology, who hold similar roles and responsibilities; although the majority of members are not qualified at PhD level or equivalent. Accountabilities were similar across companies and all groups have accountability for core battery in vivo studies and problem solving activities but differences do exist for example with in vitro safety screening and pharmacodynamic/pharmokinetic modeling (PK/PD). The majority of companies outsource less than 25% of studies, with in vitro profiling being the most commonly outsourced activity. Finally, safety pharmacology groups are publishing 1 to 4 articles each year. This short survey has highlighted areas of similarity and differences in the way large pharmaceutical companies operate safety pharmacology. Copyright © 2012 Elsevier Inc. All rights reserved.

Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa)

PubMed Central

Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten

2017-01-01

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight’s evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial. PMID:28163667

Pharmaceutical companies could serve their own interests by supporting research on the efficacy of psychotherapy on premature ejaculation.

PubMed

Rowland, D; Cooper, S; Macias, L

2008-01-01

For many men, the treatment of sexual dysfunctions such as premature ejaculation may well be most effective when pharmacotherapy is combined with psychotherapy. Yet the essential elements of psychotherapy that might best be combined with pharmacological-based therapy are currently unknown. Support for evidence-based studies that identify key components of psychotherapy that might improve positive long-term outcomes, including patient satisfaction, are needed. Pharmaceutical companies having a vested interest in achieving both treatment adherence and improved patient outcomes could benefit from such information.

[Anti-counterfeit activities of pharmaceutical companies in Japan: for patient safety].

PubMed

Shofuda, Ken-ichi; Aragane, Katsumi; Igari, Yasutaka; Matsumoto, Kinya; Ito, Kazuya

2014-01-01

Global spread of counterfeit medicines is an imminent threat for the patients' safety. Although major targets of counterfeits are still erectile dysfunction (ED) drugs in the industrialized countries, including Japan, anti-cancer agents and some medicines for metabolic syndromes are also being counterfeited and circulated to the market mainly through the Internet. Due to the global expansion of the business, pharmaceutical companies based in Japan are suffering from the damage of counterfeits, illegal sales including diversion, and thefts, which have never been experienced in the conventional domestic market. We, pharmaceutical companies, must be responsible for the prevention of the prevalence because our mission is to deliver effective and safe medicine to patients. For this end, we are taking necessary actions including, 1. Forestalling counterfeit, falsification and illicit trade: Measures to prevent counterfeiting are taken by introducing anti-counterfeit technologies to the packaging and tablets on a risk basis. It is also important to establish supply chain security on a global scale. 2. Finding out counterfeits and cooperating crackdown: We are conducting market and internet surveillances when high risk products are sold in high risk markets. The outcome of the criminal investigation is reported to authorities and police if necessary. 3. Conducting educational campaign to medical staff or patients: For example, four companies which manufacture and sell ED drug in Japan are collaboratively continuing activities to raise the awareness of the danger of Internet purchase. To deliver effective and safe medicines stably and globally, pharmaceutical companies extend comprehensive measures against counterfeit and illicit trading.

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

ERIC Educational Resources Information Center

Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

[Attractiveness of France for international clinical research: 8th survey conducted by Leem (French association for pharmaceutical companies)].

PubMed

Galaup, Ariane; Barthélémy, Philippe; Pouletty-Lefebvre, Brigitte; Béhier, Jehan-Michel; Zetlaoui, Jean; Borel, Thomas

2018-04-18

The Leem (French association of pharmaceutical companies) has conducted the eighth survey on attractiveness of France for clinical research. It serves to measure France's global competitiveness for international clinical trials and assess its strengths and areas of excellence. It also highlights the potential for progress and emerging trends at a time when the regulatory environment in France and Europe is undergoing change. This survey has been updated every two years since 2002 using the same methodology. It assesses the current status of research undertaken in France by the pharmaceutical industry between January 1st 2014 and December 31st 2015. Thirty companies (62% of the French market) have participated in this 8th survey which involved 3474 centers (versus 2860 in 2014) and 16,622 patients (versus 14,634 in 2014) enrolled in France across 586 clinical trials (versus 613 in 2014). This survey shows a reduction in the number of phase I and phase II trials. It also confirms that the studies conducted in France are primarily concerned with oncology (45%). Despite improvements across hospital contracts times (due to the adoption of the sole agreement) and performance indicators in trials (such as the number of patients enrolled by center), trial setup times in France are still overly lengthy (with stable times by French authorities). Ensuring that clinical research remains a priority issue for country is crucial for patients because of rapid access to innovation but also for the vitality of the French economy. Constructive dialogue with stakeholders on the subject of clinical research is essential to enhance the attractiveness of France and to improve the continuum between research, innovation and care. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Implementing Lean Manufacturing in Malaysian Small and Medium Startup Pharmaceutical Company

NASA Astrophysics Data System (ADS)

Ibrahim, Wan Mohd Khairi bin Wan; Rahman, Mohamed Abdul; Abu Bakar, Mohd Rushdi bin

2017-03-01

Domestic pharmaceutical industry has been identified by the Malaysian government as an industry to be developed under its 11th economic development plan. Most homegrown pharmaceutical companies fall under the category of small and medium enterprises (SME) and therefore need to be highly efficient in their operations to compete with the multinationals. Though lean manufacturing is a well-known methodology to achieve an efficient operation, only a small percentage of the local SMEs implement it. The study aims to determine the real success factors in lean implementation through systematic review of relevant literature on lean manufacturing implementation in local companies, onsite observation of a selected SME company, Global Factor Sdn. Bhd. (GFSB), that successfully implemented lean manufacturing followed by actual implementation of lean project at IKOP Sdn. Bhd., a small startup pharmaceutical company. Lean tools like Gemba, value stream map (VSM) and spaghetti diagram were used to analyze and improve a process at IKOP Sdn. Bhd. The literature review showed that the implementation of lean manufacturing at Malaysian SMEs involved in pharmaceutical industry is at its infancy. Study at GFSB indicated that successful implementation of lean manufacturing stems from management support, employee’s commitment, government support and knowledge on lean among employees. Application of lean tools in IKOP Sdn. Bhd. to improve the process cycle efficiency of hand sanitizer, i-Hand 4.0, has shown that the GMP guidelines are not jeopardized. The Kaizen improvement project resulted in 46.3% reduction in lead time. It may be concluded that implementing lean manufacturing in any small local startup pharmaceutical company is beneficial in reducing operational costs and increasing the efficiency and effectiveness and does not conflict with the existing GMP guidelines.

Legislative, educational, policy and other interventions targeting physicians' interaction with pharmaceutical companies: a systematic review.

PubMed

Alkhaled, Lina; Kahale, Lara; Nass, Hala; Brax, Hneine; Fadlallah, Racha; Badr, Kamal; Akl, Elie A

2014-07-01

Pharmaceutical company representatives likely influence the prescribing habits and professional behaviour of physicians. The objective of this study was to systematically review the effects of interventions targeting practising physicians' interactions with pharmaceutical companies. We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceutical companies. The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias. We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology. Of 11 189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceutical companies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a 'collaborative approach' between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceutical companies (by restricting free samples, promotional material, and meetings with pharmaceutical company representatives) on prescription behaviour. We identified too few studies to allow strong conclusions. Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians' prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceutical

Challenges of access to medicine and the responsibility of pharmaceutical companies: a legal perspective.

PubMed

Ahmadiani, Saeed; Nikfar, Shekoufeh

2016-05-04

The right to health as a basic human right- and access to medicine as a part of it- have been a matter of attention for several decades. Also the responsibilities of different parties- particularly pharmaceutical companies- in realization of this right has been emphasized by World Health Organization. This is while many companies find no incentive for research and development of medicines related to rare diseases. Also some legal structures such as "patent agreements" clearly cause huge difficulties for access to medicine in many countries. High prices of brand medicine and no legal production of generics can increase the catastrophic costs- as well as morbidity-mortality of medication in lower income countries. Here we evidently review the current challenges in access to medicine and critically assess its legal roots. How societies/governors can make the pharmaceutical companies responsible is also discussed to have a look on possible future and actions that policy makers- in local or global level- can take.

Corporate preparedness for pandemic influenza: a survey of pharmaceutical and biotechnology companies in Montgomery County, Maryland.

PubMed

Watkins, Rissah J; Barnett, Daniel J; Links, Jonathan M

2008-09-01

We conducted a survey of corporate preparedness for pandemic influenza among biotechnology and pharmaceutical companies in Montgomery County, Maryland, to determine the level of preparedness for this industry and geographic region. The survey, based on the HHS Business Pandemic Influenza Planning Checklist, established whether a company had a preparedness plan specific to pandemic influenza, the contents of its plan, or its reasons for a lack of a plan. A total of 50 companies participated in the survey. Of these, 40 did not have any type of preparedness plan, 3 were drafting plans, 6 had general preparedness plans that could be applied to an influenza pandemic, and only 1 company had a preparedness plan specifically designed to address pandemic influenza. Biotechnology and pharmaceutical companies in this geographic region are currently not well prepared for pandemic influenza. Public health officials should offer more help, possibly in the form of a model small business preparedness plan, and collaboration between companies should be encouraged to foster sharing of preparedness plans.

R&D implementation in a department of laboratory medicine and pathology: a systematic review based on pharmaceutical companies.

PubMed

Feulefack, Joseph; Sergi, Consolato

2015-01-01

A systematic literature review on pharmaceutical companies may be a tool for guiding some procedures of R&D implementation in a department of Laboratory Medicine and Pathology. The use of pharmaceutical companies for this specific analysis arises from less variability of standards than healthcare facilities. In this qualitative and quantitative analysis, we focused on three useful areas of implementation, including R&D productivity, commercialization strategies, and expenditures determinants of pharmaceutical companies. Studies and reports of online databases from 1965 to 2014 were reviewed according to specific search terms. Initially, 218 articles and reports were found and examined, but only 91 were considered appropriate and used for further analysis.  We identified some suggested implementation strategies relevant for marketing to enhance companies' own R&D strategies; such as reliability of companies on "sourcing-in" R&D facilities and "think-tank" events. Regardless of the study and of the country, cash flow and profitability always positively influenced R&D expenditure, while sales and firm size did not. We consider that handling R&D determinants should require caution. It seems critical that implementation of R&D systems is directly related with productivity, if it reflects dual embodiment of efficiency and effectiveness. Scrutinizing the determinants of R&D expenditures emphasizes significant factors that are worth to highlight when planning an R&D investment strategy. Although there is no receipt fitting every situation, we think that health care plan makers may find relevant data in this systematic review in creating an initial implementation framework.

[Pharmaceutical research progress of rhynchophylla based on chemical stability].

PubMed

Hao, Bo; Yang, Xiu-Juan; Feng, Yi; Hong, Yan-Long

2014-12-01

Rhynchophylla is a Chinese herb commonly used in clinical practice. It's also the primary herb of some famous Chinese herbal compound such as Tianma Gouteng decoction, and Lingyang Gouteng decoction. According the record from many previous materia medica literatures, rhynchophylla should be added later during decoction. Pharmaceutical research showed that rhynchophylla alkaloids were not stable. Which has resulted in many problems in the research and its application. For example, there was not a quantitative determination method in "Chinese Pharmacopoeia" of past and present versions, which seriously impacted its quality control and product application. Firstly, records from previous materia medica literatures and "Chinese Pharmacopoeia" were systematically sorted based on the chemical stability of rhynchophylla. Secondly, pharmaceutical research including chemical compositions and their stability, pharmacological effects, extraction process and quality analysis, was reviewed after reference of literatures published at home and abroad in recent decades. Positive reference and evidence for further research and development of rhynchophylla will be provided in the article.

The Effect of Capital Structure on the Profitability of Pharmaceutical Companies The Case of Iran

PubMed Central

Mohammadzadeh, Mehdi; Rahimi, Farimah; Rahimi, Forough; Aarabi, Seyed Mohammad; Salamzadeh, Jamshid

2013-01-01

Funding combination is the most important issue for the companies while they know the amount of required capital. Companies should be careful regarding the appliance of financial providing methods compatible with the investment strategy of company and profitability. This study seeks to examine the relationship between the capital structure and the profitability of pharmaceutical companies in Iran. For this purpose, top 30 Iranian pharmaceutical companies defined as study samples and their financial data were gathered for the period of 2001-2010. In this study, the net margin profit and debts to asset ratio were used as indicators of profitability and capital structure, respectively and sales growth was used as a control variable. Results showed that there was significant negative relationship between the profitability and the capital structure which means that the pharmaceutical companies have established a Pecking Order Theory and the internal financing has led to more profitability. PMID:24250664

The effect of capital structure on the profitability of pharmaceutical companies the case of iran.

PubMed

Mohammadzadeh, Mehdi; Rahimi, Farimah; Rahimi, Forough; Aarabi, Seyed Mohammad; Salamzadeh, Jamshid

2013-01-01

Funding combination is the most important issue for the companies while they know the amount of required capital. Companies should be careful regarding the appliance of financial providing methods compatible with the investment strategy of company and profitability. This study seeks to examine the relationship between the capital structure and the profitability of pharmaceutical companies in Iran. For this purpose, top 30 Iranian pharmaceutical companies defined as study samples and their financial data were gathered for the period of 2001-2010. In this study, the net margin profit and debts to asset ratio were used as indicators of profitability and capital structure, respectively and sales growth was used as a control variable. Results showed that there was significant negative relationship between the profitability and the capital structure which means that the pharmaceutical companies have established a Pecking Order Theory and the internal financing has led to more profitability.

Indigenous and multinational pharmaceutical companies.

PubMed

Lilja, J

1983-01-01

There is a set of complex relationships between governments and the pharmaceutical companies. These relationships can be analysed in many different ways. In the following article the drug system of each country will be the unit of analysis. The drug system includes all the decision processes, formal as well as informal, from the production or importation of drugs to the intake of the drug by the patient. The aim of this paper is to discuss how environmental factors, the strategies of the drug companies and the national policies, will effect the drug system of a country. Satisfying solutions to the economical and health goals of the country will be searched for. If we want a more rational discussion in this area, professionally and politically, we need more empirical knowledge about the multinational drug companies and their effects on society. This does not mean that we shall sit waiting for this new knowledge. We have to make decisions using todays knowledge. However, in the long run rational decision strategy must include ways to collect important empirical data about the phenomenom under investigation. The aim of this survey is to indicate areas where we already have quite good knowledge and indicate other areas where this data is missing.

Pharmaceutical company spending on research and development and promotion in Canada, 2013-2016: a cohort analysis.

PubMed

Lexchin, Joel

2018-01-01

Competing claims are made about the amount of money that pharmaceutical companies spend on research and development (R&D) versus promotion. This study investigates this question in the Canadian context. Two methods for determining industry-wide figures for spending on promotion were employed. First, total industry spending on detailing and journal advertising for 2013-2016 was abstracted from reports from QuintilesIMS. Second, the mean total promotion spending for the years 2002-2005 was used to estimate total spending for 2013-2016. Total industry spending on R&D came from the Patented Medicine Prices Review Board (PMPRB). R&D to promotion spending using each method of determining the amount spent on promotion was compared for 2013-2016 inclusive. Data on the 50 top promoted drugs, the amounts spent, the companies marketing these products and their overall sales were abstracted from the QuintilesIMS reports. Spending on R&D and promotion as a percent of sales was compared for these companies. Industry wide, the ratio of R&D to promotion spending went from 1.43 to 2.18 when promotion was defined as the amount spent on detailing and journal advertising for the 50 most promoted drugs. Calculating total promotion spending from the mean of the 2002-2005 figures the ratio was 0.88 to 1.32 for the 50 most promoted drugs. For individual companies marketing one or more of the 50 most promoted drugs, mean R&D spending ranged from 3.7% of sales to 4.1% compared to mean promotion spending that went from 1.7 to 1.9%. The ratio of spending on R&D to promotion varied from 2.11 to 2.32. Eight to 10 companies per year spent more on promotion than on R&D. Depending on the method used to determine promotion spending, industry-wide the ratio of R&D spending to promotion ranges from 1.45 to 2.18 (sales representatives and journal advertising only) or from 0.88 to 1.32 (total promotion spending estimated based 2003-2005 data.) For the individual companies promoting one or more of the

Pharmaceutical Company Influence on Non-Steroidal Anti-inflammatory Drug Prescribing Behaviors

PubMed Central

Naik, Aanand D.; Woofter, Aaron L.; Skinner, Jessica M.; Abraham, Neena S.

2010-01-01

Objectives Adherence to safer nonsteroidal anti-inflammatory drug (NSAID) prescribing strategies remains low, despite their acceptance as markers of high-quality care and their aggressive dissemination. This study describes the taxonomy of methods used by pharmaceutical companies to influence physicians’ NSAID prescribing behaviors and elicits physicians’ perceptions of and counter-balances to these influences. Study Design In-depth interviews analyzed using the constant comparative method of qualitative data analysis. Methods Qualitative interviews were conducted with physicians representing various clinical specialties. Interviews were transcribed and coded inductively using grounded theory. Recruitment was stopped at 25 participants after the attainment of thematic saturation, when no new concepts emerged from ongoing analysis of consecutive interviews. Results Physicians described a variety of influences that shaped their NSAID prescribing behaviors, including detailing and direct contact with pharmaceutical representatives, requests from patients inspired by direct-to-consumer advertisements, and marketing during medical school and residency training. Physicians described practice guidelines, peer-reviewed evidence and opinions of local physician experts as important counterweights to pharmaceutical company influence. Local physician experts interpreted and provided context for new clinical evidence, practice guidelines and NSAID related marketing. Conclusions The social and communicative strategies used by pharmaceutical companies can be adapted to improve physicians’ adoption of guidelines for safer NSAID prescribing. The communicative interactions between local experts and other physicians who prescribe NSAIDs may be the critical target for future interventions to promote safer NSAID prescribing. PMID:19341315

R&D Implementation in a Department of Laboratory Medicine and Pathology: A Systematic Review Based on Pharmaceutical Companies

PubMed Central

Feulefack, Joseph; Sergi, Consolato

2015-01-01

A systematic literature review on pharmaceutical companies may be a tool for guiding some procedures of R&D implementation in a department of Laboratory Medicine and Pathology. The use of pharmaceutical companies for this specific analysis arises from less variability of standards than healthcare facilities. In this qualitative and quantitative analysis, we focused on three useful areas of implementation, including R&D productivity, commercialization strategies, and expenditures determinants of pharmaceutical companies. Studies and reports of online databases from 1965 to 2014 were reviewed according to specific search terms. Initially, 218 articles and reports were found and examined, but only 91 were considered appropriate and used for further analysis. We identified some suggested implementation strategies relevant for marketing to enhance companies’ own R&D strategies; such as reliability of companies on “sourcing-in” R&D facilities and “think-tank” events. Regardless of the study and of the country, cash flow and profitability always positively influenced R&D expenditure, while sales and firm size did not. We consider that handling R&D determinants should require caution. It seems critical that implementation of R&D systems is directly related with productivity, if it reflects dual embodiment of efficiency and effectiveness. Scrutinizing the determinants of R&D expenditures emphasizes significant factors that are worth to highlight when planning an R&D investment strategy. Although there is no receipt fitting every situation, we think that health care plan makers may find relevant data in this systematic review in creating an initial implementation framework. PMID:25946935

Pharmaceutical companies' policies on access to trial data, results, and methods: audit study.

PubMed

Goldacre, Ben; Lane, Síle; Mahtani, Kamal R; Heneghan, Carl; Onakpoya, Igho; Bushfield, Ian; Smeeth, Liam

2017-07-26

Objectives  To identify the policies of major pharmaceutical companies on transparency of trials, to extract structured data detailing each companies' commitments, and to assess concordance with ethical and professional guidance. Design  Structured audit. Setting  Pharmaceutical companies, worldwide. Participants  42 pharmaceutical companies. Main outcome measures  Companies' commitments on sharing summary results, clinical study reports (CSRs), individual patient data (IPD), and trial registration, for prospective and retrospective trials. Results  Policies were highly variable. Of 23 companies eligible from the top 25 companies by revenue, 21 (91%) committed to register all trials and 22 (96%) committed to share summary results; however, policies commonly lacked timelines for disclosure, and trials on unlicensed medicines and off-label uses were only included in six (26%). 17 companies (74%) committed to share the summary results of past trials. The median start date for this commitment was 2005. 22 companies (96%) had a policy on sharing CSRs, mostly on request: two committed to share only synopses and only two policies included unlicensed treatments. 22 companies (96%) had a policy to share IPD; 14 included phase IV trials (one included trials on unlicensed medicines and off-label uses). Policies in the exploratory group of smaller companies made fewer transparency commitments. Two companies fell short of industry body commitments on registration, three on summary results. Examples of contradictory and ambiguous language were documented and summarised by theme. 23/42 companies (55%) responded to feedback; 7/1806 scored policy elements were revised in light of feedback from companies (0.4%). Several companies committed to changing policy; some made changes immediately. Conclusions  The commitments made by companies to transparency of trials were highly variable. Other than journal submission for all trials within 12 months, all elements of best practice

[A survey on the position of France in international clinical research as assessed by pharmaceutical laboratories].

PubMed

Courcier-Duplantier, Soizic; Bouhours, Philippe; Pinton, Philippe; Sibenaler, Claire; Lassale, Catherine

2004-01-01

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey was performed among pharmaceutical companies that are based in France or that have affiliates in France. The survey concerned international phase II and III clinical studies carried out in 2002 and 2003. Ten pharmaceutical companies representing 36% of the French market completed the survey. 134 trials were analysed in total. France recruited 8.3% of the overall number of patients recruited, and 15.0% of those recruited within Europe. France was within the overall mean with regard to the percentage of active centres (78.5% versus 79.5%) and the percentage of patients evaluable according to protocol (86.8% versus 87.3%). In contrast, France ranked within the last third of analysed countries with respect to the speed of recruitment (1.5 versus 1.9 patients/centre/month), and the number of queries per observation (16.8 versus 10.9). The analysis of the qualitative indicators of performance showed that, although the perception of pharmaceutical companies towards the quality of French medicine and administrative authorities is positive, France notably needs to improve the productivity of its clinical research in order to enhance its attractiveness for the pharmaceutical sponsors of clinical trials.

High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey

PubMed Central

Kurihara, Chieko; Kusuoka, Hideo; Ono, Shunsuke; Kakee, Naoko; Saito, Kazuyuki; Takehara, Kenji; Tsujide, Kiyokazu; Nabeoka, Yuzo; Sakuhiro, Takuya; Aoki, Hiroshi; Morishita, Noriko; Suzuki, Chieko; Kachi, Shigeo; Kondo, Emiko; Komori, Yukiko; Isobe, Tetsu; Kageyama, Shigeru; Watanabe, Hiroshi

2014-01-01

Introduction International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported. Method Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan. Results With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation. Conclusion Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data. PMID:24416332

Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

PubMed

Spurling, Geoffrey K; Mansfield, Peter R; Montgomery, Brett D; Lexchin, Joel; Doust, Jenny; Othman, Noordin; Vitry, Agnes I

2010-10-19

Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently

Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review

PubMed Central

Spurling, Geoffrey K.; Mansfield, Peter R.; Montgomery, Brett D.; Lexchin, Joel; Doust, Jenny; Othman, Noordin; Vitry, Agnes I.

2010-01-01

Background Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. Methods and Findings We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses

Clinical trial allocation in multinational pharmaceutical companies - a qualitative study on influential factors.

PubMed

Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik; Thomsen, Simon F

2017-06-01

Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site-related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment-related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.

Ghost marketing: pharmaceutical companies and ghostwritten journal articles.

PubMed

Moffatt, Barton; Elliott, Carl

2007-01-01

The use of ghostwriters by industry is subject to increasing public attention and scrutiny. This article addresses the practice and ethics of scientific ghostwriting. We focus on the type of ghostwriting that involves a pharmaceutical company hiring a medical education and communications company to write a paper favorable of their product, who then hires a well-known academic to publish it under his or her name without disclosing the paper's true origins. We argue that this practice is harmful both to the public and to the institutions of science and that it is not justified by an analogy to accepted scientific authorship practices. Finally, we consider ways to discourage the practice.

Pharmaceutical companies and their drugs on social media: a content analysis of drug information on popular social media sites.

PubMed

Tyrawski, Jennifer; DeAndrea, David C

2015-06-01

Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies' social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers who interacted with pharmaceutical

The ethics of pharmaceutical research funding: a social organization approach.

PubMed

Gray, Garry C

2013-01-01

This paper advances a social organization approach to examining unethical behavior. While unethical behaviors may stem in part from failures in individual morality or psychological blind spots, they are both generated and performed through social interactions among individuals and groups. To illustrate the value of a social organization approach, a case study of a medical school professor's first experience with pharmaceutical-company-sponsored research is provided in order to examine how funding arrangements can constrain research integrity. The case illustrates three significant ways that institutional corruption can occur in the research process. First, conflicts of norms between pharmaceutical companies, universities, and affiliated teaching hospitals can result in compromises and self-censorship. Second, normal behavior is shaped through routine interactions. Unethical behaviors can be (or can become) normal behaviors when they are produced and reproduced through a network of social interactions. Third, funding arrangements can create networks of dependency that structurally distort the independence of the academic researcher in favor of the funder's interests. More broadly, the case study demonstrates how the social organization approach deepens our understanding of the practice of ethics. © 2013 American Society of Law, Medicine & Ethics, Inc.

A lesson from Japan: research and development efficiency is a key element of pharmaceutical industry consolidation process.

PubMed

Shimura, Hirohisa; Masuda, Sachiko; Kimura, Hiromichi

2014-02-01

Scholarly attention to pharmaceutical companies' ability to sustain research and development (R&D) productivity has increased as they increasingly handle business challenges. Furthermore, the deterioration of R&D productivity has long been considered a major cause of mergers and acquisitions (M&As). This study attempts to investigate quantitatively the possible causes of the deterioration and the relationship between the deterioration and M&As by examining the Japanese pharmaceutical industry. Japan from 1980 to 1997 is an ideal case because of the availability of official data, but more importantly the significant changes in its business environment at the time. Using the Malmquist Index and data envelopment analysis, we measured the deterioration of R&D productivity from 1980 to 1997 based on a sample of 15 Japanese companies. Two lessons can be learned from Japan's case. First, to sustain R&D productivity over the long term, companies should use licensing activities and focus on the dominant therapeutic franchises. Second, if a company fails significantly to catch up with the benchmark, it is likely to pursue an M&A or seek an alternative way to improve R&D productivity. These findings appear similar to the current situation of the global pharmaceutical industry, although Japan pursued more licensing activities than M&A to improve R&D productivity.

Pharmaceutical Companies and Their Drugs on Social Media: A Content Analysis of Drug Information on Popular Social Media Sites

PubMed Central

2015-01-01

Background Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Objective Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Methods Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. Results From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies’ social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers

Author Self-disclosure Compared with Pharmaceutical Company Reporting of Physician Payments.

PubMed

Alhamoud, Hani A; Dudum, Ramzi; Young, Heather A; Choi, Brian G

2016-01-01

Industry manufacturers are required by the Sunshine Act to disclose payments to physicians. These data recently became publicly available, but some manufacturers prereleased their data since 2009. We tested the hypotheses that there would be discrepancies between manufacturers' and physicians' disclosures. The financial disclosures by authors of all 39 American College of Cardiology and American Heart Association guidelines between 2009 and 2012 were matched to the public disclosures of 15 pharmaceutical companies during that same period. Duplicate authors across guidelines were assessed independently. Per the guidelines, payments <$10,000 are modest and ≥$10,000 are significant. Agreement was determined using a κ statistic; Fisher's exact and Mann-Whitney tests were used to detect statistical significance. The overall agreement between author and company disclosure was poor (κ = 0.238). There was a significant difference in error rates of disclosure among companies and authors (P = .019). Of disclosures by authors, companies failed to match them with an error rate of 71.6%. Of disclosures by companies, authors failed to match them with an error rate of 54.7%. Our analysis shows a concerning level of disagreement between guideline authors' and pharmaceutical companies' disclosures. Without ability for physicians to challenge reports, it is unclear whether these discrepancies reflect undisclosed relationships with industry or errors in reporting, and caution should be advised in interpretation of data from the Sunshine Act. Copyright © 2016 Elsevier Inc. All rights reserved.

Ties that bind: multiple relationships between clinical researchers and the pharmaceutical industry.

PubMed

Henry, David; Doran, Evan; Kerridge, Ian; Hill, Suzanne; McNeill, Paul M; Day, Richard

2005-11-28

It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.

Characteristics of Occupational Injuries in a Pharmaceutical Company in Iran

PubMed Central

Rasouli, Abbas; Hosseini, Seyed Mojtaba; Bahadori, Mohammadkarim; Ravangard, Ramin

2018-01-01

Objective: To prioritize occupational hazards in a Pharmaceutical Company in Iran using the analytical hierarchy process (AHP). Methods: This was a cross-sectional study conducted in a Pharmaceutical Company in Iran in 2017. All employees working in the administrative, production, installations and facilities, and laboratory units were studied using the consensus method (N=n=130 employees). A data collection form was designed for identifying the hazards using the Nominal Group Technique (NGT) method, as well as a pair-wise questionnaire was used for collecting required data in the quantitative phase. The collected data were analyzed using Expert Choice 10.0 and SPSS 23.0. Results: The results showed that among hazards detected in the studied units, the highest and lowest weights and priorities were, respectively, related to "inhalation of toxic gases" (W=0.253) and “being exposed to radiation” (W=0.022) in the laboratory unit, "skin injuries" (W=0.205) and “bending and straightening for a long time” (W= 0.032) in the production unit, "falling down" (W=0.271) and “standing and sitting for a long time “ (W=0.037) in the installations and facilities unit, and "hand joint failure" (W=0.295) and “working in a low-light environment” (W=0.092) in the administrative unit. Conclusion: The results of the present study showed that there were hazards in all of the studied units. These results indicated a high level of hazards in the pharmaceutical company’s units. Due to the increased medication diversification and increased workload for these companies, paying attention to the preventive and corrective measures in order to reduce the risk of emerging hazards is essential. PMID:29719847

Survey of practices around pharmaceutical company funding for continuing professional development among medical oncologists and trainees in Australia.

PubMed

Lee, Yeh Chen; Kroon, René; Koczwara, Bogda; Haines, Ian; Francis, Kay; Millward, Michael; Kefford, Richard; Olver, Ian; Mileshkin, Linda

2017-08-01

The completion of continuing professional development (CPD) is mandatory for medical oncologists and trainees (MO&T). Pharmaceutical companies may fund some CPD activities, but there is increasing debate about the potential for conflicts of interest (COI). To assess current practices around funding to attend CPD activities. An electronic survey was distributed to Australian MO&T. The survey asked questions about current practices, institutional policies and perceptions about attending CPD funded by pharmaceutical companies. The design looked at comparing responses between MO&T as well as their understanding of and training around institutional and ethical process. A total of 157 of 653 (24%) responses was received, the majority from MO (76%). Most CPD activities attended by MO&T were self-funded (53%), followed by funding from institutions (19%), pharmaceutical companies (16%) and salary award (16%). Most institutions allowed MO&T to receive CPD funding from professional organisations (104/157, 66%) or pharmaceutical companies (90/157, 57%). A minority of respondents (13/157, 8%) reported that the process to use pharmaceutical funds had been considered by an ethics committee. Although 103/157 (66%) had received pharmaceutical funding for CPD, most (109/157, 69%) reported never receiving training about potential COI. The lack of education was more noticeable among trainees (odds ratio (OR) 8.61, P = 0.02). MO&T acknowledged the potential bias towards a pharmaceutical product (P = 0.05) but believed there was adequate separation between themselves and pharmaceutical companies (P < 0.01). Majority of CPD attended by MO&T is self-funded. There is lack of clarity in institutional policies regarding external funding support for CPD activities. Formal education about potential COI is lacking. © 2017 Royal Australasian College of Physicians.

Patient Organizations’ Funding from Pharmaceutical Companies: Is Disclosure Clear, Complete and Accessible to the Public? An Italian Survey

PubMed Central

Colombo, Cinzia; Mosconi, Paola; Villani, Walter; Garattini, Silvio

2012-01-01

Background Many patients’ and consumers’ organizations accept drug industry funding to support their activities. As drug companies and patient groups move closer, disclosure become essential for transparency, and the internet could be a useful means of making sponsorship information accessible to the public. This survey aims to assess the transparency of a large group of Italian patient and consumer groups and a group of pharmaceutical companies, focusing on their websites. Methodology/Principal Findings Patient and consumer groups were selected from those stated to be sponsored by a group of pharmaceutical companies on their websites. The websites were examined using two forms with principal (name of drug companies providing funds, amount of funding) and secondary indicators of transparency (section where sponsors are disclosed, update of sponsorship). Principal indicators were applied independently by two reviewers to the patient and consumer groups’ websites. Discordances were solved by discussion. One hundred fifty-seven Italian patient and consumer groups and 17 drug companies were considered. Thirteen drug companies (76%) named at least one group funded, on their Italian websites. Of these, four (31%) indicated the activities sponsored and two (15%) the amount of funding. Of the 157 patient and consumer groups, 46 (29%) named at least one pharmaceutical company as providing funds. Three (6%) reported the amount of funding, 25 (54%) the activities funded, none the proportion of income derived from drug companies. Among the groups naming pharmaceutical company sponsors, 15 (33%) declared them in a dedicated section, five (11%) on the home page, the others in the financial report or other sections. Conclusions/Significance Disclosure of funds is scarce on Italian patient and consumer groups’ websites. The levels of transparency need to be improved. Disclosure of patient and consumer groups provided with funds is frequent on Italian pharmaceutical

The effect of educational gifts from pharmaceutical firms on medical students' recall of company names or products.

PubMed

Sandberg, W S; Carlos, R; Sandberg, E H; Roizen, M F

1997-10-01

To assess the influence of pharmaceutical advertising (in the form of books) directed at medical students and also to examine students' attitudes toward pharmaceutical representatives after interacting with them. Two groups of fourth-year medical students were surveyed: 166 residency applicants to the Department of Anesthesia and Critical Care between 1991 and 1993, who were questioned during their personal interviews with the department chair, and 39 fourth-year students from the University of Chicago Pritzker School of Medicine in 1994-95, who were surveyed by telephone. The students were asked if they had ever received a book from a pharmaceutical representative and, if so, to name the book. Then they were asked to name the book-giving company or a product associated with the company. Responses were compared using chi-square analysis. In all, 90% of the students had received one or more books and accurately recalled titles for 89% of them. However, only 25% of the named books were accurately associated with a pharmaceutical company or product. The Pritzker students, asked to recall interactions with pharmaceutical representatives, reported being skeptical of representatives who ignored them because they were students, but they rated as helpful and informative those who conversed with them or gave them gifts. Although gifts to medical students do not necessarily engender company or product recall, attention paid to medical students by pharmaceutical representatives engenders goodwill toward the representatives and their messages.

Advances in knowledge management for pharmaceutical research and development.

PubMed

Torr-Brown, Sheryl

2005-05-01

There are two assumptions that are taken for granted in the pharmaceutical industry today. Firstly, that we can generate an unprecedented amount of drug-related information along the research and development (R&D) pipeline, and secondly, that researchers are more connected to each other than they have ever been, owing to the internet revolution of the past 15 years or so. Both of these aspects of the modern pharmaceutical company have brought many benefits to the business. However, the pharmaceutical industry is currently under fire due to allegations of decreased productivity despite significant investments in R&D, which if left to continue at the present pace, will reach almost US 60 billion dollars by 2006. This article explores the role of knowledge in the industry and reviews recent developments and emerging opportunities in the field of knowledge management (KM) as it applies to pharmaceutical R&D. It is argued that systematic KM will be increasingly necessary to optimize the value of preceding advances in high-throughput approaches to R&D, and to fully realize the anticipated increase in productivity. The application of KM principles and practices to the business can highlight opportunities for balancing the current reliance on blockbuster drugs with a more patient-centric focus on human health, which is now becoming possible.

Pharmaceutical new product development: the increasing role of in-licensing.

PubMed

Edwards, Nancy V

2008-12-01

Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician.

Eli Lilly and Company's bioethics framework for human biomedical research.

PubMed

Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

2015-11-01

Current ethics and good clinical practice guidelines address various aspects of pharmaceutical research and development, but do not comprehensively address the bioethical responsibilities of sponsors. To fill this void, in 2010 Eli Lilly and Company developed and implemented a Bioethics Framework for Human Biomedical Research to guide ethical decisions. (See our companion article that describes how the framework was developed and implemented and provides a critique of its usefulness and limitations.) This paper presents the actual framework that serves as a company resource for employee education and bioethics deliberations. The framework consists of four basic ethical principles and 13 essential elements for ethical human biomedical research and resides within the context of our company's mission, vision and values. For each component of the framework, we provide a high-level overview followed by a detailed description with cross-references to relevant well regarded guidance documents. The principles and guidance described should be familiar to those acquainted with research ethics. Therefore the novelty of the framework lies not in the foundational concepts presented as much as the attempt to specify and compile a sponsor's bioethical responsibilities to multiple stakeholders into one resource. When such a framework is employed, it can serve as a bioethical foundation to inform decisions and actions throughout clinical planning, trial design, study implementation and closeout, as well as to inform company positions on bioethical issues. The framework is, therefore, a useful tool for translating ethical aspirations into action - to help ensure pharmaceutical human biomedical research is conducted in a manner that aligns with consensus ethics principles, as well as a sponsor's core values.

Ethics of pharmaceutical company relationships with the nursing profession: no free lunch...and no more pens?

PubMed

Crock, Elizabeth

2009-10-01

In recent years, nurses have increasingly become recipients of pharmaceutical company gifts, funding and sponsorship. There has been little discussion in the nursing literature, however, of the ethical and professional implications of nurses' acceptance of such sponsorship. This article examines ethical issues related to the issue of nurses' accepting benefits from pharmaceutical companies (and other commercial enterprises). It aims to encourage nurses to look critically at the implications of accepting such gifts/sponsorship, or to enter any form of relationship with commercial companies within the health sector, and to stimulate further discussion of this issue within the profession.

Pharmaceutical company perspectives on current safety risk communications in Japan.

PubMed

Urushihara, Hisashi; Kobashi, Gen; Masuda, Hideaki; Taneichi, Setsuko; Yamamoto, Michiko; Nakayama, Takeo; Kawakami, Koji; Matsuda, Tsutomu; Ohta, Kaori; Sugimori, Hiroki

2014-01-01

In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.

[France, an attractive country for international clinical research: 2010 survey assessed by Leem (French association of pharmaceutical companies)].

PubMed

Lassale, Catherine; Sibenaler, Claire; Behier, Jehan-Michel; Pletan, Yannick; Courcier, Soizic

2011-01-01

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Twenty-nine companies (72% of the French market) including 10 newly participants, have participated in the current survey which included 328 international phase II and III clinical studies, 79 countries, 24,337 centres and 249,704 patients (included in 2008/2009). France (291 patients/million inhabitants) ranked among the best European recruiters in second position behind Scandinavia. Since 2008, protocols are still to be given the go-ahead by French Authorities (Afssaps and CPP) within 60 days, in accordance with European directive. The continuation of reduction in deadlines for hospital contracts is encouraging and highlights the positive effect of CeNGEPS. French state-of-art is well recognized in Oncology/Hematology and Orphan disease which could be an example to improve the competitiveness of France in other key therapeutic areas such as Alzheimer's disease and Immuno-Inflammation. © 2011 Société Française de Pharmacologie et de Thérapeutique.

Need of the regulation for profit percentage investment by pharmaceutical companies in new drug discovery research from the various local traditional medicinal and plant systems.

PubMed

Bhattarai, M D

2012-01-01

In the modern medical systems the active pharmacological ingredients, effective against any disease is identified, purified and studied for its various effects and side-effects whereas it is not so in the traditional systems. Therefore, it is not surprising that safety concerns have often been raised about the traditional medical products. The major issue now, is to make appropriate situation with basic supports to bring all the available experts and resources together for the identification, purification, and study of efficacy and safety of the active molecules of the popular traditional medicines. Government and public sectors in the countries with such rich traditional medicinal and plant systems have related experts, but they also have much hurdle regarding recruitment and retention of expert human resources, getting fund, purchase and maintenance of equipment, bureaucratic formalities and others. The pharmaceutical companies have basic laboratories with related infrastructure and human resources as well as interest about bringing the drug molecules. To bridge the gap, there is a need of the regulation which will make the pharmaceutical companies to invest certain percentage of their profit in the field of research to identify new drug molecules and to study their effects. It is just not an issue of discovering the active molecule but also of creating the concept and culture of research, purity and quality of drugs, safety of people, and future direction of the human society.

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

PubMed

Newcombe, J P; Kerridge, I H

2007-01-01

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study.

PubMed

Parsons, Suzanne; Starling, Bella; Mullan-Jensen, Christine; Tham, Su-Gwan; Warner, Kay; Wever, Kim

2016-01-07

To explore European-based pharmaceutical industry professionals' beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Pharmaceutical companies in the UK, Poland and Spain. 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the public's lack of knowledge and interest in medicines R&D, and the pharmaceutical industry's lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

R&D investments for neglected diseases can be sensitive to the economic goal of pharmaceutical companies.

PubMed

Dimitri, Nicola

2012-08-01

A fundamental problem with neglected diseases is how to induce pharmaceutical companies to invest resources for developing effective treatments. A recent debate focused on the role of economic incentives represented by monetary transfers to the firms. In this article I focus on the economic goals of pharmaceutical companies, as determinants for R&D effort. In particular, within a stylized framework, the work compares expected profit and expected productivity maximization, arguing that the former in general induces higher R&D investments than the latter. Therefore, as it is currently the case, when pharmaceutical firms focus on productivity, appropriate economic incentives might be needed for them to invest in R&D for neglected diseases. Copyright © 2012 Elsevier Ltd. All rights reserved.

Impact of Corporate Reputation on Brand Differentiation: An Empirical Study from Iranian Pharmaceutical Companies.

PubMed

Vahabzadeh, Afshin; Vatanpour, Hossein; Dinarvand, Rasoul; Rajabzadeh, Ali; Salamzadeh, Jamshid; Mohammadzadeh, Mehdi

2017-01-01

The influence of company reputation or what is often referred to as corporate reputation on branding strategy and producing intangible asset for different industries has been researched in western countries, but there is a gap for the generalizability of findings to countries out of the United State and Europe. To establish the western researcher's external validity of theories in other countries and to obtain a better understanding of the influences of branding and company reputation on pharmaceutical business markets, the researchers applied this study for Iran, a country in the Middle East. The obtained results using SEM (by P.L.S. 2.0 software) showed a good relationship between value creation and brand differentiation (β =0.360 and t-value = 3.167), between corporate communication and brand differentiation (β = 0.022 and t-value = 3.668), and between strategic resources and brand differentiation (β = 0.289 and t-value = 2.247). This study is a pioneering attempt in Iran to measure the impact of corporate reputation on brand differentiation strategy.

Pharmaco-economic impact of demographic change on pharmaceutical expenses in Germany and France

PubMed Central

2012-01-01

Background Most European health care systems are suffering from the impact of demographic change. In short, aging of society is leading to higher costs of treatment per capita, while reproduction rates below 2.1 children per woman lead to a reduced number of younger people to provide for the necessary contributions into the health insurance system. This research paper addresses the questions what impact the demographic development will have on one particular spending area, what are pharmaceutical expenditure in two of Europe’s largest health care systems, Germany and France, and what the implications are for pharmaceutical companies. Methods The research is based on publicly available data from German and French health ministries, the OECD, and institutes which focus on projection of demographic development in those countries. In a first step, data was clustered into age groups, and average spending on pharmaceuticals was allocated to that. In the second step, these figures were extrapolated, based on the projected change in the demographic structure of the countries from 2004 until 2050. This leads to a deeper understanding of demand for pharmaceutical products in the future due to the demographic development as a single driving factor. Results Pharmaceutical expenses per head (patient) will grow only slightly until 2050 (0.5% p.a. in both countries). Demographic change alone only provides for a slowly growing market for pharmaceutical companies both in Germany and in France, but for a relevant change in the consumption mix of pharmaceutical products, based on a shift of relevance of different age groups. Conclusions Despite demographic changes pharmaceutical expenses per head (patient) and the overall pharmaceutical markets will grow only slightly until 2050 in Germany as well as in France. Nevertheless, the aging of society implies different challenges for pharmaceutical companies and also for the health care system. Companies have to cope with the shift of

Neuromarketing techniques in pharmaceutical drugs advertising. A discussion and agenda for future research.

PubMed

Orzan, G; Zara, I A; Purcarea, V L

2012-12-15

Recent years have seen an "explosion" in the abilities of scientists to use neuroscience in new domains. Unfortunately, it is little known and reported on how advertising companies make more effective pharmaceutical drugs commercials. The purpose of this paper is to analyze how neuromarketing techniques may impact the consumer response to pharmaceutical advertising campaigns. The result shows that using neuromarketing methods a pharmaceutical company can better understand the conscious and unconscious consumer's thoughts and tailor specific marketing messages.

China: current trends in pharmaceutical drug discovery.

PubMed

Luo, Ying

2008-04-01

Pharmaceutical discovery and development is expensive and highly risky, even for multinational corporations. As a developing country with limited financial resources, China has been seeking the most cost-effective means to reach the same level of innovation and productivity as Western countries in the pharmaceutical industry sector. After more than 50 years of building up talent and experience, the time for China to become a powerhouse in pharmaceutical innovation is finally approaching. Returnee scientists to China are one of the reasons for the wave of new discovery and commercialization occurring within the country. The consolidation of local Chinese pharmaceutical companies and foreign investment is also providing an agreeable environment for the evolution of a new generation of biotechnology. The opportunity for pharmaceutical innovation is also being expedited by the entry of multinational companies into the Chinese pharmaceutical market, and by the outsourcing of research from these companies to China.

Public administration and R&D localisation by pharmaceutical and biotech companies: a theoretical framework and the Italian case-study.

PubMed

Jommi, Claudio; Paruzzolo, Silvia

2007-04-01

This article has two objectives. It firstly provides a general framework for variables that influence R&D (Research and Development) localisation by pharmaceutical and biotech companies. The analysis of R&D localization includes both in-house R&D and contracted R&D. Following a systematic literature search, these variables were classified into four distinct categories: regulatory environment, institutional framework, national systems of innovation and local development and specialisation. The authors highlight that some of these factors directly depend on the action of public administrations (e.g., patent protection, price regulation, public investments in research, and incentives to private companies); others are indirectly influenced by public policies (e.g., GDP growth rate, infrastructures). This theoretical framework was used to analyse the Italian case-study. Pros and cons of the Italian context were investigated from the point of view of multinational pharmaceutical companies and the Italian Association of Biotech Companies. Interviews were chosen as the most appropriate data gathering technique given the exploratory nature of the study of the Italian context. The paper is divided into five parts. A brief introduction provides figures showing that Europe has been loosing positions compared with other Continents and the same has occurred in Italy compared with other EU countries. The second one illustrates the methodology. The third one is focused on variables affecting R&D localisation. In the fourth section the Italian case-study is discussed. Theoretical and empirical findings are summarised and discussed in the conclusions.

Multiscale mechanistic modeling in pharmaceutical research and development.

PubMed

Kuepfer, Lars; Lippert, Jörg; Eissing, Thomas

2012-01-01

Discontinuation of drug development projects due to lack of efficacy or adverse events is one of the main cost drivers in pharmaceutical research and development (R&D). Investments have to be written-off and contribute to the total costs of a successful drug candidate receiving marketing authorization and allowing return on invest. A vital risk for pharmaceutical innovator companies is late stage clinical failure since costs for individual clinical trials may exceed the one billion Euro threshold. To guide investment decisions and to safeguard maximum medical benefit and safety for patients recruited in clinical trials, it is therefore essential to understand the clinical consequences of all information and data generated. The complexity of the physiological and pathophysiological processes and the sheer amount of information available overcharge the mental capacity of any human being and prevent a prediction of the success in clinical development. A rigorous integration of knowledge, assumption, and experimental data into computational models promises a significant improvement of the rationalization of decision making in pharmaceutical industry. We here give an overview of the current status of modeling and simulation in pharmaceutical R&D and outline the perspectives of more recent developments in mechanistic modeling. Specific modeling approaches for different biological scales ranging from intracellular processes to whole organism physiology are introduced and an example for integrative multiscale modeling of therapeutic efficiency in clinical oncology trials is showcased.

Persuasion and types of enticements offered by pharmaceutical companies to Gold Coast general practitioners in an attempt to encourage a health website recommendation.

PubMed

Usher, Wayne; Skinner, James

2010-01-01

This study was undertaken to determine if pharmaceutical companies persuade and offer enticements to Gold Coast (Queensland, Australia) general practitioners (GPs), in an attempt to encourage them to recommend health websites to the health consumer. A survey instrument consisting of seven single response questions was mailed to 250 (61%) out of 410 GPs. Questions were designed to measure the percentages (%) and proportions associated with levels of persuasion and types of enticements pharmaceutical companies are offering GPs, in an attempt to encourage them to recommend health websites to the health consumer. The survey instrument allowed participants to indicate their (1) gender, (2) age and (3) years of experience (less experienced or= 10 years). One hundred and eight (43%) of the 250 GPs returned a completed survey. The return rate for male GPs was 72 (40%) and for female GPs, it was 36 (33%). Sixty-eight (63%) GPs indicated that they actively recommend health websites to their patients [male GPs--48 (71%), female GPs--20 (29%)]. This study highlights that female GPs (80%), those aged between 31 and 40 (77%) and GPs with < 10 years experience (72%) were more frequently targeted by pharmaceutical companies. This study reports that pharmaceutical companies are offering various types of enticements in an attempt to persuade Gold Coast GPs to recommend specific health websites to the health consumer. Further research should explore if similar levels of persuasion and types of enticements are being offered to GPs across Australia.

Neuromarketing techniques in pharmaceutical drugs advertising. A discussion and agenda for future research

PubMed Central

Orzan, G; Zara, IA; Purcarea, VL

2012-01-01

Recent years have seen an “explosion" in the abilities of scientists to use neuroscience in new domains. Unfortunately, it is little known and reported on how advertising companies make more effective pharmaceutical drugs commercials. The purpose of this paper is to analyze how neuromarketing techniques may impact the consumer response to pharmaceutical advertising campaigns. The result shows that using neuromarketing methods a pharmaceutical company can better understand the conscious and unconscious consumer’s thoughts and tailor specific marketing messages. PMID:23346245

Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies' professionals in the European Economic Area.

PubMed

WŁodarczak, Urszula; Swieczkowski, Damian; Religioni, Urszula; Jaguszewski, Milosz; Krysinski, Jerzy; Merks, Piotr

2017-01-01

The Falsified Medicines Directive (FMD) is a response of the European Union to the increasing number of falsified medicines present in the legal supply chain within the Member States of the community. Effective implementation of the new regulations will depend on the effective cooperation of all parties involved in the distribution of medicinal products including the managers of pharmaceutical companies. The objective of the study was to examine awareness of the Implementation of the FMD among pharmaceutical company professionals in the European Economic Area. Sampling was conducted using a method called purposive sampling. An appropriate research tool in the form of an original questionnaire was made available to the respondents in electronic form. During the period from January 2016 to June 2016, 1,496 e-mail messages were sent. The response rate was 17.37%. The study included 99 women (39.3%) and 153 men (60.7%). In the study group, 95.7% of people had heard of FMD. Doctors had rarely heard about the falsified medicine directive when compared to pharmacists (p=0.0063), people working in the pharmaceutical industry (p=0.0014), and respondents with a different professional profile (p=0.0114). In the study group, 89.6% of people were aware of the role of National Medicines Verification Organization in the process of implementing the provisions of FMD into the national system of distribution of medicinal products. The number of the respondents who knew the deadline for the implementation of FMD was significantly higher in the study population, i.e. 91.9% (p=0.0001). Both the younger respondents and those with lower level of education were less aware of the time requirements posed to national regulators (p=0.0003, p=0.0023, respectively). Awareness of the regulations related to the implementation of the FMD, although relatively high among pharmaceutical company professionals in the EEA, is still insufficient.

Critical evaluation of the claims made by pharmaceutical companies in drug promotional material in Pakistan.

PubMed

Rohra, Dileep Kumar; Gilani, Anwarul Hassan; Memon, Ismail Kamal; Perven, Ghazala; Khan, Muhammad Talha; Zafar, Hina; Kumar, Rakesh

2006-01-01

In Pakistan, there is no mechanism to monitor the drug promotional campaign by pharmaceutical industry despite the fact that there is enough evidence that irrational pharmacotherapy is increasingly encountered even in the developed countries due to unethical practices of pharmaceutical promotion. Objectives. To audit the drug promotional claims made by the pharmaceutical companies in Pakistan. Drug promotional pamphlets and brochures containing claims for the drugs, which were circulated by the pharmaceutical representatives were collected from 122 general practitioners (GPs) from Karachi and Larkana cities of the Sindh Province. The claims were critically analyzed and audited with the help of currently available evidence in the medical literature. 345 distinct advertisements covering 182 drugs from different manufacturers were critically analyzed for information content. Sixty two out of 345 (18%) of the reviewed advertisements were adjudged to be misleading / unjustifiable, which were again classified as, exaggerated (32%), ambiguous (21%), false (26%), and controversial (21%). The primary source of information (approximately 78%) about the newly launched drugs for the GPs was found to be the pharmaceutical representatives followed by hospital doctors (5%) and colleagues (5%). Furthermore, 110 (90%) GPs were of the view that the drug promotion has definitely an influence on their prescribing pattern. Since GPs in Pakistan rate pharmaceutical companies as their primary source of information regarding drugs, it can be anticipated that inappropriate advertisement claims would lead to irrational prescribing if physicians had no any other information to follow.

A cross-sectional evidence-based review of pharmaceutical promotional marketing brochures and their underlying studies: is what they tell us important and true?

PubMed

Cardarelli, Roberto; Licciardone, John C; Taylor, Lockwood G

2006-03-03

A major marketing technique used by pharmaceutical companies is direct-to-physician marketing. This form of marketing frequently employs promotional marketing brochures, based on clinical research, which may influence how a physician prescribes medicines. This study's objective was to investigate whether or not the information in promotional brochures presented to physicians by pharmaceutical representatives is accurate, consistent, and valid with respect to the actual studies upon which the promotional brochures are based. Physicians in five clinics were asked to consecutively collect pharmaceutical promotional brochures and to send them all to a centralized location. The brochures for any class of medication were collected on a continuous basis until 20 distinct promotional brochures were received by a central location. Once the brochure was received, the corresponding original study was obtained. Two blinded reviewers performed an evidence-based review of the article, comparing data that was printed on the brochure to what was found in the original study. Among the 20 studies, 75% of the studies were found to be valid, 80% were funded by the pharmaceutical company, 60% of the studies and the corresponding brochures presented patient-oriented outcomes, and 40% were compared to another treatment regimen. Of the 19 brochures that presented the data as graphs, 4 brochures presented a relative risk reduction while only 1 brochure presented an absolute risk reduction. 15% of the promotional marketing brochures presented data that was different from what was in the original published study. Given the present findings, physicians should be cautious about drawing conclusions regarding a medication based on the marketing brochures provided by pharmaceutical companies.

A Collaborative Assessment Among 11 Pharmaceutical Companies of Misinformation in Commonly Used Online Drug Information Compendia.

PubMed

Randhawa, Amarita S; Babalola, Olakiitan; Henney, Zachary; Miller, Michele; Nelson, Tanya; Oza, Meerat; Patel, Chandni; Randhawa, Anupma S; Riley, Joyce; Snyder, Scott; So, Sherri

2016-05-01

Online drug information compendia (ODIC) are valuable tools that health care professionals (HCPs) and consumers use to educate themselves on pharmaceutical products. Research suggests that these resources, although informative and easily accessible, may contain misinformation, posing risk for product misuse and patient harm. Evaluate drug summaries within ODIC for accuracy and completeness and identify product-specific misinformation. Between August 2014 and January 2015, medical information (MI) specialists from 11 pharmaceutical/biotechnology companies systematically evaluated 270 drug summaries within 5 commonly used ODIC for misinformation. Using a standardized approach, errors were identified; classified as inaccurate, incomplete, or omitted; and categorized per sections of the Full Prescribing Information (FPI). On review of each drug summary, content-correction requests were proposed and supported by the respective product's FPI. Across the 270 drug summaries reviewed within the 5 compendia, the median of the total number of errors identified was 782, with the greatest number of errors occurring in the categories of Dosage and Administration, Patient Education, and Warnings and Precautions. The majority of errors were classified as incomplete, followed by inaccurate and omitted. This analysis demonstrates that ODIC may contain misinformation. HCPs and consumers should be aware of the potential for misinformation and consider more than 1 drug information resource, including the FPI and Medication Guide as well as pharmaceutical/biotechnology companies' MI departments, to obtain unbiased, accurate, and complete product-specific drug information to help support the safe and effective use of prescription drug products. © The Author(s) 2016.

Development, implementation and critique of a bioethics framework for pharmaceutical sponsors of human biomedical research.

PubMed

Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

2015-11-01

Pharmaceutical human biomedical research is a multi-dimensional endeavor that requires collaboration among many parties, including those who sponsor, conduct, participate in, or stand to benefit from the research. Human subjects' protections have been promulgated to ensure that the benefits of such research are accomplished with respect for and minimal risk to individual research participants, and with an overall sense of fairness. Although these protections are foundational to clinical research, most ethics guidance primarily highlights the responsibilities of investigators and ethics review boards. Currently, there is no published resource that comprehensively addresses bioethical responsibilities of industry sponsors; including their responsibilities to parties who are not research participants, but are, nevertheless key stakeholders in the endeavor. To fill this void, in 2010 Eli Lilly and Company instituted a Bioethics Framework for Human Biomedical Research. This paper describes how the framework was developed and implemented and provides a critique based on four years of experience. A companion article provides the actual document used by Eli Lilly and Company to guide ethical decisions regarding all phases of human clinical trials. While many of the concepts presented in this framework are not novel, compiling them in a manner that articulates the ethical responsibilities of a sponsor is novel. By utilizing this type of bioethics framework, we have been able to develop bioethics positions on various topics, provide research ethics consultations, and integrate bioethics into the daily operations of our human biomedical research. We hope that by sharing these companion papers we will stimulate discussion within and outside the biopharmaceutical industry for the benefit of the multiple parties involved in pharmaceutical human biomedical research.

Evaluating the reliability and accuracy of the promotional brochures for the generic pharmaceutical companies in Iraq using World Health Organization guidelines

PubMed Central

Mikhael, Ehab Mudher

2015-01-01

Background: Pharmaceutical industries worldwide are heavily involved in aggressive drug promotions. Physician targeted promotion through medical representatives is one of the most common tactic for drug promotion by pharmaceutical drug companies. WHO states that medical representatives to work in an ethical way should make available to prescribers and dispensers complete and unbiased information for each product discussed; therefore this study aimed to evaluate the ethics in the medical brochures of generic pharmaceutical companies that are given through medical representatives to physicians in Iraq. Materials and Methods: An observational, cross-sectional study was conducted in Iraq – Baghdad from February to April 2014. Promotional drug brochures were collected mainly from pharmaceutical exhibition during attendance of medical conferences that were sponsored by generic pharmaceutical companies. Evaluation of each brochure was based primarily on WHO criteria for ethical medicinal drug promotion. The availability of emotional pictures in each brochure was also examined. Furthermore, references were checked to find their retrievability, source, and authenticity of presentations. Results: Most medical brochures were for antibiotics, and drugs for cardiovascular diseases. All brochures mention drug name, with its active ingredient and indication, but there is a significant absence for drug interaction, while drug side effects and contraindications if present were written in a small font. Emotional picture presented in 70% of brochures. Reference citation was present in 72% of brochures, however only 75% of references in these brochures were correct. Conclusions: The information that is provided in medical brochures is biased and mainly persuasive since it is mainly focusing on the positive aspect of drug therapy. PMID:25709340

Measuring the efficiency of large pharmaceutical companies: an industry analysis.

PubMed

Gascón, Fernando; Lozano, Jesús; Ponte, Borja; de la Fuente, David

2017-06-01

This paper evaluates the relative efficiency of a sample of 37 large pharmaceutical laboratories in the period 2008-2013 using a data envelopment analysis (DEA) approach. We describe in detail the procedure followed to select and construct relevant inputs and outputs that characterize the production and innovation activity of these pharmaceutical firms. Models are estimated with financial information from Datastream, including R&D investment, and the number of new drugs authorized by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) considering the time effect. The relative performances of these firms-taking into consideration the strategic importance of R&D-suggest that the pharmaceutical industry is a highly competitive sector given that there are many laboratories at the efficient frontier and many inefficient laboratories close to this border. Additionally, we use data from S&P Capital IQ to analyze 2071 financial transactions announced by our sample of laboratories as an alternative way to gain access to new drugs, and we link these transactions with R&D investment and DEA efficiency. We find that efficient laboratories make on average more financial transactions, and the relative size of each transaction is larger. However, pharmaceutical companies that simultaneously are more efficient and invest more internally in R&D announce smaller transactions relative to total assets.

Impact of Corporate Reputation on Brand Differentiation: An Empirical Study from Iranian Pharmaceutical Companies

PubMed Central

vahabzadeh, Afshin; vatanpour, Hossein; dinarvand, Rasoul; rajabzadeh, Ali; salamzadeh, Jamshid; mohammadzadeh, Mehdi

2017-01-01

The influence of company reputation or what is often referred to as corporate reputation on branding strategy and producing intangible asset for different industries has been researched in western countries, but there is a gap for the generalizability of findings to countries out of the United State and Europe. To establish the western researcher’s external validity of theories in other countries and to obtain a better understanding of the influences of branding and company reputation on pharmaceutical business markets, the researchers applied this study for Iran, a country in the Middle East. The obtained results using SEM (by P.L.S. 2.0 software) showed a good relationship between value creation and brand differentiation (β =0.360 and t-value = 3.167), between corporate communication and brand differentiation (β = 0.022 and t-value = 3.668), and between strategic resources and brand differentiation (β = 0.289 and t-value = 2.247). This study is a pioneering attempt in Iran to measure the impact of corporate reputation on brand differentiation strategy. PMID:29552075

Customer relationship management in the contract pharmaceutical industry: an exploratory study for measuring success.

PubMed

Kros, John F; Nadler, Scott; Molis, Justin

2007-01-01

Managing customer relationships is a very important issue in business-to-business markets. This research investigates the growing number of available resources defining Customer Relationship Management (CRM) efforts, and how they are being applied within the Contract Pharmaceutical Manufacturing industry. Exploratory study results using face-to-face and telephone questionnaires based on four criteria for rating a company's CRM efforts are presented. Data was collected from large Contract Pharmaceutical Manufacturing companies in the US market. The results and conclusions are discussed relating how the Contract Pharmaceutical Manufacturing industry is implementing CRM including some potential steps to take when considering a CRM initiative.

Arabian nights—1001 tales of how pharmaceutical companies cater to the material needs of doctors: case report

PubMed Central

Giannakakis, Ioannis A; Ioannidis, John P A

2000-01-01

Objective To describe how pharmaceutical companies cater to the material needs of doctors. Design Case report of memoirs. Setting Facilities that have nothing to do with medicine, somewhere in the Arabian peninsula. Patient population Random sample of doctors. Interventions Promotion by the pharmaceutical industry. Main outcome measures Short term outcomes were travel, pleasure, amusement, and gifts, and long term outcomes were the market share of specific companies. Results Short term outcomes were heterogeneous, underlying the diversity of the means employed by the pharmaceutical industry to subvert, divert, and influence medical practice. Overall, 200 doctors were dressed in white gowns, a doctor in preventive medicine quoted Hippocrates in favour of smoking, a senior doctor became a poet, a doctor trying to understand the Methods section of a poster paper wondered whether he should have been sunbathing at the beach instead, and two women doctors were kidnapped by Bedouin warriors. Long term outcomes on the sales of the company drugs are pending but are likely to be most favourable. Conclusions Eat, drink, be merry, and boost prescriptions. PMID:11124175

Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.

PubMed

Hecker, Sandra J; Preston, Christopher; Foote, MaryAnn

2003-01-01

Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions. The timely production of high-quality new drug marketing applications requires close collaborations between the drug company and the CRO. The views of both CRO and industry in ensuring best practices are discussed.

Awareness and attitudes of the Lebanese population with regard to physician-pharmaceutical company interaction: a survey study.

PubMed

Ammous, Ahmad; Bou Zein Eddine, Savo; Dani, Alia; Dbaibou, Jana; El-Asmar, Jose M; Sadder, Liane; Akl, Elie A

2017-03-31

To assess the awareness and attitudes of the general public in Lebanon regarding the interactions between physicians and pharmaceutical companies. Primary healthcare clinics and shopping malls in the Greater Beirut Area. 263 participants completed the questionnaire, of whom 62% were female and 38% were male. Eligible participants were Arabic-speaking or English-speaking adults (age≥18 years) residing in Lebanon for at least 5 years. Awareness, attitudes and beliefs of the general public. 263 out of 295 invited individuals (89% completion rate) completed the questionnaire. While the majority of participants were aware of pharmaceutical company presence (or absence) in physicians' offices (range of 71-76% across questions), smaller percentages were aware of gift-related practices of physicians (range of 26-69% across questions). 40% thought that the acceptance of small gifts or meals by physicians is wrong/unethical. The percentage of participants reporting lower trust in physicians due to their participation in various pharmaceutical company-related activities ranged from 12% to 45% (the highest percentage being for large gifts). Participants who reported receiving free medication samples were significantly more likely to consider physicians' acceptance of small gifts as 'not a problem' than 'unethical' (OR=1.53; p=0.044). Participants in our survey were generally more aware of pharmaceutical company presence (or absence) in physicians' offices than of gift-related practices of physicians. While the level of trust was not affected for the majority of participants for various types of interactions, it was affected the most for accepting large gifts. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Adverse-drug-event data provided by pharmaceutical companies.

PubMed

Cudny, Magdalena E; Graham, Angie S

2008-06-01

Pharmaceutical company drug information center (PCDIC) responses to queries about adverse drug events (ADEs) were studied to determine whether PCDICs search sources other than the prescribing information on the package insert (PI) and whether the PCDICs' approach differs according to whether an ADE is listed in the PI (labeled) or not (unlabeled). Companies were selected from a list of PCDICs in the Physicians' Desk Reference. One oral or injectable prescription drug from each company was selected. For each drug, a labeled ADE and an unlabeled ADE about which to query the PCDICs were randomly selected from the index of an annual publication on ADEs. The investigators telephoned the PCDICs with an open-ended inquiry about the incidence, timing, and management of the ADE as reported in the literature and the company's internal data; they clarified that the request did not concern a specific patient. Whether or not information was provided, the source searched was recorded (PI, literature, internal database), and the percentages of PCDICs that used each source for labeled and for unlabeled ADEs were analyzed. Results were obtained from 100 companies to questions about 100 drugs (200 ADEs). For ADEs overall, 80% used the PI, 50% the medical literature, and 38% internal data. For labeled versus unlabeled ADEs, respectively, the PI was used by 84% and 76%; literature, both 50%; and internal data, 35% and 41%. The PCDIC specialists referencing the PI did not always provide accurate or up-to-date information. Some specialists, when asked to query internal databases, said that was not an option. For both labeled and unlabeled ADEs, the PI was the primary source used by PCDICs to answer safety questions about their products, and internal data were the least-used source. Most resources used by PCDICs are readily available to practicing pharmacists.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

PubMed

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-12-05

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

A cross-sectional evidence-based review of pharmaceutical promotional marketing brochures and their underlying studies: Is what they tell us important and true?

PubMed Central

Cardarelli, Roberto; Licciardone, John C; Taylor, Lockwood G

2006-01-01

Background A major marketing technique used by pharmaceutical companies is direct-to-physician marketing. This form of marketing frequently employs promotional marketing brochures, based on clinical research, which may influence how a physician prescribes medicines. This study's objective was to investigate whether or not the information in promotional brochures presented to physicians by pharmaceutical representatives is accurate, consistent, and valid with respect to the actual studies upon which the promotional brochures are based. Methods Physicians in five clinics were asked to consecutively collect pharmaceutical promotional brochures and to send them all to a centralized location. The brochures for any class of medication were collected on a continuous basis until 20 distinct promotional brochures were received by a central location. Once the brochure was received, the corresponding original study was obtained. Two blinded reviewers performed an evidence-based review of the article, comparing data that was printed on the brochure to what was found in the original study. Results Among the 20 studies, 75% of the studies were found to be valid, 80% were funded by the pharmaceutical company, 60% of the studies and the corresponding brochures presented patient-oriented outcomes, and 40% were compared to another treatment regimen. Of the 19 brochures that presented the data as graphs, 4 brochures presented a relative risk reduction while only 1 brochure presented an absolute risk reduction. 15% of the promotional marketing brochures presented data that was different from what was in the original published study. Conclusion Given the present findings, physicians should be cautious about drawing conclusions regarding a medication based on the marketing brochures provided by pharmaceutical companies. PMID:16515686

Attitudes of medical students towards incentives offered by pharmaceutical companies- perspective from a developing nation- a cross sectional study

PubMed Central

2014-01-01

Background A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study aimed to assess the association of socio-demographic variables with the attitudes of medical students towards pharmaceutical companies and their incentives. Methods As part of a cross-sectional survey, a validated questionnaire previously used for assessing attitude of medical students towards pharmaceutical industry, was modified, pre-tested and distributed among consenting clinical year students at DUHS and AKU. Questions included acceptability of pharmaceutically sponsored gifts, events and tuition fee, and their impact on future prescription. Responses were graded as agree, disagree or neutral which were then scored according to the AMSA guidelines of ethical conduct. Results Out of a total of 353 targeted students 303 responded, corresponding to a response rate of 85.8%. Responses indicated that 42.7% students believed in no interaction with drug companies during medical school. However, 81% of students favored pharmaceutical sponsorship of student-body events/seminars at medical colleges. More than one-third of the students were comfortable receiving gifts from drug companies. Overall, the results of this study offer an interesting comparison between the students of a private medical school (AKU) and a public medical school (DUHS); AKU students exhibited a greater degree of mistrust towards drug information provided by pharmaceutical companies compared to DUHS students (p = 0.040). Furthermore, when asked if there was a need to incorporate guidelines in the undergraduate curriculum with regard to interaction with drug companies, 84.2% students at AKU agreed

Pharmaceutical supply chain risks: a systematic review

PubMed Central

2013-01-01

Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

Pharmaceutical supply chain risks: a systematic review.

PubMed

Jaberidoost, Mona; Nikfar, Shekoufeh; Abdollahiasl, Akbar; Dinarvand, Rassoul

2013-12-19

Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies.

Renal studies in safety pharmacology and toxicology: A survey conducted in the top 15 pharmaceutical companies.

PubMed

Benjamin, Amanda; Gallacher, David J; Greiter-Wilke, Andrea; Guillon, Jean-Michel; Kasai, Cheiko; Ledieu, David; Levesque, Paul; Prelle, Katja; Ratcliffe, Sian; Sannajust, Frederick; Valentin, Jean-Pierre

2015-01-01

With the recent development of more sensitive biomarkers to assess kidney injury preclinically, a survey was designed i) to investigate what strategies are used to investigate renal toxicity in both ICH S7A compliant Safety Pharmacology (SP) studies after a single dose of a compound and within repeat-dose toxicity studies by large pharmaceutical companies today; ii) to understand whether renal SP studies have impact or utility in drug development and/or if it may be more appropriate to assess renal effects after multiple doses of compounds; iii) to ascertain how much mechanistic work is performed by the top 15 largest pharmaceutical companies (as determined by R&D revenue size); iv) to gain an insight into the impact of the validation of DIKI biomarkers and their introduction in the safety evaluation paradigm; and v) to understand the impact of renal/urinary safety study data on progression of projects. Two short anonymous surveys were submitted to SP leaders of the top 15 pharmaceutical companies, as defined by 2012 R&D portfolio size. Fourteen multiple choice questions were designed to explore the strategies used to investigate renal effects in both ICH S7A compliant SP studies and within toxicology studies. A 67% and 60% response rate was obtained in the first and second surveys, respectively. Nine out of ten respondent companies conduct renal excretory measurements (eg. urine analysis) in toxicology studies whereas only five out of ten conduct specific renal SP studies; and all of those 5 also conduct the renal excretory measurements in toxicology studies. These companies measure and/or calculate a variety of parameters as part of these studies, and also on a case by case basis include regulatory qualified and non-qualified DIKI biomarkers. Finally, only one company has used renal/urinary functional data alone to stop a project, whereas the majority of respondents combine renal data with other target organ assessments to form an integrated decision-making set

Pharmaceutical lobbying in Brazil: a missing topic in the public health research agenda.

PubMed

Paumgartten, Francisco José Roma

2016-12-22

In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.

[Development and Distribution of Drugs for NTDs: Efforts of One Pharmaceutical Company].

PubMed

Asada, Makoto

2016-01-01

The Pharmaceutical Industry is expected to play a proactive global role in combatting neglected tropical diseases (NTDs) and other tropical diseases affecting low-income countries. Such a role would include novel medicine R&D, manufacturing and distribution. In order to succeed in this role, several challenges need to be overcome: a) the economic challenge or cost benefit balance for the development of these medicines, and b) sparse in-house experience with these diseases within the Industry. During the last decade, the Product Development Partnership (PDP) model has become an effective strategy to address such challenges. Organizations such as the Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases initiative (DNDi), TB alliance, PATH (formerly the Program for Appropriate Technology in Health), and others have linked pharmaceutical companies, funding organizations, academic researchers and others, and have thus been able to successfully populate treatment pipelines directed at NTDs, Malaria, tuberculosis (TB), and human immunodeficiency virus (HIV)/AIDS. In this paper, our experience working with one of these organizations, DNDi, is described. We have been collaborating with DNDi in evaluating the actions of Eisai's antifungal compound, E1224, in a clinical study for treating Chagas Disease. In addition, other Eisai initiatives directed at NTDs and improving patients' access to medicines are introduced.

[Early achievements of the Danish pharmaceutical industry--3. Alfred Benzon].

PubMed

Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

2011-01-01

The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 3 deals with products from the company founded by Alfred Benzon in 1849. Alfred Nicolai Benzon owned the Swan Pharmacy in Copenhagen. In 1863 he started an independent company manufacturing branded pharmaceuticals, thus combining the pharmacy's activities with the wholesale business. The family owned the company until 1952, when it was converted into a foundation. After several restructuring rounds, the medicine production business continued as Benzon Pharma A/S until 1990, when Nycomed Pharma A/S bought up all the branded pharmaceuticals. As the first pharmaceutical company in Denmark, Alfred Benzon was an industrial frontrunner in the country at the time, supplying not only the domestic market but foreign markets as well. Alfred Benzon was the first Danish company to produce ether for anesthesia, and malt extract, a dietetic preparation. The high quality of both products made them valuable export articles. In the early 1890s, Alfred Benzon became the first Danish company to start the research-based production of extract of thyroid glands from slaughtered cattle. This was the beginning of a long-standing specialization in producing organotherapeutic substances from animal organs originating from Danish animal husbandry. In 1932 the company had 26 preparations of this type in its range, many of them on the market for several years. These medicine substances included iron preparations and effervescent salts followed by sulfonamides, synthetic hormones and a substance to counteract motion sickness.

Create a translational medicine knowledge repository--research downsizing, mergers and increased outsourcing have reduced the depth of in-house translational medicine expertise and institutional memory at many pharmaceutical and biotech companies: how will they avoid relearning old lessons?

PubMed

Littman, Bruce H; Marincola, Francesco M

2011-05-10

Pharmaceutical industry consolidation and overall research downsizing threatens the ability of companies to benefit from their previous investments in translational research as key leaders with the most knowledge of the successful use of biomarkers and translational pharmacology models are laid off or accept their severance packages. Two recently published books may help to preserve this type of knowledge but much of this type of information is not in the public domain. Here we propose the creation of a translational medicine knowledge repository where companies can submit their translational research data and access similar data from other companies in a precompetitive environment. This searchable repository would become an invaluable resource for translational scientists and drug developers that could speed and reduce the cost of new drug development.

Does brand differentiate pharmaceuticals?

PubMed

Bednarik, Josef

2005-12-01

Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

Solar process steam for a pharmaceutical company in Jordan

NASA Astrophysics Data System (ADS)

Berger, M.; Mokhtar, M.; Zahler, C.; Al-Najami, M. M. R.; Krüger, D.; Hennecke, K.

2016-05-01

This paper presents details of the recent installation of a linear Fresnel collector to provide saturated steam for process heat usage through Direct Steam Generation (DSG) for industrial use in the Jordanian pharmaceuticals manufacturing company RAM Pharma, where first solar steam has been provided in March 2015. This commercial DSG project also represents the first solar DSG plant in MENA. During sunshine, the system achieves a solar fraction of 100 %, and the conventional steam boiler is not needed. In the evening the fossil fired backup takes over automatically and replaces the solar collector in operation. Operational experience, details of the control strategy, and measurement data are presented in the paper.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

PubMed Central

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-01-01

Objectives To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Design Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data sources Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Outcome measures Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. Results The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%–100%) of trials in patients were registered, 71% (IQR 57%–100%) reported results or shared a CSR synopsis, 80% (70%–100%) were published and 96% (80%–100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%–100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Conclusions Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval

Improving Overall Equipment Effectiveness Using CPM and MOST: A Case Study of an Indonesian Pharmaceutical Company

NASA Astrophysics Data System (ADS)

Omega, Dousmaris; Andika, Aditya

2017-12-01

This paper discusses the results of a research conducted on the production process of an Indonesian pharmaceutical company. The company is experiencing low performance in the Overall Equipment Effectiveness (OEE) metric. The OEE of the company machines are below world class standard. The machine that has the lowest OEE is the filler machine. Through observation and analysis, it is found that the cleaning process of the filler machine consumes significant amount of time. The long duration of the cleaning process happens because there is no structured division of jobs between cleaning operators, differences in operators’ ability, and operators’ inability in utilizing available cleaning equipment. The company needs to improve the cleaning process. Therefore, Critical Path Method (CPM) analysis is conducted to find out what activities are critical in order to shorten and simplify the cleaning process in the division of tasks. Afterwards, The Maynard Operation and Sequence Technique (MOST) method is used to reduce ineffective movement and specify the cleaning process standard time. From CPM and MOST, it is obtained the shortest time of the cleaning process is 1 hour 28 minutes and the standard time is 1 hour 38.826 minutes.

[Incentives and disincentives for research and development of new drugs by the pharmaceutical industry].

PubMed

Curcio, Pasqualina Curcio

2008-10-01

The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment) and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and policies must be orientated towards strengthening basic and applied research by public institutions.

Accounting- versus economic-based rates of return: implications for profitability measures in the pharmaceutical industry.

PubMed

Skrepnek, Grant H

2004-01-01

Accounting-based profits have indicated that pharmaceutical firms have achieved greater returns relative to other sectors. However, partially due to the theoretically inappropriate reporting of research and development (R&D) expenditures according to generally accepted accounting principles, evidence suggests that a substantial and upward bias is present in accounting-based rates of return for corporations with high levels of intangible assets. Given the intensity of R&D in pharmaceutical firms, accounting-based profit metrics in the drug sector may be affected to a greater extent than other industries. The aim of this work was to address measurement issues associated with corporate performance and factors that contribute to the bias within accounting-based rates of return. Seminal and broadly cited works on the subject of accounting- versus economic-based rates of return were reviewed from the economic and finance literature, with an emphasis placed on issues and scientific evidence directly related to the drug development process and pharmaceutical industry. With international convergence and harmonization of accounting standards being imminent, stricter adherence to theoretically sound economic principles is advocated, particularly those based on discounted cash-flow methods. Researchers, financial analysts, and policy makers must be cognizant of the biases and limitations present within numerous corporate performance measures. Furthermore, the development of more robust and valid economic models of the pharmaceutical industry is required to capture the unique dimensions of risk and return of the drug development process. Empiric work has illustrated that estimates of economic-based rates of return range from approximately 2 to approximately 11 percentage points below various accounting-based rates of return for drug companies. Because differences in the nature of risk and uncertainty borne by drug manufacturers versus other sectors make comparative assessments

[The influence of the relationship between physicians and pharmaceutical companies on the patient from the point of view of policy-makers in Israel].

PubMed

Nissanholtz-Gannot, Rachel; Shani, Segev; Shvarts, Shifra

2010-11-01

The relationship between doctors and pharmaceutical companies is an integral part of the health system in Israel and the whole world. The mutual need for such a relationship requires us, as a society, to examine its influence on the individual and the system as a whole. This research examines the relationship from the points of view of the relevant parties within the health system and outside the health system (decision-makers). The authors used in-depth interviews and qualitative research methods in order to examine and understand the various positions of decision-makers. The position of the decision-makers, regarding all the aspects of this relationship, expresses their wishes and depends on their point of view. The impact of the relationship between the doctors and the pharmaceutical companies was examined with regard to the prescription behavior of the doctor. All the government representatives, all the physicians' representatives and those of the health funds, believe that the physicians' prescription behavior is impacted by the relationship. There are those who perceive this to be a negative trend and some doctors believe it to be a positive trend. With regard to possible harm to the patient, the parties believe that the relationship does not harm the patient, whereas most of the government representatives identify harm to the patients, both on the economic and health levels. The authors believe that the "influence" which exists or could exist on the part of the pharmaceutical companies is the main stumbling block in this relationship, which is expressed in the decision-makers' perspective.

Ovation Pharmaceuticals, Inc.

PubMed

Deutsch, Barry

2002-11-01

Ovation Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company that focuses on products in central nervous system (CNS) disorders, oncology and other therapeutic areas where a small number of specialized physicians treat patients. Ovation serves unmet medical needs by acquiring underpromoted branded pharmaceutical products and promising late-stage development products no longer being actively promoted or developed by larger companies. Ovation supports acquired products through active sales and marketing activities and a clinical development program focused on new formulations, new indications and other product improvements. In April 2002, Ovation received a US$150 million commitment in private equity financing, believed to be the largest private equity investment received to date by an early-stage specialty pharmaceutical firm. Ovation used a portion of those funds to purchase its first two products from a major pharmaceutical company in August 2002.

India's pharmaceutical industry: hype or high tech take-off?

PubMed

Malhotra, Prabodh; Lofgren, Hans

2004-11-08

India has built a large pharmaceutical industry through an array of measures in support of domestic firms. The absence of product patents enabled Indian companies to become world leading producers of generic versions of patented drugs. Low costs and a strong engineering tradition continue to sustain competitive strength. The implementation of the World Trade Organization patent regime in 2005 is driving a transformation of the industry. Key elements of the present shake-up include the return of 'big pharma' companies on a large scale and the emergence of several Indian firms that aim to become fully-fledged research-based multinationals. This article provides a description of the development and structure of the Indian pharmaceutical industry and explores questions and challenges arising from its integration into global markets.

Create a translational medicine knowledge repository - Research downsizing, mergers and increased outsourcing have reduced the depth of in-house translational medicine expertise and institutional memory at many pharmaceutical and biotech companies: how will they avoid relearning old lessons?

PubMed Central

2011-01-01

Pharmaceutical industry consolidation and overall research downsizing threatens the ability of companies to benefit from their previous investments in translational research as key leaders with the most knowledge of the successful use of biomarkers and translational pharmacology models are laid off or accept their severance packages. Two recently published books may help to preserve this type of knowledge but much of this type of information is not in the public domain. Here we propose the creation of a translational medicine knowledge repository where companies can submit their translational research data and access similar data from other companies in a precompetitive environment. This searchable repository would become an invaluable resource for translational scientists and drug developers that could speed and reduce the cost of new drug development. PMID:21569250

What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study

PubMed Central

Parsons, Suzanne; Starling, Bella; Mullan-Jensen, Christine; Warner, Kay; Wever, Kim

2016-01-01

Objectives To explore European-based pharmaceutical industry professionals’ beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Setting Pharmaceutical companies in the UK, Poland and Spain. Participants 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Method Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. Results 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. Conclusions Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the public's lack of knowledge and interest in medicines R&D, and the pharmaceutical industry's lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships. PMID:26743701

Exposure of medical students to pharmaceutical marketing in primary care settings: frequent and influential.

PubMed

Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-12-01

It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts. Considering the move toward early clinical encounters and community-based education, which expose students early to pharmaceutical representatives, the influence of those gifts is becoming a matter of concern. This study examines the frequency and influence of student exposure to drug marketing in primary care settings, as well as student perceptions of physician-pharmaceutical company relationships. This was a two-phase study consisting of qualitative research followed by a cross-sectional survey. Clinical experience logbooks of 280 second-year students in one school were analysed, and the themes that emerged were used to develop a survey that was administered to 308 third-year students from two medical schools. Survey results showed a 91.2% exposure to any type of marketing, and 56.8% of students were exposed to all classes of marketing methods studied. Deliberate targeting of students by pharmaceutical representatives, in particular, was correlated with being less sensitive to the negative effects of and having positive opinions about interactions with pharmaceutical companies. The vast majority of students are exposed to drug marketing in primary care settings, and may become more vulnerable to that strategy. Considering that medical students are vulnerable and are targeted deliberately by pharmaceutical companies, interventions aimed at developing skills in the rational use of medicines and in strategies for coping with drug marketing should be devised.

Pharmaceutical company payments to physicians: early experiences with disclosure laws in Vermont and Minnesota.

PubMed

Ross, Joseph S; Lackner, Josh E; Lurie, Peter; Gross, Cary P; Wolfe, Sidney; Krumholz, Harlan M

2007-03-21

Recent legislation in 5 states and the District of Columbia mandated state disclosure of payments made to physicians by pharmaceutical companies. In 2 of these states, Vermont and Minnesota, payment disclosures are publicly available. To determine the accessibility and quality of the data available in Vermont and Minnesota and to describe the prevalence and magnitude of disclosed payments. Cross-sectional analysis of publicly available data from July 1, 2002, through June 30, 2004, in Vermont and from January 1, 2002, through December 31, 2004, in Minnesota. Accessibility and quality of disclosure data and the number, value, and type of payments of $100 or more to physicians. Access to payment data required extensive negotiation with the Office of the Vermont Attorney General and manual photocopying of individual disclosure forms at Minnesota's State Board of Pharmacy. In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years. In Vermont, among 12,227 payments totaling $2.18 million publicly disclosed, there were 2416 payments of $100 or more to physicians; total, $1.01 million; median payment, $177 (range, $100-$20,000). In Minnesota, among 6946 payments totaling $30.96 million publicly disclosed, there were 6238 payments of $100 or more to physicians; total, $22.39 million; median payment, $1000 (range, $100-$922,239). Physician-specific analyses were possible only in Minnesota, identifying 2388 distinct physicians who received payment of $100 or more; median number of payments received, 1 (range, 1-88) and the median amount received, $1000 (range, $100-$1,178,203). The Vermont and Minnesota laws requiring disclosure of payments do not provide easy access to payment information for the public and are of limited quality once accessed

Analysis on Time-Lag Effect of Research and Development Investment in the Pharmaceutical Industry in Korea

PubMed Central

Lee, Munjae; Choi, Mankyu

2015-01-01

Objectives The aim of this study is to analyze the influence of the research and development (R&D) investment of pharmaceutical companies on enterprise value. Methods The period of the empirical analysis is from 2000 to 2012, considering the period after the influence of the financial crisis. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association, and data related to stock price were extracted from KISVALUE-III of National Information and Credit Evaluation Information Service Co., Ltd. STATA 12.0 was used as the statistical package for panel analysis. Results In the pharmaceutical firms, the influence of the R&D intensity with regard to Tobin's q was found to be positive. However, only the R&D expenditure intensities of previous years 2 and 5 (t–2 and t–5, respectively) were statistically significant (p < 0.1), whereas those of previous years 1, 3, and 4 years (t–1, t–3, and t–4, respectively) were not statistically significant. Conclusion R&D investment not only affects the enterprise value but is also evaluated as an investment activity that raises the long-term enterprise value. The research findings will serve as valuable data to understand the enterprise value of the Korea pharmaceutical industry and to strengthen reform measures. Not only should new drug development be made, but also investment and support should be provided according to the specific factors suitable to improve the competitiveness of each company, such as generic, incrementally modified drugs, and biosimilar products. PMID:26473091

Analysis on Time-Lag Effect of Research and Development Investment in the Pharmaceutical Industry in Korea.

PubMed

Lee, Munjae; Choi, Mankyu

2015-08-01

The aim of this study is to analyze the influence of the research and development (R&D) investment of pharmaceutical companies on enterprise value. The period of the empirical analysis is from 2000 to 2012, considering the period after the influence of the financial crisis. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association, and data related to stock price were extracted from KISVALUE-III of National Information and Credit Evaluation Information Service Co., Ltd. STATA 12.0 was used as the statistical package for panel analysis. In the pharmaceutical firms, the influence of the R&D intensity with regard to Tobin's q was found to be positive. However, only the R&D expenditure intensities of previous years 2 and 5 (t-2 and t-5, respectively) were statistically significant (p < 0.1), whereas those of previous years 1, 3, and 4 years (t-1, t-3, and t-4, respectively) were not statistically significant. R&D investment not only affects the enterprise value but is also evaluated as an investment activity that raises the long-term enterprise value. The research findings will serve as valuable data to understand the enterprise value of the Korea pharmaceutical industry and to strengthen reform measures. Not only should new drug development be made, but also investment and support should be provided according to the specific factors suitable to improve the competitiveness of each company, such as generic, incrementally modified drugs, and biosimilar products.

Sex, drugs and gender roles: mapping the use of sex and gender based analysis in pharmaceutical policy research

PubMed Central

2010-01-01

Background Sex and gender sensitive inquiry is critical in pharmaceutical policy due to the sector's historical connection with women's health issues and due to the confluence of biological, social, political, and economic factors that shape the development, promotion, use, and effects of medicinal treatments. A growing number of research bodies internationally have issued laws, guidance or encouragement to support conducting sex and gender based analysis (SGBA) in all health related research. Methods In order to investigate the degree to which attempts to mainstream SGBA have translated into actual research practices in the field of pharmaceutical policy, we employed methods of literature scoping and mapping. A random sample of English-language pharmaceutical policy research articles published in 2008 and indexed in MEDLINE was analysed according to: 1) use of sex and gender related language, 2) application of sex and gender related concepts, and 3) level of SGBA employed. Results Two thirds of the articles (67%) in our sample made no mention of sex or gender. Similarly, 69% did not contain any sex or gender related content whatsoever. Of those that did contain some sex or gender content, the majority focused on sex. Only 2 of the 85 pharmaceutical policy articles reviewed for this study were primarily focused on sex or gender issues; both of these were review articles. Eighty-one percent of the articles in our study contained no SGBA, functioning instead at a sex-blind or gender-neutral level, even though the majority of these (86%) were focused on topics with sex or gender aspects. Conclusions Despite pharmaceutical policy's long entwinement with issues of sex and gender, and the emergence of international guidelines for the inclusion of SGBA in health research, the community of pharmaceutical policy researchers has not internalized, or "mainstreamed," the practice. Increased application of SGBA is, in most cases, not only appropriate for the topics under

Measuring US pharmaceutical industry R&D spending.

PubMed

Golec, Joseph; Vernon, John

2008-01-01

Government policy debates on pharmaceutical pricing often turn on whether higher drug prices fund greater company-financed R&D spending. In the US, debate breaks down because each side uses a different measure of R&D spending, and the measures are far apart. Government agencies, Congress and consumer groups use government-generated survey data from the National Science Foundation (NSF), and the pharmaceutical industry uses survey data from the Pharmaceutical Research and Manufacturers of America (PhRMA). This issue is also relevant to academic work because some studies use NSF data, and others use PhRMA data. This article illustrates the pros and cons of these survey data series, and offers a more reliable, comprehensive and replicable alternative series, based on Compustat data.

Report raises questions about drug companies advertising budgets.

PubMed

1999-08-06

A report by AIDS Action cites that data, indicates the pharmaceutical industry is spending more resources on marketing and advertising than on research and development (R&D). The pharmaceutical industry blames the high cost of AIDS drugs on R&D information compiled from annual reports and industry publications show excessive marketing as the source. A spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA) disputes the information in the AIDS Action report as misleading. According to PhRMA, research spending has been steadily increasing, and at a greater rate than any other industry. In addition, PhRMA noted that pharmaceutical companies have already dedicated money to fund initiatives in developing countries. Solutions proposed by AIDS Action include lowering drug prices or transferring funds from marketing to research, and reestablishing the "reasonable pricing clause" between National Institutes of Health and those companies seeking tax breaks for R&D.

Pharmacist, the pharmaceutical industry and pharmacy education in Saudi Arabia: A questionnaire-based study

PubMed Central

Bin Saleh, Ghada; Rezk, Naser L.; Laika, Laila; Ali, Anna; El-Metwally, Ashraf

2015-01-01

Background: In Saudi Arabia there is an estimated need of more than 100,000 pharmacy graduates to cover all present sectors. The shortage of pharmacists has affected many of these sectors especially the pharmaceutical industry. The contribution of Saudi pharmacists to local pharmaceuticals industry would be extremely beneficial and important for shaping the future of the drug industry within the Kingdom. It is not clear whether future Saudi pharmacists are willing to contribute to local pharmaco-industrial fields. Methods: A cross-sectional, questionnaire-based survey was conducted on all final-year pharmacy students in King Saud University (KSU), Riyadh, Kingdom of Saudi Arabia (KSA). Results: Out of a total of 130 students registered in the final-year of the pharmacy program in KSU, 122 (93.8%) were able to complete the questionnaire. The results showed that the majority (83%) of Saudi pharmacy students indicated that they had not received practical training in the pharmaceutical companies, while only 17.2% of the students felt that they had the knowledge and the skills to work in the pharmaceutical industry after graduation. The majority of the students (66.7%) chose clinical pharmacy as their future career field while only 10.9% indicated willingness to work in a pharmaceutical industry career. Only 8.2% selected working in the pharmaceutical industry. The significant predictor of possibly choosing a career in the local drug industry is a student with a bachelor’s degree (compared to Pharm D degree) in pharmacy (OR = 2.7 [95% CI 1.1–6.3]). Conclusion: Pharmacy students who are enrolled in the capital city of Riyadh are not properly trained to play an influential role in local drug companies. As a result, their level of willingness to have a career in such important business is not promising (more among Pharm D program). Future research in other pharmacy colleges within Saudi Arabia is needed to confirm such results. PMID:26594125

Pharmacist, the pharmaceutical industry and pharmacy education in Saudi Arabia: A questionnaire-based study.

PubMed

Bin Saleh, Ghada; Rezk, Naser L; Laika, Laila; Ali, Anna; El-Metwally, Ashraf

2015-10-01

In Saudi Arabia there is an estimated need of more than 100,000 pharmacy graduates to cover all present sectors. The shortage of pharmacists has affected many of these sectors especially the pharmaceutical industry. The contribution of Saudi pharmacists to local pharmaceuticals industry would be extremely beneficial and important for shaping the future of the drug industry within the Kingdom. It is not clear whether future Saudi pharmacists are willing to contribute to local pharmaco-industrial fields. A cross-sectional, questionnaire-based survey was conducted on all final-year pharmacy students in King Saud University (KSU), Riyadh, Kingdom of Saudi Arabia (KSA). Out of a total of 130 students registered in the final-year of the pharmacy program in KSU, 122 (93.8%) were able to complete the questionnaire. The results showed that the majority (83%) of Saudi pharmacy students indicated that they had not received practical training in the pharmaceutical companies, while only 17.2% of the students felt that they had the knowledge and the skills to work in the pharmaceutical industry after graduation. The majority of the students (66.7%) chose clinical pharmacy as their future career field while only 10.9% indicated willingness to work in a pharmaceutical industry career. Only 8.2% selected working in the pharmaceutical industry. The significant predictor of possibly choosing a career in the local drug industry is a student with a bachelor's degree (compared to Pharm D degree) in pharmacy (OR = 2.7 [95% CI 1.1-6.3]). Pharmacy students who are enrolled in the capital city of Riyadh are not properly trained to play an influential role in local drug companies. As a result, their level of willingness to have a career in such important business is not promising (more among Pharm D program). Future research in other pharmacy colleges within Saudi Arabia is needed to confirm such results.

An analysis of the relationship between staff qualification and export readiness of pharmaceutical companies: the case of iran.

PubMed

Mohammadzadeh, Mehdi

2012-01-01

Export and the readiness to export constitute the first step of international marketing, which are affected by both internal and external factors of firms. One of the most important internal factors is the presence of skilled personnel. The purpose of this study was to define the relationship between staff qualification and encouragment with the readiness level of Iranian pharmacuetical firms for engagement in export marketing. The research was based on a single case study on a basket of seven leading domestic firms. For the bias reduction, questionnaires as well as interviews with managers were used. The performance of the studied factor was lower than the desired level for export readiness and there was much scope for improvement in staff qualifications to achieve such readiness. The results of this research enable small and medium-sized pharmaceutical companies to evaluate their staff qualification levels needed for export readiness and to detect their shortcomings in order to improve them.

An Analysis of the Relationship Between Staff Qualification and Export Readiness of Pharmaceutical Companies: The Case of Iran

PubMed Central

Mohammadzadeh, Mehdi

2012-01-01

Export and the readiness to export constitute the first step of international marketing, which are affected by both internal and external factors of firms. One of the most important internal factors is the presence of skilled personnel. The purpose of this study was to define the relationship between staff qualification and encouragment with the readiness level of Iranian pharmacuetical firms for engagement in export marketing. The research was based on a single case study on a basket of seven leading domestic firms. For the bias reduction, questionnaires as well as interviews with managers were used. The performance of the studied factor was lower than the desired level for export readiness and there was much scope for improvement in staff qualifications to achieve such readiness. The results of this research enable small and medium-sized pharmaceutical companies to evaluate their staff qualification levels needed for export readiness and to detect their shortcomings in order to improve them. PMID:24250528

Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.

PubMed

Beran, Roy G

2004-01-01

Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal

[Dangerous liaisons--physicians and pharmaceutical sales representatives].

PubMed

Granja, Mónica

2005-01-01

Interactions between physicians and detailers (even when legitimate ones) raise scientific and ethical questions. In Portugal little thinking and discussion has been done on the subject and the blames for bribery have monopolized the media. This work intended to review what has been said in medical literature about these interactions. How do physicians see themselves when interacting with pharmaceutical companies and their representatives? Do these companies in fact change their prescriptive behaviour, and, if so, how do they change it? How can physicians interact with detailers and still keep their best practice? A Medline research, from 1966 till 2002, was performed using the key-words as follows. A database similar to Medline but concerning medical journals published in Portugal, Index das Revistas Médicas Portuguesas, was also researched from 1992 to 2002. Pharmaceutical companies are profit bound and they allot promoting activities, and detailing in particular, huge amounts of money. Most physicians hold firmly to the belief that they are able to resist and not be influenced by drug companies promotion activities. Nevertheless, all previous works on literature tell us the opposite. Market research also indicates that detailers effectively promote drug sales. Various works also suggest that the information detailers provide to physicians may be largely incorrect, even comparing it to the written information provided by the pharmaceutical companies they work for. The frequency at which portuguese physicians (especially family physicians) contact with pharmaceutical sales representatives is higher than the frequency reported in countries where the available studies come from (namely, Canada and the United States of America). This may put portuguese physicians at a higher risk, making it imperative that work and wide debate are initiated among the class.

The case for entrepreneurship in R&D in the pharmaceutical industry.

PubMed

Douglas, Frank L; Narayanan, V K; Mitchell, Lesa; Litan, Robert E

2010-09-01

A lack of entrepreneurial behaviour has often been highlighted as a contributor to the decline in the research and development (R&D) productivity of the pharmaceutical industry. Here, we present an assessment of entrepreneurship in the industry, based on interviews with 26 former and current leaders of R&D departments at major pharmaceutical and biotechnology companies. Factors are highlighted that could be important in promoting entrepreneurial behaviour, which might serve as a catalyst for revitalizing R&D productivity.

Critical analysis of valuation and strategical orientation of merger and acquisition deals in the pharmaceutical industry.

PubMed

Dierks, Raphaela Marie Louisa; Bruyère, Olivier; Reginster, Jean-Yves

2018-04-01

The pharmaceutical industry is undergoing major shifts due to changing macro and micro factors. As the industry is highly capital intensive and patents are expiring, the outlook is on generating inorganic growth, mainly through M&A. Using the income valuation approach, one analyses two completed deals in 2016 above 1bn USD. Thereafter one outlines the main motives behind M&A deals and concluded by discussing whether M&A harms medical innovations. Areas covered: The paper is based on empirical study questioning existing literature in order to critically analyse valuation and the strategical orientation of pharmaceutical companies Expert commentary: Pharmaceutical companies understand the changing market conditions and favour their expertise. The restructuring of the industry moves to small niche companies (I.e. Biopharma or biotech companies) researching key innovations and big companies purchasing them to develop them, create clinical trials and distribute them as this is a costly manner Conclusion: One can expect more M&A deals during the next years focusing on value rather than volume. Pharmaceutical players resilient to the market changes may survive if they change their business model from a traditional vertical one to outsourcing and diversification including external players.

[A comprehensive evaluation of intervention effects on workplace health promotion in a pharmaceutical company].

PubMed

Li, Shuang; Li, Tao; Li, Jian-guo; Chen, Li; Ren, Jun; Li, Chao-lin

2012-02-01

To evaluate the comprehensive workplace health promotion intervention effect in a pharmaceutical company. The evaluation was conducted by using questionnaires, access to information, on-site surveys, satisfaction surveys and interviews. After the intervention, the awareness rate of the staff on "Occupational Disease Prevention Law", occupational disease prevention measures, the definition of hypertension, HIV transmission and high blood pressure, coronary heart disease preventive measures, have been raised from 72.4%, 13.8%, 67.5%, 45.8%, 51.7% to 97.8%, 19.9%, 82.3%, 94.7%, 53.1% respectively. The lifestyle of the staff has been improved, the improvement rate of smoking, drinking, having breakfast 4 times a week and above are 98.5%, 70.2% and 30.6% separately. Out of the 47 evaluation indicators, 41 meet the requirements, 5 basically meet the requirements. After implementing workplace health promotion activities, the level of occupational safety and health management of the pharmaceutical company has been enhanced, the physical and mental health of the staff have been promoted. The WHP comprehensive interventions are feasible and effective.

Trust: Need for an Improved Communication between the Public World and the Pharmaceutical Companies

PubMed Central

Heinemann, Lutz

2009-01-01

In the industrialized world, the negative image that many people (including politicians) have of pharmaceutical companies not only makes the life for those working in this field more difficult, in a sense it is a road block. Without an improvement in communication between the public world and the pharmaceutical industry, one can foresee this industry steadily becoming a more difficult environment to work in. There is a clear need for knowing more about all the work done inside these companies before a new drug is approved (it is not all about marketing…). That society has no understanding of the ever-increasing costs of new drugs is also related to this lack of understanding of how tricky and cumbersome the process is to take a new idea for treating a certain disease to production of a marketed drug. With a relatively small investment of money, but with an investment of much good will, brain power, and trust, it should be possible to bring all relevant parties together and make a change. PMID:20046667

A prospective view on European pharmaceutical research and development. Policy options to reduce fragmentation and increase competitiveness.

PubMed

Kanavos, P

1998-02-01

This article analyses 3 areas of policy that could reduce the fragmentation and improve the competitiveness of the European pharmaceutical sector. It argues that a potential solution to the issue of fragmentation of pharmaceutical research, development and innovation may be the development of policies at the European level, in those areas that European institutions have a competence. These areas may not necessarily rely exclusively on solving the issue of pricing and reimbursing pharmaceuticals as European Union (EU) Member States invoke the subsidiarity principle to claim policy exclusivity in this area. By contrast, policy areas where European institutions have a competence may include: i) a more intensified collaboration in science and technology policy (supporting the science base, identifying education needs for the future, collaborating in the development of new technologies and fostering university-industry collaboration); ii) support of research and development (R&D) by means of directly channelling funds into basic pharmaceutical research, avoiding duplication of the research effort, developing a set of research priorities, tackling the issue of technology transfer, promoting university-industry and cross-border collaborations or providing incentives that would induce private R&D activities in areas with large socioeconomic impact; and iii) an improvement in the environment for the financing of innovation in the EU, by means of selective use of tax policy at the national level (and where applicable, at the EU level), institutional reform in order to widen the pool of available funds for private investment, and the introduction of schemes that would encourage individuals and institutions to hold equity in innovative companies. The article identifies specific research, regulatory, medical and financing needs that require policy intervention, evaluates the possible dynamic implications of such interventions and highlights the benefits that may accrue from

Investigating pharmaceutical marketing in Canada using American prosecutions.

PubMed

Shoucri, Rami; Persaud, Navindra

2014-01-01

Pharmaceutical companies are prohibited from marketing medications for off-label uses in both the United States and Canada. In the United States, there have been several recent multi-billion dollar settlements with pharmaceutical companies based, partly, on off-label promotion. Health Canada has not publicized any investigations into, or prosecutions of, pharmaceutical companies for off-label promotion in Canada even though many of the same medications are marketed here. The prohibition on off-label promotion is largely directed at preventing pharmaceutical companies from circumventing the drug licensing process and attendant safety checks. To determine if sanctions for off-label pharmaceutical promotion in one jurisdiction can be used to regulate marketing in another. We reviewed and compared the laws and regulatory bodies in Canada and the United States to determine if Canadian regulators could use the findings of American regulators. There were no important differences in the laws and regulatory bodies in Canada and the United States related to off-label promotion. Canadian regulators can use the findings of American regulators to investigate off-label promotion in Canada. All countries should consider using sanctions in other jurisdictions to direct the deployment of limited regulatory resources.

Microcap pharmaceutical firms: linking drug pipelines to market value.

PubMed

Beach, Robert

2012-01-01

This article examines predictors of the future market value of microcap pharmaceutical companies. This is problematic since the large majority of these firms seldom report positive net income. Their value comes from the potential of a liquidity event such as occurs when a key drug is approved by the FDA. The typical scenario is one in which the company is either acquired by a larger pharmaceutical firm or enters into a joint venture with another pharmaceutical firm. Binary logistic regression is used to determine the impact of the firm's drug treatment pipeline and its investment in research and development on the firm's market cap. Using annual financial data from 2007 through 2010, this study finds that the status of the firm's drug treatment pipeline and its research and development expenses are significant predictors of the firm's future stock value relative to other microcap pharmaceutical firms.

Association between physicians’ interaction with pharmaceutical companies and their clinical practices: A systematic review and meta-analysis

PubMed Central

Al-Khaled, Lina; Kahale, Lara A.; Nas, Hala; El-Jardali, Fadi

2017-01-01

Background Pharmaceutical company representatives likely influence the prescribing habits and professional behaviors of physicians. The objective of this study was to systematically review the association between physicians’ interactions with pharmaceutical companies and their clinical practices. Methods We used the standard systematic review methodology. Observational and experimental study designs examining any type of targeted interaction between practicing physicians and pharmaceutical companies were eligible. The search strategy included a search of MEDLINE and EMBASE databases up to July 2016. Two reviewers selected studies, abstracted data, and assessed risk of bias in duplicate and independently. We assessed the quality of evidence using the GRADE approach. Results Twenty articles reporting on 19 studies met our inclusion criteria. All of these studies were conducted in high-income countries and examined different types of interactions, including detailing, industry-funded continuing medical education, and receiving free gifts. While all included studies assessed prescribing behaviors, four studies also assessed financial outcomes, one assessed physicians’ knowledge, and one assessed their beliefs. None of the studies assessed clinical outcomes. Out of the 19 studies, 15 found a consistent association between interactions promoting a medication, and inappropriately increased prescribing rates, lower prescribing quality, and/or increased prescribing costs. The remaining four studies found both associations and lack of significant associations for the different types of exposures and drugs examined in the studies. A meta-analysis of six of these studies found a statistically significant association between exposure and physicians’ prescribing behaviors (OR = 2.52; 95% CI 1.82–3.50). The quality of evidence was downgraded to moderate for risk of bias and inconsistency. Sensitivity analysis excluding studies at high risk of bias did not substantially

Pharmaceutical companies' variation of drug prices within and among countries can improve long-term social well-being.

PubMed

Lichtenberg, Frank R

2011-08-01

Drug prices vary considerably across and within countries. On average, pharmaceutical companies charge lower prices in low-income countries than in industrialized nations. Manufacturers' ability to price products differently for different markets--a practice known as price discrimination--increases their profits overall. But it is also likely to result in greater investment in research and development, and therefore in more new drugs on the market. Although reducing price discrimination in order to cut costs might benefit consumers in the short run, it would harm them in the long run by reducing the number of new drugs developed.

Institutional mistrust in the organization of pharmaceutical clinical trials

PubMed Central

2010-01-01

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. PMID:18633728

Reducing systems biology to practice in pharmaceutical company research; selected case studies.

PubMed

Benson, N; Cucurull-Sanchez, L; Demin, O; Smirnov, S; van der Graaf, P

2012-01-01

Reviews of the productivity of the pharmaceutical industry have concluded that the current business model is unsustainable. Various remedies for this have been proposed, however, arguably these do not directly address the fundamental issue; namely, that it is the knowledge required to enable good decisions in the process of delivering a drug that is largely absent; in turn, this leads to a disconnect between our intuition of what the right drug target is and the reality of pharmacological intervention in a system such as a human disease state. As this system is highly complex, modelling will be required to elucidate emergent properties together with the data necessary to construct such models. Currently, however, both the models and data available are limited. The ultimate solution to the problem of pharmaceutical productivity may be the virtual human, however, it is likely to be many years, if at all, before this goal is realised. The current challenge is, therefore, whether systems modelling can contribute to improving productivity in the pharmaceutical industry in the interim and help to guide the optimal route to the virtual human. In this context, this chapter discusses the emergence of systems pharmacology in drug discovery from the interface of pharmacokinetic-pharmacodynamic modelling and systems biology. Examples of applications to the identification of optimal drug targets in given pathways, selecting drug modalities and defining biomarkers are discussed, together with future directions.

[The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s].

PubMed

Sihn, Kyu-Hwan

2015-12-01

vitamins and health tonics showed particularly explosive growth. As Korean industrial workers worked night and day to increase exports in the 1960s, they needed vitamins and health tonics for recovery from fatigue and to support vitality. The expansion of the general pharmaceuticals market was accompanied by increases in numbers of pharmaceutical companies. Competition intensified between pharmaceutical companies, leading some companies to search for new survival plans. The pharmaceutical industry underwent structural reform in 1960s, replacing imported medical substances with local products and inventing the new market of general pharmaceuticals. The market for vitamins and health tonics was increased, and a successful product could support a pharmaceutical company. On the contrary, a general pharmaceutical could affect the very existence of the company: if a company chased a popular product and the imitation bubble burst, then the company have lost its competitiveness in the world market.

The role of marketing in pharmaceutical research and development.

PubMed

Calfee, John E

2002-01-01

Pharmaceutical marketing, which is primarily targeted at physicians, has been criticised because it may distort physician prescribing and thus potentially raise costs and/or worsen health. An alternative view, presented in this paper, is that successful marketing of pharmaceuticals can improve consumer welfare by increasing incentives for research and development (R&D) investment and by providing guidance to R&D to make it more consistent with consumer preferences. There are a number of arguments that support this view, despite impediments to pharmaceutical marketing such as the prohibited dissemination of off-label information in the US, difficulties in estimating potential pharmaceutical demand, and the long time lag between demand assessment and the introduction of new drugs. For example, physicians are often slow to modify their prescribing practices, even when new evidence-based practice guidelines are issued by prestigious organisations. Pharmaceutical promotion is likely to be particularly valuable because information plays a key role, is highly technical, and can change rapidly. Even consumer advertising can potentially improve health, for example, by improving patient compliance with drug therapy. In addition to disseminating information about the benefits of new therapies, an essential (and perhaps unique) role for pharmaceutical promotion is to encourage physicians and payers to pay closer attention to consumer needs (i.e. willingness to pay) for new medical technology. Moreover, successful marketing of pharmaceuticals increases the returns from R&D, thus increasing incentives to explore consumer demand and to contribute to basic research on the role of drug therapy. Consumer benefits from this process may be very large.

Why trash don't pass? pharmaceutical licensing and safety performance of drugs.

PubMed

Banerjee, Tannista; Nayak, Arnab

2017-01-01

This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.

Improvement of Clinical Skills through Pharmaceutical Education and Clinical Research.

PubMed

Ishizaki, Junko

2017-01-01

Professors and teaching staff in the field of pharmaceutical sciences should devote themselves to staying abreast of relevant education and research. Similarly those in clinical pharmacies should contribute to the advancement of pharmaceutical research and the development of next generation pharmacists and pharmaceuticals. It is thought that those who work in clinical pharmacies should improve their own skills and expertise in problem-finding and -solving, i.e., "clinical skills". They should be keen to learn new standard treatments based on the latest drug information, and should try to be in a position where collecting clinical information is readily possible. In the case of pharmacists in hospitals and pharmacies, they are able to aim at improving their clinical skills simply through performing their pharmaceutical duties. On the other hand, when a pharmaceutical educator aims to improve clinical skills at a level comparable to those of clinical pharmacists, it is necessary to devote or set aside considerable time for pharmacist duties, in addition to teaching, which may result in a shortage of time for hands-on clinical practice and/or in a decline in the quality of education and research. This could be a nightmare for teaching staff in clinical pharmacy who aim to take part in such activities. Nonetheless, I believe that teaching staff in the clinical pharmacy area could improve his/her clinical skills through actively engaging in education and research. In this review, I would like to introduce topics on such possibilities from my own experiences.

Pharmaceutical Company Corruption and the Moral Crisis in Medicine.

PubMed

Batt, Sharon

2016-07-01

A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics "pharmascolds." Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. © 2016 The Hastings Center.

Sale strategies of pharmaceutical companies in a "pharmerging" country: the problems will not improve if the gaps remain.

PubMed

Civaner, Murat

2012-08-01

This study aimed to examine the types of sales strategies used by pharmaceutical companies in a "pharmerging" market and to gain insight into the ways of avoiding the negative effects of these strategies. In-depth interviews were conducted with 22 physicians and company employees in the six largest cities of Turkey. The interviews were analyzed using content analysis. Various sales strategies, both legal and illegal, are universally applied. These methods target prescribers, patients, pharmacists, and society in general. Different types of companies, organizations, professionals, and science and ethical principles are used as means. Companies intervene immediately to prevent developments that may decrease sales, and exploit the educational and infrastructural needs. In contrast, physicians are overconfident about the effects of marketing and insufficiently educated on how to cope with the strategies and the drugs on the market, which make them vulnerable. Under these conditions, along with worldwide competition and economic volatility, policies that aim to set frameworks for pharmaceutical relationships have failed. Interventions are crucial, including instituting a national drug policy, minimizing the exposure to marketing, and addressing the educational and infrastructural needs of the prescribers. Without these interventions, gaps will continue to be exploited by companies for their own advantage, and the problems related to marketing will persist. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

PubMed

Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

2017-09-18

Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

The impact of generic substitution on the turnover and gross margin of pharmaceutical companies a survey 1 year and 5 years after the introduction of generic substitution in Finland.

PubMed

Timonen, Johanna; Karttunen, Pekka; Bengtström, Marina; Ahonen, Riitta

2009-10-01

To explore and compare the impact of generic substitution (GS) on the turnover and gross margin per cent of pharmaceutical companies representing mainly original or generic products in Finland. A mail survey to pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market 1 year (2004) and nearly 5 years (2008) after GS. The questionnaire were answered by 16 original and 7 generic product companies in 2004 (response rate 56%, n=41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n=39). Turnover had decreased in the original product companies and increased in the generic product companies. The gross margin per cent had decreased in the original and generic product companies, and the companies had also compensated for it in many ways. The study suggests that GS has promoted the sales of generic product companies in Finland. However, price competition caused by GS has generally decreased the proportion of profit from turnover in the original and generic product companies. The companies have also compensated for their decreased gross margin, which suggests that the profit in euros has not been sufficient to cover fixed costs in the companies.

Development of an Integrated Performance Measurement (PM) Model for Pharmaceutical Industry

PubMed Central

Shabaninejad, Hosein; Mirsalehian, Mohammad Hossein; Mehralian, Gholamhossein

2014-01-01

With respect to special characteristics of pharmaceutical industry and lack of reported performance measure, this study tries to design an integrated PM model for pharmaceutical companies. For generating this model; we first identified the key performance indicators (KPIs) and the key result indicators (KRIs) of a typical pharmaceutical company. Then, based on experts᾽ opinions, the identified indicators were ranked with respect to their importance, and the most important of them were selected to be used in the proposed model; In this model, we identified 25 KPIs and 12 KRIs. Although, this model is mostly appropriate to measure the performances of pharmaceutical companies, it can be also used to measure the performances of other industries with some modifications. We strongly recommend pharmaceutical managers to link these indicators with their payment and reward system, which can dramatically affect the performance of employees, and consequently their organization`s success. PMID:24711848

Implementing an online pharmaceutical service using design science research.

PubMed

Lapão, Luís Velez; da Silva, Miguel Mira; Gregório, João

2017-03-27

The rising prevalence of chronic diseases is pressing health systems to introduce reforms. Primary healthcare and multidisciplinary models have been suggested as approaches to deal with this challenge, with new roles for nurses and pharmacists being advocated. More recently, implementing healthcare based on information systems and technologies (e.g. eHealth) has been proposed as a way to improve health services. However, implementing online pharmaceutical services, including their adoption by pharmacists and patients, is still an open research question. In this paper we present ePharmacare, a new online pharmaceutical service implemented using Design Science Research. The Design Science Research Methodology (DSRM) was chosen to implement this online service for chronic diseases management. In the paper, DSRM's different activities are explained, from the definition of the problem to the evaluation of the artifact. During the design and development activities, surveys, observations, focus groups, and eye-tracking glasses were used to validate pharmacists' and patients' requirements. During the demonstration and evaluation activities the new service was used with real-world pharmacists and patients. The results show the contribution of DSRM in the implementation of online services for pharmacies. We found that pharmacists spend only 50% of their time interacting with patients, uncovering a clear opportunity to implement online pharmaceutical care services. On the other hand, patients that regularly visit the same pharmacy recognize the value in patient follow-up demanding to use channels such as the Internet for their pharmacy interactions. Limitations were identified regarding the high workload of pharmacists, but particularly their lack of know-how and experience in dealing with information systems (IST) for the provision of pharmaceutical services. This paper summarizes a research project in which an online pharmaceutical service was proposed, designed, developed

How pharmaceutical industry employees manage competing commitments in the face of public criticism.

PubMed

Lipworth, Wendy; Montgomery, Kathleen; Little, Miles

2013-10-01

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the "medical affairs" departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance.

Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history

PubMed Central

Nagaich, Upendra; Sadhna, Divya

2015-01-01

There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm's recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall. PMID:25599028

Quality assessment of the visits of pharmaceutical company representatives to hospital pharmacists.

PubMed

Fonzo-Christe, Caroline; Herrmann, François; Bonnabry, Pascal

2005-11-19

To evaluate whether the quality of pharmaceutical company representatives' (PCRs) visits to hospital pharmacists can be improved by written communication of the results of an evaluation of their visits. Pilot study with prospective evaluation of overall visit quality and strength of request for adding drugs to the hospital formulary, and of the scientific quality of products presentations using a standardized form. Two one-year study periods (59 vs. 61 visits) separated by the intervention (global results of the first period sent to each drug company). No difference was observed between both periods in overall visit quality (VAS 0 = null, 10 = excellent: mean 4.7 (2.1 SD) vs. 5.2 (2.1) or strength of request for adding drug to hospital formulary (VAS 0 = null, 10 = extreme: 7.0 [2.6] vs. 7.2 [2.7]). Clarity and scientific value of products' presentations and scientific value of responses were better during the second study period, as a sign of quality improvement. This study suggests that systematic quality evaluation of PCRs visits and communication of results to drug companies may improve the scientific quality of products' presentation.

Sulfite-containing Canadian pharmaceutical products available in 1991.

PubMed Central

Miyata, M; Schuster, B; Schellenberg, R

1992-01-01

OBJECTIVE: To compile an inclusive list of Canadian pharmaceutical products available in 1991 that contained sulfites. DATA SOURCES: Written and oral responses from 94 pharmaceutical companies selected from the 1989 Compendium of Pharmaceuticals and Specialties. RESULTS: A list of sulfite-containing pharmaceutical products was compiled from data supplied by the 90 responding companies. Companies whose products contained no sulfites were separately identified. CONCLUSIONS: Sulfites are present in many pharmaceutical products and are one of many excipients and additives that have been reported to cause severe adverse reactions. The provided list should be a useful aid for health care practitioners when prescribing pharmaceutical products for sulfite-sensitive patients. PMID:1483237

Technological innovation capability in Malaysian-owned resource-based manufacturing companies: Early findings

NASA Astrophysics Data System (ADS)

Razali, Nur Fhathyhah; Mohd Suradi, Nur Riza; Ahmad Shahabuddin, Faridatul Azna; Ismail, Wan Rosmanira; Abidin, Norkisme Zainal; Ahmad, Nor Amalina; Mustafa, Zainol

2013-04-01

This study aims to identify the determinants of technological innovation capability of Malaysian-owned companies in the resources-based manufacturing, to identify the relationship between technological innovation capability (TIC) and technological innovation performance (TIP) for the resource-based manufacturing. Furthermore, this study also aims to identify innovation capability factors that need more emphasis and improvements from the respective authority. The scope of the study covers four industries which are petrochemical industries, pharmaceutical industries, palm oil-based industries and food processing industries which are located in the state of Selangor. Descriptive analysis, correlation analysis and performance capability analysis were used in this study. It was found that, technological innovation capabilities (TIC) for companies in the resource-based manufacturing are moderate. Factors such as policies capability, human resources capability and facilities capability have a positive relationship with the performance of technological innovation (TIP). These findings will help the government in making decisions and better implementation of policies to strengthen the competitiveness of the company, particularly in resource-based manufacturing.

Marketing the use of the space environment for the processing of biological and pharmaceutical materials

NASA Technical Reports Server (NTRS)

1984-01-01

The perceptions of U.S. biotechnology and pharmaceutical companies concerning the potential use of the space environment for the processing of biological substances was examined. Physical phenomena that may be important in space-base processing of biological materials are identified and discussed in the context of past and current experiment programs. The capabilities of NASA to support future research and development, and to engage in cooperative risk sharing programs with industry are discussed. Meetings were held with several biotechnology and pharmaceutical companies to provide data for an analysis of the attitudes and perceptions of these industries toward the use of the space environment. Recommendations are made for actions that might be taken by NASA to facilitate the marketing of the use of the space environment, and in particular the Space Shuttle, to the biotechnology and pharmaceutical industries.

[Chapter 5. The internationalization of the Japanese pharmaceutical industry (1980-2010)].

PubMed

Yongue, Julia S

2014-01-01

The Japanese pharmaceutical industry experienced a period of rapid and economic growth following the introduction of the national healthcare system in 1961. Triggered by a major revision in Japanese legislation from process to substance patents, leading Japanese pharmaceutical companies began to invest in research and development (R&D). By the mid-1980s, some had managed to develop their first internationally marketable drugs, many of which were antibiotics. The emergence of novel drugs gave companies the impetus to engage in progressively more appreciable investments in Asia, Europe and the United States. In the 1980s, internationalization was mainly inwardly focused so as to limit firms' exposure to risk. However, as profits increased in the 1990s from the sale of new drugs, Japanese pharmaceutical companies were able to engage in even more sizeable, outwardly focused investments. By 2010, Japan's leading pharmaceutical enterprises had succeeded in putting place three types of global operations: manufacturing, marketing and R&D.

Pharmaceutical portfolio management: global disease burden and corporate performance metrics.

PubMed

Daems, Rutger; Maes, Edith; Mehra, Maneesha; Carroll, Benjamin; Thomas, Adrian

2014-09-01

Biopharmaceutical companies face multiple external pressures. Shareholders demand a profitable company while governments, nongovernmental third parties, and the public at large expect a commitment to improving health in developed and, in particular, emerging economies. Current industry commercial models are inadequate for assessing opportunities in emerging economies where disease and market data are highly limited. The purpose of this article was to define a conceptual framework and build an analytic decision-making tool to assess and enhance a company's global portfolio while balancing its business needs with broader social expectations. Through a case-study methodology, we explore the relationship between business and social parameters associated with pharmaceutical innovation in three distinct disease areas. The global burden of disease-based theoretical framework using disability-adjusted life-years provides an overview of the burden associated with particular diseases. The social return on investment is expressed as disability-adjusted life-years averted as a result of the particular pharmaceutical innovation. Simultaneously, the business return on investment captures the research and development costs and projects revenues in terms of a profitability index. The proposed framework can assist companies as they strive to meet the medical needs of populations around the world for decades to come. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Nontraditional roles for certified pharmacy technicians in a pharmaceutical company.

PubMed

Fung, Stacey M; Gilmour, Christine; McCracken, David; Shane, Korban; Matsuura, Gary

2006-01-01

To describe nontraditional roles for Certified Pharmacy Technicians (CPhTs) within pharmaceutical industry. Drug information department within a large biotechnology/pharmaceutical organization. The Medical Communications department within Genentech uses a skills-mix staffing model in which employees with varying educational and training backgrounds work as a team on meeting the informational needs of consumers and health professionals who contact the company. One position within the department is that of Medical Communications Associate, responsible primarily for managing product inquiries. Medical Communications Associates have degrees in life sciences or an equivalent combination of education and experience, including a minimum of 2 years of related experience in the health care industry. Currently, four of the seven Medical Communications Associates in the department are CPhTs. Not applicable. Ability to recruit CPhTs for Medical Communications Associate positions, and job satisfaction of those hired into these positions. Critical basic skills needed for the Medical Communications Associate position include strong computer literacy, ability to multitask, and ability to work in an environment with frequent interruptions. Strong oral and written communications skills, customer service skills, ability to deal with stressful situations, product-specific knowledge, ability to work on a daily basis with Medical Communications Pharmacists, and knowledge of medical terminology are also important. The skills set of CPhTs matches these requirements, as evidenced by the experiences of the four staff members who have worked in the department for a total of 17 person-years. This nontraditional role for CPhTs can be rewarding and beneficial to all, affording an unique opportunity within the pharmaceutical industry. The skill set and experience of CPhTs can be used in the nontraditional pharmacy practice setting of drug information.

Trade secrets in life science and pharmaceutical companies.

PubMed

Nealey, Tara; Daignault, Ronald M; Cai, Yu

2014-11-20

Trade secret protection arises under state common law and state statutes. In general, a trade secret is information that is not generally known to the public and is maintained as a secret, and it provides a competitive advantage or economic benefit to the trade secret holder. Trade secrets can be worth tens or hundreds of millions of dollars, and damage awards in trade secret litigation have been high; often, there is a lot at stake. Obtaining a trade secret through "improper means" is misappropriation. If the alleged trade secret, however, was developed independently, known publicly, or not maintained as a secret, then those defenses may successfully overcome a claim for trade secret misappropriation. With today's interconnectedness in the biotechnology and pharmaceutical fields, more collaborations, joint ventures, and outsourcing arrangements among firms, and increased mobility of employees' careers, life science companies need to not only understand how to protect their trade secrets, but also know how to defend against a claim for trade secret theft. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

Trade Secrets in Life Science and Pharmaceutical Companies

PubMed Central

Nealey, Tara; Daignault, Ronald M.; Cai, Yu

2015-01-01

Trade secret protection arises under state common law and state statutes. In general, a trade secret is information that is not generally known to the public and is maintained as a secret, and it provides a competitive advantage or economic benefit to the trade secret holder. Trade secrets can be worth tens or hundreds of millions of dollars, and damage awards in trade secret litigation have been high; often, there is a lot at stake. Obtaining a trade secret through “improper means” is misappropriation. If the alleged trade secret, however, was developed independently, known publicly, or not maintained as a secret, then those defenses may successfully overcome a claim for trade secret misappropriation. With today’s interconnectedness in the biotechnology and pharmaceutical fields, more collaborations, joint ventures, and outsourcing arrangements among firms, and increased mobility of employees’ careers, life science companies need to not only understand how to protect their trade secrets, but also know how to defend against a claim for trade secret theft. PMID:25414378

Chemistry in the Pharmaceutical Industry

NASA Astrophysics Data System (ADS)

Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

Research on a simulation-based ship production support system for middle-sized shipbuilding companies

NASA Astrophysics Data System (ADS)

Song, Young Joo; Woo, Jong Hun; Shin, Jong Gye

2009-12-01

Today, many middle-sized shipbuilding companies in Korea are experiencing strong competition from shipbuilding companies in other nations. This competition is particularly affecting small- and middle-sized shipyards, rather than the major shipyards that have their own support systems and development capabilities. The acquisition of techniques that would enable maximization of production efficiency and minimization of the gap between planning and execution would increase the competitiveness of small- and middle-sized Korean shipyards. In this paper, research on a simulation-based support system for ship production management, which can be applied to the shipbuilding processes of middle-sized shipbuilding companies, is presented. The simulation research includes layout optimization, load balancing, work stage operation planning, block logistics, and integrated material management. Each item is integrated into a network system with a value chain that includes all shipbuilding processes.

The prevalence and incidence of medical conditions in healthy pharmaceutical company employees who volunteer to participate in medical research

PubMed Central

Singh, S D; Williams, A J

1999-01-01

Aims Although clinical research in healthy volunteers is commonly performed there have been few studies of the value of the medical screening of subjects. The aim of this study was to investigate the prevalence and incidence of medical conditions found during the medical screening of ‘healthy’ subjects employed in a pharmaceutical company who volunteered to participate in medical research. Methods This was a retrospective study of the medical notes of all the subjects who volunteered for membership of the Zeneca Clinical Pharmacology Unit’s healthy volunteer panel over a 4 year period from 1990 to 1994. The prevalence of medical conditions found at presentation was determined. The incidence of medical conditions during the 4 year observation period was also ascertained. Medical screening included a full medical history and examination, clinical chemistry, haematology and urinalysis screens, pulmonary function tests, ECGs, 24 h ambulatory cardiac monitoring and a request for information from the volunteer’s General Practitioner. Results Prevalence-1293 subjects volunteered to join the panel of which 156 subjects (12%) were not accepted at presentation including 141 (10.9%) for medical reasons. The most medical common reasons were; previously diagnosed medical conditions (3.3%), cardiovascular abnormalities (1.9%), abnormal liver function tests (1.9%), anaemia (1.2%), hyperlipidaemia (1.1%), excess alcohol intake (0.6%) and thyroid disease (0.5%). Incidence—36 of the 1137 volunteers (0.8% per year) accepted onto the panel subsequently developed medical conditions of which the most common were; anaemia (0.29% per year), cardiovascular abnormalities (0.13% per year) and vasovagal syncope (0.13% per year). Conclusions This study demonstrates the importance of medical screening before healthy volunteers participate in clinical research. PMID:10383556

Pharmaceutical technology management--profitable business avenue.

PubMed

Puthli, Shivanand P

2010-01-01

Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey.

PubMed

Van Campen, Luann E; Allen, Albert J; Watson, Susan B; Therasse, Donald G

2015-04-03

Background : Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods : Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results : Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions : Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service

A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey

PubMed Central

Van Campen, Luann E.; Allen, Albert J.; Watson, Susan B.; Therasse, Donald G.

2015-01-01

Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

PubMed

Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

2013-01-22

The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5�

[Advertising and Zeitgeist. The advertising of Schwabe Pharmaceuticals].

PubMed

Hofmann, Cornelia; Riha, Ortrun

2015-01-01

This contribution explores the advertisements for homeopathic products in magazines in the first half of the twentieth century, focusing on the period between 1933 and 1945 and based on the example of the pharmaceutical company Dr Willmar Schwabe. In the first half of the twentieth century, Schwabe Pharmaceuticals was market leader for homeopathic and other complementary medical products (phytotherapy, biochemicals). The example chosen as well as the time frame complement the existing research. We searched three German publications (the homeopathy journal Leipziger Populäre Zeitschrift für Homöopathie, the medical weekly Münchner Medizinische Wochenschrift and the pharma magazine Pharmazeutische Zeitung) and collected target-group-specific results for laypersons, physicians and pharmacists. Analysis of the images and texts in the selected advertisements often reflected the historical background and the respective health policies (wartime requirements, times of need, "Neue Deutsche Heilkunde"). The history of this traditional company was seen as an important point in advertising, as were the recognisability of the brand through the company logo, the emphasis on the high quality of their products and the reference to the company's own research activities. We furthermore found the kind of argumentation that is typical of natural medicine (naturalness, the power of the sun, prominent representatives). Schwabe met the expectations of its clients, who were interested in complementary medicine, whilst pursuing an approach to homeopathy that was compatible with natural science, and it presented itself as a modern, scientifically oriented enterprise. The company did not lose credibility as a result, but increased its clientele by expanding to include the whole naturopathic market.

Scientific misconduct, the pharmaceutical industry, and the tragedy of institutions.

PubMed

Cohen-Kohler, Jillian Clare; Esmail, Laura C

2007-09-01

This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient.

An Instructional Design Model for Developing a Computer Curriculum To Increase Employee Productivity in a Pharmaceutical Company.

ERIC Educational Resources Information Center

Stumpf, Mark R.

This report presents an instructional design model that was developed for use by the End-Users Computing department of a large pharmaceutical company in developing effective--but not lengthy--microcomputer training seminars to train office workers and executives in the proper use of computers and thus increase their productivity. The 14 steps of…

New Product Development in the Pharmaceutical Industry: Evidence from a generic market.

PubMed

Yousefi, Nazila; Mehralian, Gholamhossein; Rasekh, Hamid Reza; Yousefi, Mina

2017-01-01

In today's competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires structured based on the AHP (Analytical Hierarchy Process) approach. Although the NPD success factors seem the same in both generic and bio-generic pharmaceutical industries, the underlying factors and related sub-factors show the different importance in these two industries. However, this study reveal that, the company capabilities is the most important factor affecting new product development success in both pharmaceutical generic and bio-generic industry. The results of this study contribute to create baseline information for pharmaceutical industry especially Iranian pharmaceutical companies to be more effective in budget allocation on improving NPD success factors so that they can boost the success rate of NPD more effectively.

New Product Development in the Pharmaceutical Industry: Evidence from a generic market

PubMed Central

Yousefi, Nazila; Mehralian, Gholamhossein; Rasekh, Hamid Reza; Yousefi, Mina

2017-01-01

In today’s competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires structured based on the AHP (Analytical Hierarchy Process) approach. Although the NPD success factors seem the same in both generic and bio-generic pharmaceutical industries, the underlying factors and related sub-factors show the different importance in these two industries. However, this study reveal that, the company capabilities is the most important factor affecting new product development success in both pharmaceutical generic and bio-generic industry. The results of this study contribute to create baseline information for pharmaceutical industry especially Iranian pharmaceutical companies to be more effective in budget allocation on improving NPD success factors so that they can boost the success rate of NPD more effectively. PMID:28979339

Quantitative magnetic resonance micro-imaging methods for pharmaceutical research.

PubMed

Mantle, M D

2011-09-30

The use of magnetic resonance imaging (MRI) as a tool in pharmaceutical research is now well established and the current literature covers a multitude of different pharmaceutically relevant research areas. This review focuses on the use of quantitative magnetic resonance micro-imaging techniques and how they have been exploited to extract information that is of direct relevance to the pharmaceutical industry. The article is divided into two main areas. The first half outlines the theoretical aspects of magnetic resonance and deals with basic magnetic resonance theory, the effects of nuclear spin-lattice (T(1)), spin-spin (T(2)) relaxation and molecular diffusion upon image quantitation, and discusses the applications of rapid magnetic resonance imaging techniques. In addition to the theory, the review aims to provide some practical guidelines for the pharmaceutical researcher with an interest in MRI as to which MRI pulse sequences/protocols should be used and when. The second half of the article reviews the recent advances and developments that have appeared in the literature concerning the use of quantitative micro-imaging methods to pharmaceutically relevant research. Copyright © 2010 Elsevier B.V. All rights reserved.

Incentives for Starting Small Companies Focused on Rare and Neglected Diseases.

PubMed

Ekins, Sean; Wood, Jill

2016-04-01

Starting biotech or pharmaceutical companies is traditionally thought to be based around a scientist, their technology platform or a clinical candidate spun out from another company. Between us we have taken a different approach and formed two small early stage companies after initially leveraging the perspective of a parent with a child with a life-threatening rare disease. Phoenix Nest ( http://www.phoenixnestbiotech.com/ ) was co-founded to work on treatments for Sanfilippo syndrome a devastating neurodegenerative lysosomal storage disorder. In the space of just over 3 years we have built up collaborations with leading scientists in academia and industry and been awarded multiple NIH small business grants. The second company, Collaborations Pharmaceuticals Inc. ( http://www.collaborationspharma.com/ ) was founded to address some of the other 7000 or so rare diseases as well as neglected infectious diseases. The Rare Pediatric Disease Priority Review Voucher is likely the most important incentive for companies working on rare diseases with very small populations. This may also be partially responsible for the recent acquisitions of rare disease companies with late stage candidates. Lessons learned in the process of starting our companies are that rare disease parents or patients can readily partner with a scientist and fund research through NIH grants rather than venture capital or angel investors initially. This process may be slow so patience and perseverance is key. We would encourage other pharmaceutical scientists to meet rare disease parents, patients or advocates and work with them to further the science on their diseases and create a source of future drugs.

Incentives for Starting Small Companies Focused on Rare and Neglected Diseases

PubMed Central

Ekins, Sean; Wood, Jill

2015-01-01

Starting biotech or pharmaceutical companies is traditionally thought to be based around a scientist, their technology platform or a clinical candidate spun out from another company. Between us we have taken a different approach and formed two small early stage companies after initially leveraging the perspective of a parent with a child with a life-threatening rare disease. Phoenix Nest (http://www.phoenixnestbiotech.com/) was co-founded to work on treatments for Sanfilippo syndrome a devastating neurodegenerative lysosomal storage disorder. In the space of just over 3 years we have built up collaborations with leading scientists in academia and industry and been awarded multiple NIH small business grants. The second company, Collaborations Pharmaceuticals Inc. (http://www.collaborationspharma.com/) was founded to address some of the other 7000 or so rare diseases as well as neglected infectious diseases. The Rare Pediatric Disease Priority Review Voucher is likely the most important incentive for companies working on rare diseases with very small populations. This may also be partially responsible for the recent acquisitions of rare disease companies with late stage candidates. Lessons learned in the process of starting our companies are that rare disease parents or patients can readily partner with a scientist and fund research through NIH grants rather than venture capital or angel investors initially. This process may be slow so patience and perseverance is key. We would encourage other pharmaceutical scientists to meet rare disease parents, patients or advocates and work with them to further the science on their diseases and create a source of future drugs. PMID:26666772

Code of ethics for the national pharmaceutical system: Codifying and compilation

PubMed Central

Salari, Pooneh; Namazi, Hamidreza; Abdollahi, Mohammad; Khansari, Fatemeh; Nikfar, Shekoufeh; Larijani, Bagher; Araminia, Behin

2013-01-01

Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended. PMID:24174954

Medicine and pharmacy--facts and myths about the development of an innovative pharmaceutical industry in Poland.

PubMed

Kubiak, Włodzimierz

2005-01-01

Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines and a wide range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. Innovation is necessary. The human population is ageing, and the task of an innovative pharmaceutical industry is to keep it in a good condition. The use of innovative drugs can translate directly into lowering the costs of illness. A continuous reduction in spending on healthcare has been observed. The costs of inventing an innovative drug are enormous though (US dollar 800 million), and studies on a new drug last between 10 and 13 years. An essential element in recovering the incurred costs and ensuring funds needed for new research is protection by patent. Innovative pharmaceutical companies in Poland are committed to increasing the competitiveness and sustaining the development of not only the market, but also the entire pharmaceutical sector. It is a group of companies of crucial importance to the Polish healthcare system, as it influences improvement in the quality of medical services. Through their investments and spending on research and development, innovative companies accelerate economic growth. In Poland, the innovative pharmaceutical industry is represented by the Association of Pharmaceutical Companies Representatives in Poland (SPFFwP).

Pharmaceutical companies and global lack of access to medicines: strengthening accountability under the right to health.

PubMed

Grover, Anand; Citro, Brian; Mankad, Mihir; Lander, Fiona

2012-01-01

Many medicines currently available on the market are simply too expensive for millions around the world to afford. Many medicines available in the developing world are only available to a small percentage of the population due to economic inequities. The profit-seeking behavior of pharmaceutical companies exacerbates this problem. In most cases, the price reductions required to make drugs affordable to a broader class of people in the developing world are not offset by the resultant increase in sales volume. Simply stated, in most of the developing world, it is more profitable to sell drugs to the very wealthy at high prices than it is to sell cheaper drugs to a greater number of people. As a result, medicines remain unaffordable for the vast majority of people in many parts of the world. While this might be an acceptable outcome for certain commodities, such as luxury goods, it is completely unacceptable for life-saving medicines. Therefore, in order to effectively address the global lack of access to medicines, the role pharmaceutical companies play in the international intellectual property regime must be critically examined. © 2012 American Society of Law, Medicine & Ethics, Inc.

Dropwise additive manufacturing of pharmaceutical products for solvent-based dosage forms.

PubMed

Hirshfield, Laura; Giridhar, Arun; Taylor, Lynne S; Harris, Michael T; Reklaitis, Gintaras V

2014-02-01

In recent years, the US Food and Drug Administration has encouraged pharmaceutical companies to develop more innovative and efficient manufacturing methods with improved online monitoring and control. Mini-manufacturing of medicine is one such method enabling the creation of individualized product forms for each patient. This work presents dropwise additive manufacturing of pharmaceutical products (DAMPP), an automated, controlled mini-manufacturing method that deposits active pharmaceutical ingredients (APIs) directly onto edible substrates using drop-on-demand (DoD) inkjet printing technology. The use of DoD technology allows for precise control over the material properties, drug solid state form, drop size, and drop dynamics and can be beneficial in the creation of high-potency drug forms, combination drugs with multiple APIs or individualized medicine products tailored to a specific patient. In this work, DAMPP was used to create dosage forms from solvent-based formulations consisting of API, polymer, and solvent carrier. The forms were then analyzed to determine the reproducibility of creating an on-target dosage form, the morphology of the API of the final form and the dissolution behavior of the drug over time. DAMPP is found to be a viable alternative to traditional mass-manufacturing methods for solvent-based oral dosage forms. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

Understanding pharmaceutical research manipulation in the context of accounting manipulation.

PubMed

Brown, Abigail

2013-01-01

The problem of the manipulation of data that arises when there is both opportunity and incentive to mislead is better accepted and studied - though by no means solved - in financial accounting than in medicine. This article analyzes pharmaceutical company manipulation of medical research as part of a broader problem of corporate manipulation of data in the creation of accounting profits. The article explores how our understanding of accounting fraud and misinformation helps us understand the risk of similar information manipulation in the medical sciences. This understanding provides a framework for considering how best to improve the quality of medical research and analysis in light of the current system of medical information production. I offer three possible responses: (1) use of the Dodd-Frank whistleblower provisions to encourage reporting of medical research fraud; (2) a two-step academic journal review process for clinical trials; and (3) publicly subsidized trial-failure insurance. These would improve the release of negative information about drugs, thereby increasing the reliability of positive information. © 2013 American Society of Law, Medicine & Ethics, Inc.

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

PubMed

Fisher, Adam C; Lee, Sau L; Harris, Daniel P; Buhse, Lucinda; Kozlowski, Steven; Yu, Lawrence; Kopcha, Michael; Woodcock, Janet

2016-12-30

Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public. Published by Elsevier B.V.

Rho Chi lecture. Pharmaceutical sciences in the next millennium.

PubMed

Triggle, D J

1999-02-01

Even a cursory survey of this article suggests that the pharmaceutical sciences are being rapidly transformed under the influence of both the new technologies and sciences and the economic imperatives. Of particular importance are scientific and technological advances that may greatly accelerate the critical process of discovery. The possibility of a drug discovery process built around the principles of directed diversity, self-reproduction, evolution, and self-targeting suggests a new paradigm of lead discovery, one based quite directly on the paradigms of molecular biology. Coupled with the principles of nanotechnology, we may contemplate miniature molecular machines containing directed drug factories, circulating the body and capable of self-targeting against defective cells and pathways -- the ultimate "drug delivery machine." However, science and technology are not the only factors that will transform the pharmaceutical sciences in the next century. The necessary reductions in the costs of drug discovery brought about by the rapidly increasing costs of the current drug discovery paradigms means that efforts to decrease the discovery phase and to make drug development part of drug discovery will become increasingly important. This is likely to involve increasing numbers of "alliances," as well as the creation of pharmaceutical research cells -- highly mobile and entrepreneurial groups within or outside of a pharmaceutical company that are formed to carry out specific discovery processes. Some of these will be in the biotechnology industry, but an increasing number will be in universities. The linear process from basic science to applied technology that has been the Western model since Vannevar Bush's Science: The Endless Frontier has probably never been particularly linear and, in any event, is likely to be rapidly supplanted by models where science, scientific development, and technology are more intimately linked. The pharmaceutical sciences have always been

The productivity crisis in pharmaceutical R&D.

PubMed

Pammolli, Fabio; Magazzini, Laura; Riccaboni, Massimo

2011-06-01

Advances in the understanding of the molecular basis of diseases have expanded the number of plausible therapeutic targets for the development of innovative agents in recent decades. However, although investment in pharmaceutical research and development (R&D) has increased substantially in this time, the lack of a corresponding increase in the output in terms of new drugs being approved indicates that therapeutic innovation has become more challenging. Here, using a large database that contains information on R&D projects for more than 28,000 compounds investigated since 1990, we examine the decline of R&D productivity in pharmaceuticals in the past two decades and its determinants. We show that this decline is associated with an increasing concentration of R&D investments in areas in which the risk of failure is high, which correspond to unmet therapeutic needs and unexploited biological mechanisms. We also investigate the potential variations in productivity with regard to the regional location of companies and find that although companies based in the United States and Europe differ in the composition of their R&D portfolios, there is no evidence of any productivity gap.

[An analysis of the pharmaceuticals market in Vietnam].

PubMed

Simonet, D

2001-01-01

pharmaceutical researchers. A strong decentralisation process characterises the pharmaceutical sector, with pharmacies in the provinces and districts while wholesalers remain located in Hanoi and Saigon. The presence of many middlemen has contributed to an increase in prices. Today, a concentration of pharmacies is still noted in inner cities while the suburbs and the villages still have difficulties supplying drugs for inhabitants. Solutions have been implemented such as the opening of new pharmacies and additional professional training for pharmacists. Prices were lowered while the quality of the supply chain was improved. Local production is encouraged as hospitals are prompted to prescribe Vietnamese products. The modernisation of the Vietnamese pharmaceutical industry is also visible through the importation of medical materials and an increase in the number of private hospitals financed with both the help of local and foreign investors, mainly through joint-ventures, most often in Saigon and Hanoi. The renovation of local hospitals was also possible with the help of France and Japan. Columbia Gia Dinh International, located in Saigon, is one of the very few US/Vietnamese medical institutions created with a local partner, the Gia Dinh hospital. The recovery of the economy will accelerate the creation of new projects designed to improve local medical infrastructures. Other private companies, some of which are based in Singapore, have been specifically designed to deliver care to expatriates working in Vietnam. Insurance coverage has been provided in Vietnam since in 1992. Other improvements concern the implementation of "Good Manufacturing Practices" (GMP) and "Good Laboratory Practices" and "Good Storage Practices". Most norms were implemented at the end of the 90s in joint companies linking foreign investors and local partners or in independent foreign drug manufacturers based in Vietnam. Special areas were created to receive high tech investments in the medical and

[Early achievements of the Danish pharmaceutical industry-6 Pharmacia].

PubMed

Grevsen, Jørgen V; Kruse, Edith; Kruse, Poul R

2014-01-01

The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 6 deals with products from A/S Pharmacia. A/S Pharmacia was established in Copenhagen in 1922 as a Danish limited company by the enterprising pharmacist Edward Jacobsen. Pharmacia was not Jacobsen's first pharmaceutical company as previously he had established a pharmaceutical agency already in 1913 which in 1919 was reorganized to a limited company by the name of A/S Edward Jacobsen. This agency was later extended to include a production of generics. Jacobsen remained the co-owner and manager of Pharmacia until 1934 where he resigned and established another company, A/S Ejco, for the manufacture of generics. It is worth mentioning that already in 1911 a Swedish pharmaceutical company was established named AB Pharmacia. Today we do not know whether Edward Jacobsen knew about this Swedish company. Later on in 1936 AB Pharmacia and A/S Pharmacia made a contract concerning mutual market sharing, and a research cooperation was brought about between the two companies which resulted in an increase of turnover for A/S Pharmacia. In 1955 the cooperation between the two companies was increased as the Swedish company joined as principal shareholder with the purpose of continuing and developing the Danish company as an independent pharmaceutical company with its own research and development as well as manufacture, control and marketing. Therefore Pharmacia in Denmark was able to establish a synthesis factory in Koge and move the domicile to new premises in Hillered. In 1993 Pharmacia was presented in a printed matter as "The largest Nordic pharmaceutical company" as a result of the merger between the Swedish Kabi Pharmacia, formerly established by a merger between Kabi Vitrum and AB Pharmacia, and the Italian Farmitalia Carlo Erba. Only two years later in 1995 Pharmacia merged with the American pharmaceutical company The

Australian consumer responses to DTCA and other pharmaceutical company sponsored advertisements.

PubMed

Hall, Danika V; Jones, Sandra C

2008-10-01

This study aimed to elicit and compare the responses of Australian consumers towards New Zealand (NZ) direct-to-consumer-advertisements (DTCA) for prescription medicines and matched pharmaceutical company-sponsored advertisements from Australia. A survey questionnaire was mailed to a random sample of residents in a metropolitan area in NSW. Potential participants were randomised to receive one of four different advertisements: two for weight loss and two for Alzheimer's disease. A total of 413 responses were received and analysed. Participants reported that they were not likely to ask for a prescription from their doctor as a result of seeing any of the advertisements in the study. The Australian disease awareness advertisement that did not refer to a medicinal treatment was perceived as more valuable than the NZ DTCA or other Australian advertisement. Overall, participants found it easier to make sense of the more informational advertisements, and felt that there was insufficient information regarding the disease/condition and treatments in the more emotive and transformational advertisements. While there is concern over potential negative effects of pharmaceutical-sponsored disease awareness advertisements, this study found that Australian consumers perceived an informational advertisement with a list of disease symptoms to be valuable. These findings contribute to debate in New Zealand and Australia regarding DTCA and disease awareness advertising, and have the potential to inform guidelines relevant to the advertising of prescription medicine in each country.

Paying for On-Patent Pharmaceuticals

PubMed Central

Goldfield, Norbert

2016-01-01

In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets. For payers to adopt use of a new pharmaceutical, they would require objective third-party evaluation and pharmaceutical manufacturer accountability for projected outcomes efficacy of their treatments on population health. The pay for outcomes underpinning of this approach falls within the wider aspirations of health reform. PMID:26945298

Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation: an industry perspective

PubMed Central

Auby, Philippe

2008-01-01

A large proportion of medicines used in children are prescribed off-label, and children have often been denied access to new or innovative medications. Because such situation is unethical, the need to obtain paediatric information for medicines used in children seems nowadays a matter of consensus on a global basis. Based on this, it was clear in EU, like what has happened in the US, that there was a need for a legal obligation for Pharmaceutical Companies to perform studies. This new European Paediatric Regulation that entered into force in 2007 opens a new era of European drug regulatory history and will offer a major opportunity to improve children's health through advancements in research by providing a new framework for evaluating the efficacy and safety of medicines for children. But, paediatric development remains challenging and the hurdles of conducting research in paediatric population are numerous. The article presents the new European Paediatric Regulation, illustrates its rationale through paediatric psychopharmacology, and discusses some of its consequences on paediatric research from an industry perspective. Recommendations for further international collaboration are also suggested to make global paediatric development plans. PMID:19063723

[Animal welfare and corporate welfare in pharmaceutical R&D - the future of third-party assessment].

PubMed

Suzuki, Makoto

For research and development (R&D) of new drugs, animal experimentation is indispensable, and research institutes, pharmaceutical companies, or contract research organizations routinely conduct preclinical studies of efficacy, safety, or metabolism using laboratory animals. However, animal experimentation entails some organizational risks. One is the suspension of R&D of a new drug, because in the course of clinical studies it becomes apparent that the drug has limited efficacy, unexpected side effects, and/or unexpected metabolites. Another risk is damage to the company image by development of an unfavorable reputation. Society has accepted animal experimentation as a necessary evil, but if such experimentation is not conducted with adequate concern for animal welfare, social sanctions will against that institute, company or organization will result. Once this happens, it is difficult to recover a good public image. Therefore, pharmaceutical companies must conduct animal experiments so as to obtain highly useful data without sacrificing public favor. One way to maintain a good reputation is through third-party accreditation, which verifies that the institute, company or organization and its researchers value animal welfare appropriately.

The impact of mergers on pharmaceutical R&D.

PubMed

LaMattina, John L

2011-08-01

Mergers and acquisitions in the pharmaceutical industry have substantially reduced the number of major companies over the past 15 years. The short-term business rationale for this extensive consolidation might have been reasonable, but at what cost to research and development productivity?

Inkjet printing for pharmaceutics - A review of research and manufacturing.

PubMed

Daly, Ronan; Harrington, Tomás S; Martin, Graham D; Hutchings, Ian M

2015-10-30

Global regulatory, manufacturing and consumer trends are driving a need for change in current pharmaceutical sector business models, with a specific focus on the inherently expensive research costs, high-risk capital-intensive scale-up and the traditional centralised batch manufacturing paradigm. New technologies, such as inkjet printing, are being explored to radically transform pharmaceutical production processing and the end-to-end supply chain. This review provides a brief summary of inkjet printing technologies and their current applications in manufacturing before examining the business context driving the exploration of inkjet printing in the pharmaceutical sector. We then examine the trends reported in the literature for pharmaceutical printing, followed by the scientific considerations and challenges facing the adoption of this technology. We demonstrate that research activities are highly diverse, targeting a broad range of pharmaceutical types and printing systems. To mitigate this complexity we show that by categorising findings in terms of targeted business models and Active Pharmaceutical Ingredient (API) chemistry we have a more coherent approach to comparing research findings and can drive efficient translation of a chosen drug to inkjet manufacturing. Copyright © 2015 Elsevier B.V. All rights reserved.

Nurse practitioners' perceptions and participation in pharmaceutical marketing.

PubMed

Crigger, Nancy; Barnes, Kristen; Junko, Autumn; Rahal, Sarah; Sheek, Casey

2009-03-01

This paper reports on a study conducted to describe family nurse practitioners' perceptions towards and participation in pharmaceutical marketing and to explore the relationships among related variables. The pharmaceutical industry's intense global marketing strategies have resulted in widespread concern in healthcare professionals and professional groups, sectors of the public in many countries, and in the World Health Organization. Research on healthcare providers' participation in pharmaceutical marketing indicates that these relationships are conflicts of interests and compromise healthcare providers' prescribing practices and trust. Nursing, as a discipline, appears to be slow to address the impact of pharmaceutical marketing on nursing practice. Questionnaires about perceptions and participation in pharmaceutical marketing were completed by a random sample of 84 licensed family nurse practitioners in the United States of America in 2007. Family nurse practitioners viewed pharmaceutical company marketing uncritically as educational and beneficial. They also perceived other providers but not themselves as influenced by pharmaceutical marketing. The findings supported those found in previous research with nurses and physicians. Lack of education, participation in marketing and psychological and social responses may impede family nurse practitioners' ability to respond critically and appropriately to marketing strategies and the conflict of interest it creates.

Pharmaceutical marketing research and the prescribing physician.

PubMed

Greene, Jeremy A

2007-05-15

Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.

Pharmaceutical industry research and cost savings in community-acquired pneumonia.

PubMed

Kessler, Lori A; Waterer, Grant W; Barca, Robin; Wunderink, Richard G

2002-09-01

To provide financial justification for continuing pharmaceutical research in an environment that has met with increasing resistance from insurance carriers to paying for the care of patients enrolled in research studies. Matched case-control study of patients enrolled into inpatient community-acquired pneumonia (CAP) pharmaceutical research protocols. Case patients were enrolled into a CAP pharmaceutical research trial. Control patients were obtained from a prospective cohort study of CAP. Cases were matched to controls on the basis of age, sex, pneumonia severity index (PSI) grade, and comorbid illnesses as measured by the PSI and Acute Physiologic and Chronic Health Evaluation II (APACHE II) scoring systems. Financial data were obtained from hospital billing records. Twenty-five cases were identified and matched to appropriate controls. There was no statistically significant difference in mean PSI and APACHE II scores between cases and controls. There was a significant reduction in the total charges for hospital care of patients enrolled into a pharmaceutical industry trial ($6267 vs $9979; P = .03). As expected, the most dramatic reduction was in pharmacy charges ($642 vs $1797; P = .002), but there were trends toward lower charges in all cost subgroups. Interestingly, there was also a strong trend toward reduced length of hospital stay associated with enrollment in a pharmaceutical trial (4.5 vs 6.0 days; P = .06). Enrollment in a pharmaceutical research protocol results in significant cost savings in patients admitted to the hospital with CAP and may lead to earlier hospital discharge.

Vulnerabilities to misinformation in online pharmaceutical marketing.

PubMed

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2013-05-01

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.

Developing a suitable model for supplier selection based on supply chain risks: an empirical study from Iranian pharmaceutical companies.

PubMed

Mehralian, Gholamhossein; Rajabzadeh Gatari, Ali; Morakabati, Mohadese; Vatanpour, Hossein

2012-01-01

The supply chain represents the critical link between the development of new product and the market in pharmaceutical industry. Over the years, improvements made in supply chain operations have focused largely on ways to reduce cost and gain efficiencies in scale. In addition, powerful regulatory and market forces have provided new incentives for pharmaceutical firms to basically rethink the way they produce and distribute products, and also to re-imagine the role of the supply chain in driving strategic growth, brand differentiation and economic value in the health continuum. The purpose of this paper is to formulate basic factors involved in risk analysis of pharmaceutical industry, and also determine the effective factors involved in suppliers selection and their priorities. This paper is based on the results of literature review, experts' opinion acquisition, statistical analysis and also using MADM models on data gathered from distributed questionnaires. The model consists of the following steps and components: first factors involved in to supply chain risks are determined. Based on them a framework is considered. According the result of statistical analysis and MADM models the risk factors are formulated. The paper determines the main components and influenceial factors involving in the supply chain risks. Results showed that delivery risk can make an important contribution to mitigate the risk of pharmaceutical industry.

Developing a Suitable Model for Supplier Selection Based on Supply Chain Risks: An Empirical Study from Iranian Pharmaceutical Companies

PubMed Central

Mehralian, Gholamhossein; Rajabzadeh Gatari, Ali; Morakabati, Mohadese; Vatanpour, Hossein

2012-01-01

The supply chain represents the critical link between the development of new product and the market in pharmaceutical industry. Over the years, improvements made in supply chain operations have focused largely on ways to reduce cost and gain efficiencies in scale. In addition, powerful regulatory and market forces have provided new incentives for pharmaceutical firms to basically rethink the way they produce and distribute products, and also to re-imagine the role of the supply chain in driving strategic growth, brand differentiation and economic value in the health continuum. The purpose of this paper is to formulate basic factors involved in risk analysis of pharmaceutical industry, and also determine the effective factors involved in suppliers selection and their priorities. This paper is based on the results of literature review, experts’ opinion acquisition, statistical analysis and also using MADM models on data gathered from distributed questionnaires. The model consists of the following steps and components: first factors involved in to supply chain risks are determined. Based on them a framework is considered. According the result of statistical analysis and MADM models the risk factors are formulated. The paper determines the main components and influenceial factors involving in the supply chain risks. Results showed that delivery risk can make an important contribution to mitigate the risk of pharmaceutical industry. PMID:24250442

An Export-Marketing Model for Pharmaceutical Firms (The Case of Iran)

PubMed Central

Mohammadzadeh, Mehdi; Aryanpour, Narges

2013-01-01

Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires. PMID:24250597

An export-marketing model for pharmaceutical firms (the case of iran).

PubMed

Mohammadzadeh, Mehdi; Aryanpour, Narges

2013-01-01

Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires.

Herbicide and pharmaceutical relationships

USDA-ARS?s Scientific Manuscript database

For many years, virtually all pharmaceutical companies had an agrochemical division. This was partly to maximize the benefits of expensive chemical synthesis efforts by searching for many types of useful biological activities. Leads for pharmaceuticals and pesticides often overlap, in some cases l...

Pharmaceutical strategy and innovation: an academics perspective.

PubMed

Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

2007-06-01

The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences.

The view of the pharmaceutical industry.

PubMed

Roche, G; Helenport, J P

1994-06-01

Rhône-Poulenc Rorer has committed itself to the development of artemether because we believe the drug will be of considerable benefit to sufferers from severe falciparum malaria, and because it is a stable, effective and economical compound that can be given by intramuscular injection. The quality of the pharmaceutical product meets international regulatory standards. Artemether is unlikely to yield big profits, but we believe that major pharmaceutical companies have a responsibility to develop such much-needed products. To develop this project further, we will need the assistance of academic institutions, research organizations and international bodies.

Foresight scanning: future directions of clinical and pharmaceutical research.

PubMed

Foster, Brian C

2008-01-01

Foresight Scanning: Future Directions of Clinical and Pharmaceutical Research. Brian C. Foster, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada ABSTRACT The Canadian Society for Pharmaceutical Sciences Satellite Symposium on Foresight Scanning, May 26 and 27, 2008, Nordegg, Alberta, Canada, focussed on the future directions of clinical and pharmaceutical research. The symposium brought together a group of clinicians, regulatory scientists, researchers and students to examine where clinical, pharmaceutical, and regulatory science might be in 10 to 15 years. Industry, regulatory, analytical, and clinical perspectives were presented and discussed, as well as the impact of exogenous (indirect) and endogenous (direct) change drivers. Unconditional funding was provided by Bayer HealthCare; they had no input on the direction of the meeting or selection of speakers. It was envisioned that the more important endogenous drivers may not be new information or changes in technology, policy, regulation, or health care delivery, but amplification of long-term underlying trends by emergence of new technologies, convergence of existing technologies or new communication and collaboration vehicles such as Web 2.0.

Presentation of a Novel Model for Evaluation of Commercialization of Research and Development: Case Study of the Pharmaceutical Biotechnology Industry

PubMed Central

Emami, Hassan; Radfar, Reza

2017-01-01

The current situation in Iran suggests an appropriate basis for developing biotechnology industries, because the patents for the majority of hi-tech medicines registered in developed countries are ending. Biosimilar and technology-oriented companies which do not have patents will have the opportunity to enter the biosimilar market and move toward innovative initiatives. The present research proposed a model by which one can evaluate commercialization of achievements obtained from research with a focus on the pharmaceutical biotechnology industry. This is a descriptive-analytic study where mixed methodology is followed by a heuristic approach. The statistical population was pharmaceutical biotechnology experts at universities and research centers in Iran. Structural equations were employed in this research. The results indicate that there are three effective layers within commercialization in the proposed model. These are a general layer (factors associated with management, human capital, legal infrastructure, communication infrastructure, a technical and executive infrastructures, and financial factors), industrial layer (internal industrial factors and pharmaceutical industry factors), and a third layer that included national and international aspects. These layers comprise 6 domains, 21 indices, 41 dimensions, and 126 components. Compilation of these layers (general layer, industrial layer, and national and international aspects) can serve commercialization of research and development as an effective evaluation package. PMID:29201110

Presentation of a Novel Model for Evaluation of Commercialization of Research and Development: Case Study of the Pharmaceutical Biotechnology Industry.

PubMed

Emami, Hassan; Radfar, Reza

2017-01-01

The current situation in Iran suggests an appropriate basis for developing biotechnology industries, because the patents for the majority of hi-tech medicines registered in developed countries are ending. Biosimilar and technology-oriented companies which do not have patents will have the opportunity to enter the biosimilar market and move toward innovative initiatives. The present research proposed a model by which one can evaluate commercialization of achievements obtained from research with a focus on the pharmaceutical biotechnology industry. This is a descriptive-analytic study where mixed methodology is followed by a heuristic approach. The statistical population was pharmaceutical biotechnology experts at universities and research centers in Iran. Structural equations were employed in this research. The results indicate that there are three effective layers within commercialization in the proposed model. These are a general layer (factors associated with management, human capital, legal infrastructure, communication infrastructure, a technical and executive infrastructures, and financial factors), industrial layer (internal industrial factors and pharmaceutical industry factors), and a third layer that included national and international aspects. These layers comprise 6 domains, 21 indices, 41 dimensions, and 126 components. Compilation of these layers (general layer, industrial layer, and national and international aspects) can serve commercialization of research and development as an effective evaluation package.

The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures

PubMed Central

Lee, Munjae; Choi, Mankyu

2015-01-01

Objectives This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. Methods The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association (KLCA), and data related to stock price is extracted from KISVALUE-Ⅲ of NICE Information Service Co., Ltd. Stata 12.0 was used as the statistical package for panel analysis. Results The current ratio had a positive influence on R&D investment, the debt ratio had a negative influence on R&D investment, and return on investment and net sales growth rate did not have a significant influence on R&D investment. Conclusion It was found in this study that the higher liquidity ratio, the greater the R&D investment. The stability of pharmaceutical companies has a negative influence on R&D investment. This finding is consistent with the prediction that if a company faces a financial risk, it will be passive in R&D investment due to its financial difficulties. PMID:26730355

The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures.

PubMed

Lee, Munjae; Choi, Mankyu

2015-10-01

This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association (KLCA), and data related to stock price is extracted from KISVALUE-Ⅲ of NICE Information Service Co., Ltd. Stata 12.0 was used as the statistical package for panel analysis. The current ratio had a positive influence on R&D investment, the debt ratio had a negative influence on R&D investment, and return on investment and net sales growth rate did not have a significant influence on R&D investment. It was found in this study that the higher liquidity ratio, the greater the R&D investment. The stability of pharmaceutical companies has a negative influence on R&D investment. This finding is consistent with the prediction that if a company faces a financial risk, it will be passive in R&D investment due to its financial difficulties.

The Utilization of Project Management in the Pharmaceutical Industry.

ERIC Educational Resources Information Center

Krusko, Diane; Cangemi, Robert R.

1987-01-01

A survey of 99 pharmaceutical companies concerning their organization and use of project management techniques for research and development found that the industry is using project management increasingly in a variety of ways for better business planning and operations. (MSE)

In silico prediction of pharmaceutical degradation pathways: a benchmarking study.

PubMed

Kleinman, Mark H; Baertschi, Steven W; Alsante, Karen M; Reid, Darren L; Mowery, Mark D; Shimanovich, Roman; Foti, Chris; Smith, William K; Reynolds, Dan W; Nefliu, Marcela; Ott, Martin A

2014-11-03

Zeneth is a new software application capable of predicting degradation products derived from small molecule active pharmaceutical ingredients. This study was aimed at understanding the current status of Zeneth's predictive capabilities and assessing gaps in predictivity. Using data from 27 small molecule drug substances from five pharmaceutical companies, the evolution of Zeneth predictions through knowledge base development since 2009 was evaluated. The experimentally observed degradation products from forced degradation, accelerated, and long-term stability studies were compared to Zeneth predictions. Steady progress in predictive performance was observed as the knowledge bases grew and were refined. Over the course of the development covered within this evaluation, the ability of Zeneth to predict experimentally observed degradants increased from 31% to 54%. In particular, gaps in predictivity were noted in the areas of epimerizations, N-dealkylation of N-alkylheteroaromatic compounds, photochemical decarboxylations, and electrocyclic reactions. The results of this study show that knowledge base development efforts have increased the ability of Zeneth to predict relevant degradation products and aid pharmaceutical research. This study has also provided valuable information to help guide further improvements to Zeneth and its knowledge base.

[The aspects of pricing policy in Azerbaijan pharmaceutical sector].

PubMed

Dzhalilova, K I; Alieva, K Ia

2012-01-01

The effect of macro-, middle- and microeconomic factors on price formation in Azerbaijan pharmaceutical market has been studied. Worldwide pharmaceutical leaders have the goals to become leader on the pharmaceutical market of Azerbaijan and maximize their market share. Non-leaders pharmaceutical companies use different strategies of price formation: prime cost plus markup, or price formation on the base of current prices. It was revealed that domestic pharmaceutical market has high demand elasticity. Future market development is related to stimulation of product development, and hard penetration to the market through realization of price formation strategy. Non-state pharmaceutical organizations to achieve the purpose of survive in conditions of high competition should take in to account the factor perceptions of assortment by customers.

Vulnerabilities to misinformation in online pharmaceutical marketing

PubMed Central

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2013-01-01

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527

Materials science tetrahedron--a useful tool for pharmaceutical research and development.

PubMed

Sun, Changquan Calvin

2009-05-01

The concept of materials science tetrahedron (MST) concisely depicts the inter-dependent relationship among the structure, properties, performance, and processing of a drug. Similar to its role in traditional materials science, MST encompasses the development in the emerging field of pharmaceutical materials science and forms a scientific foundation to the design and development of new drug products. Examples are given to demonstrate the applicability of MST to both pharmaceutical research and product development. It is proposed that a systematic implementation of MST can expedite the transformation of pharmaceutical product development from an art to a science. By following the principle of MST, integration of research among different laboratories can be attained. The pharmaceutical science community as a whole can conduct more efficient, collaborative, and coherent research.

Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape.

PubMed

Schuck, Edgar; Bohnert, Tonika; Chakravarty, Arijit; Damian-Iordache, Valeriu; Gibson, Christopher; Hsu, Cheng-Pang; Heimbach, Tycho; Krishnatry, Anu Shilpa; Liederer, Bianca M; Lin, Jing; Maurer, Tristan; Mettetal, Jerome T; Mudra, Daniel R; Nijsen, Marjoleen Jma; Raybon, Joseph; Schroeder, Patricia; Schuck, Virna; Suryawanshi, Satyendra; Su, Yaming; Trapa, Patrick; Tsai, Alice; Vakilynejad, Majid; Wang, Shining; Wong, Harvey

2015-03-01

The application of modeling and simulation techniques is increasingly common in preclinical stages of the drug discovery and development process. A survey focusing on preclinical pharmacokinetic/pharmacodynamics (PK/PD) analysis was conducted across pharmaceutical companies that are members of the International Consortium for Quality and Innovation in Pharmaceutical Development. Based on survey responses, ~68% of companies use preclinical PK/PD analysis in all therapeutic areas indicating its broad application. An important goal of preclinical PK/PD analysis in all pharmaceutical companies is for the selection/optimization of doses and/or dose regimens, including prediction of human efficacious doses. Oncology was the therapeutic area with the most PK/PD analysis support and where it showed the most impact. Consistent use of more complex systems pharmacology models and hybrid physiologically based pharmacokinetic models with PK/PD components was less common compared to traditional PK/PD models. Preclinical PK/PD analysis is increasingly being included in regulatory submissions with ~73% of companies including these data to some degree. Most companies (~86%) have seen impact of preclinical PK/PD analyses in drug development. Finally, ~59% of pharmaceutical companies have plans to expand their PK/PD modeling groups over the next 2 years indicating continued growth. The growth of preclinical PK/PD modeling groups in pharmaceutical industry is necessary to establish required resources and skills to further expand use of preclinical PK/PD modeling in a meaningful and impactful manner.

Institutionalizing dissent: a proposal for an adversarial system of pharmaceutical research.

PubMed

Biddle, Justin

2013-12-01

There are serious problems with the way in which pharmaceutical research is currently practiced, many of which can be traced to the influence of commercial interests on research. One of the most significant is inadequate dissent, or organized skepticism. In order to ameliorate this problem, I develop a proposal that I call the "Adversarial Proceedings for the Evaluation of Pharmaceuticals," to be instituted within a regulatory agency such as the Food and Drug Administration for the evaluation of controversial new drugs and controversial drugs already in the market. This proposal is an organizational one based upon the "science court" proposal by Arthur Kantrowitz in the 1960s and 1970s. The primary benefit of this system is its ability to institutionalize dissent, thereby ensuring that one set of interests does not dominate all others.

Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics.

PubMed

Dresser, Rebecca

2006-01-01

Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies' internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical companies' ethics materials and describe shortcomings in the companies' existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs.

Company observational post-marketing studies: drug risk assessment and drug research in special populations--a study-based analysis.

PubMed

Hasford, J; Lamprecht, T

1998-01-01

Company observational post-marketing studies (COPS) claim to provide essential data about drug risks and effectiveness in special populations not admitted to pre-approval clinical trials. Since COPS are often mainly regarded as a marketing activity, this study-based analysis tries to evaluate the scientific contributions of COPS. Thirty-five COPS were identified by hand-searching through medical journals, writing to pharmaceutical manufacturers and using MEDLINE. Fourteen COPS evaluated cardiovascular drugs, 9 evaluated NSAIDs and 12 evaluated various other indications. Thirty-five COPS listed effectiveness, 31 listed safety and 8 listed patient compliance as principal objectives. Not a single COPS included a control group. Seventeen of 21 evaluable COPS mentioned extensive exclusion criteria similar to those in clinical trials. Median observation time was 8 weeks, too short for chronic diseases and for adverse drug reactions with longer latency periods. One new adverse event was regarded. Global assessments of the outcomes by physicians dominated and were not based on objective clinical findings. None of the studies specified any details concerning the standardisation of observations or quality-control procedures. The current COPS scheme does not contribute significantly to our knowledge of drug safety and the effects in special populations. Despite serious criticism over the past 20 years, the poor quality of COPS compared with dramatic improvements of pre-approval trials - implies a need for detailed guidelines for non-experimental phase IV research, similar to the Good Clinical Practice-Guideline of the European Community.

Models for open innovation in the pharmaceutical industry.

PubMed

Schuhmacher, Alexander; Germann, Paul-Georg; Trill, Henning; Gassmann, Oliver

2013-12-01

The nature of the pharmaceutical industry is such that the main driver for its growth is innovation. In view of the vast challenges that the industry has been facing for several years and, in particular, how to manage stagnating research and development (R&D) productivity, pharmaceutical companies have opened their R&D organizations to external innovation. Here, we identify and characterize four new types of open innovator, which we call 'knowledge creator', 'knowledge integrator', 'knowledge translator' and 'knowledge leverager', and which describe current open R&D models. Copyright © 2013 Elsevier Ltd. All rights reserved.

Mergers and innovation in the pharmaceutical industry.

PubMed

Comanor, William S; Scherer, F M

2013-01-01

Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? Copyright © 2012 Elsevier B.V. All rights reserved.

New strategies for innovation in global health: a pharmaceutical industry perspective.

PubMed

Witty, Andrew

2011-01-01

Diseases that disproportionately affect developing countries play a large role in stalling economic and social development. Pharmaceutical companies are driving crucial research into new vaccines and medicines; however, although there is an imperative for industry to research new therapies for diseases of the poor, the financial returns are often seen as limited. This is beginning to change. The pharmaceutical industry and the public sector are thinking differently than before about how to improve access to medicines and advance research and development for neglected diseases. The public and private sectors must work together to develop a wide range of innovative tools, partnerships, and approaches.

Ethical pharmaceutical promotion and communications worldwide: codes and regulations

PubMed Central

2014-01-01

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

Ethical pharmaceutical promotion and communications worldwide: codes and regulations.

PubMed

Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul

2014-03-29

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.

[Impact of European e-commerce liberalisation on pharmaceutical crime : The ALPhA research project].

PubMed

Sinn, Arndt

2017-11-01

The trading of illicit and falsified pharmaceuticals is a growth market. Factors influencing this illegal market are high profit margins, a low risk of detection, low control density, an obscure legal situation, and lastly, the easy and anonymous ways of selling over the Internet, usually across national borders. This situation was the background for the research project on the impact of European e‑commerce liberalisation on pharmaceutical crime (ALPhA). The goal of the project was to develop concrete recommendations for action regarding the improved prosecution of internet-based pharmaceutical crime and to create a broad body of data for effective law-making by legislators.In this article the initial situation regarding pharmaceutical crime and its risk potential is described and some of the results from the comparative-law investigation of the ALPhA research project are presented along with its final recommendations. The latter are directed at policy-makers and law enforcement agencies in addition to industry and science and demonstrate the type of framework to be designed to increase safety for the public and to minimize risks when purchasing pharmaceuticals.

"Does organizational culture influence the ethical behavior in the pharmaceutical industry?".

PubMed

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-12-01

Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer's V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceutical companies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India.

Risk Communication and the Pharmaceutical Industry: what is the reality?

PubMed

Edwards, Brian; Chakraborty, Sweta

2012-11-01

Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards 'Dear Healthcare Professional Communications', there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances. The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the fundamental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a company's risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are

Internet pharmaceutical sales: attributes, concerns, and future forecast.

PubMed

Bruckel, Katy; Capozzoli, Ernest A

2003-01-01

Internet pharmaceutical sales continue to skyrocket as healthcare providers and consumers are increasingly relying on the efficiencies and convenience that is available via such transactions. Managed care companies, increasing demands to reduce healthcare inefficiencies while maximizing the quality of patient care is a significant contributing factor to the expanding utilization and success of online pharmaceutical sales. However, with the expansion of Internet pharmaceutical sales, healthcare providers, pharmacy benefit management and insurance companies, and consumers realize new opportunities and risks. This paper will review the attributes and concerns associated with online pharmaceutical sales, discussing current and pending legislation intended to more effectively manage these parameters.

[E-commerce of pharmaceuticals].

PubMed

Shani, Segev

2003-05-01

The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

Supramolecular Pharmaceutical Sciences: A Novel Concept Combining Pharmaceutical Sciences and Supramolecular Chemistry with a Focus on Cyclodextrin-Based Supermolecules.

PubMed

Higashi, Taishi; Iohara, Daisuke; Motoyama, Keiichi; Arima, Hidetoshi

2018-01-01

Supramolecular chemistry is an extremely useful and important domain for understanding pharmaceutical sciences because various physiological reactions and drug activities are based on supramolecular chemistry. However, it is not a major domain in the pharmaceutical field. In this review, we propose a new concept in pharmaceutical sciences termed "supramolecular pharmaceutical sciences," which combines pharmaceutical sciences and supramolecular chemistry. This concept could be useful for developing new ideas, methods, hypotheses, strategies, materials, and mechanisms in pharmaceutical sciences. Herein, we focus on cyclodextrin (CyD)-based supermolecules, because CyDs have been used not only as pharmaceutical excipients or active pharmaceutical ingredients but also as components of supermolecules.

Metabolic engineering: the ultimate paradigm for continuous pharmaceutical manufacturing.

PubMed

Yadav, Vikramaditya G; Stephanopoulos, Gregory

2014-07-01

Research and development (R&D) expenditures by pharmaceutical companies doubled over the past decade, yet candidate attrition rates and development times rose markedly during this period. Understandably, companies have begun downsizing their pipelines and diverting investments away from R&D in favor of manufacturing. It is estimated that transitioning to continuous manufacturing could enable companies to compete for a share in emerging markets. Accordingly, the model for continuous manufacturing that has emerged commences with the conversion of late-stage intermediates into the active pharmaceutical ingredient (API) in a series of continuous flow reactors, followed by continuous solid processing to form finished tablets. The use of flow reactions for API synthesis will certainly generate purer products at higher yields in shorter times compared to equivalent batch reactions. However, transitioning from batch to flow configuration simply alleviates transport limitations within the reaction milieu. As the catalogue of reactions used in flow syntheses is a subset of batch-based chemistries, molecules such as natural products will continue to evade drug prospectors. Also, it is uncertain whether flow synthesis can deliver improvements in the atom and energy economies of API production at the scales that would achieve the levels of revenue growth targeted by companies. Instead, it is argued that implementing metabolic engineering for the production of oxidized scaffolds as gateway molecules for flow-based addition of electrophiles is a more effective and scalable strategy for accessing natural product chemical space. This new paradigm for manufacturing, with metabolic engineering as its engine, would also permit rapid optimization of production variables and allow facile scale-up from gram to ton scale to meet material requirements for clinical trials, thus recasting manufacturing as a tool for discovery. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Effective Partnering in Conducting Benefit-Risk Patient Preference Studies: Perspectives From a Patient Advocacy Organization, a Pharmaceutical Company, and Academic Stated-Preference Researchers.

PubMed

Wolka, Anne M; Fairchild, Angelyn O; Reed, Shelby D; Anglin, Greg; Johnson, F Reed; Siegel, Michael; Noel, Rebecca

2017-01-01

Formal incorporation of patients' perspectives is becoming increasingly important in medical product development and decision making. This article shares practical advice regarding how patient advocacy organizations, the pharmaceutical industry, and academic experts in stated-preference research can effectively partner on benefit-risk patient preference studies. The authors partnered on a benefit-risk patient preference study related to the treatment of psoriasis. The authors from Duke Clinical Research Institute also share their experiences in collaborating with numerous other organizations in conducting benefit-risk patient preference studies. Upon initiation of the study partnership with appropriate experts, training is important to ensure all collaborators have a common understanding of the methodology, what objectives stated-preference methods can support, and expectations for the project. To the extent possible, partners should align on and document relevant clinical and logistical details prior to study implementation. During study implementation, partners should use good communication practices and document and maintain a record of any changes to the original plan. Presentation of the study results should be tailored to the particular audience, with the appropriate partner leading the presentation based on its format and audience. Partners from patient advocacy organizations, the pharmaceutical industry, and academia can effectively collaborate on benefit-risk patient preference studies with sufficient planning and ongoing communication. This article is a call for action for other organizations to engage in sharing of experiences regarding effective partnering in quantifying patient preferences in medical product development.

Impact of Corporate Governance on Research and Development Investment in the Pharmaceutical Industry in South Korea.

PubMed

Lee, Munjae

2015-08-01

The purpose of this study is to analyze the influence of the corporate governance of pharmaceutical companies on research and development (R&D) investment. The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general, and internal transactions were extracted from TS-2000 of the Korea Listed Company Association. Sample firms were those that belong to the medical substance and drug manufacturing industries. Ultimately, 786 firm-year data of 81 firms were included in the sample (unbalanced panel data). The shareholding ratio of major shareholders and foreigners turned out to have a statistically significant influence on R&D investment (p < 0.05). No statistical significance was found in the shareholding ratio of institutional investors and the ratio of outside directors. The higher the shareholding ratio of the major shareholders, the greater the R&D investment. There will be a need to establish (or switch to) a holding company structure. Holding companies can directly manage R&D in fields with high initial risks, and they can diversify these risks. The larger the number of foreign investors, the greater the R&D investment, indicating that foreigners directly or indirectly impose pressure on a manager to make R&D investments that bring long-term benefits.

Interactions between physicians and the pharmaceutical industry: what does the literature say?

PubMed Central

Lexchin, J

1993-01-01

this source. Company funding of clinical trials may affect the quality of the trials and the types of research that physicians undertake. Company-sponsored CME courses may have a commercial bias even if conducted under guidelines designed to ensure the independence of the event. All three types of interactions affect physicians' prescribing behaviour and, in the case of obtaining information from detailers, physicians' prescribing practices are less appropriate as a result of the interaction. CONCLUSIONS: Physicians are affected by their interactions with the pharmaceutical industry. Further research needs to be done in most cases to determine whether such interactions lead to more or less appropriate prescribing practices. The CMA's guidelines on this topic should be evaluated to see whether they are effective in controlling physician-industry interactions. Further measures may be necessary if the guidelines fail to prevent negative effects on prescribing practices. PMID:8221424

The Effects of Technology Entrepreneurship on Customers and Society: A Case Study of a Spanish Pharmaceutical Distribution Company

PubMed Central

Muñoz, Rosa M.; Sánchez de Pablo, Jesús D.; Peña, Isidro; Salinero, Yolanda

2016-01-01

The main purpose of this paper is to provide an understanding, within the field of corporate entrepreneurship, of the various factors that enable technology entrepreneurship in established firms and its principal effects on customers and society. The paper reports on a case study regarding technology entrepreneurship in a Spanish company whose activity is pharmaceutical distribution. This company has been able to overcome the consequences of the worldwide crisis and start an innovative process which includes the installation of new information technology (IT) and an investment of 6 million Euros. It is, in this respect, a model to imitate and the objective of this paper is therefore to discover the managers’ entrepreneurial orientation (EO) characteristics which have made this possible, along with the organizational and social effects resulting from the process. We verify that EO is present in this company and that the development of new IT has important effects on customers and the population. PMID:27445938

The Effects of Technology Entrepreneurship on Customers and Society: A Case Study of a Spanish Pharmaceutical Distribution Company.

PubMed

Muñoz, Rosa M; Sánchez de Pablo, Jesús D; Peña, Isidro; Salinero, Yolanda

2016-01-01

The main purpose of this paper is to provide an understanding, within the field of corporate entrepreneurship, of the various factors that enable technology entrepreneurship in established firms and its principal effects on customers and society. The paper reports on a case study regarding technology entrepreneurship in a Spanish company whose activity is pharmaceutical distribution. This company has been able to overcome the consequences of the worldwide crisis and start an innovative process which includes the installation of new information technology (IT) and an investment of 6 million Euros. It is, in this respect, a model to imitate and the objective of this paper is therefore to discover the managers' entrepreneurial orientation (EO) characteristics which have made this possible, along with the organizational and social effects resulting from the process. We verify that EO is present in this company and that the development of new IT has important effects on customers and the population.

Financial aspects and the future of the pharmaceutical industry in the United States of america.

PubMed

Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

2013-12-01

The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as "companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use". Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers' lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. THIS PAPER REPRESENTS A THOROUGH LITERATURE REVIEW OF THE MULTIFACETED SOURCES INCLUDING: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or - at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and

Financial Aspects and the Future of the Pharmaceutical Industry in the United States of America

PubMed Central

Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

2013-01-01

Introduction: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as “companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use”. Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers’ lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. Purpose: The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. Methodology: This paper represents a thorough literature review of the multifaceted sources including: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). Discussion: In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or – at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Conclusion: Numerous blockbuster drugs will be coming off

Appeals court reverses verdict favoring drug companies.

PubMed

1995-06-02

An appeals court reversed a verdict favoring drug companies after the widow of a hemophiliac, whose death was linked to HIV-tainted blood products, sued four pharmaceutical companies to pay damages. The four companies, Alpha Therapeutic Corp., Miles Laboratories Inc., Armour Pharmaceutical Co., and Baxter Travenol Laboratories Inc., provided Factor VIII, a clotting concentrate, to [name removed] [name removed], the plaintiff's husband, from 1972 until his death in 1987. [Name removed]'s wife sued the companies, alleging that the defendants negligently solicited blood plasma from paid donors who had a high risk of having HIV, failed to determine whether any lots of Factor VIII contained plasma from an at-risk donor, failed to warn consumers of possible risks, and failed to heat-treat HIV and other viruses in Factor VIII, despite industry-wide knowledge of the risk of infection. The three-judge panel said the trial judge's decision to avoid ruling on the antigenic stimulation theory, based on insufficient evidence, was improper. In addition, the appeals court said a retrial is necessary because of improper remarks made by Alpha's attorney.

[Attractiveness of France for international clinical trials in 2012: 6(th) survey assessed by Leem (French association of pharmaceutical companies)].

PubMed

Lassale, Catherine; Sibenaler, Claire; Béhier, Jehan-Michel; Barthélémy, Philippe; Plétan, Yannick; Courcier, Soizic

2013-01-01

Since 2002, the Leem (French Association of Pharmaceutical Companies) has conducted a survey every two years to update the attractiveness of France for international clinical trials. Thirty companies (68% of the French market) have participated in this 6(th) survey which involved 79 countries, a greater number of Phases I/II, II and III studies (420 versus 352 in 2010), a relatively stable number of included patients (246,895 versus 249,704 in 2010) and a greater number of centers (32,965 versus 24,337 in 2010). The evolution of time-lines for the go-ahead by French Authorities is heterogeneous (shorter time-lines by the French National Agency of Drug and Health Products Safety [ANSM] but longer time-lines by Research Ethics Comittees [CPP]). The time-lines for first hospital contracts remain stable. France ranks at an average position among European countries in regards to quantitative and qualitative data, and its state-of-art in early stages is still recognized. Its good performance in oncology and orphan diseases are major assets of competitiveness. © 2013 Société Française de Pharmacologie et de Thérapeutique.

Informational content of official pharmaceutical industry web sites about treatments for erectile dysfunction.

PubMed

Waack, Katherine E; Ernst, Michael E; Graber, Mark A

2004-12-01

In the last 5 years, several treatments have become available for erectile dysfunction (ED). During this same period, consumer use of the Internet for health information has increased rapidly. In traditional direct-to-consumer advertisements, viewers are often referred to a pharmaceutical company Web site for further information. To evaluate the accessibility and informational content of 5 pharmaceutical company Web sites about ED treatments. Using 10 popular search engines and 1 specialized search engine, the accessibility of the official pharmaceutical company-sponsored Web site was determined by searching under brand and generic names. One company also manufactures an ED device; this site was also included. A structured, explicit review of information found on these sites was conducted. Of 110 searches (1 for each treatment, including corresponding generic drug name, using each search engine), 68 yielded the official pharmaceutical company Web site within the first 10 links. Removal of outliers (for both brand and generic name searches) resulted in 68 of 77 searches producing the pharmaceutical company Web site for the brand-name drug in the top 10 links. Although all pharmaceutical company Web sites contained general information on adverse effects and contraindications to use, only 2 sites gave actual percentages. Three sites provided references for their materials or discussed other treatment or drug options, while 4 of the sites contained profound advertising or emotive content. None mentioned cost of the therapy. The information contained on pharmaceutical company Web sites for ED treatments is superficial and aimed primarily at consumers. It is largely promotional and provides only limited information needed to effectively compare treatment options.

[Conflict of interest regarding clinical physicians' relationship with pharmaceutical industry and medical education].

PubMed

Miyata, Yasushi

2010-01-01

The relationship between clinical physicians and the pharmaceutical industry is becoming an important social issue. Many lawsuits against drug companies in the area of psychiatric medicine have been heavily covered by the mass media in the U.S., and the injustices of drug companies and clinical physicians have been revealed in court. Although there are few such large social issues in Japan, the relationship between clinical physicians and the pharmaceutical industry in Japan appears inappropriate. A study on the relationship between Japanese clinical physicians and the pharmaceutical industry revealed that many physicians received "gifts" from pharmaceutical companies. This is one form of evidence for the inappropriate relationship between Japanese physicians and pharmaceutical industries. Recently, many recommendations to realize an appropriate relationship between physicians and the pharmaceutical industry have been published in the U.S. However, discussion concerning the relationship between clinical physicians and pharmaceutical companies in Japan is not active. We have received a lot of financial support for continuing medical education from pharmaceutical industries. Without such support, we may not be able to maintain the same level of medical education. Understanding such present conditions, we need to discuss what is an appropriate relationship between clinical physicians and the pharmaceutical industry.

[How are the websites of pharmaceutical companies directed at users?].

PubMed

López Hidalgo, María Jesús; Aguado Gómez, Alicia; Sánchez Ruiz, Marceliana; García-Moreno Rodríguez, Gregoria; Alejandre Lázaro, Gemma

2010-05-01

To describe the content and structure of the websites of pharmaceutical companies (PC) with health information to patients. Descriptive, cross-sectional. health topics treated, and 9 sections: objectives and target population; editorial policy, authoring, updating of content, personal data protection, interactivity, accessibility, advertising labels. Internet. All PC websites with patient health information in Spanish. We studied 60 sites found. Most common: 19.3% neurology, mental health and 12% digestive diseases. Few specify the address of the person responsible for the site (51.7%), responsible for quality (10%) or the authors of the text (15%). Nearly 2/3 show the date of publication of content (66.7%), but only 13.3% updated. Privacy and data protection are mentioned in 65%, with only 28.3% allowing control of the use of personal data. Only 10% allow expressing doubts online and 1/3 of the sites have frequently asked questions. A total of 41.7% omitted to say their information does not replace medical advice. Educational materials (for children) can be downloaded in 11.7%. Almost all (93.3%) adapted their language to the recipient, but none are accessible to disabled people. The majority (86.7%) have the company logo on all pages. Only 16.7% are fronts for advertising, and only 9 sites have a quality seal (HONcode). Pages are designed to give superficial information on a disease than directly advertise a particular brand or active ingredient. However, their reliability has to be low due to the authors and sources of information being unknown. If Internet health information was truthful and backed up by authors or appropriate information sources, the Internet could well be a genuine health education tool. Copyright 2009 Elsevier España, S.L. All rights reserved.

Proteomics in pharmaceutical research and development.

PubMed

Cutler, Paul; Voshol, Hans

2015-08-01

In the 20 years since its inception, the evolution of proteomics in pharmaceutical industry has mirrored the developments within academia and indeed other industries. From initial enthusiasm and subsequent disappointment in global protein expression profiling, pharma research saw the biggest impact when relating to more focused approaches, such as those exploring the interaction between proteins and drugs. Nowadays, proteomics technologies have been integrated in many areas of pharmaceutical R&D, ranging from the analysis of therapeutic proteins to the monitoring of clinical trials. Here, we review the development of proteomics in the drug discovery process, placing it in a historical context as well as reviewing the current status in light of the contributions to this special issue, which reflect some of the diverse demands of the drug and biomarker pipelines. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[The pharmaceutical market in Mexico: size, value, and concentration].

PubMed

Torres Guerra, Sandra; Gutiérrez, Juan Pablo

2009-07-01

To describe the pharmaceutical drug market in Mexico in terms of its size, structure, business' market power, and consumer negotiating power. A descriptive study based on data from the 2004 Economics Census and the reports of IMS Health, Inc. (Norwalk, Connecticut, United States of America). Sales amounts and volumes of Mexico's pharmaceutical companies from 2002-2005 were obtained and the Herfindahl-Hirschman Index (HHI) and its inverse were calculated as indicators of the market's degree of concentration; also, price elasticity was determined by a product index. The total value of the products manufactured by the pharmaceutical sector was 115 billion in 2006 Mexican pesos, of which 99% pertained to companies categorized as large. This amount constituted 1.2% of the national gross domestic product that year (20.0% of the health sector's portion, estimated to be 6.0%) and 3.9% of the total value of manufactured goods. The HHI of Mexico's pharmaceutical market during the study period was about 0.04, albeit with a steady decline, and its inverse decreased from 23 to 26. The price elasticity of pharmaceutical products was minimal (0.007, 0.003, and -0.002). This study constitutes a preliminary description of Mexico's pharmaceutical market, one of the country's most dynamic economic sectors. It confirmed that the market is a rigid oligopoly, and thus supports enactment of firmer regulatory tools to reduce the power of the manufacturers in favor of that of the consumers.

“Does Organizational Culture Influence the Ethical Behavior in the Pharmaceutical Industry?”

PubMed Central

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-01-01

Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer’s V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceutical companies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India. PMID:24826027

Pharmaceutical supply chain risk assessment in Iran using analytic hierarchy process (AHP) and simple additive weighting (SAW) methods.

PubMed

Jaberidoost, Mona; Olfat, Laya; Hosseini, Alireza; Kebriaeezadeh, Abbas; Abdollahi, Mohammad; Alaeddini, Mahdi; Dinarvand, Rassoul

2015-01-01

Pharmaceutical supply chain is a significant component of the health system in supplying medicines, particularly in countries where main drugs are provided by local pharmaceutical companies. No previous studies exist assessing risks and disruptions in pharmaceutical companies while assessing the pharmaceutical supply chain. Any risks affecting the pharmaceutical companies could disrupt supply medicines and health system efficiency. The goal of this study was the risk assessment in pharmaceutical industry in Iran considering process's priority, hazard and probability of risks. The study was carried out in 4 phases; risk identification through literature review, risk identification in Iranian pharmaceutical companies through interview with experts, risk analysis through a questionnaire and consultation with experts using group analytic hierarchy process (AHP) method and rating scale (RS) and risk evaluation of simple additive weighting (SAW) method. In total, 86 main risks were identified in the pharmaceutical supply chain with perspective of pharmaceutical companies classified in 11 classes. The majority of risks described in this study were related to the financial and economic category. Also financial management was found to be the most important factor for consideration. Although pharmaceutical industry and supply chain were affected by current political conditions in Iran during the study time, but half of total risks in the pharmaceutical supply chain were found to be internal risks which could be fixed by companies, internally. Likewise, political status and related risks forced companies to focus more on financial and supply management resulting in less attention to quality management.

Medical student views on interactions with pharmaceutical representatives.

PubMed

Ganzini, Linda; Chen, Zunqiu; Peters, Dawn; Misra, Sahana; Macht, Madison; Osborne, Molly; Keepers, George

2012-05-01

In 2006, the Housestaff Association presented the Dean at Oregon Health and Science University (OHSU) with a proposal to effectively end the influence of the pharmaceutical industry on campus. The Dean convened a workgroup to examine the issue, and faculty, residents, and medical students were surveyed on their views and interactions. Authors present here the responses from medical students. A web-based, anonymous survey was sent to all OHSU medical students in 2007; 59% completed it. The survey included items measuring attitudes about the pharmaceutical industry and interactions with pharmaceutical representatives (PRs). Only 5% of clinical and 7% of preclinical students agreed that PRs have an important teaching role, and fewer than 1 in 6 believed that PRs provided useful and accurate information on either new or established drugs; 54% of clinical students indicated that PRs should be restricted from making presentations on campus, versus 32% of preclinical students, and only 30% of clinical students agreed that accepting gifts had no impact on their own prescribing, versus 50% of preclinical students. Students who acknowledged the influence of PRs and perceived less educational benefit were less likely to accept gifts such as textbooks; however, 84% of clinical students had attended an on-campus event sponsored by a pharmaceutical company in the previous year. Only a small proportion of OHSU medical students value interactions with PRs, but many still attend events sponsored by pharmaceutical companies.

A survey of pharmaceutical company representative interactions with doctors in Libya

PubMed Central

Alssageer, Mustafa A.; Kowalski, Stefan R.

2012-01-01

Objectives To examine the frequency of pharmaceutical company representative (PCR) interactions with doctors in Libya and review possible associations between these interactions and the personal and practice setting characteristics of doctors. Method An anonymous survey questionnaire was circulated to 1,000 Libyan doctors in selected public and private practice settings in Tripoli, Benghazi and Sebha. Results A questionnaire return rate of 61% (608 returned questionnaires) was achieved. Most respondents (94%) reported that they had been visited by PCRs at least ‘once’ in the last year. Fifty per cent of respondents met with PCRs at least once a month, and 20% at least once a week. The following characteristics were significantly associated with meeting with a representative more than once a week: age, gender (male > female), years of practice, being a specialist (other than an anaesthesiologist) or working in private practice. Ninety-one per cent of doctors reported that they had received at least one kind of relationship gift during the last year. Printed materials (79%), simple gifts (73%) and drug samples (69%) were the most common relationship products given to respondents. Reimbursements or sponsored items were reported by 33% of respondents. Physician specialists were more likely to receive drug samples or sponsored items than residents, general practitioners, anaesthesiologists or surgeons (P<0.01). Participants working in private practice alone or in both sectors were more likely to receive printed materials, simple gifts or free samples from PCRs than doctors working in the public sector (P<0.05). Conclusion Libyan doctors are frequently visited by PCRs. Doctors, working in private practice or specialist practice, are especially targeted by promotional activities. An agreed code of conduct for pharmaceutical promotion in Libya between doctors and PCRs should be created. PMID:23002397

Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

PubMed

Battisti, Wendy P; Wager, Elizabeth; Baltzer, Lise; Bridges, Dan; Cairns, Angela; Carswell, Christopher I; Citrome, Leslie; Gurr, James A; Mooney, LaVerne A; Moore, B Jane; Peña, Teresa; Sanes-Miller, Carol H; Veitch, Keith; Woolley, Karen L; Yarker, Yvonne E

2015-09-15

This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.

Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations.

PubMed

Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

2014-01-01

Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan's regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan.

Impact of Corporate Governance on Research and Development Investment in the Pharmaceutical Industry in South Korea

PubMed Central

Lee, Munjae

2015-01-01

Objectives The purpose of this study is to analyze the influence of the corporate governance of pharmaceutical companies on research and development (R&D) investment. Methods The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general, and internal transactions were extracted from TS-2000 of the Korea Listed Company Association. Sample firms were those that belong to the medical substance and drug manufacturing industries. Ultimately, 786 firm-year data of 81 firms were included in the sample (unbalanced panel data). Results The shareholding ratio of major shareholders and foreigners turned out to have a statistically significant influence on R&D investment (p < 0.05). No statistical significance was found in the shareholding ratio of institutional investors and the ratio of outside directors. Conclusion The higher the shareholding ratio of the major shareholders, the greater the R&D investment. There will be a need to establish (or switch to) a holding company structure. Holding companies can directly manage R&D in fields with high initial risks, and they can diversify these risks. The larger the number of foreign investors, the greater the R&D investment, indicating that foreigners directly or indirectly impose pressure on a manager to make R&D investments that bring long-term benefits. PMID:26473092

Online Pharmaceutical Care Provision: Full-Implementation of an eHealth Service Using Design Science Research.

PubMed

Gregório, João; Pizarro, Ângela; Cavaco, Afonso; Wipfli, Rolf; Lovis, Christian; Mira da Silva, Miguel; Lapão, Luís Velez

2015-01-01

Chronic diseases are pressing health systems to introduce reforms, focused on primary care and multidisciplinary models. Community pharmacists have developed a new role, addressing pharmaceutical care and services. Information systems and technologies (IST) will have an important role in shaping future healthcare provision. However, the best way to design and implement an IST for pharmaceutical service provision is still an open research question. In this paper, we present a possible strategy based on the use of Design Science Research Methodology (DSRM). The application of the DSRM six stages is described, from the definition and characterization of the problem to the evaluation of the artefact.

Pharmaceutical care in community pharmacies: practice and research in Sweden.

PubMed

Westerlund, Lo Tommy; Björk, H Thony

2006-06-01

To describe the organization and delivery of community pharmacy and medical care, as well as pharmaceutical care practice and research, in Sweden. The Swedish retail pharmacy system of 800 community pharmacies and nearly 80 hospital pharmacies is unique in that it is organized into one single, government-owned chain, known as Apoteket AB. The pharmacy staff consists of pharmacists, prescriptionists, and pharmacy technicians. Some activities related to pharmaceutical care have been directed toward specific patient groups during annual theme campaigns. In the past few years, there has been a growing emphasis on the identification, resolution, and documentation of drug-related problems (DRPs) in Swedish pharmacy practice. A classification system for documenting DRPs and pharmacy interventions was developed in 1995 and incorporated into the software of all community pharmacies in 2001. A national DRP database (SWE-DRP) was established in 2004 to collect and analyze DRPs and interventions on a nationwide basis. Recently, a new counseling technique composed of key questions to facilitate the detection of DRPs has been tested successfully. Patient medication profiles are kept in 160 pharmacies, and a new national register of drugs dispensed to patients became available in 2006. Most pharmaceutical care studies in Sweden have focused on DRPs and resulting pharmacy interventions. Swedish community pharmacy DRP work is in the international forefront but there is a potential for further developing cognitive services, given the beneficial organization of the country's pharmacies into one single pharmacy chain. The introduction of patient medication profiles has been both late and slow and has only had a marginal effect on pharmaceutical care practice so far. The universities do not appear to have any desire to influence the practice of pharmacy and could potentially take on a more active role in preparing pharmacy students for patient-oriented services. Current threats to

The nature of outsourced preclinical research--the example of chemical synthesis.

PubMed

Festel, Gunter W

2013-09-01

The possibility to buy standardized external services or even new and innovative methods within drug discovery has increased dramatically during the last decades. Service providers are able to provide timely and efficient solutions to any given problem within preclinical research. The outsourcing behavior depends on the specific company type. Generally, the outsourcing level of emerging pharmaceutical and biotechnology companies is much higher than established companies due to low or missing internal resources. Whereas the "make-or-buy" decisions of large and fully integrated pharmaceutical companies are mainly competency driven, those of mid-size and small pharmaceutical, as well as biotech companies show a specific combination of cost/capacity and competency. The three different cooperation models "price competition", "project selection," and "strategic partnership" were identified. For all types of companies, the cooperation model of "strategic partnership" offers access to high-level expertise while reducing fixed costs and complexity. This was shown using chemical synthesis as an example but is also true for other areas of preclinical research.

Creating knowledge structures in the pharmaceutical industry: the increasing significance of virtual organisation.

PubMed

Salazar, A; Howells, J

2000-01-01

This paper explores the specific trend and challenges facing the pharmaceutical industry regarding the exploitation of Internet e-commerce technology and virtual organisation to develop and maintain competitive advantage. There are two important facets of the current trend. One is the rapid development of a complex network of alliances between the established pharmaceutical companies and the specialised biotechnology company start-ups. The other is the rapid growth of internet e-commerce companies dedicated to developing specialised technological platforms for acquiring and selling genetic and biochemical knowledge. The underlying challenge is how big pharmaceutical companies can emulate some of the innovation processes of smaller biotechnology company start-ups, and how they can appropriate and applied new technological knowledge on the development of new drugs. Pharmaceutical companies in order to retain competitive advantage need to continuously monitor all aspects of knowledge management with regard to the R&D and manufacturing process (as well as customer management and marketing). Technological change and organisational restructuring should be aimed at boosting the capacity of large firms to innovate rapidly.

Identifying and prioritizing industry-level competitiveness factors: evidence from pharmaceutical market.

PubMed

Shabaninejad, Hosein; Mehralian, Gholamhossein; Rashidian, Arash; Baratimarnani, Ahmad; Rasekh, Hamid Reza

2014-04-03

Pharmaceutical industry is knowledge-intensive and highly globalized, in both developed and developing countries. On the other hand, if companies want to survive, they should be able to compete well in both domestic and international markets. The main purpose of this paper is therefore to develop and prioritize key factors affecting companies' competitiveness in pharmaceutical industry. Based on an extensive literature review, a valid and reliable questionnaire was designed, which was later filled up by participants from the industry. To prioritize the key factors, we used the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS). The results revealed that human capital and macro-level policies were two key factors placed at the highest rank in respect of their effects on the competitiveness considering the industry-level in pharmaceutical area. This study provides fundamental evidence for policymakers and managers in pharma context to enable them formulating better polices to be proactively competitive and responsive to the markets' needs.

Pharmaceutical and biomedical applications of lipid-based nanocarriers.

PubMed

Carbone, Claudia; Leonardi, Antonio; Cupri, Sarha; Puglisi, Giovanni; Pignatello, Rosario

2014-03-01

Increasing attention is being given to lipid nanocarriers (LNs) as drug delivery systems, due to the advantages offered of a higher biocompatibility and lower toxicity compared with polymeric nanoparticles. Many administration routes are being investigated for LNs, including topical, oral and parenteral ones. LNs are also proposed for specific applications such as cancer treatment, gene therapy, diagnosis and medical devices production. However, the high number of published research articles does not match an equal amount of patents. A recent Review of ours, published in Pharmaceutical Patent Analyst, reported the patents proposing novel methods for the production of LNs. This review work discusses recent patents, filed in 2007-2013 and dealing with the industrial applications of lipid-based nanocarriers for the vectorization of therapeutically relevant molecules, as well as biotech products such as proteins, gene material and vaccines, in the pharmaceutical, diagnostic and biomedical areas.

[Written pharmaceutical advertising--still unreliable?].

PubMed

Gladsø, Kristin Haugen; Garberg, Hedda Rosland; Spigset, Olav; Slørdal, Lars

2014-09-02

Marketing by the pharmaceutical industry affects doctors' prescribing habits. All pharmaceutical advertising received by nine doctors in two GP offices over a period of three months was collected. The advertising material was sorted by compound. For each compound, the advert with the highest number of references was selected. The cited references were obtained, and the claims in the adverts were assessed in terms of their consistency with the source data based on the provisions in the Norwegian regulations on pharmaceuticals. The references were also assessed with regard to the incidence of conflicts of interest among authors. The doctors received a total of 270 shipments of advertising for 46 different compounds. Altogether 95% of the 173 references cited in the 46 selected adverts could be obtained. The adverts contained a total of 156 claims. Of these, 56% were assessed as correct when compared to the source data and as having clinical relevance. Altogether 75% of the journal articles reported relevant conflicts of interest for the authors. About half the claims in the adverts were found to be correct and clinically relevant. These results concur with those from a methodologically identical study based on advertising material collected in 2004. The cited literature was of varying quality and often funded by the pharmaceutical companies. The findings indicate that the target group should be sceptical of this type of marketing.

Research on simulation based material delivery system for an automobile company with multi logistics center

NASA Astrophysics Data System (ADS)

Luo, D.; Guan, Z.; Wang, C.; Yue, L.; Peng, L.

2017-06-01

Distribution of different parts to the assembly lines is significant for companies to improve production. Current research investigates the problem of distribution method optimization of a logistics system in a third party logistic company that provide professional services to an automobile manufacturing case company in China. Current research investigates the logistics leveling the material distribution and unloading platform of the automobile logistics enterprise and proposed logistics distribution strategy, material classification method, as well as logistics scheduling. Moreover, the simulation technology Simio is employed on assembly line logistics system which helps to find and validate an optimization distribution scheme through simulation experiments. Experimental results indicate that the proposed scheme can solve the logistic balance and levels the material problem and congestion of the unloading pattern in an efficient way as compared to the original method employed by the case company.

Waste-based alternative adsorbents for the remediation of pharmaceutical contaminated waters: Has a step forward already been taken?

PubMed

Silva, Carla Patrícia; Jaria, Guilaine; Otero, Marta; Esteves, Valdemar I; Calisto, Vânia

2018-02-01

When adsorption is considered for water treatment, commercial activated carbon is usually the chosen adsorbent for the removal of pollutants from the aqueous phase, particularly pharmaceuticals. In order to decrease costs and save natural resources, attempts have been made to use wastes as raw materials for the production of alternative carbon adsorbents. This approach intends to increase efficiency, cost-effectiveness, and also to propose an alternative and sustainable way for the valorization/management of residues. This review aims to provide an overview on waste-based adsorbents used on pharmaceuticals' adsorption. Experimental facts related to the adsorption behaviour of each adsorbent/pharmaceutical pair and some key factors were addressed. Also, research gaps that subsist in this research area, as well as future needs, were identified. Simultaneously, this review aims to clarify the current status of the research on pharmaceuticals' adsorption by waste-based adsorbents in order to recognize if the right direction is being taken. Copyright © 2017 Elsevier Ltd. All rights reserved.

Pharmaceutical patents and price controls.

PubMed

Vogel, Ronald J

2002-07-01

Since 1995, every member-country of the World Trade Organization (WTO) has agreed to honor a 20-year patent-life, from the date of a pharmaceutical company's application for the patent, in the country of application. Patent protection retards competitive imitation of an invented product. This kind of protection is particularly important for pharmaceuticals, because pharmaceuticals that are not derived from biotechnology can be imitated easily and inexpensively. The economic function of a patent is to allow a period of above-normal profits for a technically and commercially successful product; these profits stimulate further investment and invention. However, direct price controls, or permutations of direct price controls on pharmaceutical compounds, can fully or partially circumvent the economic intent of patent agreements. This paper formulates an economic model that takes into account demand and cost/supply dimensions of the output and pricing of a hypothetical pharmaceutical, extrapolating about the respective effects of direct price controls and lack of price controls, and describing permutations of direct price controls in different countries. The pharmaceutical industry depends on patents to fund the development and introduction of new products. A country can indirectly circumvent the economic logic of a patent by using price controls, but it cannot shift the economic costs of such a policy to another country that does not use price controls. Instead, less money is available for research and development (R&D). Pharmaceutical price controls allow some countries to avoid the constraints of patent agreements without breaking those agreements outright. This, in turn, reduces the amount of profit available for further R&D, which is a detriment to consumers worldwide.

Evaluating the impact of Brexit on the pharmaceutical industry.

PubMed

Kazzazi, Fawz; Pollard, Cleo; Tern, Paul; Ayuso-Garcia, Alejandro; Gillespie, Jack; Thomsen, Inesa

2017-01-01

The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and research investment, the importance of this industry cannot be understated. At stake is the global leadership in the sector, which produces some of the field's most influential basic science and translation work. However, interruptions and losses may occur at multiple levels, affecting patients, researchers, universities, companies and government. By understanding the current state of pharmaceutical sector, the potential effect of leaving the European Union (EU) on this successful industry can be better understood. This paper aims to address the priorities for negotiations by collating the analyses of professionals in the field, leading companies and non-EU member states. A government healthcare policy advisor and Chief Science Officer (CSO) for a major pharmaceutical firm were consulted to scope the paper. In these discussions, five key areas were identified: contribution, legislative processes, regulatory processes, research and outcomes, commercial risk. Multiple search engines were utilised for selecting relevant material, predominantly PubMed and Google Scholar. To supplement this information, Government documents were located using the "GOV.UK" publications tool, and interviews and commentaries were found through the Google News search function. With thorough investigation of the literature, we propose four foundations in the advancement of negotiations. These prioritise: negotiation of 'associated country' status, bilaterally favourable trade agreements, minimal interruption to regulatory bodies and special protection for the movement of workforce in the life sciences industry.

The structure of the pharmaceutical market in Iran using concentration indices.

PubMed

Mohseni, Mohammad; Gorji, Hasan Abolghasem; Ahadinezhad, Bahman; Khosravizadeh, Omid; Keykaleh, Meysam Safi; Moosavi, Ahmad; Mohtashamzadeh, Bahareh

2017-04-01

The efficiency and function of the pharmaceutical sector, as a vital portion of the health system, have a significant effect on intermediate and final indices of health. In this research, the structure of the pharmaceutical market in Iran was examined through the calculation of concentration indices in 2011. In this cross-sectional study, the needed data was gathered from the Food and Drug Administration in the year 2011. Data were analyzed using SPSS software version 20 and Microsoft Office Excel software. Finally, two common measures of market concentration, the Concentration Ratio and the Herfindahl-Hirschman Index, were calculated. The largest and the smallest shares of the industry were 5.57% and 0.01%, respectively. The average industry share was 1.09%. The share range was calculated to be 5.56%. The Herfindahl-Hirschman Index was 248.5, which indicates a very low concentration of the pharmaceutical market in Iran. Also, based on the Concentration Ratio of 4 companies (18.39%), the concentration of the pharmaceutical market has been too low. The pharmaceutical market in Iran has a very low concentration and it does not have an exclusive mode in terms of market structure. Therefore, it can be attributed to the competitive model. The policy makers in this area can use this characteristic as a leverage to improve efficiency, fairness, revenue and health indices.

The structure of the pharmaceutical market in Iran using concentration indices

PubMed Central

Mohseni, Mohammad; Gorji, Hasan Abolghasem; Ahadinezhad, Bahman; Khosravizadeh, Omid; Keykaleh, Meysam Safi; Moosavi, Ahmad; Mohtashamzadeh, Bahareh

2017-01-01

Background and objective The efficiency and function of the pharmaceutical sector, as a vital portion of the health system, have a significant effect on intermediate and final indices of health. In this research, the structure of the pharmaceutical market in Iran was examined through the calculation of concentration indices in 2011. Methods In this cross-sectional study, the needed data was gathered from the Food and Drug Administration in the year 2011. Data were analyzed using SPSS software version 20 and Microsoft Office Excel software. Finally, two common measures of market concentration, the Concentration Ratio and the Herfindahl-Hirschman Index, were calculated. Results The largest and the smallest shares of the industry were 5.57% and 0.01%, respectively. The average industry share was 1.09%. The share range was calculated to be 5.56%. The Herfindahl-Hirschman Index was 248.5, which indicates a very low concentration of the pharmaceutical market in Iran. Also, based on the Concentration Ratio of 4 companies (18.39%), the concentration of the pharmaceutical market has been too low. Conclusion The pharmaceutical market in Iran has a very low concentration and it does not have an exclusive mode in terms of market structure. Therefore, it can be attributed to the competitive model. The policy makers in this area can use this characteristic as a leverage to improve efficiency, fairness, revenue and health indices. PMID:28607663

Generics market in Greece: the pharmaceutical industry's beliefs.

PubMed

Geitona, Mary; Zavras, Dimitrios; Hatzikou, Magda; Kyriopoulos, John

2006-11-01

The aim of this study was to investigate the beliefs and perspectives of the pharmaceutical industry on generic medication in Greece. Questionnaires were mailed to all 58 members of the Hellenic Association of Pharmaceutical Companies from November 2002 to February 2003. The response rate was 52%, namely 30 questionnaires were completed and returned. The questionnaire requested information on companies' involvement in generics, their opinion on generics' characteristics and on public policies affecting the demand and supply of generic medication. A descriptive analysis of the outcomes, that is percentage comparison through binomial tests and Fisher tests, was performed. According to our findings, 43% of the respondents were involved in the production and distribution of generics and the mean period of their involvement was 12 years. The majority of the respondents were in favor of their companies' involvement in generics, despite the relatively small market share of generics in Greece; 9.7% of total pharmaceutical market in 2003. Bearing in mind that in Greece the promotion of generics is not encouraged, pharmaceutical companies believe that the mandatory introduction of bioequivalence studies is an indirect promotional strategy towards generics. Additionally, the majority declared that their main competitive advantages are their safety, efficacy and effectiveness as well as their economic benefit to the society. Finally, the respondents expressed their preference for the introduction of pharmacoeconomic submissions for drugs' reimbursement by social insurance funds.

Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

PubMed Central

Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

2014-01-01

Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan. PMID:25342901

Pharmaceutical sales representatives and the doctor/patient relationship.

PubMed

Wall, L Lewis; Brown, Douglas

2002-09-01

As marketing efforts by drug companies become more aggressive, physicians are being asked to provide clinical "preceptorships" to pharmaceutical sales representatives. During a "preceptorship" of this type, the company representative spends a day with the physician seeing patients "as an educational experience," and the physician receives an "honorarium" from the drug company in return. We explore the implications of this practice. First, we examine the nature of the doctor/patient relationship and the fiduciary obligations incumbent upon physicians in their role as healers. Second, we examine four interlocking ethical principles-nonmaleficence, beneficence, respect for patient autonomy, and justice-that should govern doctor/patient encounters. Third, we critique several hypothetical scenarios involving individuals who might put forth a claim to enter the doctor/patient relationship (ie, a pharmacist, a social scientist, the husband of the patient, and a pharmaceutical sales representative). We conclude that the practice of providing clinical "preceptorships" to pharmaceutical sales representatives is unjustifiable, is unethical, and should not be permitted.

Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry.

PubMed

Song, Chie Hoon; Han, Jeung-Whan

2016-01-01

Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explores various strategic and tactical management approaches by synthesizing the relevant literature and practical examples on patent expiration strategies. It further discusses how the mix of competition policies and strategic instruments can be used to maintain declining revenue streams from the blockbuster business model of the pharmaceutical industry. The review provides a comprehensive overview of the research on various strategies, offers both theoretical and practical guidelines for strategy transformation that companies can use to prolong the market exclusivity, and identifies knowledge gaps that needed to be addressed in order to improve efficiency in policy design.

International pharmaceutical social risk regulation: An ethical perspective.

PubMed

Gordon, Cameron

2011-03-01

Pharmaceutical production and distribution constitute big business. For the companies the rewards can be substantial. Rates of return on drug company investments tend to be higher than many other manufacturing enterprises. But reward is only one side of the story. There is also the issue of social risk, the focus of this article. Social risk for pharmaceutical production is especially pronounced. An ineffective or, worse, dangerous drug, can have dire consequences for the population at large. For this reason, there is elaborate government regulation and oversight of drug safety and risk. These systems, especially in the US and Europe, will be the main focus of this paper. The two systems will be described, and then compared and contrasted in terms of their framing of social risk and actions governments take to limit it. Systems elsewhere, especially in the developing world, are increasing in relative importance and these will be briefly discussed as well. Ethical issues that have arisen in these various systems will be surfaced and analysed. The paper will close with some conclusions and suggestions for further research.

Approaches to education of pharmaceutical biotechnology in faculties of pharmacy.

PubMed

Calis, S; Oner, F; Kas, S; Hincal, A A

2001-06-01

Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.

The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.

PubMed

Kelleher, Finnuala

2004-01-01

Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions.

United States private-sector physicians and pharmaceutical contract research: a qualitative study.

PubMed

Fisher, Jill A; Kalbaugh, Corey A

2012-01-01

There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities. We conducted a qualitative study in 2003-2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers. Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary.

"But doctors do it...": nurses' views of gifts and information from the pharmaceutical industry.

PubMed

Jutel, Annemarie; Menkes, David B

2009-06-01

Most nurses, like their physician counterparts, lack education regarding pharmaceutical marketing strategies, and little is known of their beliefs and practices regarding this industry. Nurses are increasingly targeted by pharmaceutical companies as they become more involved in prescription and as policies restrict pharmaceutical companies' contact with physicians. To assess nurses' beliefs and reported practices concerning pharmaceutical marketing and sponsorship strategies. We conducted parallel Web- and paper-based surveys of a sample of senior registered nurses employed by government-funded health boards in 2 regions of New Zealand to explore their contact with the pharmaceutical industry as well as their beliefs and practices regarding information, gifts, and sponsorship provided by pharmaceutical companies. Returns were tested using Fisher's exact test to determine consistency in response between regions. Results for key outcome variables, including attitude toward the value of industry-derived information, were analyzed by region and in aggregate. Most nurses had contact with pharmaceutical sales representatives (69/106), accepted gifts from representatives (79/105), and believed information from the pharmaceutical industry probably improved their practice (71/106). Half believed that they would be able to detect misleading information if it were present, and 35% believed that accepting gifts and sponsorship was ethically acceptable. We found positive associations between the belief that information from the industry improved practice and reported acceptance of conference funding (OR 3.63; 95% CI 1.41 to 11.55), free food (OR 3.24; 95% CI 2.03 to 7.55), or gifts (OR 3.52; 95% CI 1.38 to 8.95). Nurses generally acknowledge the presence of pharmaceutical marketing in the hospital and the ethical challenges it presents; nonetheless, they also generally accept marketing gifts and may underestimate both the ethical challenges and their own susceptibility to

Exposure to the drug company marketing in Greece: Interactions and attitudes in a non-regulated environment for medical students.

PubMed

Filippiadou, Magdalini; Kouvelas, Dimitrios; Garyfallos, Georgios; Tsakiridis, Ioannis; Tzachanis, Dimitrios; Spachos, Dimitrios; Papazisis, Georgios

2017-07-01

Medical students are targeted by the pharmaceutical industry and are exposed to their marketing strategies even in the preclinical years of study. The marketing strategies used by pharmaceutical companies with physicians are also applied to students, affecting their future prescribing behaviour, and include low-cost non-educational gifts, travel expenses and conferences registration fees. In Greece, there are no national or institutional regulations and guidelines concerning drug company-medical student interactions. This study is the first time this estimate has been made in Greece and assessed a) the interactions between pharmaceutical companies and medical students, and b) students' attitudes towards pharmaceutical marketing. A sampling of undergraduate medical students completed an anonymous, self-administered, web-based survey. The first part of the survey investigated the interaction between the students and pharmaceutical companies; the possible answers were the binomial variables 'yes' or 'no'. The second part assessed the students' opinions of pharmaceutical company marketing and the answer options were 'agree', 'don't know/don't answer' and 'disagree'. The survey was completed by 412 undergraduate medical students (mean age 22 ± 2.2 years, 52.7% were women); the overall response rate was 58.9%. Although the majority did not consider accepting gifts and meals from drug companies as ethical, most of them (59%) had accepted meals and low-cost non-educational gifts, especially the clinical-level students. Further, 52,6% of the students did not believe that accepting gifts from pharmaceutical companies would affect their own prescription behaviour, whereas surprisingly they held the opposite opinion of their classmates. The vast majority (85.9%) agreed that sponsored lectures were biased in favour of a company's products; however, 47.6% agreed that promotional material is useful for learning about new medications and 34.5% believed that medical schools

Pharmaceutical counseling: Between evidence-based medicine and profits.

PubMed

Egorova, S N; Akhmetova, T

2015-01-01

pharmaceutical counseling standards: Article 1.1 "Code of Ethics of the pharmaceutical worker of Russia" states: "The main task of the professional activity of the pharmaceutical worker - protection of human health", Article 1.3 states that a pharmaceutical worker must take professional decisions solely in the interests of a patient [1]. However, the pharmacy is a trade organization, thus as a retailer the pharmacy is directly interested in making profits and increasing sales of pharmaceutical products, including non-prescription medicines. Moreover, while the clinical medicine is monitored for unjustified prescribing and measures are being taken to prevent polypharmacy, for a pharmacist the growing sales of over-the-counter drugs, active promotion of dietary supplements, homeopathic medicines, medical devices, and, consequently, an increase of financial indicators (particularly "average purchase size") - all are characteristics of success [2].Rational use of over-the-counter medicines requires introduction of pharmaceutical counseling standards (pharmaceutical care) according to symptoms - major reasons to visit a pharmacy as part of responsible self-medication (cold, sore throat, headache, diarrhea, etc.). Standards of pharmaceutical counseling should be objective, reliable and up-to-date and contain recommendations for the rational use of over-the-counter drugs as well as indications requiring treatment to the doctor. Standardization of pharmaceutical counseling in terms of Evidence-based Pharmacy would enhance the efficiency, safety and cost-effectiveness of over-the-counter medicines.Currently, the lack of clinical component in the higher pharmaceutical education and the lack of approved standards of pharmaceutical counseling lead to the introduction of cross-selling technologies (which are broadly applied in other areas of trade, for example, the offer of a boot-polish during the sale of shoes) to the pharmaceutical practice [2, 3]. However, drugs belong to a special group

Recognizing misleading pharmaceutical marketing online.

PubMed

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2014-01-01

In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.

PHL7/441: Fixing a Broken Line between the Perceived "Anarchy" of the Web and a Process-Comfortable Pharmaceutical Company

PubMed Central

Vercellesi, L

1999-01-01

Introduction In 1998 a pharmaceutical company published its Web site to provide: an institutional presence multifunctional information to primary customers and general public a new way of access to the company a link to existing company-sponsored sites a platform for future projects Since the publication, some significant integration have been added; in particular one is a primary interactive service, addressed to a selected audience. The need has been felt to foster new projects and establish the idea of routinely considering the site as a potential tool in the marketing mix, to provide advanced services to customers. Methods Re-assessment of the site towards objectives. Assessment of its perception with company potential suppliers. Results The issue "web use" was discussed in various management meetings; the trend of use of Internet among the primary customers was known; major concerns expressed were about staffing and return of investment for activities run in the Web. These perceptions are being addressed by making the company more comfortable by: Running the site through a detailed process and clear procedures, defining A new process of maintenance of the site, involving representatives of all the functions. Procedures and guidelines. A master file of approved answers and company contacts. Categories of activities (information, promotion, education, information to investors, general services, target-specific services). Measures for all the activities run in the Web site Specifically for the Web site a concise periodical report is being assessed, covering 1. Statistics about hits and mails, compared to the corporate data. Indication of new items published. Description by the "supplier" of new or ongoing innovative projects, to transfer best practice. Basic figures on the Italian trend in internet use and specifically in the pharmaceutical and medical fields. Comments to a few competitor sites. Examples of potential uses deriving from other Web sites. Discussion

Cannabis-based medicines--GW pharmaceuticals: high CBD, high THC, medicinal cannabis--GW pharmaceuticals, THC:CBD.

PubMed

2003-01-01

GW Pharmaceuticals is undertaking a major research programme in the UK to develop and market distinct cannabis-based prescription medicines [THC:CBD, High THC, High CBD] in a range of medical conditions. The cannabis for this programme is grown in a secret location in the UK. It is expected that the product will be marketed in the US in late 2003. GW's cannabis-based products include selected phytocannabinoids from cannabis plants, including D9 tetrahydrocannabinol (THC) and cannabidiol (CBD). The company is investigating their use in three delivery systems, including sublingual spray, sublingual tablet and inhaled (but not smoked) dosage forms. The technology is protected by patent applications. Four different formulations are currently being investigated, including High THC, THC:CBD (narrow ratio), THC:CBD (broad ratio) and High CBD. GW is also developing a specialist security technology that will be incorporated in all its drug delivery systems. This technology allows for the recording and remote monitoring of patient usage to prevent any potential abuse of its cannabis-based medicines. GW plans to enter into agreements with other companies following phase III development, to secure the best commercialisation terms for its cannabis-based medicines. In June 2003, GW announced that exclusive commercialisation rights for the drug in the UK had been licensed to Bayer AG. The drug will be marketed under the Sativex brand name. This agreement also provides Bayer with an option to expand their license to include the European Union and certain world markets. GW was granted a clinical trial exemption certificate by the Medicines Control Agency to conduct clinical studies with cannabis-based medicines in the UK. The exemption includes investigations in the relief of pain of neurological origin and defects of neurological function in the following indications: multiple sclerosis (MS), spinal cord injury, peripheral nerve injury, central nervous system damage, neuroinvasive

Cell-Based Veterinary Pharmaceuticals - Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union.

PubMed

Faltus, Timo; Brehm, Walter

2016-01-01

Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States.

Using design science research to develop online enhanced pharmaceutical care services.

PubMed

Lapão, Luís Velez; Gregório, João; Mello, Diogo; Cavaco, Afonso; Mira Da Silva, Miguel; Lovis, Christian

2014-01-01

The ePharmaCare project aims at assessing the potential of eHealth services for the provision of pharmaceutical services interacting actively with patients. The results presented here focus on the first three steps of Design Science Research Methodology. A mixed methods approach was used with an online survey to collect data on use of information technologies in community pharmacy, followed by an exploratory observational time and business processes study, which use the shadowing method to identify and assess the opportunity to lunch online services. Combining this with the Service Experiment Blueprint and the Dáder method an enhanced pharmaceutical service was designed. Next, an artifact is developed and a prototype is implemented to demonstrate the value of online pharmaceutical services' delivery. This new service could represent a new perspective for pharmaceutical services integration within the health system.

Exposure of Medical Students to Pharmaceutical Marketing in Primary Care Settings: Frequent and Influential

ERIC Educational Resources Information Center

Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-01-01

It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts.…

Research Using the Roter Method of Interaction Process Analysis (RIAS) for Communication Education in the Pharmaceutical Sciences.

PubMed

Arita, Etsuko

2017-01-01

The ability to communicate effectively as a healthcare professional has come into greater focus as the role of pharmacists expands from "medicine-based" to "client-based" (e.g., working with patients, their families, and in multidisciplinary interactions). The ability to communicate cannot be acquired solely in the classroom; a large part of acquiring such skill is based on practical experience. Role-playing with simulated patients has already been implemented in pharmaceutical education; in that sense, opportunities to receive education in practical communication are increasing. However, in order to assure that these educational opportunities are more than "experiences" in theory alone, aspects of communications training that are satisfactory or need improvement must be clarified through empirical studies. While data used in pharmaceutical studies have mainly been quantitative in nature, data required for medical communication studies is generally more qualitative. Only recently the importance of qualitative research has been recognized in pharmaceutical studies, a field in which any aspect difficult to express numerically has been considered subjective, and thus less acceptable. Against this backdrop, this report introduces an aspect of communication research that employs the Roter method of interaction process analysis (RIAS), a medical communication analyzing method by Professor Debra Roter at Johns Hopkins University. RIAS is a quantitative analysis of qualitative data. I want to discuss the significance of using results of research based on qualitative data to improve the quality of communication.

United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study

PubMed Central

Fisher, Jill A.; Kalbaugh, Corey A.

2012-01-01

Background There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities. Methods and Findings We conducted a qualitative study in 2003–2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers. Conclusions Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary. PMID:22911055

Effective executive management in the pharmaceutical industry.

PubMed

Tran, Hoang; Kleiner, Brian H

2005-01-01

Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceutical companies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they

Attention-deficit hyperactivity disorder, drug companies and the internet.

PubMed

Mitchell, Jessica; Read, John

2012-01-01

This study investigated the influence of drug-company funding on websites about attention-deficit hyperactivity disorder (ADHD). Websites in the top 60 for either Google or Yahoo!Xtra with information about causation and treatment were analysed. Likert scales, based on those used in previous similar studies, were developed to rate aetiological explanations and recommended treatment approaches, on a dimension from psycho-social to biological. Overall, the quality of information on websites was poor with a strong bias towards bio-genetic aetiological explanations of ADHD. Twenty-one of the 57 websites (37%) were funded by drug companies. The drug-company funded (DCF) websites were significantly more likely than non-DCF websites to recommend medication rather than psycho-social treatments. The selective lack of consideration of psycho-social treatments by DCF websites is discussed in relation to the relevant research literature, including the evidence in favour of a multimodal approach. The findings, which are consistent with previous similar studies in relation to websites about adult mental health problems, confirm that the pharmaceutical industry is seeking to influence public opinion via the internet.

Valuing Trial Designs from a Pharmaceutical Perspective Using Value-Based Pricing.

PubMed

Breeze, Penny; Brennan, Alan

2015-11-01

Our aim was to adapt the traditional framework for expected net benefit of sampling (ENBS) to be more compatible with drug development trials from the pharmaceutical perspective. We modify the traditional framework for conducting ENBS and assume that the price of the drug is conditional on the trial outcomes. We use a value-based pricing (VBP) criterion to determine price conditional on trial data using Bayesian updating of cost-effectiveness (CE) model parameters. We assume that there is a threshold price below which the company would not market the new intervention. We present a case study in which a phase III trial sample size and trial duration are varied. For each trial design, we sampled 10,000 trial outcomes and estimated VBP using a CE model. The expected commercial net benefit is calculated as the expected profits minus the trial costs. A clinical trial with shorter follow-up, and larger sample size, generated the greatest expected commercial net benefit. Increasing the duration of follow-up had a modest impact on profit forecasts. Expected net benefit of sampling can be adapted to value clinical trials in the pharmaceutical industry to optimise the expected commercial net benefit. However, the analyses can be very time consuming for complex CE models. © 2014 The Authors. Health Economics published by John Wiley & Sons Ltd.

Hazardous Waste Cleanup: Bristol-Myers Squibb Company Worldwide Medicines in Brunswick, New Jersey

EPA Pesticide Factsheets

The Bristol-Myers Squibb Company (BMS) is located at 1 Squibb Drive in New Brunswick, New Jersey. The site has been an active pharmaceutical manufacturing and research and development facility since it began operation by E.R. Squibb and Sons, Inc. in 1907.

Legal considerations for social media marketing by pharmaceutical industry.

PubMed

Yang, Y Tony; Chen, Brian

2014-01-01

Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.

Cell-Based Veterinary Pharmaceuticals – Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union

PubMed Central

Faltus, Timo; Brehm, Walter

2016-01-01

Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States. PMID:27965965

Penicillin dust exposure and penicillin resistance among pharmaceutical workers in Tehran, Iran.

PubMed

Farshad, Ali Asghar; Enferadi, Mojtaba; Bakand, Shahnaz; Jamshidi Orak, Rouhangiz; Mirkazemi, Roksana

2016-07-01

Antimicrobial resistance (AMR) adversely impacts the prevention and treatment of a wide range of infections and is considered as a serious threat to global public health. Occupational-related AMR is a neglected area of research. To assess exposure to penicillin dust, penicillin active materials, and to report the frequency of penicillin resistance among pharmaceutical workers in Tehran, Iran. A quasi-experimental study was conducted among workers on a penicillin production line in a pharmaceutical company (n = 60) and workers in a food producing company (n = 60). Data were collected via survey, air sampling, and throat swab. The mean overall concentrations of penicillin dust and penicillin active material were 6.6 and 4.3 mg/m 3 , respectively, in the pharmaceutical industry. Streptococcus pneumoniae (S. pneumoniae) was detected in 45% (27) individuals in the exposed group, 92.6% of which showed penicillin resistance. Resistance was significantly higher among workers in penicillin production line (p = 0.014). High level of AMR among workers in penicillin production line is a health risk for the workers as well as society as a whole through the spread of drug resistant micro-organisms.

The 2002 PhRMA Code and Pharmaceutical Marketing: did anybody bother to ask the reps?

PubMed

Sillup, George P; Trombetta, Bill; Klimberg, Ronald

2010-10-01

After marketing tactics resulted in $1.2 billion fines, the 2002 PhRMA Code attempted to standardize marketing and sales practices. Self-regulation had varied success by other industries and by pharmaceutical industries in other countries. Similarly, the Code addressed negative responses about pharmaceutical's practices but had no provisions for monitoring violations. Representative's (reps) perspectives were assessed using an 18-item instrument with 72 reps from 25 companies. Analyses indicated that reps from bigger companies, PhRMA and non-PhRMA, adhered better. The way reps adhered was split between adhering reluctantly and following faithfully. Two thirds felt it was more difficult to do their jobs, resulting from prior entertainment-based relationships with physicians.

Characterizing the interaction between physicians, pharmacists and pharmaceutical representatives in a middle-income country: A qualitative study.

PubMed

Hajjar, Rima; Bassatne, Aya; Cheaito, Mohamad Ali; Naser El Dine, Rabie; Traboulsy, Sarah; Haddadin, Fadi; Honein-AbouHaidar, Gladys; Akl, Elie A

2017-01-01

Studies around the world have shown that interactions between pharmaceutical companies, pharmacists and physicians have a great influence on prescribing and drug dispensing practices. In middle-income countries, the nature and extent of these interactions have not been well researched. Our objectives were to qualitatively explore the nature of the interactions between pharmaceutical companies, physicians and pharmacists, their impact on drug prescription and dispensing practices in Lebanon. We used grounded theory approach as well as the known sponsor, purposive, and snowballing sampling strategies to identify interviewees from the three respective groups: physicians, pharmacists, and pharmaceutical representatives. We conducted semi-structured and analyzed transcripts thematically. This study encompassed 6 pharmaceutical representatives, 13 physicians and 13 pharmacists. The following themes emerged: purpose and driver for the interactions, nature of the interactions, incentives, impact on prescription practices, ethical considerations, and suggestions for managing the interactions. The main purposes for the interaction were educational, promotional, and monitoring prescription practices and dispensing, while the main drivers for these interactions were market potential and neighborhood socio-economic status. Physicians, pharmacists and pharmaceutical representatives who engage in these interactions benefit from a variety of incentives, some of which were characterized as unethical. It appears that pharmaceutical companies give prominence to selected physicians within their communities. Although members of the three interviewed groups refer to some of the interactions as being problematic, they described a culture of acceptance of gift giving. We developed a framework that depicts the prevailing politico-cultural environment, the interactions between the three professional groups, and their impact on drug prescription. Underreporting is the main limitation of this

Actor modelling and its contribution to the development of integrative strategies for management of pharmaceuticals in drinking water.

PubMed

Titz, Alexandra; Döll, Petra

2009-02-01

Widespread presence of human pharmaceuticals in water resources across the globe is documented. While some, but certainly not enough, research on the occurrence, fate and effect of pharmaceuticals in water resources has been carried out, a holistic risk management strategy is missing. The transdisciplinary research project "start" aimed to develop an integrative strategy by the participation of experts representing key actors in the problem field "pharmaceuticals in drinking water". In this paper, we describe a novel modelling method, actor modelling with the semi-quantitative software DANA (Dynamic Actor Network Analysis), and its application in support of identifying an integrative risk management strategy. Based on the individual perceptions of different actors, the approach allows the identification of optimal strategies. Actors' perceptions were elicited by participatory model building and interviews, and were then modelled in perception graphs. Actor modelling indicated that an integrative strategy that targets environmentally-responsible prescription, therapy, and disposal of pharmaceuticals on one hand, and the development of environmentally-friendly pharmaceuticals on the other hand, will likely be most effective for reducing the occurrence of pharmaceuticals in drinking water (at least in Germany where the study was performed). However, unlike most other actors, the pharmaceutical industry itself does not perceive that the production of environmentally-friendly pharmaceuticals is an action that helps to achieve its goals, but contends that continued development of highly active pharmaceutical ingredients will help to reduce the occurrence of pharmaceuticals in the water cycle. Investment in advanced waste or drinking water treatment is opposed by both the wastewater treatment company and the drinking water supplier, and is not mentioned as appropriate by the other actors. According to our experience, actor modelling is a useful method to suggest effective

'Get with the Program!': pharmaceutical marketing, symptom checklists and self-diagnosis.

PubMed

Ebeling, Mary

2011-09-01

During more than a decade of direct-to-consumer advertising (DTC) of pharmaceuticals in the United States, several highly controversial and contested disease states have been promoted to affect diagnostic and prescribing outcomes that are favorable to a company's branded drug. Influencing medical diagnosis is essential to the branding of a disease, which helps to protect pharmaceutical intellectual property and assures higher profits for drug companies. Enormous marketing as well as medical resources are deployed to ensure that new diagnoses of disease states are recognized. While much work has been done investigating the marketing processes necessary to shape and define diagnoses for many of these new disease states, such as Premenstrual Dysphoric Disorder (PMDD), the promotion of self-diagnosis within pharmaceutical marketing campaigns garner little sociological attention. This article reviews and analyzes branded disease awareness campaigns sponsored by pharmaceutical companies that employ self-diagnostic "tools". By using the example of one specific disease state, PMDD, I illustrate how the marketing of self-diagnosis transforms the patient into a consumer in order to achieve the aims of a drug company. This example is contextualized within the larger theoretical framework on the sociology of diagnosis. Consideration is given to how the marketing of self-diagnosis goes beyond Jutel's (2009) description of diagnosis as being the "classification tool of medicine" and becomes a marketing tool to construct a well-educated consumer who will demand medical diagnoses inline with a drug company's objectives. Copyright © 2011 Elsevier Ltd. All rights reserved.

Effect of mergers and acquisitions on drug discovery: perspective from a case study of a Japanese pharmaceutical company.

PubMed

Shibayama, Sotaro; Tanikawa, Kunihiro; Fujimoto, Ryuhei; Kimura, Hiromichi

2008-01-01

The pharmaceutical industry has experienced intermittent waves of mergers and acquisitions (M&As) since the 1980s and recently appeared to be in yet another wave. Previous studies indicated rather negative impacts of consolidation on research and development, suggesting that they do not necessarily lead to long-term reinforcement of research capabilities, although they may enrich the drug pipeline in the short term. However, recent studies have implied a positive side in terms of knowledge-base transfer. Further micro-organizational studies suggested that scientists learned new knowledge and approaches from partner scientists and improved their performance and innovation. These findings imply that measures for the scientist-level integration after M&As would reinforce fundamental research capabilities in the long term.

Pharmaceutical market access in emerging markets: concepts, components, and future.

PubMed

Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

2014-01-01

This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.

3rd annual symposium of chemical and pharmaceutical structure analysis.

PubMed

Weng, Naidong; Zheng, Jenny; Lee, Mike

2012-08-01

The 3rd Annual Symposium on Chemical and Pharmaceutical Structure Analysis was once again held in Shanghai, where a rich history of 'East meets West' continued. This meeting is dedicated to bringing together scientists from pharmaceutical companies, academic institutes, CROs and instrument vendors to discuss current challenges and opportunities on the forefront of pharmaceutical research and development. The diversified symposia and roundtables are highly interactive events where scientists share their experiences and visions in a collegial setting. The symposium highlighted speakers and sessions that provided first-hand experiences as well as the latest guidance and industrial/regulatory thinking, which was reflected by the theme of this year's meeting 'From Bench to Decision Making - from Basics to Application.' In addition to the highly successful Young Scientist Excellence Award, new events were featured at this year's meeting, such as the Executive Roundtable and the inaugural Innovator Award.

[The pharmaceutical industry in France: the turning point of 1915].

PubMed

Bonnemain, Bruno

2015-12-01

For several convergent reasons, 1915 was a key period for the pharmaceutical industry in France. The overall realization that France was dependent on Germany for chemical and pharmaceutical products came from shortages of key drugs but also from massive use of poison gas for which France was not able to face this unexpected event. France's shortage for chemists properly trained to answer the needs of industry, the weak relationship between industry and faculty, the uncomfortable situation of specialty drugs, the regulations on patents and trademarks were many subjects of controversies which will contribute to the analysis of the source of this French dependence to Germany. It will be at the origin of new orientations after the war for the pharmaceutical industry and the French society. The objective was to be independent for drugs and consequently to resolve the identified issues, as well as to have a dynamic industrial research. The creation and development of several pharmaceutical companies after the war was a more or less direct benefit from the considerations starting in 1915.

Differential pricing of new pharmaceuticals in lower income European countries.

PubMed

Kaló, Zoltán; Annemans, Lieven; Garrison, Louis P

2013-12-01

Pharmaceutical companies adjust the pricing strategy of innovative medicines to the imperatives of their major markets. The ability of payers to influence the ex-factory price of new drugs depends on country population size and income per capita, among other factors. Differential pricing based on Ramsey principles is a 'second-best' solution to correct the imperfections of the global market for innovative pharmaceuticals, and it is also consistent with standard norms of equity. This analysis summarizes the boundaries of differential pharmaceutical pricing for policymakers, payers and other stakeholders in lower-income countries, with special focus on Central-Eastern Europe, and describes the feasibility and implications of potential solutions to ensure lower pharmaceutical prices as compared to higher-income countries. European stakeholders, especially in Central-Eastern Europe and at the EU level, should understand the implications of increased transparency of pricing and should develop solutions to prevent the limited accessibility of new medicines in lower-income countries.

The evolution analysis of listed companies co-holding non-listed financial companies based on two-mode heterogeneous networks

NASA Astrophysics Data System (ADS)

An, Pengli; Li, Huajiao; Zhou, Jinsheng; Chen, Fan

2017-10-01

Complex network theory is a widely used tool in the empirical research of financial markets. Two-mode and multi-mode networks are new trends and represent new directions in that they can more accurately simulate relationships between entities. In this paper, we use data for Chinese listed companies holding non-listed financial companies over a ten-year period to construct two networks: a two-mode primitive network in which listed companies and non-listed financial companies are considered actors and events, respectively, and a one-mode network that is constructed based on the decreasing-mode method in which listed companies are considered nodes. We analyze the evolution of the listed company co-holding network from several perspectives, including that of the whole network, of information control ability, of implicit relationships, of community division and of small-world characteristics. The results of the analysis indicate that (1) China's developing stock market affects the share-holding condition of listed companies holding non-listed financial companies; (2) the information control ability of co-holding networks is focused on a few listed companies and the implicit relationship of investment preference between listed companies is determined by the co-holding behavior; (3) the community division of the co-holding network is increasingly obvious, as determined by the investment preferences among listed companies; and (4) the small-world characteristics of the co-holding network are increasingly obvious, resulting in reduced communication costs. In this paper, we conduct an evolution analysis and develop an understanding of the factors that influence the listed companies co-holding network. This study will help illuminate research on evolution analysis.

Characterization of the evolution of the pharmaceutical regulatory environment.

PubMed

Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

2013-01-01

This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

E-detailing: information technology applied to pharmaceutical detailing.

PubMed

Montoya, Isaac D

2008-11-01

E-detailing can be best described as the use of information technology in the field of pharmaceutical detailing. It is becoming highly popular among pharmaceutical companies because it maximizes the time of the sales force, cuts down the cost of detailing and increases physician prescribing. Thus, the application of information technology is proving to be beneficial to both physicians and pharmaceutical companies. When e-detailing was introduced in 1996, it was limited to the US; however, numerous other countries soon adopted this novel approach to detailing and now it is popular in many developed nations. The objective of this paper is to demonstrate the rapid growth of e-detailing in the field of pharmaceutical marketing. A review of e-detailing literature was conducted in addition to personal conversations with physicians. E-detailing has the potential to reduce marketing costs, increase accessibility to physicians and offer many of the advantages of face-to-face detailing. E-detailing is gaining acceptance among physicians because they can access the information of a pharmaceutical product at their own time and convenience. However, the drug safety aspect of e-detailing has not been examined and e-detailing remains a supplement to traditional detailing and is not yet a replacement to it.

The initial pharmaceutical development of an artesunate/amodiaquine oral formulation for the treatment of malaria: a public-private partnership.

PubMed

Lacaze, Catherine; Kauss, Tina; Kiechel, Jean-René; Caminiti, Antonella; Fawaz, Fawaz; Terrassin, Laurent; Cuart, Sylvie; Grislain, Luc; Navaratnam, Visweswaran; Ghezzoul, Bellabes; Gaudin, Karen; White, Nick J; Olliaro, Piero L; Millet, Pascal

2011-05-23

Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical batch manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Médecins Sans Frontières and the Drugs for Neglected Disease initiative (DNDi). The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main obstacle hampering the development process

[Production of autologous keratinocytes for therapeutic purposes within a pharmaceutical company].

PubMed

Guillot, F L

2001-01-01

Because biotechnologies are growing and are becoming key players in the pharmaceutical industry scene, Genévrier Laboratories inaugurated in January 1998, a new department especially designed for the production of cultured cells as therapeutic agents. Meeting clinician therapeutic needs by providing autologous keratinocytes and chondrocytes in the near future, represents the primary aim of the Biotechnology department. Concrete cell-based products are already being used for the treatment of burns and cutaneous chronic wounds such as the EPIBASE graft, which corresponds to an epidermis sheet composed of cultured autologous keratinocytes.

Market Size and Innovation: Effects of Medicare Part D on Pharmaceutical Research and Development

PubMed Central

Sood, Neeraj

2012-01-01

Recent evidence suggests that Medicare Part D increased prescription drug use among seniors, and increased pharmaceutical firms’ revenues from sales. Previous studies also indicate that increases in market size induce pharmaceutical innovation. This paper assesses the impact of the Medicare Part D legislation on pharmaceutical research and development (R&D), using time-series data on the number of drugs entering preclinical and clinical development by therapeutic class and phase. We find that the passage and implementation of Medicare Part D is associated with significant increases in pharmaceutical R&D for therapeutic classes with higher Medicare market share. PMID:23869113

Acquiring Pharmaceutical Industry Assets in the UK: 1 + 1 = 1?

PubMed

Kanavos, Panos; Angelis, Aris

2014-01-01

The recent AstraZeneca takeover bid from Pfizer puts pharmaceutical R&D once again on the public agenda. Three pertinent questions are (a) what can be expected from this acquisition, (b) what are the implications for the UK economy and science base, and (c) whether such a deal should go ahead. Although the key driver behind this acquisition would be an improvement in company performance and shareholder value, past evidence suggests that mergers and acquisitions (M&A) of large pharmaceutical companies imply a neutral net effect on productivity, if not a decline, with employment decreasing and R&D spend following a similar trend. Similarities between the two companies include dropping sales; however, relative to its size, AstraZeneca has a more promising R&D pipeline, especially in therapeutic areas where Pfizer's strength is currently limited (e.g. oncology). Ensuring a portfolio diversification would make Pfizer's takeover proposal a knight's one, but history points towards a knave-like behavior.

Boycott threat forces French company to abandon RU486.

PubMed

Dorozynski, A

1997-04-19

Threatened boycotts by American anti-abortion groups have forced the French pharmaceutical company Roussel-Uclaf, a subsidiary of the German company Hoechst, to stop production and distribution of mifepristone (RU-486), which the protesters call "the abortion pill." All patent rights have been transferred, without charge, to Dr. Edouard Sarkiz, one of the pill's developers. Hoechst, which had acquired Marion Pharmaceuticals to form a new group, Hoechst-Marion-Roussel, had increased its share of the US pharmaceutical market from 1% to 4% in doing so and could not tolerate a boycott. RU-486, which was discovered by Professor Etienne Baulieu, was introduced in France in 1987 as an alternative to surgical abortion. Although Hoechst, then a majority stockholder of Roussel-Uclaf, had asked the French firm to interrupt production of the pill in 1988, the French minister of health and social affairs at that time, Claude Evin, ordered production to be continued. Approximately 25% of French women seeking abortion use RU-486; it is also used in Britain, Sweden, and China (women in China must pay for the drug, while surgical abortion is free). All American firms have refused to buy the drug from Roussel-Uclaf. An offer to the World Health Organization was ignored. The American Population Council obtained the right to use RU-486 in 1993. Dr. Sarkiz has formed Exelgyn, a small nonprofit company, to produce and distribute RU-486; research into other uses for the drug will also be conducted. There has been limited research into its use as an emergency contraceptive and as a treatment for endometriosis, uterine fibroma, and breast cancer. According to Professor Baulieu, the drug could be used in treating wounds and burns because of its antiglucocorticoid and immunosuppressive properties; preliminary research by the professor indicates the drug could also possibly be used as a reversible male contraceptive because of its action on the membranes of spermatozoa. The drug's use in

Pharmaceutical science faculty publication records at research-intensive pharmacy colleges and schools.

PubMed

Thompson, Dennis F; Nahata, Milap C

2012-11-12

To determine yearly (phase 1) and cumulative (phase 2) publication records of pharmaceutical science faculty members at research-intensive colleges and schools of pharmacy. The publication records of pharmaceutical science faculty members at research-intensive colleges and schools of pharmacy were searched on Web of Science. Fifty colleges and schools of pharmacy were randomly chosen for a search of 1,042 individual faculty members' publications per year from 2005 to 2009. A stratified random sample of 120 faculty members also was chosen, and cumulative publication counts were recorded and bibliometric indices calculated. The median number of publications per year was 2 (range, 0-34). Overall, 22% of faculty members had no publications in any given year, but the number was highly variable depending on the faculty members' colleges or schools of pharmacy. Bibliometric indices were higher for medicinal chemistry and pharmaceutics, with pharmacology ranking third and social and administrative sciences fourth. Higher bibliometric indices were also observed for institution status (ie, public vs private) and academic rank (discipline chairperson vs non-chairperson and professor vs junior faculty member) (p<0.01 for each). The median number of cumulative publications per faculty member was 34 (range, 0-370). Significant differences exist in yearly and cumulative publication rates for faculty members and bibliometric indices among pharmaceutical science disciplines and academic ranks within research-intensive colleges and schools of pharmacy. These data may be important for benchmarking purposes.

From the Research Laboratory to the Operating Company: How Information Travels.

ERIC Educational Resources Information Center

Coppin, Ann S.; Palmer, Linda L.

1980-01-01

Reviews transmission processes of Chevron Oil Field Research Company (COFRC) research results from laboratories to end-user operating companies worldwide. Information dissemination methods described included informal communication, intercompany meetings, visits by COFRC personnel to operating company offices, distribution of written reports,…

The impact of the cox-2 inhibitor issue on perceptions of the pharmaceutical industry: content analysis and communication implications.

PubMed

Lofstedt, Ragnar E

2007-01-01

The field of risk communication has its roots in the environmental, chemical, space, and nuclear arenas. As a number of these sectors have now vastly improved their communication strategies, attention is being placed on sectors that have been more problematic as of late. Examples of such sectors, include the food industries and the pharmaceutical/health sector. This article focuses on how large, multinational pharmaceutical companies can better communicate risks by analysis of one specific case, namely, that of the Cox-2 controversy.(1) For purposes of this article, risk communication is best described as "the flow of information and risk evaluations back and forth between academic experts, regulatory practitioners, interest groups and the general public," and "big pharma" refers to the more traditional R & D-based, innovative pharmaceutical companies.

[Early achievements of the Danish pharmaceutical industry-7].

PubMed

Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

2014-01-01

A/S GEA Farmaceutisk Fabrik was established as a family business in 1927 by the pharmacist Knud L. Gad Andresen who until then had been employed in the pharmaceutical industry. Gad Andresen wanted to run a company focusing on the development of generics, and he wanted this development to take place in a close cooperation with Danish physicians. This has indeed been achieved with success. In 1995 GEA was purchase'd by the American pharmaceutical company Bristol-Myers Squibb who in a press release characterized GEA as Denmark's second largest manufacturer of generics. Immediately after this takeover GEA's R&D department ceased the research in innovative products and from now on exclusively focused on the development of generics. Three years later GEA was sold to the German generic company Hexal who later on resold GEA to the Swiss generic company Sandoz. GEA changed ownership another couple of times until the last owner went bankrupt in 2011. GEA is yet again a model example of an early Danish pharmaceutical company which was established as an individual company, and which had a long commercial success with the production and marketing of generics. GEA's earliest products, the organotherapeutics, were not innovations. The innovative products were developed already in the 1890s in Denmark by Alfred Benzon, and later on copies followed a.o. from Medicinalco and from foreign companies before GEA marketed their generics. Therefore GEA had to promote their preparations as especially qualified medicinal products and to intimate that the products of the competitors were less "active'". At the end of the 1920s the Ministry of Health became aware of the fact that there might be health problems related to the none-existing control of both the or- ganotherapeutic preparations and actually also the other medicinal products of the pharmaceutical industry. Therefore the Ministry had requested the National Board of Health for a statement regarding this problem. The National Board

Guiding principles of value creation through collaborative innovation in pharmaceutical research.

PubMed

Schweizer, Liang; He, Jeff

2018-02-01

Open innovation has become the main trend in pharmaceutical research. Potential obstacles and pitfalls of collaborations often lead to missed opportunities and/or poorly executed partnerships. This paper aims to provide a framework that facilitates the execution of successful collaborations. We start by mapping out three checkpoints onto early-stage collaborative partnerships: inception, ignition and implementation. Different value types and value drivers are then laid out for each phase of the partnership. We proceed to propose a ratio-driven approach and a value-adjustment mechanism, enhancing the probability of successes in pharmaceutical research collaborations. These guiding principles combined should help the partners either reach agreement more quickly or move on to the next potential project. Copyright © 2017 Elsevier Ltd. All rights reserved.

Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners.

PubMed Central

Wise, P.; Drury, M.

1996-01-01

OBJECTIVE: To assess the outcome of 100 general practice based, multicentre research projects submitted to the ethics committee of the Royal College of General Practitioners by pharmaceutical companies or their agents between 1984 and 1989. DESIGN: Analysis of consecutive submitted protocols for stated objectives, study design, and outcomes; detailed review of committee minutes and correspondence in relation to amendment and approval; assessment of final reports submitted at conclusion of studies. SUBJECTS: 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. MAIN OUTCOME MEASURES: Success at enrolling subjects and investigators; commencement and completion data; validity of final report's assessment of efficacy, safety, tolerability, and acceptability; and method of use and dissemination of findings. RESULTS: 18 studies were not approved and 45 had to be amended. Randomised controlled trials comprised 46 of the original submissions. Remuneration considerations, inadequate information or consent sheets, pregnancy safety, the need to discontinue existing therapy, and suboptimal scientific content were major reasons for rejecting studies or asking for amendments. Of the 82 approved studies 8 were not started. Shortfalls of investigators (of 39%) and trial subjects (of 37%) and an overall 23% withdrawal rate were responsible for a significant incidence of inconclusive results. Within the six year follow up interval, only 19 of the studies had been formally published. CONCLUSIONS: This audit identified substantial ethical concerns in the process of approving multicentre general practice pharmaceutical research. PMID:8939118

Factors influencing the success of company-based carpooling programs. University research

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pun, C.F.; Kidder, A.E.

1976-05-01

Results are reported of two successive interviews with selected companies in Greensboro, North Carolina which undertook to review workers' interest in carpooling before, during and after the energy crisis. Companies are compared for extent of carpool formation. It is observed that companies which actively encouraged participation in carpool matching programs ended up with higher rates of carpool formation than companies which maintained a passive stance on carpooling. Carpooling appears slightly more prevalent among older workers, and among white collar workers. However, the sample of companies is biased in favor of white collar companies; therefore the relationship between occupation and carpoolingmore » remains unsettled. Corporate executives in some of the larger manufacturing concerns in Greensboro were unwilling to promote carpool matching efforts by the firm, because they do not want to invade workers' privacy, because they felt the majority did not want to carpool, and because they did not wish to interfere in the workers' mode choices. Of interest is the fact that in four out of the five companies studied, the percentage of workers carpooling rose after the end of the energy crisis. New patterns of commuting by ridesharing evolved during the days of the gasoline lines, and continued thereafter, spreading to other workers over time.« less

[Chapter 4. Transitions in pharmaceutical market, production and sales in Japan (1980-2010)].

PubMed

Yoshioka, Ryuzo; Matsumoto, Kazuo

2014-01-01

In this paper, the writers reviewed in detail the pharmaceutical market and the shifts in manufacturing and sales including the trade balance in Japan over a thirty-year period from 1980 to 2010. From the 1980s to the 1990s, many innovative pharmaceutical products were developed and launched in the Japanese market. During the same period, some Japanese companies managed to develop their first internationally marketable drugs, which were antibiotics and effective remedies for the digestive and circulatory organs. During this period, Japanese pharmaceutical companies were also able to launch some of blockbuster drugs. For two decades, the pharmaceutical market grew rapidly. For this reason, it can be called "The Growth Period for Pharmaceutical Products" in Japan. After that period, drug development and sales slowed down due to a lack of expertise in genetic engineering and biotechnologies. This situation caused a large deficit in the trade balance for Japanese pharmaceutical products. However, with regard to the trade balance (including technical royalties) for pharmaceutical product technologies, Japan remains in the black even today.

Strategic imperatives for globalization of industries in developing countries: an Indian pharmaceutical industry example.

PubMed

Srivastava, Rajesh; Chandra, Ashish; Kumar, Girish

2004-01-01

The annual global pharmaceutical sales have grown over 466 billion dollars, almost 50% of which comes from North America. Among developing countries, India, with 16% of the world population, accounts for only a small percentage of the global pharmaceutical industry. Until recently, India has had virtually no pharmaceutical industry worth the name producing drugs from basic raw materials and it used to rely mostly on the imports from countries like the USA and England for all its requirements of drugs. On the other hand, India has seen a plethora of multinational pharmaceutical companies come and do business in India. This paper develops a matrix which provides a broad guidance to the mid- to large-size Indian pharmaceutical domestic companies, which should embark on the path to global expansion to establish their might as well.

Schizophrenia, drug companies and the internet.

PubMed

Read, John

2008-01-01

To investigate differences in the content of websites funded, and not funded, by drug companies, the top 50 websites about 'schizophrenia' in Google and Yahoo were analysed in relation to five variables: three scales relating to causes, treatments and violence, and two categorical variables about the condition being extremely severe and about linking coming off medication to violence. Fifty eight percent of the websites analysed received funding from drug companies. Drug company funded websites were significantly more likely to espouse bio-genetic rather than psycho-social causal explanations, to emphasise medication rather than psycho-social treatments, to portray 'schizophrenia' as a debilitating, devastating and long-term illness, and to link violence to coming off medication. They were neither more nor less likely to describe 'schizophrenics' as violent. These results suggest that the documented influence of the pharmaceutical industry over research, professional organisations, teaching institutions, clinical practice and regulatory bodies may now extend to public promotion, via the internet, of perspectives conducive to maximisation of sales.

Penicillin dust exposure and penicillin resistance among pharmaceutical workers in Tehran, Iran

PubMed Central

Farshad, Ali Asghar; Enferadi, Mojtaba; Bakand, Shahnaz; Jamshidi Orak, Rouhangiz; Mirkazemi, Roksana

2016-01-01

Background Antimicrobial resistance (AMR) adversely impacts the prevention and treatment of a wide range of infections and is considered as a serious threat to global public health. Occupational-related AMR is a neglected area of research. Objective To assess exposure to penicillin dust, penicillin active materials, and to report the frequency of penicillin resistance among pharmaceutical workers in Tehran, Iran. Methods A quasi-experimental study was conducted among workers on a penicillin production line in a pharmaceutical company (n = 60) and workers in a food producing company (n = 60). Data were collected via survey, air sampling, and throat swab. Results The mean overall concentrations of penicillin dust and penicillin active material were 6.6 and 4.3 mg/m3, respectively, in the pharmaceutical industry. Streptococcus pneumoniae (S. pneumoniae) was detected in 45% (27) individuals in the exposed group, 92.6% of which showed penicillin resistance. Resistance was significantly higher among workers in penicillin production line (p = 0.014). Conclusions High level of AMR among workers in penicillin production line is a health risk for the workers as well as society as a whole through the spread of drug resistant micro-organisms. PMID:27388022

RFID in the pharmaceutical industry: addressing counterfeits with technology.

PubMed

Taylor, Douglas

2014-11-01

The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity.

Global health: the ethical responsibility of the pharmaceutical industry.

PubMed

Lassen, Lars Christian; Thomsen, Mads Krogsgaard

2007-02-01

Health as a global issue concerns all and clearly manifests global inequality. All stakeholders of the healthcare systems and disease treatment--including the pharmaceutical industry--have an ethical obligation to contribute to promoting global health. At Novo Nordisk we primarily focus on providing our contribution to global health through defeating diabetes. At the same time we stand by being a private company required to deliver a financial profit, which is why we must create positive results on the financial, the environmental and the social bottom lines. In this article we attempt to provide a brief overview of some of the initiatives that we think business companies can take--and therefore are also obliged to in promoting global health. Further, we have pointed out a number of dilemmas within research and development as well as business ethics that all companies face when they convert the ethical principles to daily practice globally.

The Australian Pharmaceutical Benefits Scheme data collection: a practical guide for researchers.

PubMed

Mellish, Leigh; Karanges, Emily A; Litchfield, Melisa J; Schaffer, Andrea L; Blanch, Bianca; Daniels, Benjamin J; Segrave, Alicia; Pearson, Sallie-Anne

2015-11-02

The Pharmaceutical Benefits Scheme (PBS) is Australia's national drug subsidy program. This paper provides a practical guide to researchers using PBS data to examine prescribed medicine use. Excerpts of the PBS data collection are available in a variety of formats. We describe the core components of four publicly available extracts (the Australian Statistics on Medicines, PBS statistics online, section 85 extract, under co-payment extract). We also detail common analytical challenges and key issues regarding the interpretation of utilisation using the PBS collection and its various extracts. Research using routinely collected data is increasing internationally. PBS data are a valuable resource for Australian pharmacoepidemiological and pharmaceutical policy research. A detailed knowledge of the PBS, the nuances of data capture, and the extracts available for research purposes are necessary to ensure robust methodology, interpretation, and translation of study findings into policy and practice.

Innovation strategies for generic drug companies: moving into supergenerics.

PubMed

Ross, Malcolm S F

2010-04-01

Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

Could the Pharmaceutical Industry Benefit from Full-Scale Adoption of Radio-Frequency Identification (RFID) Technology with New Regulations?

PubMed

Coustasse, Alberto; Kimble, Craig A; Stanton, Robert B; Naylor, Mariah

2016-01-01

Healthcare regulators are directing attention to the pharmaceutical supply chain with the passage of the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA). Adoption of Radio-Frequency Identification (RFID) technology has the ability to improve compliance, reduce costs, and improve safety in the supply chain but its implementation has been limited; primarily because of hardware and tag costs. The purpose of this research study was to analyze the benefits to the pharmaceutical industry and healthcare system of the adoption of RFID technology as a result of newly implemented supply chain regulations. The methodology was a review following the steps of a systematic review with a total of 96 sources used. With the DSCSA, pharmaceutical companies must track and trace prescription drugs across the supply chain, and RFID can resolve many track-and-trace issues with manufacturer control of data. The practical implication of this study is that pharmaceutical companies must continue to have the potential to increase revenues, decrease associated costs, and increase compliance with new FDA regulations with RFID. Still, challenges related to regulatory statute wording, implementation of two-dimensional barcode technology, and the variety of interfaces within the pharmaceutical supply chain have delayed adoption and its full implementation.

Could the Pharmaceutical Industry Benefit from Full-Scale Adoption of Radio-Frequency Identification (RFID) Technology with New Regulations?

PubMed Central

Coustasse, Alberto; Kimble, Craig A.; Stanton, Robert B.; Naylor, Mariah

2016-01-01

Healthcare regulators are directing attention to the pharmaceutical supply chain with the passage of the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA). Adoption of Radio-Frequency Identification (RFID) technology has the ability to improve compliance, reduce costs, and improve safety in the supply chain but its implementation has been limited; primarily because of hardware and tag costs. The purpose of this research study was to analyze the benefits to the pharmaceutical industry and healthcare system of the adoption of RFID technology as a result of newly implemented supply chain regulations. The methodology was a review following the steps of a systematic review with a total of 96 sources used. With the DSCSA, pharmaceutical companies must track and trace prescription drugs across the supply chain, and RFID can resolve many track-and-trace issues with manufacturer control of data. The practical implication of this study is that pharmaceutical companies must continue to have the potential to increase revenues, decrease associated costs, and increase compliance with new FDA regulations with RFID. Still, challenges related to regulatory statute wording, implementation of two-dimensional barcode technology, and the variety of interfaces within the pharmaceutical supply chain have delayed adoption and its full implementation. PMID:27843419

Principles of pharmacoeconomics and their impact on strategic imperatives of pharmaceutical research and development.

PubMed

Bodrogi, József; Kaló, Zoltán

2010-04-01

The importance of evidence-based health policy is widely acknowledged among health care professionals, patients and politicians. Health care resources available for medical procedures, including pharmaceuticals, are limited all over the world. Economic evaluations help to alleviate the burden of scarce resources by improving the allocative efficiency of health care financing. Reimbursement of new medicines is subject to their cost-effectiveness and affordability in more and more countries. There are three major approaches to calculate the cost-effectiveness of new pharmaceuticals. Economic analyses alongside pivotal clinical trials are often inconclusive due to the suboptimal collection of economic data and protocol-driven costs. The major limitation of observational naturalistic economic evaluations is the selection bias and that they can be conducted only after registration and reimbursement. Economic modelling is routinely used to predict the cost-effectiveness of new pharmaceuticals for reimbursement purposes. Accuracy of cost-effectiveness estimates depends on the quality of input variables; validity of surrogate end points; and appropriateness of modelling assumptions, including model structure, time horizon and sophistication of the model to differentiate clinically and economically meaningful outcomes. These economic evaluation methods are not mutually exclusive; in practice, economic analyses often combine data collection alongside clinical trials or observational studies with modelling. The need for pharmacoeconomic evidence has fundamentally changed the strategic imperatives of research and development (R&D). Therefore, professionals in pharmaceutical R&D have to be familiar with the principles of pharmacoeconomics, including the selection of health policy-relevant comparators, analytical techniques, measurement of health gain by quality-adjusted life-years and strategic pricing of pharmaceuticals.

Principles of pharmacoeconomics and their impact on strategic imperatives of pharmaceutical research and development

PubMed Central

Bodrogi, József; Kaló, Zoltán

2010-01-01

The importance of evidence-based health policy is widely acknowledged among health care professionals, patients and politicians. Health care resources available for medical procedures, including pharmaceuticals, are limited all over the world. Economic evaluations help to alleviate the burden of scarce resources by improving the allocative efficiency of health care financing. Reimbursement of new medicines is subject to their cost-effectiveness and affordability in more and more countries. There are three major approaches to calculate the cost-effectiveness of new pharmaceuticals. Economic analyses alongside pivotal clinical trials are often inconclusive due to the suboptimal collection of economic data and protocol-driven costs. The major limitation of observational naturalistic economic evaluations is the selection bias and that they can be conducted only after registration and reimbursement. Economic modelling is routinely used to predict the cost-effectiveness of new pharmaceuticals for reimbursement purposes. Accuracy of cost-effectiveness estimates depends on the quality of input variables; validity of surrogate end points; and appropriateness of modelling assumptions, including model structure, time horizon and sophistication of the model to differentiate clinically and economically meaningful outcomes. These economic evaluation methods are not mutually exclusive; in practice, economic analyses often combine data collection alongside clinical trials or observational studies with modelling. The need for pharmacoeconomic evidence has fundamentally changed the strategic imperatives of research and development (R&D). Therefore, professionals in pharmaceutical R&D have to be familiar with the principles of pharmacoeconomics, including the selection of health policy-relevant comparators, analytical techniques, measurement of health gain by quality-adjusted life-years and strategic pricing of pharmaceuticals. PMID:20132213

How to revive breakthrough innovation in the pharmaceutical industry.

PubMed

Munos, Bernard H; Chin, William W

2011-06-29

Over the past 20 years, pharmaceutical companies have implemented conservative management practices to improve the predictability of therapeutics discovery and success rates of drug candidates. This approach has often yielded compounds that are only marginally better than existing therapies, yet require larger, longer, and more complex trials. To fund them, companies have shifted resources away from drug discovery to late clinical development; this has hurt innovation and amplified the crisis brought by the expiration of patents on many best-selling drugs. Here, we argue that more breakthrough therapeutics will reach patients only if the industry ceases to pursue "safe" incremental innovation, re-engages in high-risk discovery research, and adopts collaborative innovation models that allow sharing of knowledge and costs among collaborators.

Toward Value-Based Pricing to Boost Cancer Research and Innovation.

PubMed

Ocana, Alberto; Amir, Eitan; Tannock, Ian F

2016-06-01

The high market price of new anticancer agents has stimulated debate about the long-term sustainability of healthcare systems and whether these new agents can continue to be supported by public healthcare or by private insurers. In addition, some drugs have been approved with limited clinical benefit, raising concerns about setting a minimum requirement for medical benefit. Options to resolve these problems include raising the bar for approval of new drugs and/or pricing of new agents based on the medical benefit that they offer to patients. In this commentary, we suggest that new agents should be marketed in a two-step process that would include first the approval of the new drug by the regulatory agencies and second the introduction of a market price based on the medical benefit that the new intervention offers to patients. Introduction of value-based pricing would maintain the sustainability of health care systems and would improve drug development, as it would pressure pharmaceutical companies to become more innovative and avoid the development of compounds with limited benefit. Value-based pricing could also stimulate the funding of research directed to development of new anticancer drugs with novel mechanisms of action. Cancer Res; 76(11); 3127-9. ©2016 AACR. ©2016 American Association for Cancer Research.

Tour of Research Laboratories at the Ford Company

NASA Astrophysics Data System (ADS)

Reitz, J. R.

1981-01-01

A brief description of the physics programs encountered on the tour of the Ford Motor Company Research Laboratories is provided. A visit to the Research Laboratories of the Ford Motor Company is part of the Conference on Physics in the Automotive Industry. The visit will show a cross-section of the programs in Research Staff which are clearly identified as physics research as well as other areas where physicists have established themselves as dominant or team members in what might traditionally be regarded as the province of engineering R&D. After a brief orientation, the Conference visitors will be divided into tour groups and will visit laboratories involved in combustion research, arc-discharge physics, various spectroscopic applications, metal gauging, energy management, optical display systems and solar energy research. Synopses of the specific tour visits follow.

Grid computing in large pharmaceutical molecular modeling.

PubMed

Claus, Brian L; Johnson, Stephen R

2008-07-01

Most major pharmaceutical companies have employed grid computing to expand their compute resources with the intention of minimizing additional financial expenditure. Historically, one of the issues restricting widespread utilization of the grid resources in molecular modeling is the limited set of suitable applications amenable to coarse-grained parallelization. Recent advances in grid infrastructure technology coupled with advances in application research and redesign will enable fine-grained parallel problems, such as quantum mechanics and molecular dynamics, which were previously inaccessible to the grid environment. This will enable new science as well as increase resource flexibility to load balance and schedule existing workloads.

Does Targeted, Disease-Specific Public Research Funding Influence Pharmaceutical Innovation?

ERIC Educational Resources Information Center

Blume-Kohout, Margaret E.

2012-01-01

Public funding for biomedical research is often justified as a means to encourage development of more (and better) treatments for disease. However, few studies have investigated the relationship between these expenditures and downstream pharmaceutical innovation. In particular, although recent analyses have shown a clear contribution of federally…

A new e-beam application in the pharmaceutical industry

NASA Astrophysics Data System (ADS)

Sadat, Theo; Malcolm, Fiona

2005-10-01

The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a "miniature" low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned.

Considering the Future of Pharmaceutical Promotions in Social Media

PubMed Central

Carpentier, Francesca Renee Dillman

2016-01-01

This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. PMID:27239874

The availability of references and the sponsorship of original research cited in pharmaceutical advertisements

PubMed Central

Cooper, Richelle J.; Schriger, David L.

2005-01-01

Background The primary goal of pharmaceutical advertisements is to convince physicians to prescribe the manufacturer's product. We sought to determine what materials are cited in support of claims in pharmaceutical ads and medical research articles, and whether health care professionals seeking to verify the claims could obtain these references. Methods We reviewed 438 unique ads from the 1999 issues of 10 American medical journals, and a random sample of 400 references in medical research articles selected from the same journals. We classified references as journal article, data on file, meeting abstract or presentation, book or monograph, marketing report, prescribing information, government document or Internet site. We attempted to confirm or obtain each reference through library and Internet searches or by direct request from the manufacturer. The main outcome we sought to determine was the availability of the reference to a clinician. We also ascertained the source of funding for original research cited in the ads and the research articles. Results In the 438 ads with medical claims, 126 contained no references and 312 contained 721 unique references. Of these ad references, 55% (396/721) cited journal articles and 19% (135/721) cited data on file. In contrast, in the sample of research article references, 88% (351/400) cited journal articles and 8% (33/400) cited books. Overall, 84% of the citations from the ads were available: 98% of journal articles, 86% of books, 71% of meeting abstracts or presentations and 20% of data-on-file references. In all, 99% of the sample of research article references were available. We determined that 58% of the original research cited in the pharmaceutical ads was sponsored by or had an author affiliated with the product's manufacturer, as compared with 8% of the articles cited in the research articles. Interpretation Many pharmaceutical ads contain no references for medical claims. Although references to journal articles

The availability of references and the sponsorship of original research cited in pharmaceutical advertisements.

PubMed

Cooper, Richelle J; Schriger, David L

2005-02-15

The primary goal of pharmaceutical advertisements is to convince physicians to prescribe the manufacturer's product. We sought to determine what materials are cited in support of claims in pharmaceutical ads and medical research articles, and whether health care professionals seeking to verify the claims could obtain these references. We reviewed 438 unique ads from the 1999 issues of 10 American medical journals, and a random sample of 400 references in medical research articles selected from the same journals. We classified references as journal article, data on file, meeting abstract or presentation, book or monograph, marketing report, prescribing information, government document or Internet site. We attempted to confirm or obtain each reference through library and Internet searches or by direct request from the manufacturer. The main outcome we sought to determine was the availability of the reference to a clinician. We also ascertained the source of funding for original research cited in the ads and the research articles. In the 438 ads with medical claims, 126 contained no references and 312 contained 721 unique references. Of these ad references, 55% (396/721) cited journal articles and 19% (135/721) cited data on file. In contrast, in the sample of research article references, 88% (351/400) cited journal articles and 8% (33/400) cited books. Overall, 84% of the citations from the ads were available: 98% of journal articles, 86% of books, 71% of meeting abstracts or presentations and 20% of data-on-file references. In all, 99% of the sample of research article references were available. We determined that 58% of the original research cited in the pharmaceutical ads was sponsored by or had an author affiliated with the product's manufacturer, as compared with 8% of the articles cited in the research articles. Many pharmaceutical ads contain no references for medical claims. Although references to journal articles were usually obtainable, other published

Characteristics of physicians targeted by the pharmaceutical industry to participate in e-detailing.

PubMed

Alkhateeb, Fadi M; Khanfar, Nile M; Doucette, William R; Loudon, David

2009-01-01

Electronic detailing (e-detailing) has been introduced in the last few years by the pharmaceutical industry as a new communication channel through which to promote pharmaceutical products to physicians. E-detailing involves using digital technology, such as Internet, video conferencing, and interactive voice response, by which drug companies target their marketing efforts toward specific physicians with pinpoint accuracy. A mail survey of 671 Iowa physicians was used to gather information about the physician characteristics and practice setting characteristics of those who are usually targeted by pharmaceutical companies to participate in e-detailing. A model is developed and tested to explain firms' targeting strategy for targeting physicians for e-detailing.

Characterizing the interaction between physicians, pharmacists and pharmaceutical representatives in a middle-income country: A qualitative study

PubMed Central

Naser El Dine, Rabie; Traboulsy, Sarah; Haddadin, Fadi; Honein-AbouHaidar, Gladys

2017-01-01

Background Studies around the world have shown that interactions between pharmaceutical companies, pharmacists and physicians have a great influence on prescribing and drug dispensing practices. In middle-income countries, the nature and extent of these interactions have not been well researched. Our objectives were to qualitatively explore the nature of the interactions between pharmaceutical companies, physicians and pharmacists, their impact on drug prescription and dispensing practices in Lebanon. Methods and findings We used grounded theory approach as well as the known sponsor, purposive, and snowballing sampling strategies to identify interviewees from the three respective groups: physicians, pharmacists, and pharmaceutical representatives. We conducted semi-structured and analyzed transcripts thematically. This study encompassed 6 pharmaceutical representatives, 13 physicians and 13 pharmacists. The following themes emerged: purpose and driver for the interactions, nature of the interactions, incentives, impact on prescription practices, ethical considerations, and suggestions for managing the interactions. The main purposes for the interaction were educational, promotional, and monitoring prescription practices and dispensing, while the main drivers for these interactions were market potential and neighborhood socio-economic status. Physicians, pharmacists and pharmaceutical representatives who engage in these interactions benefit from a variety of incentives, some of which were characterized as unethical. It appears that pharmaceutical companies give prominence to selected physicians within their communities. Although members of the three interviewed groups refer to some of the interactions as being problematic, they described a culture of acceptance of gift giving. We developed a framework that depicts the prevailing politico-cultural environment, the interactions between the three professional groups, and their impact on drug prescription

Business Communication Consulting and Research in Multinational Companies.

ERIC Educational Resources Information Center

Hildebrandt, Herbert W.

1978-01-01

Describes three issues involved in communication research and consulting for multinational companies, particularly those in Germany: qualifications for doing international consulting and research, problems of American scholar-researchers in those firms, and suggestions for dealing with those issues. (JMF)

[Innovation in pharmaceutical and health biotechnology industries: challenges for a virtuous agenda].

PubMed

Vargas, Marco; Gadelha, Carlos Augusto Grabois; Costa, Laís Silveira; Maldonado, José

2012-12-01

Pharmaceutical and biotechnology industries comprise a major production subsystem of the health industrial complex in Brazil. It stands out for both its economic importance and its prominent role in developing new technologies in strategic areas. Strengthening the local production of generic drugs in the last decade has significantly increased the number of Brazilian companies in the local pharmaceutical market and has been an important turning point for this industry's growth. However, there remain major structural bottlenecks both in terms of production and continuous innovation. These bottlenecks reveal the high vulnerability of the Brazilian National Health System and point to the need of public policies that promote strengthening the production base and innovation in the pharmaceutical industry and that at the same time meet health-related social demands in health in Brazil.

26 CFR 1.954-1 - Foreign base company income.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 10 2013-04-01 2013-04-01 false Foreign base company income. 1.954-1 Section 1... (CONTINUED) INCOME TAXES (CONTINUED) Controlled Foreign Corporations § 1.954-1 Foreign base company income... computing the foreign base company income of a controlled foreign corporation. Foreign base company income...

26 CFR 1.954-1 - Foreign base company income.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 10 2011-04-01 2011-04-01 false Foreign base company income. 1.954-1 Section 1... (CONTINUED) INCOME TAXES (CONTINUED) Controlled Foreign Corporations § 1.954-1 Foreign base company income... computing the foreign base company income of a controlled foreign corporation. Foreign base company income...

26 CFR 1.954-1 - Foreign base company income.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 10 2012-04-01 2012-04-01 false Foreign base company income. 1.954-1 Section 1... (CONTINUED) INCOME TAXES (CONTINUED) Controlled Foreign Corporations § 1.954-1 Foreign base company income... computing the foreign base company income of a controlled foreign corporation. Foreign base company income...

GW-1000. GW Pharmaceuticals.

PubMed

Smith, Paul F

2004-07-01

GW Pharmaceuticals is developing GW-1000 (Sativex), a narrow ratio delta9-tetrahydrocannabinol:cannabidiol product for the potential treatment of multiple sclerosis, spinal cord injury, neurogenic pain and peripheral neuropathy. In March 2003, the company filed for approval for the treatment of MS with the UK Medicines Control Agency, and in May 2004, filed for new drug submission with Health Canada.

The initial pharmaceutical development of an artesunate/amodiaquine oral formulation for the treatment of malaria: a public-private partnership

PubMed Central

2011-01-01

Background Artemisinin-based combination therapy is currently recommended worldwide for the treatment of uncomplicated malaria. Fixed-dose combinations are preferred as they favour compliance. This paper reports on the initial phases of the pharmaceutical development of an artesunate-amodiaquine (ASAQ) bilayer co-formulation tablet, undertaken following pre-formulation studies by a network of scientists and industrials from institutions of both industrialized and low income countries. Methods Pharmaceutical development was performed by a research laboratory at the University Bordeaux Segalen, School of Pharmacy, for feasibility and early stability studies of various drug formulations, further transferred to a company specialized in pharmaceutical development, and then provided to another company for clinical batch manufacturing. The work was conducted by a regional public-private not-for-profit network (TropiVal) within a larger Public Private partnership (the FACT project), set up by WHO/TDR, Médecins Sans Frontières and the Drugs for Neglected Disease initiative (DNDi). Results The main pharmaceutical goal was to combine in a solid oral form two incompatible active principles while preventing artesunate degradation under tropical conditions. Several options were attempted and failed to provide satisfactory stability results: incorporating artesunate in the external phase of the tablets, adding a pH regulator, alcoholic wet granulation, dry granulation, addition of an hydrophobic agent, tablet manufacturing in controlled conditions. However, long-term stability could be achieved, in experimental batches under GMP conditions, by physical separation of artesunate and amodiaquine in a bilayer co-formulation tablet in alu-alu blisters. Conduction of the workplan was monitored by DNDi. Conclusions Collaborations between research and industrial groups greatly accelerated the process of development of the bi-layered ASAQ tablet. Lack of public funding was the main

Technology evaluation: PRO-542, Progenics Pharmaceuticals inc.

PubMed

Mukhtar, M; Parveen, Z; Pomerantz, R J

2000-12-01

Progenics's rCD4-IgG2 (PRO-542) is a recombinant fusion protein, which has been developed using the company's Universal Antiviral Binding (UnAB) technology, and is in phase I/II clinical trials for the treatment of human immunodeficiency virus type I (HIV-1) infection [273391]. At the beginning of 1997, Progenics received a Phase II Small Business Innovation Research Program (SBIR) grant from the National Institute of Allergy and Infectious diseases (NIAID) to fund the development of PRO-542 [236048]. A further grant of $2.7 million was awarded in August 1998 for the clinical evaluation of PRO-542 and other anti-HIV therapies [294200]. Progenics is collaborating with the Aaron Diamond AIDS Research Center (ADARC) in New York and the Center for Disease Control and Prevention in Atlanta [178410]. In February 2000, Progenics and Genzyme Transgenics Corp signed an agreement to continue the development of a transgenic source of PRO-542. Genzyme will develop transgenic goats that produce PRO-542 in their milk in exchange for undisclosed fees and milestone payments. Genzyme will supply PRO-542 to Progenics for clinical trials with a possibility for eventual commercial supply [357291]. Following on from this, in October 2000, Progenics received an SBIR grant to fund a two-year project with Genzyme Transgenics into the development of cost-effective methods for the manufacture of PRO-542, by optimization of the production of the drug in the milk of transgenic dairy animals [385982]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of PRO-542 and GMK (Progenics Pharmaceuticals) in 2002 [390063].

Do Spin-Offs Make the Academics' Heads Spin? The Impacts of Spin-Off Companies on Their Parent Research Organisation

ERIC Educational Resources Information Center

Zomer, Arend H.; Jongbloed, Ben W. A.; Enders, Jurgen

2010-01-01

As public research organisations are increasingly driven by their national and regional governments to engage in knowledge transfer, they have started to support the creation of companies. These research based spin-off companies (RBSOs) often keep contacts with the research institutes they originate from. In this paper we present the results of a…

Attention to 'details': etiquette and the pharmaceutical salesman in postwar American.

PubMed

Greene, Jeremy A

2004-04-01

This paper provides a sketch of the emerging role of the pharmaceutical salesman, or 'detail man', in the growth years of the American post-World War II pharmaceutical industry. Using training manuals, trade literature, in-house company newsletters, memoirs, and a variety of other published sources, the paper follows the delicate tactics employed by salesmen and their managers in their attempts to recast drug salesmanship as a 'professional service' fulfilling vital functions within medical education. As they worked to legitimate their presence in the nation's hospitals and clinics, particular emphasis was given to precise management of the etiquette of doctor-salesman interaction. Ultimately, the techniques employed by mid-century salesmen and their managers were to prove successful in generating a widespread acceptance of the industry representative within the clinical spaces of hospital and clinic. Indeed, many of the practices of market research and market strategy employed across the pharmaceutical industry today have their origins in the practices of the individual detail man. Exploration of the postwar pharmaceutical salesman as an overlooked historical 'type' provides significant insights into the intersection of medicine and the consumer marketplace during the later 20th century.

Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

PubMed

Twine, Richard

2013-12-01

In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.

Computational chemistry in pharmaceutical research: at the crossroads.

PubMed

Bajorath, Jürgen

2012-01-01

Computational approaches are an integral part of pharmaceutical research. However, there are many of unsolved key questions that limit the scientific progress in the still evolving computational field and its impact on drug discovery. Importantly, a number of these questions are not new but date back many years. Hence, it might be difficult to conclusively answer them in the foreseeable future. Moreover, the computational field as a whole is characterized by a high degree of heterogeneity and so is, unfortunately, the quality of its scientific output. In light of this situation, it is proposed that changes in scientific standards and culture should be seriously considered now in order to lay a foundation for future progress in computational research.

After slow start, project to channel drug company funds to universities builds steam.

PubMed

Berkowitz, P

1996-08-01

Drug companies appear to have been listening when researchers began complaining about their lack of participation in the MRC/PMAC Health Program, for the 30-month-old project appears to have taken on new life. It is designed to increase collaboration between university and pharmaceutical industry researchers by directing more of the industry's growing investment in Canada through the MRC's peer-review process. By mid-May, program commitments stood at $60 million.

Influence of pharmaceutical marketing on Medicare prescriptions in the District of Columbia.

PubMed

Wood, Susan F; Podrasky, Joanna; McMonagle, Meghan A; Raveendran, Janani; Bysshe, Tyler; Hogenmiller, Alycia; Fugh-Berman, Adriane

2017-01-01

Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists. To analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber. Gifts data from the District of Columbia's (DC) AccessRx program and the federal Center for Medicare and Medicaid Services (CMS) Open Payments program were analyzed with claims data from the CMS 2013 Medicare Provider Utilization and Payment Data. Washington DC, 2013. Physicians, nurse practitioners, physician assistants, podiatrists, and other licensed Medicare Part D prescribers who participated in Medicare Part D (a Federal prescription drug program that covers patients over age 65 or who are disabled). Gifts to healthcare prescribers (including cash, meals, and ownership interests) from pharmaceutical companies. Average number of Medicare Part D claims per prescriber, number of claims per patient, cost per claim, and proportion of branded claims. In 2013, 1,122 (39.1%) of 2,873 Medicare Part D prescribers received gifts from pharmaceutical companies totaling $3.9 million in 2013. Compared to non-gift recipients, gift recipients prescribed 2.3 more claims per patient, prescribed medications costing $50 more per claim, and prescribed 7.8% more branded drugs. In six specialties (General Internal Medicine, Family Medicine, Obstetrics/Gynecology, Urology, Ophthalmology, and Dermatology), gifts were associated with a significantly increased average cost of claims. For Internal Medicine, Family Medicine, and Ophthalmology, gifts were associated with

Big-pharmaceuticalisation: clinical trials and Contract Research Organisations in India.

PubMed

Sariola, Salla; Ravindran, Deapica; Kumar, Anand; Jeffery, Roger

2015-04-01

The World Trade Organisation's Trade Related Intellectual Property Rights [TRIPS] agreement aimed to harmonise intellectual property rights and patent protection globally. In India, the signing of this agreement resulted in a sharp increase in clinical trials since 2005. The Indian government, along with larger Indian pharmaceutical companies, believed that they could change existing commercial research cultures through the promotion of basic research as well as attracting international clinical trials, and thus create an international level, innovation-based drug industry. The effects of the growth of these outsourced and off-shored clinical trials on local commercial knowledge production in India are still unclear. What has been the impact of the increasing scale and commercialisation of clinical research on corporate science in India? In this paper we describe Big-pharmaceuticalisation in India, whereby the local pharmaceutical industry is moving from generic manufacturing to innovative research. Using conceptual frameworks of pharmaceuticalisation and innovation, this paper analyses data from research conducted in 2010-2012 and describes how Contract Research Organisations (CROs) enable outsourcing of randomised control trials to India. Focussing on twenty-five semi-structured interviews CRO staff, we chart the changes in Indian pharmaceutical industry, and implications for local research cultures. We use Big-pharmaceuticalisation to extend the notion of pharmaceuticalisation to describe the spread of pharmaceutical research globally and illustrate how TRIPS has encouraged a concentration of capital in India, with large companies gaining increasing market share and using their market power to rewrite regulations and introduce new regulatory practices in their own interest. Contract Research Organisations, with relevant, new, epistemic skills and capacities, are both manifestations of the changes in commercial research cultures, as well as the vehicles to

The Next Era: Deep Learning in Pharmaceutical Research.

PubMed

Ekins, Sean

2016-11-01

Over the past decade we have witnessed the increasing sophistication of machine learning algorithms applied in daily use from internet searches, voice recognition, social network software to machine vision software in cameras, phones, robots and self-driving cars. Pharmaceutical research has also seen its fair share of machine learning developments. For example, applying such methods to mine the growing datasets that are created in drug discovery not only enables us to learn from the past but to predict a molecule's properties and behavior in future. The latest machine learning algorithm garnering significant attention is deep learning, which is an artificial neural network with multiple hidden layers. Publications over the last 3 years suggest that this algorithm may have advantages over previous machine learning methods and offer a slight but discernable edge in predictive performance. The time has come for a balanced review of this technique but also to apply machine learning methods such as deep learning across a wider array of endpoints relevant to pharmaceutical research for which the datasets are growing such as physicochemical property prediction, formulation prediction, absorption, distribution, metabolism, excretion and toxicity (ADME/Tox), target prediction and skin permeation, etc. We also show that there are many potential applications of deep learning beyond cheminformatics. It will be important to perform prospective testing (which has been carried out rarely to date) in order to convince skeptics that there will be benefits from investing in this technique.

The Next Era: Deep Learning in Pharmaceutical Research

PubMed Central

Ekins, Sean

2016-01-01

Over the past decade we have witnessed the increasing sophistication of machine learning algorithms applied in daily use from internet searches, voice recognition, social network software to machine vision software in cameras, phones, robots and self-driving cars. Pharmaceutical research has also seen its fair share of machine learning developments. For example, applying such methods to mine the growing datasets that are created in drug discovery not only enables us to learn from the past but to predict a molecule’s properties and behavior in future. The latest machine learning algorithm garnering significant attention is deep learning, which is an artificial neural network with multiple hidden layers. Publications over the last 3 years suggest that this algorithm may have advantages over previous machine learning methods and offer a slight but discernable edge in predictive performance. The time has come for a balanced review of this technique but also to apply machine learning methods such as deep learning across a wider array of endpoints relevant to pharmaceutical research for which the datasets are growing such as physicochemical property prediction, formulation prediction, absorption, distribution, metabolism, excretion and toxicity (ADME/Tox), target prediction and skin permeation, etc. We also show that there are many potential applications of deep learning beyond cheminformatics. It will be important to perform prospective testing (which has been carried out rarely to date) in order to convince skeptics that there will be benefits from investing in this technique. PMID:27599991

76 FR 57746 - Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... ``Pharmaceutical Quality System (ICH Q10) Conference: A Practical Approach to Effective Life- Cycle Implementation... Pharmaceutical Quality System across the product life cycle according to the ICH Q10 model. These companies are...] Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A Practical...

Pharmaceutical advertising as a consumer empowerment device.

PubMed

Rubin, P H

2001-01-01

Pharmaceutical companies have greatly increased their level of "direct-to-consumer" (DTC) advertising in recent years. For 1998, estimates are that over $1.1 billion was spent on this form of advertising, increased from $850 million in 1997 and $600 million in 1996. In 1998, 84 separate drugs were advertised to consumers. The impetus was a decision in August of 1997 by the Food and Drug Administration to reduce the restrictions on DTC advertising on television. As a result, such ads have become very common on TV, and 32 products were advertised on TV in 1998. Pharmaceutical companies advertise because they think that advertising will make money for them. But how will this make money? It will make money by providing consumers with the information they need to make proper decisions about medication. That is, DTC advertising is profitable exactly because it empowers consumers and enables them to purchase useful drugs. The goals of advertising companies and consumers are both for consumers to have information about the most beneficial drug for particular conditions, and so advertising is beneficial both to manufacturers and to consumers. This article describes emerging trends in DTC within the context of the life sciences sector.

Information flow in the pharmaceutical supply chain.

PubMed

Yousefi, Nazila; Alibabaei, Ahmad

2015-01-01

Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead.

Information flow in the pharmaceutical supply chain

PubMed Central

Yousefi, Nazila; Alibabaei, Ahmad

2015-01-01

Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401

Patents for critical pharmaceuticals: the AZT case.

PubMed

Ackiron, E

1991-01-01

Patents and other statutory types of market protections are used in the United States to promote scientific research and innovation. This incentive is especially important in research intensive fields such as the pharmaceutical industry. Unfortunately, these same protections often result in higher monopoly pricing once a successful product is brought to market. Usually this consequence is viewed as the necessary evil of an incentive system that encourages costly research and development by promising large rewards to the successful inventor. However, in the case of the AIDS drug Zidovudine (AZT), the high prices charged by the pharmaceutical company owning the drug have led to public outcry and a re-examination of government incentive systems. This Note traces the evolution of these incentive programs--the patent system, and, to a lesser extent, the orphan drug program--and details the conflicting interests involved in their development. It then demonstrates how the AZT problem brings the interest of providing inventors with incentives for risky innovative efforts into a sharp collision with the ultimate goal of such systems: ensuring that the public has access to the resulting products at a reasonable price. Finally, the Note describes how Congress and the courts have attempted to resolve these problems in the past, and how they might best try to solve the AZT problem in the near future.

Pharmaceutical penetration of new drug and pharmaceutical market structure in Taiwan: hospital-level prescription of thiazolidinediones for diabetes.

PubMed

Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune

2010-06-01

This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.

Cooperation and competition in business on example of Internet research of opto-electronic companies

NASA Astrophysics Data System (ADS)

Kaliczyńska, Małgorzata

2006-10-01

Based on findings from earlier studies which showed that links to academic web sites contain important information, the following study examines the practicability of using co-link data to describe cooperation and competition in optoelec-tronic business. The analysis was based on 32 companies and organizations which were found in an issue of a specialist magazine. For the purpose of the research three search engines - Google, Yahoo! and MSN Search were used. Assuming that a number of co-links to a pair of Web sites is a measure of the similarity between the two companies, the study aims at search for the sets of companies that would be similar to one another. The method applied is the MDS - multidimensional scaling that allows to present results of the analysis on a 2D map.

Drug Information Residency Rotation with Pharmaceutical Industry.

ERIC Educational Resources Information Center

Cramer, Richard L.

1986-01-01

Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

Do cost-sharing and entry deregulation curb pharmaceutical innovation?

PubMed

Grossmann, Volker

2013-09-01

This paper examines the role of both cost-sharing schemes in health insurance systems and the regulation of entry into the pharmaceutical sector for pharmaceutical R&D expenditure and drug prices. The analysis suggests that both an increase in the coinsurance rate and stricter price regulations adversely affect R&D spending in the pharmaceutical sector. In contrast, entry deregulation may lead to higher R&D spending of pharmaceutical companies. The relationship between R&D spending per firm and the number of firms may be hump-shaped. In this case, the number of rivals which maximizes R&D expenditure per firm is decreasing in the coinsurance rate and increasing in labor productivity. Copyright © 2013 Elsevier B.V. All rights reserved.

Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

PubMed

Fisher, Jill A; Cottingham, Marci D; Kalbaugh, Corey A

2015-04-01

In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry's investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industry's pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

77 FR 45385 - Capital Research and Management Company, et al.; Notice of Application

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

...] Capital Research and Management Company, et al.; Notice of Application July 25, 2012. AGENCY: Securities... Management Company (``CRMC''). Filing Dates: The application was filed on December 19, 2008, and amended on... NE., Washington, DC 20549-1090. Applicants, Capital Research and Management Company, 333 South Hope...

Identifying and prioritizing industry-level competitiveness factors: evidence from pharmaceutical market

PubMed Central

2014-01-01

Background Pharmaceutical industry is knowledge-intensive and highly globalized, in both developed and developing countries. On the other hand, if companies want to survive, they should be able to compete well in both domestic and international markets. The main purpose of this paper is therefore to develop and prioritize key factors affecting companies’ competitiveness in pharmaceutical industry. Based on an extensive literature review, a valid and reliable questionnaire was designed, which was later filled up by participants from the industry. To prioritize the key factors, we used the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS). Results The results revealed that human capital and macro-level policies were two key factors placed at the highest rank in respect of their effects on the competitiveness considering the industry-level in pharmaceutical area. Conclusion This study provides fundamental evidence for policymakers and managers in pharma context to enable them formulating better polices to be proactively competitive and responsive to the markets’ needs. PMID:24708770

Emerging trends in contract research industry in India.