Personalized Medicine: Ethical Aspects.

PubMed

Sharrer, G Terry

2017-01-01

In our time of genome-based personalized medicine, clinical research and clinical medicine are accelerating at a quick pace. Faster and cheaper DNA sequencing and protein profiling, microfluidic devices for capturing blood biomarkers, nanoparticles for precise drug delivery and enhanced imaging, rapid computational analysis of massive data inputs, and other technological wonders coalesce to create a kind of Moore's Law for medicine. Needs are obvious, knowledge grows, capital becomes available, but these factors are not entirely sufficient to make health more achievable. Personalized medicine also requires social acceptability, not only for accuracy and efficacy but also because medicine is a moral domain. This chapter deals with medical ethics that determine the choices a society makes regarding healthcare; and it has not always been a steady, morally correct course of progress. Indeed, medical ethics has largely derived from socio-scientific calamities in the past. Personalized medicine, with its enhanced capacity to access the individuality of illness, must have a continuously evolving feedback mechanism-the most important element being the physician-patient relationship-which is its ethical footing.

"What Goes Around Comes Around": Lessons Learned from Economic Evaluations of Personalized Medicine Applied to Digital Medicine.

PubMed

Phillips, Kathryn A; Douglas, Michael P; Trosman, Julia R; Marshall, Deborah A

2017-01-01

The growth of "big data" and the emphasis on patient-centered health care have led to the increasing use of two key technologies: personalized medicine and digital medicine. For these technologies to move into mainstream health care and be reimbursed by insurers, it will be essential to have evidence that their benefits provide reasonable value relative to their costs. These technologies, however, have complex characteristics that present challenges to the assessment of their economic value. Previous studies have identified the challenges for personalized medicine and thus this work informs the more nascent topic of digital medicine. To examine the methodological challenges and future opportunities for assessing the economic value of digital medicine, using personalized medicine as a comparison. We focused specifically on digital biomarker technologies and multigene tests. We identified similarities in these technologies that can present challenges to economic evaluation: multiple results, results with different types of utilities, secondary findings, downstream impact (including on family members), and interactive effects. Using a structured review, we found that there are few economic evaluations of digital biomarker technologies, with limited results. We conclude that more evidence on the effectiveness of digital medicine will be needed but that the experiences with personalized medicine can inform what data will be needed and how such analyses can be conducted. Our study points out the critical need for typologies and terminology for digital medicine technologies that would enable them to be classified in ways that will facilitate research on their effectiveness and value. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Building a personalized medicine infrastructure at a major cancer center.

PubMed

Meric-Bernstam, Funda; Farhangfar, Carol; Mendelsohn, John; Mills, Gordon B

2013-05-20

Our understanding of cancer biology is rapidly increasing, as is the availability and affordability of high throughput technologies for comprehensive molecular characterization of tumors and the individual's own genetic makeup. Thus, the time is right to implement personalized molecular medicine for all patients with cancer. Personalized approaches span the full cancer care spectrum from risk stratification to prevention, screening, therapy, and survivorship programs. Several molecular therapeutics have entered clinical trials creating a huge opportunity to couple genomic markers with this emerging drug tool kit. The number of patients managed in major cancer centers creates a challenge to the implementation of genomic technologies required to successfully deliver on the promise of personalized cancer care. This requires a major investment in infrastructure to facilitate rapid deployment of multiplex, cost-effective, and tissue-sparing assays relevant across multiple tumor lineages in the Clinical Laboratory Improvement Amendments (CLIA) environment. Efforts must be made to ensure that assays are accessible to patients most likely to be enrolled onto molecular-marker-driven trials and that the tests are billable and payable, which will make them accessible to a wide range of patients. As the number of patients and aberrations increase, it will become critical to provide decision support for genomic medicine. Institutional commitment is needed to optimize accessibility and quality of research biopsies and to facilitate novel personalized cancer therapy trials. This article will focus on the challenges and opportunities that accompany the building of infrastructure for personalized cancer therapy.

“What Goes Around Comes Around”: Lessons Learned from Economic Evaluations of Personalized Medicine Applied to Digital Medicine

PubMed Central

Phillips, Kathryn A.; Douglas, Michael P.; Trosman, Julia R.; Marshall, Deborah A.

2016-01-01

Two key trends that emerge from the growth of “Big Data” and the emphasis on patient-centered healthcare are the increasing use of personalized medicine and digital medicine. In order for these technologies to move into mainstream health care and be reimbursed by insurers, it will be essential to have evidence that their benefits provide reasonable value relative to their costs. However, these technologies have complex characteristics that present challenges to assessment of their economic value. Previous work has identified these challenges for personalized medicine and thus this work can inform the more nascent topic of digital medicine. Our objective is to examine the methodological challenges and future opportunities for assessing the economic value of digital medicine, using personalized medicine as a comparison. We focus specifically on “digital biomarker technologies” and “multigene tests”. We identified similarities in these technologies that can present challenges to economic evaluation: multiple results, results with different types of utilities, secondary findings, downstream impact (including on family members), and interactive effects. Using a structured review, we found that there are few economic evaluations of digital biomarker technologies, with limited results. We conclude that more evidence on effectiveness of digital medicine will be needed but that the experiences with personalized medicine can inform what data will be needed and how such analyses can be conducted. Our study points out the critical need for typologies and terminology for digital medicine technologies that would enable them to be classified in ways that will facilitate research on their effectiveness and value. PMID:28212968

Personalized physiological medicine.

PubMed

Ince, Can

2017-12-28

This paper introduces the concept of personalized physiological medicine that is specifically directed at the needs of the critically ill patient. This differs from the conventional view of personalized medicine, characterized by biomarkers and gene profiling, instead focusing on time-variant changes in the pathophysiology and regulation of various organ systems and their cellular and subcellular constituents. I propose that personalized physiological medicine is composed of four pillars relevant to the critically ill patient. Pillar 1 is defined by the frailty and fitness of the patient and their physiological reserve to cope with the stress of critical illness and therapy. Pillar 2 involves monitoring of the key physiological variables of the different organ systems and their response to disease and therapy. Pillar 3 concerns the evaluation of the success of resuscitation by assessment of the hemodynamic coherence between the systemic and microcirculation and parenchyma of the organ systems. Finally, pillar 4 is defined by the integration of the physiological and clinical data into a time-learning adaptive model of the patient to provide feedback about the function of organ systems and to guide and assess the response to disease and therapy. I discuss each pillar and describe the challenges to research and development that will allow the realization of personalized physiological medicine to be practiced at the bedside for critically ill patients.

[Personalized medicine: equity and access].

PubMed

Joly, Yann; Knoppers, Bartha M

2014-11-01

Personalized medicine has seen a recent increase in popularity amongst medical researchers and policymakers. Nevertheless, there are persistent legal, ethical, and social questions that need to be explored, particularly related to the criticism that personalized medicine constitutes an elitist model of healthcare. Investigating this critique the current manuscript argues that personalized medicine has the potential to become a positive force for equitable access to better healthcare at a national and international level. © 2014 médecine/sciences – Inserm.

Facilitators and barriers of herbal medicine use in Accra, Ghana: an inductive exploratory study.

PubMed

Aziato, Lydia; Antwi, Hannah Ohemeng

2016-05-26

The use of complementary and alternative medicine including herbal medicine is increasing in many countries including Ghana. However, there is paucity of research on the perspectives of patrons of herbal medicine regarding the facilitators and barriers of herbal medicine use. This study sought to investigate the facilitators and barriers of herbal medicine among Ghanaian adults who use one form of herbal medicine or the other. The study employed an inductive exploratory qualitative approach. It was conducted at a private herbal clinic in Accra. Purposive sampling was employed to recruit 16 participants. Data collection was through individual face-to-face interviews and these were transcribed and analysed using content analysis procedures. It was realized that the factors that enhanced the use of herbal medicine included use of convincing information to enhance the initiation of herbal medicine use, effectiveness of herbal medicine, personal preference for herbal medicine, perceived ineffectiveness of western medicine and integration of spirituality in herbal medicine. The factors that hindered herbal medicine use included negative perceptions and attitudes about herbal medicine, poor vending environment, poor knowledge of vendors, high cost of herbal products at credible herbal clinics and inconsistent effectiveness of some herbal products. Participants desired that the national health insurance scheme will cover the cost of herbal medicine to alleviate the financial burden associated with herbal medicine use. Although some Ghanaians patronize herbal medicine, the negative perceptions about herbal medicine resulting from deceitful producers and vendors call for enhanced education and monitoring to ensure that effective herbal products are used.

Facilitating Scholarly Writing in Academic Medicine

PubMed Central

Pololi, Linda; Knight, Sharon; Dunn, Kathleen

2004-01-01

Scholarly writing is a critical skill for faculty in academic medicine; however, few faculty receive instruction in the process. We describe the experience of 18 assistant professors who participated in a writing and faculty development program which consisted of 7 monthly 75-minute sessions embedded in a Collaborative Mentoring Program (CMP). Participants identified barriers to writing, developed personal writing strategies, had time to write, and completed monthly writing contracts. Participants provided written responses to open-ended questions about the learning experience, and at the end of the program, participants identified manuscripts submitted for publication, and completed an audiotaped interview. Analysis of qualitative data using data reduction, data display, and conclusion drawing/verification showed that this writing program facilitated the knowledge, skills, and support needed to foster writing productivity. All participants completed at least 1 scholarly manuscript by the end of the CMP. The impact on participants’ future academic productivity requires long-term follow-up. PMID:14748862

Progress in oral personalized medicine: contribution of 'omics'.

PubMed

Glurich, Ingrid; Acharya, Amit; Brilliant, Murray H; Shukla, Sanjay K

2015-01-01

Precision medicine (PM), representing clinically applicable personalized medicine, proactively integrates and interprets multidimensional personal health data, including clinical, 'omics', and environmental profiles, into clinical practice. Realization of PM remains in progress. The focus of this review is to provide a descriptive narrative overview of: 1) the current status of oral personalized medicine; and 2) recent advances in genomics and related 'omic' and emerging research domains contributing to advancing oral-systemic PM, with special emphasis on current understanding of oral microbiomes. A scan of peer-reviewed literature describing oral PM or 'omic'-based research conducted on humans/data published in English within the last 5 years in journals indexed in the PubMed database was conducted using mesh search terms. An evidence-based approach was used to report on recent advances with potential to advance PM in the context of historical critical and systematic reviews to delineate current state-of-the-art technologies. Special focus was placed on oral microbiome research associated with health and disease states, emerging research domains, and technological advances, which are positioning realization of PM. This review summarizes: 1) evolving conceptualization of personalized medicine; 2) emerging insight into roles of oral infectious and inflammatory processes as contributors to both oral and systemic diseases; 3) community shifts in microbiota that may contribute to disease; 4) evidence pointing to new uncharacterized potential oral pathogens; 5) advances in technological approaches to 'omics' research that will accelerate PM; 6) emerging research domains that expand insights into host-microbe interaction including inter-kingdom communication, systems and network analysis, and salivaomics; and 7) advances in informatics and big data analysis capabilities to facilitate interpretation of host and microbiome-associated datasets. Furthermore, progress in

Clinical practice on the horizon: personalized medicine.

PubMed

Chadwell, Katherine

2013-01-01

With the advent of the human genome project, we have never known so much about the uniqueness of individuals. Personalized medicine is poised to use this genetic and genomic information along with the impact of environment and clinical presentation to provide healthcare from an individual perspective. This offers the opportunity to improve our ability to diagnose and predict disease, provide earlier intervention, identify new treatment regimens, and address the safety and efficacy of drug use. The impact of personalized medicine to our current model of healthcare delivery is tremendous, and although strides have been made, there are still challenges and barriers to overcome before personalized medicine can be fully implemented. Advanced practice nurses may not be fully aware of the personalized medicine initiative or may not be well versed on genetic and genomic content, which is a key concept of personalized medicine. The role of advanced practice nurses is an integral part of the healthcare system, and as such, they are poised to be key providers and contributors to personalized medicine. The personalized medicine initiative is discussed along with examples of genetic and genomic information that lend to our understanding, diagnosis, and treatment of disease, as well as the role and responsibilities of advanced practice nurses. Resources for personalized medicine and genetic and genomic content are provided.

The ethical framing of personalized medicine.

PubMed

Joly, Yann; Saulnier, Katie M; Osien, Gladys; Knoppers, Bartha M

2014-10-01

Personalized medicine encompasses the use of biological information such as genomics to provide tailored interventions for patients. The review explores the ethical, legal, and social issues that have emerged with personalized medicine and must be considered because of the complex nature of providing individualized care within a clinical setting. Recent studies found that the use of personalized medicine presents challenges in multiple areas: biobanking and informed consent, confidentiality, genetic discrimination, return of results, access to treatment, clinical translation, direct-to-consumer genetic testing, emerging duties, and knowledge mobilization. Although personalized medicine provides benefits in treating patients in a manner that is more suited to their genetic profile, there are challenges that must be discussed to ensure the protection and fair treatment of individuals. The issues concerning personalized medicine are widespread, and range from individual privacy to the stratification and discrimination of sub-populations based on ethnicity. These issues have considerable impact on the individual and society. A thorough exploration of these ethical issues may identify novel challenges as well as potential avenues for resolution.

Person-centred medicines optimisation policy in England: an agenda for research on polypharmacy.

PubMed

Heaton, Janet; Britten, Nicky; Krska, Janet; Reeve, Joanne

2017-01-01

Aim To examine how patient perspectives and person-centred care values have been represented in documents on medicines optimisation policy in England. There has been growing support in England for a policy of medicines optimisation as a response to the rise of problematic polypharmacy. Conceptually, medicines optimisation differs from the medicines management model of prescribing in being based around the patient rather than processes and systems. This critical examination of current official and independent policy documents questions how central the patient is in them and whether relevant evidence has been utilised in their development. A documentary analysis of reports on medicines optimisation published by the Royal Pharmaceutical Society (RPS), The King's Fund and National Institute for Health and Social Care Excellence since 2013. The analysis draws on a non-systematic review of research on patient experiences of using medicines. Findings The reports varied in their inclusion of patient perspectives and person-centred care values, and in the extent to which they drew on evidence from research on patients' experiences of polypharmacy and medicines use. In the RPS report, medicines optimisation is represented as being a 'step change' from medicines management, in contrast to the other documents which suggest that it is facilitated by the systems and processes that comprise the latter model. Only The King's Fund report considered evidence from qualitative studies of people's use of medicines. However, these studies are not without their limitations. We suggest five ways in which researchers could improve this evidence base and so inform the development of future policy: by facilitating reviews of existing research; conducting studies of patient experiences of polypharmacy and multimorbidity; evaluating medicines optimisation interventions; making better use of relevant theories, concepts and tools; and improving patient and public involvement in research and in

Is Personalized Medicine Achievable in Obstetrics?

PubMed Central

Quinney, Sara K; Flockhart, David A; Patil, Avinash S

2014-01-01

Personalized medicine seeks to identify the right dose of the right drug for the right patient at the right time. Typically, individualization of therapy is based on the pharmacogenomic make-up of the individual and environmental factors that alter drug disposition and response. In addition to these factors, during pregnancy a woman’s body undergoes many changes that can impact the therapeutic efficacy of medications. Yet, there is minimal research regarding personalized medicine in obstetrics. Adoption of pharmacogenetic testing into the obstetrical care is dependent on evidence of analytical validity, clinical validity, and clinical utility. Here, we briefly present information regarding the potential utility of personalized medicine for treating the obstetric patient for pain with narcotics, hypertension, and preterm labor and discuss the impediments of bringing personalized medicine to the obstetrical clinic. PMID:25282474

Essential elements of personalized medicine.

PubMed

Burke, Wylie; Brown Trinidad, Susan; Press, Nancy A

2014-02-01

Genomic information has been promoted as the basis for "personalized" health care. We considered the benefits provided by genomic testing in context of the concept of personalized medicine. We evaluated current and potential uses of genomic testing in health care, using prostate cancer as an example, and considered their implications for individualizing or otherwise improving health care. Personalized medicine is most accurately seen as a comprehensive effort to tailor health care to the individual, spanning multiple dimensions. While genomic tests will offer many potential opportunities to improve the delivery of care, including the potential for genomic research to offer opportunities to improve prostate cancer screening and treatment, such advances do not in themselves constitute a paradigm shift in the delivery of health care. Rather, personalized medicine is based on a partnership between clinician and patient that utilizes shared decision making to determine the best health care options among the available choices, weighing the patient's personal values and preferences together with clinical findings. This approach is particularly important for difficult clinical decisions involving uncertainty and trade-offs, such as those involved in prostate cancer screening and management. The delivery of personalized medicine also requires adequate health care access and assurance that basic health needs have been met. Substantial research investment will be needed to identify how genomic tests can contribute to this effort. © 2014 Published by Elsevier Inc.

[Personalized medicine, privatized medicine? legal and public health stakes].

PubMed

Rial-Sebbag, Emmanuelle

2014-11-01

Personalized medicine is booming. It tends to provide a medical management "tailored" for groups of patients, or for one unique patient, but also to identify risk groups to develop public health strategies. In this context, some radicalization phenomenon can emerge, leading to not only personalized medicine but also privatized medicine, which can lead to a capture of the medical public resource. If the "privatization" of medicine is not limited to producing adverse effects, several potentially destabilizing phenomena for patients still remain. First, some objective factors, like the adjustment of scientific prerequisites, are emerging from personalized medicine practices (clinical trial, public health policy) and are interfering with the medical doctor/patient relationship. Another risk emerges for patients concomitantly to their demand for controlling their own health, in terms of patients' security although these risks are not clearly identified and not effectively communicated. These practices, related to a privatized medicine, develop within the healthcare system but also outside, and the government and legislators will have to take into account these new dimensions in drafting their future regulations and policies. © 2014 médecine/sciences – Inserm.

Progress in oral personalized medicine: contribution of ‘omics’

PubMed Central

Glurich, Ingrid; Acharya, Amit; Brilliant, Murray H.; Shukla, Sanjay K.

2015-01-01

Background Precision medicine (PM), representing clinically applicable personalized medicine, proactively integrates and interprets multidimensional personal health data, including clinical, ‘omics’, and environmental profiles, into clinical practice. Realization of PM remains in progress. Objective The focus of this review is to provide a descriptive narrative overview of: 1) the current status of oral personalized medicine; and 2) recent advances in genomics and related ‘omic’ and emerging research domains contributing to advancing oral-systemic PM, with special emphasis on current understanding of oral microbiomes. Design A scan of peer-reviewed literature describing oral PM or ‘omic’-based research conducted on humans/data published in English within the last 5 years in journals indexed in the PubMed database was conducted using mesh search terms. An evidence-based approach was used to report on recent advances with potential to advance PM in the context of historical critical and systematic reviews to delineate current state-of-the-art technologies. Special focus was placed on oral microbiome research associated with health and disease states, emerging research domains, and technological advances, which are positioning realization of PM. Results This review summarizes: 1) evolving conceptualization of personalized medicine; 2) emerging insight into roles of oral infectious and inflammatory processes as contributors to both oral and systemic diseases; 3) community shifts in microbiota that may contribute to disease; 4) evidence pointing to new uncharacterized potential oral pathogens; 5) advances in technological approaches to ‘omics’ research that will accelerate PM; 6) emerging research domains that expand insights into host–microbe interaction including inter-kingdom communication, systems and network analysis, and salivaomics; and 7) advances in informatics and big data analysis capabilities to facilitate interpretation of host and

Is personalized medicine achievable in obstetrics?

PubMed

Quinney, Sara K; Patil, Avinash S; Flockhart, David A

2014-12-01

Personalized medicine seeks to identify the right dose of the right drug for the right patient at the right time. Typically, individualization of therapy is based on the pharmacogenomic makeup of the individual and environmental factors that alter drug disposition and response. In addition to these factors, during pregnancy, a woman's body undergoes many changes that can impact the therapeutic efficacy of medications. Yet, there is minimal research regarding personalized medicine in obstetrics. Adoption of pharmacogenetic testing into the obstetrical care is dependent on evidence of analytical validity, clinical validity, and clinical utility. Here, we briefly present information regarding the potential utility of personalized medicine for treating the obstetric patient for pain with narcotics, hypertension, and preterm labor, and discuss the impediments of bringing personalized medicine to the obstetrical clinic. Copyright © 2014 Elsevier Inc. All rights reserved.

Personalized medicine in multiple sclerosis.

PubMed

Giovannoni, Gavin

2017-11-01

The therapeutic approach in multiple sclerosis (MS) requires a personalized medicine frame beyond the precision medicine concept, which is not currently implementable due to the lack of robust biomarkers and detailed understanding of MS pathogenesis. Personalized medicine demands a patient-focused approach, with disease taxonomy informed by characterization of pathophysiological processes. Important questions concerning MS taxonomy are: when does MS begin? When does the progressive phase begin? Is MS really two or three diseases? Does a therapeutic window truly exist? Newer evidence points to a disease spectrum and a therapeutic lag of several years for benefits to be observed from disease-modifying therapy. For personalized treatment, it is important to ascertain disease stage and any worsening of focal inflammatory lesions over time.

Personalized medicine, availability, and group disparity: an inquiry into how physicians perceive and rate the elements and barriers of personalized medicine.

PubMed

Petersen, Katelin E; Prows, Cynthia A; Martin, Lisa J; Maglo, Koffi N

2014-01-01

The success of personalized medicine depends on factors influencing the availability and implementation of its new tools to individualize clinical care. However, little is known about physicians' views of the availability of personalized medicine across racial/ethnic groups and the relationship between perceived availability and clinical implementation. This study examines physicians' perceptions of key elements/tools and potential barriers to personalized medicine in connection with their perceptions of the availability of the latter across subpopulations. Study subjects consisted of physicians recruited from Cincinnati Children's Hospital Medical Center and UC Health. An electronic survey conducted from September 2012 to November 2012 recruited 104 physicians. Wilcoxon rank sum analysis compared groups. Physicians were divided about whether personalized medicine contributes to health equality, as 37.4% of them believe that personalized medicine is currently available only for some subpopulations. They also rated the importance of racial/ethnic background almost as high as the importance of genetic information in the delivery of personalized medicine. Actual elements of personalized medicine rated highest include family history, drug-drug interaction alerts in medical records, and biomarker measurements to guide therapy. Costs of gene-based therapies and genetic testing were rated the most significant barriers. The ratings of several elements and barriers were associated with perceived availability of personalized medicine across subpopulations. While physicians hold differing views about the availability and implementation of personalized medicine, they likewise establish complex relationships between race/ethnicity and personalized medicine that may carry serious implications for its clinical success. © 2014 S. Karger AG, Basel.

Personalized medicine and chronic obstructive pulmonary disease.

PubMed

Wouters, E F M; Wouters, B B R A F; Augustin, I M L; Franssen, F M E

2017-05-01

The current review summarizes ongoing developments in personalized medicine and precision medicine in chronic obstructive pulmonary disease (COPD). Our current approach is far away of personalized management algorithms as current recommendations for COPD are largely based on a reductionist disease description, operationally defined by results of spirometry. Besides precision medicine developments, a personalized medicine approach in COPD is described based on a holistic approach of the patient and considering illness as the consequence of dynamic interactions within and between multiple interacting and self-adjusting systems. Pulmonary rehabilitation is described as a model of personalized medicine. Largely based on current understanding of inflammatory processes in COPD, targeted interventions in COPD are reviewed. Augmentation therapy for α-1-antitrypsine deficiency is described as model of precision medicine in COPD based in profound understanding of the related genetic endotype. Future developments of precision medicine in COPD require identification of relevant endotypes combined with proper identification of phenotypes involved in the complex and heterogeneous manifestations of COPD.

Role of intellectual property in investment-backed personalized medicine.

PubMed

Norviel, Vern; Akhavan, Ray; Alemozafar, Ali R

2010-01-01

Personalized medicine is a growing field that promises to provide individualized treatment that is tailored to each patient. For a startup personalized medicine company, an initial step in securing financing is to protect its intellectual property (IP), for example, through patent protection. When deciding whether to invest in a personalized medicine company, investors, such as venture capitalists, assess the scope of a personalized medicine company's protection of its IP. Patent protection is a powerful way for a personalized medicine startup company to protect its IP, but patent protection for personalized medicine inventions can differ from one country to another. A personalized medicine company could benefit from developing a well-defined IP strategy for maximizing the scope and breadth of its IP protection.

Personalized medicine: reality and reality checks.

PubMed

Leeder, J Steven; Spielberg, Stephen P

2009-05-01

The evolving era of pharmacogenomics and personalized medicine is greeted with optimism by many, but this sentiment is not universally shared. The existence of diametrically opposed opinions concerning the potential benefits and obstacles facing the widespread implementation of genomic medicine should stimulate discussion and guide the design of studies to establish the value of interventions targeted at the level of individual patients. One of the more controversial aspects of personalized medicine is whether the anticipated benefits will be realized at an acceptable cost. Recently released analyses suggest that the returns on investment depend on the particular scenario and are different for different stakeholders. On the other hand, cost is only one of the challenges regarding implementation of personalized medicine. Among these are the development of universal standards for managing genomic information in electronic medical records, improvement in the collection and interpretation of clinical phenotype data, and new strategies to educate practitioners and patients/consumers. The reality is that personalized medicine is upon us; open discourse and periodic reality checks will be necessary as we confront it.

Personalized medicine in interstitial lung diseases.

PubMed

Spagnolo, Paolo; Oldham, Justin M; Jones, Mark G; Lee, Joyce S

2017-05-01

A number of recent studies have explored the possibility to apply personalized medicine to interstitial lung diseases (ILDs), particularly idiopathic pulmonary fibrosis (IPF), the most common and deadly of the idiopathic interstitial pneumonias. In our review, we summarize and discuss the most recent literature on personalized medicine in IPF as well as hypersensitivity pneumonitis and sarcoidosis, with emphasis on patient subgroups for which a personalized approach to disease prognostication and management may become a reality in the near future. Most of the studies that have explored the applicability of personalized medicine to ILDs have been conducted in patients with IPF. Such studies have suggested the existence of several distinct disease subgroups defined by similar genetic profiles, molecular pathways, exposures and individual lifestyles. Personalized medicine in hypersensitivity pneumonitis is in its infancy. The development and applicability of personalized medicine to sarcoidosis, on the other hand, remains problematic for several reasons, including the lack of a diagnostic gold standard, the highly variable and unpredictable disease course, particularly across patients of different ethnicities, the poor correlation between disease activity and disease severity and the lack of a validated management algorithm. A number of distinct patient subgroups have been identified in ILDs. Although available data need to be validated longitudinally, the possibility to study homogeneous groups of patients may allow prediction of disease behavior and response to treatment with dramatic clinical implications.

The Translational Medicine Ontology and Knowledge Base: driving personalized medicine by bridging the gap between bench and bedside

PubMed Central

2011-01-01

Background Translational medicine requires the integration of knowledge using heterogeneous data from health care to the life sciences. Here, we describe a collaborative effort to produce a prototype Translational Medicine Knowledge Base (TMKB) capable of answering questions relating to clinical practice and pharmaceutical drug discovery. Results We developed the Translational Medicine Ontology (TMO) as a unifying ontology to integrate chemical, genomic and proteomic data with disease, treatment, and electronic health records. We demonstrate the use of Semantic Web technologies in the integration of patient and biomedical data, and reveal how such a knowledge base can aid physicians in providing tailored patient care and facilitate the recruitment of patients into active clinical trials. Thus, patients, physicians and researchers may explore the knowledge base to better understand therapeutic options, efficacy, and mechanisms of action. Conclusions This work takes an important step in using Semantic Web technologies to facilitate integration of relevant, distributed, external sources and progress towards a computational platform to support personalized medicine. Availability TMO can be downloaded from http://code.google.com/p/translationalmedicineontology and TMKB can be accessed at http://tm.semanticscience.org/sparql. PMID:21624155

Racial differences in attitudes toward personalized medicine.

PubMed

Diaz, V A; Mainous, A G; Gavin, J K; Wilson, D

2014-01-01

Patient concerns regarding personalized medicine may limit its use. This study assesses racial differences in attitudes toward personalized medicine, evaluating variables that may influence these attitudes. A convenience sample of 190 adults (≥18 years) from an academic primary care practice was surveyed regarding awareness and acceptance of personalized medicine, plus concerns and benefits regarding its use. Logistic regressions predicting awareness, acceptance and concerns were performed, controlling for race, gender, marital status, education, children, internet use, and self-reported discrimination. The sample was 35% non-Hispanic white (NHW) and 34.7% male. More NHW participants expressed acceptance of personalized medicine than non-Hispanic black (NHB) participants (94.4 vs. 81.9%, p = 0.0190). More NHBs were concerned about the use of genes without consent (57.3 vs. 20.6%, p < 0.0001), sharing genetic information without consent (65.0 vs. 35.6%, p < 0.0001), discrimination based on genes (62.4 vs. 34.3%, p = 0.0002), and lack of access due to cost (75.0 vs. 48.0%, p = 0.0002). In logistic regressions, NHBs (OR = 7.46, 95% CI = 3.04-18.32) and those self-reporting discrimination (OR = 2.87, 95% CI = 1.22-6.78) had more concerns about the misuse of genes and costs associated with personalized medicine. Racial differences exist in attitudes toward personalized medicine and may be influenced by self-reported discrimination. Further study to understand factors influencing the acceptance of personalized medicine could help encourage its use.

Personalized medicine and ethics.

PubMed

Josko, Deborah

2014-01-01

An entire series could be dedicated to the topic of ethics in personalized medicine. Due to the advancements in NGS and genetic testing, personalized medicine is no longer something that will occur in the future, the reality is upon us now. Sequencing an individual's genome can have a substantial impact on the patient's treatment and overall quality of life. However, this can open "Pandora's box" especially if an individual does not want to know the information obtained. In addition, will insurance companies require genetic testing in order to pay for a targeted treatment? If the patient refuses to have the genetic testing, will they have to pay for their treatment out of pocket? In the human interest story presented, the researcher and his team discovered over activity of the FTL3 protein through RNA sequencing which resulted in rapid proliferation of his leukemic cells. He identified a drug marketed for advanced kidney cancer which was a FTL3 inhibitor. However, his insurance company refused to pay for the drug because it was not a known treatment for his condition of ALL. He incurred numerous out of pocket expenses in order to go into remission. Was it unethical for the insurance company to not pay for a treatment that ultimately worked but was not marketed or FDA cleared for his type of leukemia? There are so many questions and concerns when personalized medicine is implemented. Only time will tell the effects next generation sequencing and its role in personalized medicine will have in the future.

[Clinical and health economic challenges of personalized medicine].

PubMed

Brüggenjürgen, B; Kornbluth, L; Ferrara, J V; Willich, S N

2012-05-01

Healthcare systems across the globe are currently challenged by aging populations, increases in chronic diseases and the difficult task of managing a healthcare budget. In this health economic climate, personalized medicine promises not only an improvement in healthcare delivery but also the possibility of more cost-effective therapies. It is important to remember, however, that personalized medicine has the potential to both increase and decrease costs. Each targeted therapy must be evaluated individually. However, standard clinical trial design is not suitable for personalized therapies. Therefore, both scientists and regulatory authorities will need to accept innovative study designs in order to validate personalized therapies. Hence correct economic evaluations are difficult to carry out due to lack of clear clinical evidence, longitudinal accounting and experience with patient/clinician behavior in the context of personalized medicine. In terms of reimbursement, payers, pharmaceutical companies and companion diagnostic manufacturers will also need to explore creative risk-sharing concepts. Germany is no exception to the challenges that face personalized medicine and for personalized medicine to really become the future of medicine many health economic challenges first need to be overcome. The health economic implications of personalized medicine remain unclear but it is certain that the expansion of targeted therapies in current healthcare systems will create a host of challenges.

Multifunctional Quantum Dots for Personalized Medicine

PubMed Central

Zrazhevskiy, Pavel; Gao, Xiaohu

2009-01-01

Successes in biomedical research and state-of-the-art medicine have undoubtedly improved the quality of life. However, a number of diseases, such as cancer, immunodeficiencies, and neurological disorders, still evade conventional diagnostic and therapeutic approaches. A transformation towards personalized medicine may help to combat these diseases. For this, identification of disease molecular fingerprints and their association with prognosis and targeted therapy must become available. Quantum dots (QDs), semiconductor nanocrystals with unique photo-physical properties, represent a novel class of fluorescence probes to address many of the needs of personalized medicine. This review outlines the properties of QDs that make them a suitable platform for advancing personalized medicine, examines several proof-of-concept studies showing utility of QDs for clinically relevant applications, and discusses current challenges in introducing QDs into clinical practice. PMID:20161004

Personality and recovery: integrating personality assessment data to facilitate the recovery process.

PubMed

Donat, D C

2001-01-01

The relatively enduring and persistent nature of personality traits means that they will likely continue to impact the course of psychiatric recovery after Axis I symptoms are stabilized. These traits can significantly impact the choices that recovering persons make and the quality of interpersonal relationships with care providers who are trying to facilitate the recovery process. Despite this, they are often inadequately assessed and considered in providing psychiatric care. This manuscript reviews the common combinations of personality traits that have emerged across a variety of clinical samples. The implications of these personality features for the provision of care in an inpatient setting to facilitate recovery are discussed.

Personomics: The Missing Link in the Evolution from Precision Medicine to Personalized Medicine.

PubMed

Ziegelstein, Roy C

2017-10-16

Clinical practice guidelines have been developed for many common conditions based on data from randomized controlled trials. When medicine is informed solely by clinical practice guidelines, however, the patient is not treated as an individual, but rather a member of a group. Precision medicine, as defined herein, characterizes unique biological characteristics of the individual or of specimens obtained from an individual to tailor diagnostics and therapeutics to a specific patient. These unique biological characteristics are defined by the tools of precision medicine: genomics, proteomics, metabolomics, epigenomics, pharmacogenomics, and other "-omics." Personalized medicine, as defined herein, uses additional information about the individual derived from knowing the patient as a person. These unique personal characteristics are defined by tools known as personomics which takes into account an individual's personality, preferences, values, goals, health beliefs, social support network, financial resources, and unique life circumstances that affect how and when a given health condition will manifest in that person and how that condition will respond to treatment. In this paradigm, precision medicine may be considered a necessary step in the evolution of medical care to personalized medicine, with personomics as the missing link.

Revitalizing Personalized Medicine: Respecting Biomolecular Complexities Beyond Gene Expression

PubMed Central

Jayachandran, D; Ramkrishna, U; Skiles, J; Renbarger, J; Ramkrishna, D

2014-01-01

Despite recent advancements in “omic” technologies, personalized medicine has not realized its fullest potential due to isolated and incomplete application of gene expression tools. In many instances, pharmacogenomics is being interchangeably used for personalized medicine, when actually it is one of the many facets of personalized medicine. Herein, we highlight key issues that are hampering the advancement of personalized medicine and highlight emerging predictive tools that can serve as a decision support mechanism for physicians to personalize treatments. PMID:24739991

The Personalized Medicine Coalition: goals and strategies.

PubMed

Abrahams, Edward; Ginsburg, Geoffrey S; Silver, Mike

2005-01-01

The concept of personalized medicine--that medical care can be tailored to the genomic and molecular profile of the individual--has repercussions that extend far beyond the technology that makes it possible. The adoption of personalized medicine will require changes in healthcare infrastructure, diagnostics and therapeutics business models, reimbursement policy from government and private payers, and a different approach to regulatory oversight. Personalized medicine will shift medical practices upstream from the reactive treatment of disease, to proactive healthcare management including screening, early treatment, and prevention, and will alter the roles of both physician and patient. It will create a greater reliance on electronic medical records and decision support systems in an industry that has a long history of resistance to information technology. Personalized medicine requires a systems approach to implementation. But in a healthcare economy that is highly decentralized and market driven, it is incumbent upon the stakeholders themselves to advocate for a consistent set of policies and legislation that pave the way for the adoption of personalized medicine. To address this need, the Personalized Medicine Coalition (PMC) was formed as a nonprofit umbrella organization of pharmaceutical, biotechnology, diagnostic, and information technology companies, healthcare providers and payers, patient advocacy groups, industry policy organizations, major academic institutions, and government agencies. The PMC provides a structure for achieving consensus positions among these stakeholders on crucial public policy issues, a role which will be vital to translating personalized medicine into widespread clinical practice. In this article, we outline the goals of the PMC, and the strategies it will take to foster communication, debate, and consensus on issues such as genetic discrimination, the reimbursement structures for pharmacogenomic drugs and diagnostics, regulation

[Precision and personalized medicine].

PubMed

Sipka, Sándor

2016-10-01

The author describes the concept of "personalized medicine" and the newly introduced "precision medicine". "Precision medicine" applies the terms of "phenotype", "endotype" and "biomarker" in order to characterize more precisely the various diseases. Using "biomarkers" the homogeneous type of a disease (a "phenotype") can be divided into subgroups called "endotypes" requiring different forms of treatment and financing. The good results of "precision medicine" have become especially apparent in relation with allergic and autoimmune diseases. The application of this new way of thinking is going to be necessary in Hungary, too, in the near future for participants, controllers and financing boards of healthcare. Orv. Hetil., 2016, 157(44), 1739-1741.

Some economics on personalized and predictive medicine.

PubMed

Antoñanzas, F; Juárez-Castelló, C A; Rodríguez-Ibeas, R

2015-12-01

To contribute to the theoretical literature on personalized medicine, analyzing and integrating in an economic model, the decision a health authority faces when it must decide on the implementation of personalized medicine in a context of uncertainty. We carry out a stylized model to analyze the decision health authorities face when they do not have perfect information about the best treatment for a population of patients with a given disease. The health authorities decide whether to use a test to match patients with treatments (personalized medicine) to maximize health outcomes. Our model characterizes the situations under which personalized medicine dominates the alternative option of business-as-usual (treatment without previous test). We apply the model to the KRAS test for colorectal cancer, the PCA3 test for prostate cancer and the PCR test for the X-fragile syndrome, to illustrate how the parameters and variables of the model interact. Implementation of personalized medicine requires, as a necessary condition, having some tests with high discriminatory power. This is not a sufficient condition and expected health outcomes must be taken into account to make a decision. When the specificity and the sensitivity of the test are low, the health authority prefers to apply a treatment to all patients without using the test. When both characteristic of the test are high, the health authorities prefer to personalize the treatments when expected health outcomes are better than those under the standard treatment. When we applied the model to the three aforementioned tests, the results illustrate how decisions are adopted in real world. Although promising, the use of personalized medicine is still under scrutiny as there are important issues demanding a response. Personalized medicine may have an impact in the drug development processes, and contribute to the efficiency and effectiveness of health care delivery. Nevertheless, more accurate statistical and economic

Future perspectives of personalized medicine in traditional Chinese medicine: a systems biology approach.

PubMed

Zhang, Aihua; Sun, Hui; Wang, Ping; Han, Ying; Wang, Xijun

2012-01-01

Deconstruction of molecular pathways and advances in enabling technology platforms have opened new horizons for disease management, exploring therapeutic solutions to each individual patient beyond the one-size fits all practice. Application of personalized medicine paradigms aims to achieve the right diagnosis and right treatment for the right patient at the right time at the right cost. With the potential to transform medical practice across global communities, personalized medicine is emerging as the flagship of modern medicine. In recent years, the health care paradigm has shifted from a focus on diseases to a major hot of personalized traditional Chinese medicine (TCM) with holistic approach. TCM focuses on health maintenance, emphasizes on enhancing the body's resistance to diseases and especially showes great advantages in early intervention, personalized and combination therapies, etc. Systems biology, a new science of the 21st century, becomes practically available and resembles TCM in many aspects such as study method and design, and is current key component technologies that serves as the major driving force for translation of the personalized medicine revolution of TCM principles into practice, will advance personalized therapy principles into healthcare management tools for individuals and populations. Such system approach concepts are transforming principles of TCM to modern therapeutic approaches, enable a predictive and preventive medicine and will lead to personalized medicine. To realise the full potential of personalized TCM, we describe the current status of principles and practice of TCM integrated with systems biology platform. Some characteristic examples are presented to highlight the application of this platform to personalized TCM research and development as well as some of the necessary milestones for moving TCM into mainstream health care. Copyright © 2011 Elsevier Ltd. All rights reserved.

Ethical Issues Surrounding Personalized Medicine: A Literature Review.

PubMed

Salari, Pooneh; Larijani, Bagher

2017-03-01

More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.

[Proteomics and personalized medicine].

PubMed

Rocchiccioli, Silvia; Tedeschi, Lorena; Citti, Lorenzo; Cecchettini, Antonella

2013-05-01

With the disclosure of the human genome a new era for bio-medicine has arisen, characterized by the challenge to investigate pathogenic mechanisms, studying simultaneously metabolites, DNA, RNA, and proteins. As a result, the "omics" revolution boomed, giving birth to a new medicine named "omics-based medicine". Among the other "omics", proteomics has been widely used in medicine, since it can produce a more "holistic" overview of a disease and provide a "constellation" of possible specific markers, a molecular fingerprinting that defines the clinical condition of an individual. Endpoint of this comprehensive and detailed analysis is the "diagnostic-omics", i.e. the achievement of personalized diagnoses with obvious benefits for prevention and therapy and this goal can be reached only with a perfect integration between clinicians and proteomists. To impact on the possible key factors involved in the pathological processes, oligonucleotide-based knock-down strategies can be helpful. They exploit omics-derived molecular tools (antisense, siRNA, ribozymes, decoys, and aptamers) that can be used to inhibit, at transcriptional or post-transcriptional levels, the events leading to protein synthesis, thus decreasing its expression. The identification of the pivotal mechanisms involved in diseases using global, "scenic" approaches such as the "omics" ones, and the subsequent validation and detailed description of the processes by specific molecular tools, can result in a more preventive, predictive and personalized medicine.

Personalized medicine: from genotypes, molecular phenotypes and the quantified self, towards improved medicine.

PubMed

Dudley, Joel T; Listgarten, Jennifer; Stegle, Oliver; Brenner, Steven E; Parts, Leopold

2015-01-01

Advances in molecular profiling and sensor technologies are expanding the scope of personalized medicine beyond genotypes, providing new opportunities for developing richer and more dynamic multi-scale models of individual health. Recent studies demonstrate the value of scoring high-dimensional microbiome, immune, and metabolic traits from individuals to inform personalized medicine. Efforts to integrate multiple dimensions of clinical and molecular data towards predictive multi-scale models of individual health and wellness are already underway. Improved methods for mining and discovery of clinical phenotypes from electronic medical records and technological developments in wearable sensor technologies present new opportunities for mapping and exploring the critical yet poorly characterized "phenome" and "envirome" dimensions of personalized medicine. There are ambitious new projects underway to collect multi-scale molecular, sensor, clinical, behavioral, and environmental data streams from large population cohorts longitudinally to enable more comprehensive and dynamic models of individual biology and personalized health. Personalized medicine stands to benefit from inclusion of rich new sources and dimensions of data. However, realizing these improvements in care relies upon novel informatics methodologies, tools, and systems to make full use of these data to advance both the science and translational applications of personalized medicine.

From art to science: a new epistemological status for medicine? On expectations regarding personalized medicine.

PubMed

Wiesing, Urban

2017-12-20

Personalized medicine plays an important role in the development of current medicine. Among the numerous statements regarding the future of personalized medicine, some can be found that accord medicine a new scientific status. Medicine will be transformed from an art to a science due to personalized medicine. This prognosis is supported by references to models of historical developments. The article examines what is meant by this prognosis, what consequences it entails, and how feasible it is. It refers to the long tradition of epistemological thinking in medicine and the use of historical models for the development of medicine. The possible answers to the question "art or science" are systematized with respect to the core question about the relationship between knowledge and action. The prediction for medicine to develop from an 'empirical healing art' to a 'rational, molecular science' is nonsensical from an epistemological point of view. The historical models employed to substantiate the development of personalized medicine are questionable.

Personalized Medicine and Genomics: Challenges and Opportunities in Assessing Effectiveness, Cost-Effectiveness, and Future Research Priorities

PubMed Central

Conti, Rena; Veenstra, David L.; Armstrong, Katrina; Lesko, Lawrence J.; Grosse, Scott D.

2015-01-01

Personalized medicine is health care that tailors interventions to individual variation in risk and treatment response. Although medicine has long strived to achieve this goal, advances in genomics promise to facilitate this process. Relevant to present-day practice is the use of genomic information to classify individuals according to disease susceptibility or expected responsiveness to a pharmacologic treatment and to provide targeted interventions. A symposium at the annual meeting of the Society for Medical Decision Making on 23 October 2007 highlighted the challenges and opportunities posed in translating advances in molecular medicine into clinical practice. A panel of US experts in medical practice, regulatory policy, technology assessment, and the financing and organization of medical innovation was asked to discuss the current state of practice and research on personalized medicine as it relates to their own field. This article reports on the issues raised, discusses potential approaches to meet these challenges, and proposes directions for future work. The case of genetic testing to inform dosing with warfarin, an anticoagulant, is used to illustrate differing perspectives on evidence and decision making for personalized medicine. PMID:20086232

Nanobiotechnology and personalized medicine.

PubMed

Jain, K K

2011-01-01

This chapter will start with a definition and scope of personalized medicine and describe how various nanobiotechnologies will contribute to its development. Nanodiagnostics and its combination with therapeutics as well as nanoparticle-based drug delivery will play an important role. The most important applications of nanobiotechnology will be personalized management of cancer, neurological disorders, and cardiovascular diseases. Copyright © 2011 Elsevier Inc. All rights reserved.

Fundamentals of Pharmacogenetics in Personalized, Precision Medicine.

PubMed

Valdes, Roland; Yin, DeLu Tyler

2016-09-01

This article introduces fundamental principles of pharmacogenetics as applied to personalized and precision medicine. Pharmacogenetics establishes relationships between pharmacology and genetics by connecting phenotypes and genotypes in predicting the response of therapeutics in individual patients. We describe differences between precision and personalized medicine and relate principles of pharmacokinetics and pharmacodynamics to applications in laboratory medicine. We also review basic principles of pharmacogenetics, including its evolution, how it enables the practice of personalized therapeutics, and the role of the clinical laboratory. These fundamentals are a segue for understanding specific clinical applications of pharmacogenetics described in subsequent articles in this issue. Copyright © 2016 Elsevier Inc. All rights reserved.

Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine.

PubMed

Leyens, Lada; Richer, Étienne; Melien, Øyvind; Ballensiefen, Wolfgang; Brand, Angela

2015-01-01

Scientific knowledge and our understanding of the human body and diseases have limited any possible treatment tailoring to each patient. The technological advances enabling the integration of various data sets (e.g. '-omics', microbiome, epigenetics and environmental exposure) have facilitated a greater understanding of the human body, the molecular basis of disease and all the factors influencing disease onset, progression and response to treatment, thereby ushering in the era of personalized medicine. We evaluate the regulatory approaches available to facilitate early patient access to efficacious and safe compounds in the EU and the USA in order to make more informed recommendations in the future as to the gaps in regulations for early patient access. An in-depth analysis of conditional approvals (EU) and accelerated approvals (USA) is performed based on the publicly available information (European public assessment reports and a summary review of products approved under both programmes). The types of product, indications, time to approval and type of evidence submitted were analysed. Between 2007 and early 2015, 17 products were conditionally approved in the EU and 25 in the USA, most of them in the area of oncology and based on evidence from phase II clinical trial data. Early approval of promising products based on data from early phases of development is already possible in the EU and the USA. Some of the improvements could entail implementing a rolling assessment of evidence in Europe and extending the scope of early dialogues. © 2015 S. Karger AG, Basel.

Personalized medicine. Closing the gap between knowledge and clinical practice.

PubMed

Anaya, Juan-Manuel; Duarte-Rey, Carolina; Sarmiento-Monroy, Juan C; Bardey, David; Castiblanco, John; Rojas-Villarraga, Adriana

2016-08-01

Personalized medicine encompasses a broad and evolving field informed by a patient distinctive information and biomarker profile. Although terminology is evolving and some semantic interpretations exist (e.g., personalized, individualized, precision), in a broad sense personalized medicine can be coined as: "To practice medicine as it once used to be in the past using the current biotechnological tools." A humanized approach to personalized medicine would offer the possibility of exploiting systems biology and its concept of P5 medicine, where predictive factors for developing a disease should be examined within populations in order to establish preventive measures on at-risk individuals, for whom healthcare should be personalized and participatory. Herein, the process of personalized medicine is presented together with the options that can be offered in health care systems with limited resources for diseases like rheumatoid arthritis and type 1 diabetes. Copyright © 2016 Elsevier B.V. All rights reserved.

Personalized Lifestyle Medicine: Relevance for Nutrition and Lifestyle Recommendations

PubMed Central

Minich, Deanna M.; Bland, Jeffrey S.

2013-01-01

Public health recommendations for lifestyle modification, including diet and physical activity, have been widely disseminated for the prevention and treatment of disease. These guidelines are intended for the overall population without significant consideration for the individual with respect to one's genes and environment. Personalized lifestyle medicine is a newly developed term that refers to an approach to medicine in which an individual's health metrics from point-of-care diagnostics are used to develop lifestyle medicine-oriented therapeutic strategies for improving individual health outcomes in managing chronic disease. Examples of the application of personalized lifestyle medicine to patient care include the identification of genetic variants through laboratory tests and/or functional biomarkers for the purpose of designing patient-specific prescriptions for diet, exercise, stress, and environment. Personalized lifestyle medicine can provide solutions to chronic health problems by harnessing innovative and evolving technologies based on recent discoveries in genomics, epigenetics, systems biology, life and behavioral sciences, and diagnostics and clinical medicine. A comprehensive, personalized approach to medicine is required to promote the safety of therapeutics and reduce the cost of chronic disease. Personalized lifestyle medicine may provide a novel means of addressing a patient's health by empowering them with information they need to regain control of their health. PMID:23878520

Personalized lifestyle medicine: relevance for nutrition and lifestyle recommendations.

PubMed

Minich, Deanna M; Bland, Jeffrey S

2013-01-01

Public health recommendations for lifestyle modification, including diet and physical activity, have been widely disseminated for the prevention and treatment of disease. These guidelines are intended for the overall population without significant consideration for the individual with respect to one's genes and environment. Personalized lifestyle medicine is a newly developed term that refers to an approach to medicine in which an individual's health metrics from point-of-care diagnostics are used to develop lifestyle medicine-oriented therapeutic strategies for improving individual health outcomes in managing chronic disease. Examples of the application of personalized lifestyle medicine to patient care include the identification of genetic variants through laboratory tests and/or functional biomarkers for the purpose of designing patient-specific prescriptions for diet, exercise, stress, and environment. Personalized lifestyle medicine can provide solutions to chronic health problems by harnessing innovative and evolving technologies based on recent discoveries in genomics, epigenetics, systems biology, life and behavioral sciences, and diagnostics and clinical medicine. A comprehensive, personalized approach to medicine is required to promote the safety of therapeutics and reduce the cost of chronic disease. Personalized lifestyle medicine may provide a novel means of addressing a patient's health by empowering them with information they need to regain control of their health.

DNA Aptamer Technology for Personalized Medicine

PubMed Central

Xing, Hang; Hwang, Kevin; Li, Ji; Torabi, Seyed-Fakhreddin; Lu, Yi

2014-01-01

This review highlights recent progress in developing DNA aptamers for personalized medicine, with more focus on in vivo studies for potential clinical applications. Examples include design of aptamers in combination with DNA nanostructures, nanomaterials, or microfluidic devices as diagnostic probes or therapeutic agents for cancers and other diseases. The use of aptamers as targeting agents in drug delivery is also covered. The advantages and future directions of such DNA aptamer-based technology for the continued development of personalized medicine are discussed. PMID:24791224

[Personalized medicine and individual healthcare : Medical and information technology aspects].

PubMed

Niederlag, W; Lemke, H U; Rienhoff, O

2010-08-01

The individualization of medicine and healthcare appears to be following a general societal trend. The terms "personalized medicine" and "personal health" are used to describe this process. Here it must be emphasized that personalized medicine is not limited to pharmacogenomics, but that the spectrum of personalized medicine is much broader. Applications range from individualized diagnostics, patient-specific pharmacological therapy, therapy with individual prostheses and implants to therapy approaches using autologous cells, and from patient model-based therapy in the operating room, electronic patient records through to the individual care of patients in their home environment with the use of technical systems and services. Although in some areas practical solutions have already been found, most applications will not be fully developed for many years to come. Medical and information technology are essential to personalized medicine and personal health, each driving the other forward.

Personalized medicine could transform healthcare

PubMed Central

Mathur, Sunil; Sutton, Joseph

2017-01-01

Personalized medicine (PM) is about tailoring a treatment as individualized as the disease. The approach relies on identifying genetic, epigenomic, and clinical information that allows the breakthroughs in our understanding of how a person's unique genomic portfolio makes them vulnerable to certain diseases. PM approach is a complete extension of traditional approach (One-Size-Fits-All) to increasing our ability to predict which medical treatments will be safe and effective for individual patient, and which ones will not be, based on the patient's unique genetic profile. Implementation of PM has the potential to reduce financial and time expenditure, and increase quality of life and life extension of patients. Knowledge of PM facilitates earlier disease detection via enhanced use of existing biomarkers and detection of early genomic and epigenomic events in disease development, particularly carcinogenesis. The PM approach predominantly focuses on preventative medicine and favours taking pro-active actions rather than just reactive. This approach delays or prevents the need to apply more severe treatments which are usually less tolerated and with increased quality of life and financial considerations. Increasing healthcare costs have placed additional pressure on government funded healthcare systems globally, especially regarding end of life care. PM may increase the effectiveness of existing treatments and negate the inherent problems associated with non-PM approaches. PM is a young but rapidly expanding field of healthcare where a physician can select a treatment based on a patient's genetic profile that may not only minimize harmful side effects and guarantee a more successful result, but can be less cost effective compared with a ‘trial-and-error’ approach to disease treatment. The less efficient non-PM (‘trial-and-error’) approach, which can lead to drug toxicity, severe side effects, reactive treatment and misdiagnosis continue to contribute to

Personalized Medicine and Nonmotor Symptoms in Parkinson's Disease.

PubMed

Titova, Nataliya; Chaudhuri, K Ray

2017-01-01

Parkinson's disease (PD) is a multineurotransmitter dysfunction related disorder resulting in a range of motor and nonmotor symptoms. Phenotypic heterogeneity is pronounced in PD and nonmotor symptoms dominant subtypes have been described. These endophenotypes may be underpinned by considerable nondopaminergic dysfunction; however, conventional treatment of PD continues to be mostly reliant on dopamine replacement strategy or manipulation of brain dopaminergic pathways. Consequently, treatment of many nondopaminergic nonmotor and some motor symptoms remains a key unmet need. It is also recognized that treatment strategies for PD are influenced by a number of nondrug-related issues. These include factors such as age, personality, and preferences for treatment, cultural beliefs, lifestyle, pharmacoeconomics, pharmacogenetics as well as comorbidity. Therefore, the success of clinical therapy will rest on how much these factors are considered to develop a truly holistic treatment plan. Personalized medicine is the modern way of delivering this holistic strategy for treatment of PD. Personalized medicine thus encompasses several strands of treatment. From the pharmaceutical point of view, it should involve dopaminergic and nondopaminergic strategies. In addition, there are substrategies involving precision and tailored medicine to suit the needs and requirements of individual patients. Precision medicine would be relevant for patients who may be at risk of developing the clinical syndrome of Parkinson's as identified by specific gene mutations. Precision medicine in this scenario will attempt to be preventive. Tailored medicine would address the "single multifactorial" complex nature of PD and address symptoms as well subtype-specific strategies. Personalized medicine is now practiced for other conditions such as oncology as well as diabetes. In this chapter, we discuss the rationale and the need to develop strategies for personalized medicine for PD. © 2017 Elsevier

Personalized medicine in oncology: ethical implications for the delivery of healthcare.

PubMed

Egalite, Nathalie; Groisman, Iris Jaitovich; Godard, Beatrice

2014-09-01

While personalized medicine brings benefits for the treatment of cancer, there are still key ethical issues at stake in developing personalized medicine in oncology. We propose an ethical analysis of personalized medicine in oncology that highlights the particularities of cancer care, critically assesses the scientific advances behind personalized medicine in oncology and emphasizes fairness in resource allocation in the delivery of personalized healthcare. This allows for a broader understanding of the real impacts on both recipients and the healthcare system.

Perceptions of Personalized Medicine in an Academic Health System: Educational Findings.

PubMed

Vorderstrasse, Allison; Katsanis, Sara Huston; Minear, Mollie A; Yang, Nancy; Rakhra-Burris, Tejinder; Reeves, Jason W; Cook-Deegan, Robert; Ginsburg, Geoffrey S; Ann Simmons, Leigh

Prior reports demonstrate that personalized medicine implementation in clinical care is lacking. Given the program focus at Duke University on personalized medicine, we assessed health care providers' perspectives on their preparation and educational needs to effectively integrate personalized medicine tools and applications into their clinical practices. Data from 78 health care providers who participated in a larger study of personalized and precision medicine at Duke University were analyzed using Qualtrics (descriptive statistics). Individuals age 18 years and older were recruited for the larger study through broad email contacts across the university and health system. All participants completed an online 35-question survey that was developed, pilot-tested, and administered by a team of interdisciplinary researchers and clinicians at the Center for Applied Genomics and Precision Medicine. Overall, providers reported being ill-equipped to implement personalized medicine in clinical practice. Many respondents identified educational resources as critical for strengthening personalized medicine implementation in both research and clinical practice. Responses did not differ significantly between specialists and primary providers or by years since completion of the medical degree. Survey findings support prior calls for provider and patient education in personalized medicine. Respondents identified focus areas in training, education, and research for improving personalized medicine uptake. Given respondents' emphasis on educational needs, now may be an ideal time to address these needs in clinical training and public education programs.

Personalized medicine: challenges and opportunities for translational bioinformatics

PubMed Central

Overby, Casey Lynnette; Tarczy-Hornoch, Peter

2013-01-01

Personalized medicine can be defined broadly as a model of healthcare that is predictive, personalized, preventive and participatory. Two US President’s Council of Advisors on Science and Technology reports illustrate challenges in personalized medicine (in a 2008 report) and in use of health information technology (in a 2010 report). Translational bioinformatics is a field that can help address these challenges and is defined by the American Medical Informatics Association as “the development of storage, analytic and interpretive methods to optimize the transformation of increasing voluminous biomedical data into proactive, predictive, preventative and participatory health.” This article discusses barriers to implementing genomics applications and current progress toward overcoming barriers, describes lessons learned from early experiences of institutions engaged in personalized medicine and provides example areas for translational bioinformatics research inquiry. PMID:24039624

Tissue Banking, Bioinformatics, and Electronic Medical Records: The Front-End Requirements for Personalized Medicine

PubMed Central

Suh, K. Stephen; Sarojini, Sreeja; Youssif, Maher; Nalley, Kip; Milinovikj, Natasha; Elloumi, Fathi; Russell, Steven; Pecora, Andrew; Schecter, Elyssa; Goy, Andre

2013-01-01

Personalized medicine promises patient-tailored treatments that enhance patient care and decrease overall treatment costs by focusing on genetics and “-omics” data obtained from patient biospecimens and records to guide therapy choices that generate good clinical outcomes. The approach relies on diagnostic and prognostic use of novel biomarkers discovered through combinations of tissue banking, bioinformatics, and electronic medical records (EMRs). The analytical power of bioinformatic platforms combined with patient clinical data from EMRs can reveal potential biomarkers and clinical phenotypes that allow researchers to develop experimental strategies using selected patient biospecimens stored in tissue banks. For cancer, high-quality biospecimens collected at diagnosis, first relapse, and various treatment stages provide crucial resources for study designs. To enlarge biospecimen collections, patient education regarding the value of specimen donation is vital. One approach for increasing consent is to offer publically available illustrations and game-like engagements demonstrating how wider sample availability facilitates development of novel therapies. The critical value of tissue bank samples, bioinformatics, and EMR in the early stages of the biomarker discovery process for personalized medicine is often overlooked. The data obtained also require cross-disciplinary collaborations to translate experimental results into clinical practice and diagnostic and prognostic use in personalized medicine. PMID:23818899

Precision or Personalized Medicine for Cancer Chemotherapy: Is there a Role for Herbal Medicine.

PubMed

Wang, Zhijun; Liu, Xuefeng; Ho, Rebecca Lucinda Ka Yan; Lam, Christopher Wai Kei; Chow, Moses Sing Sum

2016-07-07

Although over 100 chemotherapeutic agents are currently available for the treatment of cancer patients, the overall long term clinical benefit is disappointing due to the lack of effectiveness or severe side effects from these agents. In order to improve the therapeutic outcome, a new approach called precision medicine or personalized medicine has been proposed and initiated by the U.S. National Institutes of Health. However, the limited availability of effective medications and the high cost are still the major barriers for many cancer patients. Thus alternative approaches such as herbal medicines could be a feasible and less costly option. Unfortunately, scientific evidence for the efficacy of a majority of herbal medicines is still lacking and their development to meet FDA approval or other regulatory agencies is a big challenge. However, herbal medicines may be able to play an important role in precision medicine or personalized medicine. This review will focus on the existing and future technologies that could speed the development of herbal products for treatment of resistant cancer in individual patients. Specifically, it will concentrate on reviewing the phenotypic (activity based) rather than genotypic (mechanism based) approach to develop herbal medicine useful for personalized cancer chemotherapy.

Personalized medicine: is it a pharmacogenetic mirage?

PubMed Central

Shah, Rashmi R; Shah, Devron R

2012-01-01

The notion of personalized medicine has developed from the application of the discipline of pharmacogenetics to clinical medicine. Although the clinical relevance of genetically-determined inter-individual differences in pharmacokinetics is poorly understood, and the genotype-phenotype association data on clinical outcomes often inconsistent, officially approved drug labels frequently include pharmacogenetic information concerning the safety and/or efficacy of a number of drugs and refer to the availability of the pharmacogenetic test concerned. Regulatory authorities differ in their approach to these issues. Evidence emerging subsequently has generally revealed the pharmacogenetic information included in the label to be premature. Revised drugs labels, together with a flurry of other collateral activities, have raised public expectations of personalized medicine, promoted as ‘the right drug at the right dose the first time.’ These expectations place the prescribing physician in a dilemma and at risk of litigation, especially when evidence-based information on genotype-related dosing schedules is to all intent and purposes non-existent and guidelines, intended to improve the clinical utility of available pharmacogenetic information or tests, distance themselves from any responsibility. Lack of efficacy or an adverse drug reaction is frequently related to non-genetic factors. Phenoconversion, arising from drug interactions, poses another often neglected challenge to any potential success of personalized medicine by mimicking genetically-determined enzyme deficiency. A more realistic promotion of personalized medicine should acknowledge current limitations and emphasize that pharmacogenetic testing can only improve the likelihood of diminishing a specific toxic effect or increasing the likelihood of a beneficial effect and that application of pharmacogenetics to clinical medicine cannot adequately predict drug response in individual patients. PMID:22591598

Is laboratory medicine ready for the era of personalized medicine? A survey addressed to laboratory directors of hospitals/academic schools of medicine in Europe.

PubMed

Malentacchi, Francesca; Mancini, Irene; Brandslund, Ivan; Vermeersch, Pieter; Schwab, Matthias; Marc, Janja; van Schaik, Ron H N; Siest, Gerard; Theodorsson, Elvar; Pazzagli, Mario; Di Resta, Chiara

2015-06-01

Developments in "-omics" are creating a paradigm shift in laboratory medicine leading to personalized medicine. This allows the increase in diagnostics and therapeutics focused on individuals rather than populations. In order to investigate whether laboratory medicine is ready to play a key role in the integration of personalized medicine in routine health care and set the state-of-the-art knowledge about personalized medicine and laboratory medicine in Europe, a questionnaire was constructed under the auspices of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the European Society of Pharmacogenomics and Personalised Therapy (ESPT). The answers of the participating laboratory medicine professionals indicate that they are aware that personalized medicine can represent a new and promising health model, and that laboratory medicine should play a key role in supporting the implementation of personalized medicine in the clinical setting. Participants think that the current organization of laboratory medicine needs additional/relevant implementations such as (i) new technological facilities in -omics; (ii) additional training for the current personnel focused on the new methodologies; (iii) incorporation in the laboratory of new competencies in data interpretation and counseling; and (iv) cooperation and collaboration among professionals of different disciplines to integrate information according to a personalized medicine approach.

Citizens' perspectives on personalized medicine: a qualitative public deliberation study

PubMed Central

Bombard, Yvonne; Abelson, Julia; Simeonov, Dorina; Gauvin, Francois-Pierre

2013-01-01

Our objective was to explore citizens' informed and reasoned values and expectations of personalized medicine, a timely yet novel genomics policy issue. A qualitative, public deliberation study was undertaken using a citizens' reference panel on health technologies, established to provide input to the health technology assessment process in Ontario, Canada. The citizens' panel consisted of five women and nine men, aged 18–71 years, with one member selected from each health authority region. There were shared expectations among the citizens' panel members for the potential of personalized medicine technologies to improve care, provided they are deemed clinically valid and effective. These expectations were tempered by concerns about value for money and the possibility that access to treatment may be limited by personalized medicine tests used to stratify patients. Although they questioned the presumed technological imperative presented by personalized medicine technologies, they called for increased efforts to prepare the health-care system to effectively integrate these technologies. This study represents an early but important effort to explore public values toward personalized medicine. This study also provides evidence of the public's ability to form coherent judgments about a new policy issue. Concerned that personalized tests might be used to ration care, they suggested that treatment should be made available if patients wanted it, irrespective of tests that indicate little benefit. This issue raises clinical and policy challenges that may undermine the value of personalized medicine. Further efforts to deliberate with the public are warranted to inform effective, efficient and equitable translation of personalized medicine. PMID:23340511

Citizens' perspectives on personalized medicine: a qualitative public deliberation study.

PubMed

Bombard, Yvonne; Abelson, Julia; Simeonov, Dorina; Gauvin, Francois-Pierre

2013-11-01

Our objective was to explore citizens' informed and reasoned values and expectations of personalized medicine, a timely yet novel genomics policy issue. A qualitative, public deliberation study was undertaken using a citizens' reference panel on health technologies, established to provide input to the health technology assessment process in Ontario, Canada. The citizens' panel consisted of five women and nine men, aged 18-71 years, with one member selected from each health authority region. There were shared expectations among the citizens' panel members for the potential of personalized medicine technologies to improve care, provided they are deemed clinically valid and effective. These expectations were tempered by concerns about value for money and the possibility that access to treatment may be limited by personalized medicine tests used to stratify patients. Although they questioned the presumed technological imperative presented by personalized medicine technologies, they called for increased efforts to prepare the health-care system to effectively integrate these technologies. This study represents an early but important effort to explore public values toward personalized medicine. This study also provides evidence of the public's ability to form coherent judgments about a new policy issue. Concerned that personalized tests might be used to ration care, they suggested that treatment should be made available if patients wanted it, irrespective of tests that indicate little benefit. This issue raises clinical and policy challenges that may undermine the value of personalized medicine. Further efforts to deliberate with the public are warranted to inform effective, efficient and equitable translation of personalized medicine.

[Personalized medicine: an elusive concept, diversified practices].

PubMed

Bateman, Simone

2014-11-01

This article proposes a brief inquiry into the field of scientific and medical practices currently referred to as "personalized medicine". Our inquiry identifies four recurring themes in the literature: health care that is tailored to the individual patient, that is enabled by emerging technologies, in which genetics and genomics occupy a prominent place, and which requires the collection of a massive amount of data. Personalized medicine, thus characterized, turns out to be less interested in the uniqueness of each patient's case than in the differences among patients within the same category. The aim of personalized medicine, thus described, is to obtain, with the help of cutting edge technology, more objective biological data on patients, in an attempt to improve the tools it has at its disposal to establish diagnoses, make therapeutic decisions, and provide more effective preventive measures. © 2014 médecine/sciences – Inserm.

Conference Scene: Personalized Medicine comes to Harvard.

PubMed

Greenberg, Tarryn

2012-01-01

The Seventh Annual Harvard Personalized Medicine Conference was held at The Joseph B Martin Conference Center at the Harvard Medical School in Boston, MA, USA on the 9-10 November 2011. The 2-day conference program was designed to highlight the impact that personalized medicine is currently making clinically as it enters the healthcare delivery system. Going forward, policies, plans and actions of stakeholders including those from government, academia and the private sector need to be informed and guided by recent experience - all of which the conference program set out to explore. The conference attracted over 600 national and international thought leaders all involved in personalized healthcare.

Strategies for integrating personalized medicine into healthcare practice.

PubMed

Pritchard, Daryl E; Moeckel, Franziska; Villa, Mary Susan; Housman, Laura T; McCarty, Catherine A; McLeod, Howard L

2017-03-01

Research and innovation in personalized medicine are surging, however, its adoption into clinical practice is comparatively slow. We identify common challenges to the clinical adoption of personalized medicine and provide strategies for addressing these challenges. Our team developed a list of common challenges through a series of group discussions, surveys and interviews, and convened a national summit to discuss solutions for overcoming these challenges. We used a framework approach for thematic analysis. We categorized challenges into five areas of need: education and awareness; patient empowerment; value recognition; infrastructure and information management; and ensuring access to care. We then developed strategies to address these challenges. In order for healthcare to transition into personalized medicine, it is necessary for stakeholders to build momentum by implementing a progression of strategies.

Personal Skills. Facilitator's Skill Packets 1-7. Social Skills Training.

ERIC Educational Resources Information Center

Model Classrooms, Bellevue, WA.

This document contains the following seven facilitators' skill packets on personal skills: (1) personal hygiene; (2) personal appearance; (3) locker hygiene; (4) dorm cleanliness; (5) punctuality and attendance; (6) responding to supervision; and (7) teamwork. Each packet contains the following sections: definition of personal skills; objective;…

The Case for Personalized Medicine

PubMed Central

Abrahams, Edward; Silver, Mike

2009-01-01

Personalized medicine may be considered an extension of traditional approaches to understanding and treating disease, but with greater precision. Physicians may now use a patient's genetic variation or expression profile as well as protein and metabolic markers to guide the selection of certain drugs or treatments. In many cases, the information provided by molecular markers predicts susceptibility to conditions. The added precision introduces the possibility of a more preventive, effective approach to clinical care and reductions in the duration and cost of clinical trials. Here, we make the case, through real-world examples, that personalized medicine is delivering significant value to individuals, to industry, and to the health care system overall and that it will continue to grow in importance if we can lift the barriers that impede its adoption and build incentives to encourage its practice. PMID:20144313

Critical Care and Personalized or Precision Medicine: Who needs whom?

PubMed

Sugeir, Shihab; Naylor, Stephen

2018-02-01

The current paradigm of modern healthcare is a reactive response to patient symptoms, subsequent diagnosis and corresponding treatment of the specific disease(s). This approach is predicated on methodologies first espoused by the Cnidean School of Medicine approximately 2500years ago. More recently escalating healthcare costs and relatively poor disease treatment outcomes have fermented a rethink in how we carry out medical practices. This has led to the emergence of "P-Medicine" in the form of Personalized and Precision Medicine. The terms are used interchangeably, but in fact there are significant differences in the way they are implemented. The former relies on an "N-of-1" model whereas the latter uses a "1-in-N" model. Personalized Medicine is still in a fledgling and evolutionary phase and there has been much debate over its current status and future prospects. A confounding factor has been the sudden development of Precision Medicine, which has currently captured the imagination of policymakers responsible for modern healthcare systems. There is some confusion over the terms Personalized versus Precision Medicine. Here we attempt to define the key differences and working definitions of each P-Medicine approach, as well as a taxonomic relationship tree. Finally, we discuss the impact of Personalized and Precision Medicine on the practice of Critical Care Medicine (CCM). Practitioners of CCM have been participating in Personalized Medicine unknowingly as it takes the protocols of sepsis, mechanical ventilation, and daily awakening trials and applies it to each individual patient. However, the immediate next step for CCM should be an active development of Precision Medicine. This developmental process should break down the silos of modern medicine and create a multidisciplinary approach between clinicians and basic/translational scientists. Copyright © 2017 Elsevier Inc. All rights reserved.

Genetics of personalized medicine: cancer and rare diseases.

PubMed

Alves, Inês Teles Siefers; Condinho, Manuel; Custódio, Sónia; Pereira, Bruna F; Fernandes, Rafael; Gonçalves, Vânia; da Costa, Paulo J; Lacerda, Rafaela; Marques, Ana Rita; Martins-Dias, Patrícia; Nogueira, Gonçalo R; Neves, Ana Rita; Pinho, Patrícia; Rodrigues, Raquel; Rolo, Eva; Silva, Joana; Travessa, André; Leite, Rosário Pinto; Sousa, Ana; Romão, Luísa

2018-06-01

The 21st annual meeting of the Portuguese Society of Human Genetics (SPGH), organized by Luísa Romão, Ana Sousa and Rosário Pinto Leite, was held in Caparica, Portugal, from the 16th to the 18th of November 2017. Having entered an era in which personalized medicine is emerging as a paradigm for disease diagnosis, treatment and prevention, the program of this meeting intended to include lectures by leading national and international scientists presenting exceptional findings on the genetics of personalized medicine. Various topics were discussed, including cancer genetics, transcriptome dynamics and novel therapeutics for cancers and rare disorders that are designed to specifically target molecular alterations in individual patients. Several panel discussions were held to emphasize (ethical) issues associated with personalized medicine, including genetic cancer counseling.

Ethical, legal and social implications of incorporating personalized medicine into healthcare.

PubMed

Brothers, Kyle B; Rothstein, Mark A

As research focused on personalized medicine has developed over the past decade, bioethics scholars have contemplated the ethical, legal and social implications of this type of research. In the next decade, there will be a need to broaden the focus of this work as personalized medicine moves into clinical settings. We consider two broad issues that will grow in importance and urgency. First, we analyze the consequences of the significant increase in health information that will be brought about by personalized medicine. Second, we raise concerns about the potential of personalized medicine to exacerbate existing disparities in healthcare.

Ethical, legal and social implications of incorporating personalized medicine into healthcare

PubMed Central

Brothers, Kyle B; Rothstein, Mark A

2015-01-01

As research focused on personalized medicine has developed over the past decade, bioethics scholars have contemplated the ethical, legal and social implications of this type of research. In the next decade, there will be a need to broaden the focus of this work as personalized medicine moves into clinical settings. We consider two broad issues that will grow in importance and urgency. First, we analyze the consequences of the significant increase in health information that will be brought about by personalized medicine. Second, we raise concerns about the potential of personalized medicine to exacerbate existing disparities in healthcare. PMID:25601880

Reflections on market access for personalized medicine: recommendations for Europe.

PubMed

Payne, Katherine; Annemans, Lieven

2013-01-01

This article aims to provide an overview of the current literature focusing on the reimbursement of personalized medicine across the European Union. The article starts by describing types of perspectives that are possible (general public, patient, payer, provider, service commissioner, and policymaker). The description of perspectives also explains the importance of understanding the different possible decision criteria and processes from the various perspectives by taking into account budget constraints. The article then focuses on an example of personalized medicine, namely, the use of companion diagnostic-medicine combinations, to describe the role of reimbursement/payer agencies across the European Union to control the introduction and coverage of such companion diagnostic-medicine technologies. The article touches on the strategic challenges and the use of economic evidence to introduce personalized medicine from a health policy perspective. The article also draws on empirical studies that have explored patients' and clinicians' views of examples of personalized medicine to illustrate the challenges for developing patient-centered and timely health care services. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

The Future of Personalized Medicine | NIH MedlinePlus the Magazine

MedlinePlus

... please turn Javascript on. The Future of Personalized Medicine, From NIH Director Dr. Francis S. Collins Past Issues / ... five priorities for NIH is to advance personalized medicine. What does this mean for the average American? ...

[ETHICS, MORALS AND SOCIETY IN PERSONALIZED MEDICINE].

PubMed

Flugelman, Anath

2015-09-01

Following the completion of the human genome project, genomic medicine including personalized medicine, widely based on pharmacogenetics and pharmacogenomics, is rapidly developing. This breakthrough should benefit humankind thanks to tailoring the most appropriate prevention, interventions and therapies to each individual, minimizing adverse side effects, based on inter-personal genetic variety and polymorphism. Yet wide spectrum ethical, legal and social issues carry significant implications regarding individuals, families, society and public health. The main issues concern genomic information and autonomy, justice and equity, resources allocation and solidarity, challenging the traditional role of medicine and dealing with unlimited boundaries of knowledge. Those issues are not new nor exceptional to genomic medicine, yet their wide unlimited scope and implications on many aspects of life renders them crucial. These aspects will be discussed in light of Beauchamp and Childress' four principles: non-maleficence, beneficence, autonomy and justice, and main moral philosophies, Kant's autonomy, Utilitarianism which promotes the common good, and Rawls' Theory of Justice.

Payer view of personalized medicine.

PubMed

Pezalla, Edmund J

2016-12-01

The process and methods used by payers when evaluating coverage of personalized medicine testing are described. Personalized medicine encompasses a number of diagnostic tools that measure drug metabolism, genetic risk for disease development, and tumor type or markers that can guide oncology treatments. However, whole genome testing, tumor marker testing, and testing for drug metabolism are additional costs to the healthcare system. In order to justify these costs, payers and health technology assessment bodies must evaluate the individual tests or groups of tests on their own merits. In order for a test to be covered by payers, test developers must demonstrate clinical utility as measured by improved outcomes or well-informed decision-making. In the United States, payers generally focus on clinical benefit to individual patients and benefits to the healthcare system. Clinical benefits include improved outcomes. Benefits to the healthcare system are generally considered to be cost offsets, which may be due to reductions in the use of unnecessary interventions or to more efficient use of resources. Provider organizations have been assuming more responsibility and liability for healthcare costs through various risk arrangements, including accountable care organizations and patient-centered medical homes. Diagnostic tests that increase efficiency, reduce unnecessary interventions, and improve outcomes will be chosen by specialists in provider organizations. For personalized medicine approaches to be adopted and covered by health plans, the methods must be shown to be analytically and clinically valid and provide clinical utility at a reasonable level of cost-effectiveness to payers. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Individual Biomarkers Using Molecular Personalized Medicine Approaches.

PubMed

Zenner, Hans P

2017-01-01

Molecular personalized medicine tries to generate individual predictive biomarkers to assist doctors in their decision making. These are thought to improve the efficacy and lower the toxicity of a treatment. The molecular basis of the desired high-precision prediction is modern "omex" technologies providing high-throughput bioanalytical methods. These include genomics and epigenomics, transcriptomics, proteomics, metabolomics, microbiomics, imaging, and functional analyses. In most cases, producing big data also requires a complex biomathematical analysis. Using molecular personalized medicine, the conventional physician's check of biomarker results may no longer be sufficient. By contrast, the physician may need to cooperate with the biomathematician to achieve the desired prediction on the basis of the analysis of individual big data typically produced by omex technologies. Identification of individual biomarkers using molecular personalized medicine approaches is thought to allow a decision-making for the precise use of a targeted therapy, selecting the successful therapeutic tool from a panel of preexisting drugs or medical products. This should avoid the treatment of nonresponders and responders that produces intolerable unwanted effects. © 2017 S. Karger AG, Basel.

Comparative Effectiveness Research, Genomics-Enabled Personalized Medicine, and Rapid Learning Health Care: A Common Bond

PubMed Central

Ginsburg, Geoffrey S.; Kuderer, Nicole M.

2012-01-01

Despite stunning advances in our understanding of the genetics and the molecular basis for cancer, many patients with cancer are not yet receiving therapy tailored specifically to their tumor biology. The translation of these advances into clinical practice has been hindered, in part, by the lack of evidence for biomarkers supporting the personalized medicine approach. Most stakeholders agree that the translation of biomarkers into clinical care requires evidence of clinical utility. The highest level of evidence comes from randomized controlled clinical trials (RCTs). However, in many instances, there may be no RCTs that are feasible for assessing the clinical utility of potentially valuable genomic biomarkers. In the absence of RCTs, evidence generation will require well-designed cohort studies for comparative effectiveness research (CER) that link detailed clinical information to tumor biology and genomic data. CER also uses systematic reviews, evidence-quality appraisal, and health outcomes research to provide a methodologic framework for assessing biologic patient subgroups. Rapid learning health care (RLHC) is a model in which diverse data are made available, ideally in a robust and real-time fashion, potentially facilitating CER and personalized medicine. Nonetheless, to realize the full potential of personalized care using RLHC requires advances in CER and biostatistics methodology and the development of interoperable informatics systems, which has been recognized by the National Cancer Institute's program for CER and personalized medicine. The integration of CER methodology and genomics linked to RLHC should enhance, expedite, and expand the evidence generation required for fully realizing personalized cancer care. PMID:23071236

Between hype and hope: What is really at stake with personalized medicine?

PubMed

Abettan, Camille

2016-09-01

Over the last decade, personalized medicine has become a buzz word, which covers a broad spectrum of meanings and generates many different opinions. The purpose of this article is to achieve a better understanding of the reasons why personalized medicine gives rise to such conflicting opinions. We show that a major issue of personalized medicine is the gap existing between its claims and its reality. We then present and analyze different possible reasons for this gap. We propose an hypothesis inspired by the Windelband's distinction between nomothetic and idiographic methodology. We argue that the fuzzy situation of personalized medicine results from a mix between idiographic claims and nomothetic methodological procedures. Hence we suggest that the current quandary about personalized medicine cannot be solved without getting involved in a discussion about the complex epistemological and methodological status of medicine. To conclude, we show that the Gadamer's view of medicine as a dialogical process can be fruitfully used and reveals that personalization is not a theoretical task, but a practical one, which takes place within the clinical encounter.

Managing the innovation supply chain to maximize personalized medicine.

PubMed

Waldman, S A; Terzic, A

2014-02-01

Personalized medicine epitomizes an evolving model of care tailored to the individual patient. This emerging paradigm harnesses radical technological advances to define each patient's molecular characteristics and decipher his or her unique pathophysiological processes. Translated into individualized algorithms, personalized medicine aims to predict, prevent, and cure disease without producing therapeutic adverse events. Although the transformative power of personalized medicine is generally recognized by physicians, patients, and payers, the complexity of translating discoveries into new modalities that transform health care is less appreciated. We often consider the flow of innovation and technology along a continuum of discovery, development, regulation, and application bridging the bench with the bedside. However, this process also can be viewed through a complementary prism, as a necessary supply chain of services and providers, each making essential contributions to the development of the final product to maximize value to consumers. Considering personalized medicine in this context of supply chain management highlights essential points of vulnerability and/or scalability that can ultimately constrain translation of the biological revolution or potentiate it into individualized diagnostics and therapeutics for optimized value creation and delivery.

Enabling personalized cancer medicine decisions: The challenging pharmacological approach of PBPK models for nanomedicine and pharmacogenomics (Review).

PubMed

Vizirianakis, Ioannis S; Mystridis, George A; Avgoustakis, Konstantinos; Fatouros, Dimitrios G; Spanakis, Marios

2016-04-01

The existing tumor heterogeneity and the complexity of cancer cell biology critically demand powerful translational tools with which to support interdisciplinary efforts aiming to advance personalized cancer medicine decisions in drug development and clinical practice. The development of physiologically based pharmacokinetic (PBPK) models to predict the effects of drugs in the body facilitates the clinical translation of genomic knowledge and the implementation of in vivo pharmacology experience with pharmacogenomics. Such a direction unequivocally empowers our capacity to also make personalized drug dosage scheme decisions for drugs, including molecularly targeted agents and innovative nanoformulations, i.e. in establishing pharmacotyping in prescription. In this way, the applicability of PBPK models to guide individualized cancer therapeutic decisions of broad clinical utility in nanomedicine in real-time and in a cost-affordable manner will be discussed. The latter will be presented by emphasizing the need for combined efforts within the scientific borderlines of genomics with nanotechnology to ensure major benefits and productivity for nanomedicine and personalized medicine interventions.

Interprofessional education for personalized medicine through technology-based learning.

PubMed

Haga, Susanne B; Mills, Rachel; Aucoin, Julia; Taekman, Jeff

2015-06-01

The delivery of personalized medicine utilizing genetic and genomic technologies is anticipated to involve many medical specialties. Interprofessional education will be key to the delivery of personalized medicine in order to reduce disjointed or uncoordinated clinical care, and optimize effective communication to promote patient understanding and engagement regarding the use of or need for these services. While several health professional organizations have endorsed and/or developed core competencies for genetics and genomics, the lack of interprofessional guidelines and training may hamper the delivery of coordinated personalized medicine. In this perspective, we consider the potential for interprofessional education and training using technology-based approaches, such as virtual simulation and gaming, compared with traditional educational approaches.

Epigenomics, Pharmacoepigenomics, and Personalized Medicine in Cervical Cancer.

PubMed

Kabekkodu, Shama Prasada; Chakrabarty, Sanjiban; Ghosh, Supriti; Brand, Angela; Satyamoorthy, Kapaettu

2017-01-01

Epigenomics encompasses the study of genome-wide changes in DNA methylation, histone modifications and noncoding RNAs leading to altered transcription, chromatin structure, and posttranscription RNA processing, respectively, resulting in an altered rate of gene expression. The role of epigenetic modifications facilitating human diseases is well established. Previous studies have identified histone and cytosine code during normal and pathological conditions with special emphasis on how these modifications regulate transcriptional events. Recent studies have also mapped these epigenetic modification and pathways leading to carcinogenesis. Discovery of drugs that target proteins/enzymes in the epigenetic pathways may provide better therapeutic opportunities, and identification of such modulators for DNA methylation, histone modifications, and expression of noncoding RNAs for several cancer types is underway. In this review, we provide a detailed description of recent developments in the field of epigenetics and its impact on personalized medicine to manage cervical cancer. © 2017 S. Karger AG, Basel.

Theranostic barcoded nanoparticles for personalized cancer medicine

PubMed Central

Yaari, Zvi; da Silva, Dana; Zinger, Assaf; Goldman, Evgeniya; Kajal, Ashima; Tshuva, Rafi; Barak, Efrat; Dahan, Nitsan; Hershkovitz, Dov; Goldfeder, Mor; Roitman, Janna Shainsky; Schroeder, Avi

2016-01-01

Personalized medicine promises to revolutionize cancer therapy by matching the most effective treatment to the individual patient. Using a nanoparticle-based system, we predict the therapeutic potency of anticancer medicines in a personalized manner. We carry out the diagnostic stage through a multidrug screen performed inside the tumour, extracting drug activity information with single cell sensitivity. By using 100 nm liposomes, loaded with various cancer drugs and corresponding synthetic DNA barcodes, we find a correlation between the cell viability and the drug it was exposed to, according to the matching barcodes. Based on this screen, we devise a treatment protocol for mice bearing triple-negative breast-cancer tumours, and its results confirm the diagnostic prediction. We show that the use of nanotechnology in cancer care is effective for generating personalized treatment protocols. PMID:27830705

Barriers for integrating personalized medicine into clinical practice: a qualitative analysis.

PubMed

Najafzadeh, Mehdi; Davis, Jennifer C; Joshi, Pamela; Marra, Carlo

2013-04-01

Personalized medicine-tailoring interventions based on individual's genetic information-will likely change routine clinical practice in the future. Yet, how practitioners plan to apply genetic information to inform medical decision making remains unclear. We aimed to investigate physician's perception about the future role of personalized medicine, and to identify the factors that influence their decision in using genetic testing in their practice. We conducted three semi-structured focus groups in three health regions (Fraser, Vancouver coastal, and Interior) in British Columbia, Canada. In the focus groups, participants discussed four topics on personalized medicine: (i) physicians' general understanding, (ii) advantages and disadvantages, (iii) potential impact and role in future clinical practice, and (iv) perceived barriers to integrating personalized medicine into clinical practice. Approximately 36% (n = 9) of physicians self-reported that they were not familiar with the concept of personalized medicine. After introducing the concept, the majority of physicians (68%, n = 19 of 28) were interested in incorporating personalized medicine in their practice, provided they have access to the necessary knowledge and tools. Participants mostly believed that genetic developments will directly affect their practice in the future. The key concerns highlighted were physician's access to clinical guidelines and training opportunities for the use of genetic testing and data interpretation. Despite the challenges that personalized medicine can create, in general, physicians in the focus groups expressed strong interest in using genetic information in their practice if they have access to the necessary knowledge and tools. Copyright © 2013 Wiley Periodicals, Inc.

Novel Applications of Metabolomics in Personalized Medicine: A Mini-Review.

PubMed

Li, Bingbing; He, Xuyun; Jia, Wei; Li, Houkai

2017-07-13

Interindividual variability in drug responses and disease susceptibility is common in the clinic. Currently, personalized medicine is highly valued, the idea being to prescribe the right medicine to the right patient. Metabolomics has been increasingly applied in evaluating the therapeutic outcomes of clinical drugs by correlating the baseline metabolic profiles of patients with their responses, i.e., pharmacometabonomics, as well as prediction of disease susceptibility among population in advance, i.e., patient stratification. The accelerated advance in metabolomics technology pinpoints the huge potential of its application in personalized medicine. In current review, we discussed the novel applications of metabolomics with typical examples in evaluating drug therapy and patient stratification, and underlined the potential of metabolomics in personalized medicine in the future.

The personalized medicine for diabetes meeting summary report.

PubMed

Klonoff, David C

2009-07-01

Personalized medicine for diabetes is a potential method to specifically identify people who are at high risk of developing type 2 diabetes based on a combination of personal history, family history, physical examination, circulating biomarkers, and genome. High-risk individuals can then be referred to lifestyle programs for risk reduction and disease prevention. Using a personalized medicine approach, a patient with already-diagnosed type 2 diabetes can be treated individually based on information specific to that individual. The field of personalized medicine for diabetes is rapidly exploding. Diabetes Technology Society convened the Personalized Medicine for Diabetes (PMFD) Meeting March 19-20, 2009 in San Francisco. The meeting was funded through a contract from the US Air Force. Diabetes experts from the military, government, academic, and industry communities participated. The purpose was to reach a consensus about PMFD in type 2 diabetes to (a) establish screening programs, (b) diagnose cases at an early stage, and (c) monitor and treat the disease with specific measures. The group defined what a PMFD program should encompass, what the benefits and drawbacks of such a PMFD program would be, and how to overcome barriers. The group reached six conclusions related to the power of PMFD to improve care of type 2 diabetes by resulting in (1) better prediction, (2) better prophylactic interventions, (3) better treatments, and (4) decreased cardiovascular disease burden. Additional research is needed to demonstrate the benefits of this approach. The US Air Force is well positioned to conduct research and develop clinical programs in PMFD. Copyright 2009 Diabetes Technology Society.

Personality and Longevity: Knowns, Unknowns, and Implications for Public Health and Personalized Medicine

PubMed Central

Chapman, Benjamin P.; Roberts, Brent; Duberstein, Paul

2011-01-01

We review evidence for links between personality traits and longevity. We provide an overview of personality for health scientists, using the primary organizing framework used in the study of personality and longevity. We then review data on various aspects of personality linked to longevity. In general, there is good evidence that higher level of conscientiousness and lower levels of hostility and Type D or “distressed” personality are associated with greater longevity. Limited evidence suggests that extraversion, openness, perceived control, and low levels of emotional suppression may be associated with longer lifespan. Findings regarding neuroticism are mixed, supporting the notion that many component(s) of neuroticism detract from life expectancy, but some components at some levels may be healthy or protective. Overall, evidence suggests various personality traits are significant predictors of longevity and points to several promising directions for further study. We conclude by discussing the implications of these links for epidemiologic research and personalized medicine and lay out a translational research agenda for integrating the psychology of individual differences into public health and medicine. PMID:21766032

Benefits, issues, and recommendations for personalized medicine in oncology in Canada.

PubMed

Butts, C; Kamel-Reid, S; Batist, G; Chia, S; Blanke, C; Moore, M; Sawyer, M B; Desjardins, C; Dubois, A; Pun, J; Bonter, K; Ashbury, F D

2013-10-01

The burden of cancer for Canadian citizens and society is large. New technologies have the potential to increase the use of genetic information in clinical decision-making, furthering prevention, surveillance, and safer, more effective drug therapies for cancer patients. Personalized medicine can have different meanings to different people. The context for personalized medicine in the present paper is genetic testing, which offers the promise of refining treatment decisions for those diagnosed with chronic and life-threatening illnesses. Personalized medicine and genetic characterization of tumours can also give direction to the development of novel drugs. Genetic testing will increasingly become an essential part of clinical decision-making. In Canada, provinces are responsible for health care, and most have unique policies and programs in place to address cancer control. The result is inconsistency in access to and delivery of therapies and other interventions, beyond the differences expected because of demographic factors and clinical education. Inconsistencies arising from differences in resources, policy, and application of evidence-informed personalized cancer medicine exacerbate patient access to appropriate testing and quality care. Geographic variations in cancer incidence and mortality rates in Canada-with the Atlantic provinces and Quebec having higher rates, and British Columbia having the lowest rates-are well documented. Our purpose here is to provide an understanding of current and future applications of personalized medicine in oncology, to highlight the benefits of personalized medicine for patients, and to describe issues and opportunities for improvement in the coordination of personalized medicine in Canada. Efficient and more rapid adoption of personalized medicine in oncology in Canada could help overcome those issues and improve cancer prevention and care. That task might benefit from the creation of a National Genetics Advisory Panel that

Primary care providers’ experiences with and perceptions of personalized genomic medicine

PubMed Central

Carroll, June C.; Makuwaza, Tutsirai; Manca, Donna P.; Sopcak, Nicolette; Permaul, Joanne A.; O’Brien, Mary Ann; Heisey, Ruth; Eisenhauer, Elizabeth A.; Easley, Julie; Krzyzanowska, Monika K.; Miedema, Baukje; Pruthi, Sandhya; Sawka, Carol; Schneider, Nancy; Sussman, Jonathan; Urquhart, Robin; Versaevel, Catarina; Grunfeld, Eva

2016-01-01

Abstract Objective To assess primary care providers’ (PCPs’) experiences with, perceptions of, and desired role in personalized medicine, with a focus on cancer. Design Qualitative study involving focus groups. Setting Urban and rural interprofessional primary care team practices in Alberta and Ontario. Participants Fifty-one PCPs. Methods Semistructured focus groups were conducted and audiorecorded. Recordings were transcribed and analyzed using techniques informed by grounded theory including coding, interpretations of patterns in the data, and constant comparison. Main findings Five focus groups with the 51 participants were conducted; 2 took place in Alberta and 3 in Ontario. Primary care providers described limited experience with personalized medicine, citing breast cancer and prenatal care as main areas of involvement. They expressed concern over their lack of knowledge, in some circumstances relying on personal experiences to inform their attitudes and practice. Participants anticipated an inevitable role in personalized medicine primarily because patients seek and trust their advice; however, there was underlying concern about the magnitude of information and pace of discovery in this area, particularly in direct-to-consumer personal genomic testing. Increased knowledge, closer ties to genetics specialists, and relevant, reliable personalized medicine resources accessible at the point of care were reported as important for successful implementation of personalized medicine. Conclusion Primary care providers are prepared to discuss personalized medicine, but they require better resources. Models of care that support a more meaningful relationship between PCPs and genetics specialists should be pursued. Continuing education strategies need to address knowledge gaps including direct-to-consumer genetic testing, a relatively new area provoking PCP concern. Primary care providers should be mindful of using personal experiences to guide care. PMID:27737998

Primary care providers' experiences with and perceptions of personalized genomic medicine.

PubMed

Carroll, June C; Makuwaza, Tutsirai; Manca, Donna P; Sopcak, Nicolette; Permaul, Joanne A; O'Brien, Mary Ann; Heisey, Ruth; Eisenhauer, Elizabeth A; Easley, Julie; Krzyzanowska, Monika K; Miedema, Baukje; Pruthi, Sandhya; Sawka, Carol; Schneider, Nancy; Sussman, Jonathan; Urquhart, Robin; Versaevel, Catarina; Grunfeld, Eva

2016-10-01

To assess primary care providers' (PCPs') experiences with, perceptions of, and desired role in personalized medicine, with a focus on cancer. Qualitative study involving focus groups. Urban and rural interprofessional primary care team practices in Alberta and Ontario. Fifty-one PCPs. Semistructured focus groups were conducted and audiorecorded. Recordings were transcribed and analyzed using techniques informed by grounded theory including coding, interpretations of patterns in the data, and constant comparison. Five focus groups with the 51 participants were conducted; 2 took place in Alberta and 3 in Ontario. Primary care providers described limited experience with personalized medicine, citing breast cancer and prenatal care as main areas of involvement. They expressed concern over their lack of knowledge, in some circumstances relying on personal experiences to inform their attitudes and practice. Participants anticipated an inevitable role in personalized medicine primarily because patients seek and trust their advice; however, there was underlying concern about the magnitude of information and pace of discovery in this area, particularly in direct-to-consumer personal genomic testing. Increased knowledge, closer ties to genetics specialists, and relevant, reliable personalized medicine resources accessible at the point of care were reported as important for successful implementation of personalized medicine. Primary care providers are prepared to discuss personalized medicine, but they require better resources. Models of care that support a more meaningful relationship between PCPs and genetics specialists should be pursued. Continuing education strategies need to address knowledge gaps including direct-to-consumer genetic testing, a relatively new area provoking PCP concern. Primary care providers should be mindful of using personal experiences to guide care. Copyright© the College of Family Physicians of Canada.

Clinical Applications of Personalized Medicine: A New Paradigm and Challenge.

PubMed

Di Sanzo, Mariantonia; Cipolloni, Luigi; Borro, Marina; La Russa, Raffaele; Santurro, Alessandro; Scopetti, Matteo; Simmaco, Maurizio; Frati, Paola

2017-01-01

The personalized medicine is an emergent and rapidly developing method of clinical practice that uses new technologies to provide decisions in regard to the prediction, prevention, diagnosis and treatment of disease. A continuous evolution of technology and the developments in molecular diagnostics and genomic analysis increased the possibility of an even more understanding and interpretation of the human genome and exome, allowing a "personalized" approach to clinical care, so that the concepts of "Systems Medicine" and "System Biology" are actually increasing. The purpose of this study is to evaluate the personalized medicine about its indications and benefits, actual clinical applications and future perspectives as well as its issues and health care implications. A careful review of the scientific literature on this field that highlighted the applicability and usefulness of this new medical approach as well as the fact that personalized medicine strategy is even more increasing in numerous fields of applications. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Decision-Making on Medical Innovations in a Changing Healthcare Environment: Insights from Accountable Care Organizations and Payers on Personalized Medicine and Other Technologies

PubMed Central

Trosman, Julia R.; Weldon, Christine B.; Douglas, Michael P.; Deverka, Patricia A.; Watkins, John; Phillips, Kathryn A.

2016-01-01

Background New payment and care organization approaches, such as the Accountable Care Organization (ACO), are reshaping accountability and shifting risk, as well as decision-making, from payers to providers, under the Triple Aim of health reform. The Triple Aim calls for improving experience of care, improving health of populations and reducing healthcare costs. In the era of accelerating scientific advancement of personalized medicine and other innovations, it is critical to understand how the transition to the ACO model impacts decision-making on adoption and utilization of innovative technologies. Methods We interviewed representatives from ten private payers and six provider institutions involved in implementing the ACO model (i.e. ACOs) to understand changes, challenges and facilitators of decision-making on medical innovations, including personalized medicine. We used the framework approach of qualitative research for study design and thematic analysis. Results We found that representatives from the participating payer companies and ACOs perceive similar challenges to ACOs’ decision-making in terms of achieving a balance between the components of the Triple Aim – improving care experience, improving population health and reducing costs. The challenges include the prevalence of cost over care quality considerations in ACOs’ decisions and ACOs’ insufficient analytical and technology assessment capacity to evaluate complex innovations such as personalized medicine. Decision-making facilitators included increased competition across ACOs and patients’ interest in personalized medicine. Conclusions As new payment models evolve, payers, ACOs and other stakeholders should address challenges and leverage opportunities to arm ACOs with robust, consistent, rigorous and transparent approaches to decision-making on medical innovations. PMID:28212967

Personalized RNA Medicine for Pancreatic Cancer.

PubMed

Gilles, Maud-Emmanuelle; Hao, Liangliang; Huang, Ling; Rupaimoole, Rajesha; Lopez-Casas, Pedro P; Pulver, Emilia; Jeong, Jong Cheol; Muthuswamy, Senthil K; Hidalgo, Manuel; Bhatia, Sangeeta N; Slack, Frank J

2018-04-01

Purpose: Since drug responses vary between patients, it is crucial to develop pre-clinical or co-clinical strategies that forecast patient response. In this study, we tested whether RNA-based therapeutics were suitable for personalized medicine by using patient-derived-organoid (PDO) and patient-derived-xenograft (PDX) models. Experimental Design: We performed microRNA (miRNA) profiling of PDX samples to determine the status of miRNA deregulation in individual pancreatic ductal adenocarcinoma (PDAC) patients. To deliver personalized RNA-based-therapy targeting oncogenic miRNAs that form part of this common PDAC miRNA over-expression signature, we packaged antimiR oligonucleotides against one of these miRNAs in tumor-penetrating nanocomplexes (TPN) targeting cell surface proteins on PDAC tumors. Results: As a validation for our pre-clinical strategy, the therapeutic potential of one of our nano-drugs, TPN-21, was first shown to decrease tumor cell growth and survival in PDO avatars for individual patients, then in their PDX avatars. Conclusions: This general approach appears suitable for co-clinical validation of personalized RNA medicine and paves the way to prospectively identify patients with eligible miRNA profiles for personalized RNA-based therapy. Clin Cancer Res; 24(7); 1734-47. ©2018 AACR . ©2018 American Association for Cancer Research.

[The invention of personalized medicine, between technological upheavals and utopia].

PubMed

Billaud, Marc; Guchet, Xavier

2015-01-01

The idea of personalized medicine raises a series of questions. If one considers that the physician takes into account the uniqueness of his patient in the frame of the medical consultation, is the definition of medicine as "personalized" not a pleonasm? If not, why has this ambiguous denomination been adopted? In addition, is this form of medicine a novel discipline capable of revolutionizing therapeutic approaches as claimed in its accompanying discourses or is it in continuity with the molecular conception of biomedicine? Rather than attempting to directly answer these questions, we focused our attention on the organizing concepts, the technological breakthroughs and the transformations in medical practices that characterize this medicine. Following this brief analysis, it appears that the choice of a term as equivocal as personalized medicine and the emphasis on the antagonistic notions of revolution and continuity in medicine are the signs of reshuffling that is emerging between actors in the health care system, in academia and in pharmaceutical companies. © 2015 médecine/sciences – Inserm.

Commitment of mathematicians in medicine: a personal experience, and generalisations.

PubMed

Clairambault, Jean

2011-12-01

I will present here a personal point of view on the commitment of mathematicians in medicine. Starting from my personal experience, I will suggest generalisations including favourable signs and caveats to show how mathematicians can be welcome and helpful in medicine, both in a theoretical and in a practical way.

Personalized medicine and stroke prevention: where are we?

PubMed

Kim, Joosup; Thrift, Amanda G; Nelson, Mark R; Bladin, Christopher F; Cadilhac, Dominique A

2015-01-01

There are many recommended pharmacological and non-pharmacological therapies for the prevention of stroke, and an ongoing challenge is to improve their uptake. Personalized medicine is seen as a possible solution to this challenge. Although the use of genetic information to guide health care could be considered as the apex of personalized medicine, genetics is not yet routinely used to guide prevention of stroke. Currently personalized aspects of prevention of stroke include tailoring interventions based on global risk, the utilization of individualized management plans within a model of organized care, and patient education. In this review we discuss the progress made in these aspects of prevention of stroke and present a case study to illustrate the issues faced by health care providers and patients with stroke that could be overcome with a personalized approach to the prevention of stroke.

Personalized medicine-a modern approach for the diagnosis and management of hypertension.

PubMed

Savoia, Carmine; Volpe, Massimo; Grassi, Guido; Borghi, Claudio; Agabiti Rosei, Enrico; Touyz, Rhian M

2017-11-15

The main goal of treating hypertension is to reduce blood pressure to physiological levels and thereby prevent risk of cardiovascular disease and hypertension-associated target organ damage. Despite reductions in major risk factors and the availability of a plethora of effective antihypertensive drugs, the control of blood pressure to target values is still poor due to multiple factors including apparent drug resistance and lack of adherence. An explanation for this problem is related to the current reductionist and 'trial-and-error' approach in the management of hypertension, as we may oversimplify the complex nature of the disease and not pay enough attention to the heterogeneity of the pathophysiology and clinical presentation of the disorder. Taking into account specific risk factors, genetic phenotype, pharmacokinetic characteristics, and other particular features unique to each patient, would allow a personalized approach to managing the disease. Personalized medicine therefore represents the tailoring of medical approach and treatment to the individual characteristics of each patient and is expected to become the paradigm of future healthcare. The advancement of systems biology research and the rapid development of high-throughput technologies, as well as the characterization of different -omics, have contributed to a shift in modern biological and medical research from traditional hypothesis-driven designs toward data-driven studies and have facilitated the evolution of personalized or precision medicine for chronic diseases such as hypertension. © 2017 The Author(s). Published by Portland Press Limited on behalf of the Biochemical Society.

Molecular Dynamics: New Frontier in Personalized Medicine.

PubMed

Sneha, P; Doss, C George Priya

2016-01-01

The field of drug discovery has witnessed infinite development over the last decade with the demand for discovery of novel efficient lead compounds. Although the development of novel compounds in this field has seen large failure, a breakthrough in this area might be the establishment of personalized medicine. The trend of personalized medicine has shown stupendous growth being a hot topic after the successful completion of Human Genome Project and 1000 genomes pilot project. Genomic variant such as SNPs play a vital role with respect to inter individual's disease susceptibility and drug response. Hence, identification of such genetic variants has to be performed before administration of a drug. This process requires high-end techniques to understand the complexity of the molecules which might bring an insight to understand the compounds at their molecular level. To sustenance this, field of bioinformatics plays a crucial role in revealing the molecular mechanism of the mutation and thereby designing a drug for an individual in fast and affordable manner. High-end computational methods, such as molecular dynamics (MD) simulation has proved to be a constitutive approach to detecting the minor changes associated with an SNP for better understanding of the structural and functional relationship. The parameters used in molecular dynamic simulation elucidate different properties of a macromolecule, such as protein stability and flexibility. MD along with docking analysis can reveal the synergetic effect of an SNP in protein-ligand interaction and provides a foundation for designing a particular drug molecule for an individual. This compelling application of computational power and the advent of other technologies have paved a promising way toward personalized medicine. In this in-depth review, we tried to highlight the different wings of MD toward personalized medicine. © 2016 Elsevier Inc. All rights reserved.

Personalized Medicine in a New Genomic Era: Ethical and Legal Aspects.

PubMed

Shoaib, Maria; Rameez, Mansoor Ali Merchant; Hussain, Syed Ather; Madadin, Mohammed; Menezes, Ritesh G

2017-08-01

The genome of two completely unrelated individuals is quite similar apart from minor variations called single nucleotide polymorphisms which contribute to the uniqueness of each and every person. These single nucleotide polymorphisms are of great interest clinically as they are useful in figuring out the susceptibility of certain individuals to particular diseases and for recognizing varied responses to pharmacological interventions. This gives rise to the idea of 'personalized medicine' as an exciting new therapeutic science in this genomic era. Personalized medicine suggests a unique treatment strategy based on an individual's genetic make-up. Its key principles revolve around applied pharmaco-genomics, pharmaco-kinetics and pharmaco-proteomics. Herein, the ethical and legal aspects of personalized medicine in a new genomic era are briefly addressed. The ultimate goal is to comprehensively recognize all relevant forms of genetic variation in each individual and be able to interpret this information in a clinically meaningful manner within the ambit of ethical and legal considerations. The authors of this article firmly believe that personalized medicine has the potential to revolutionize the current landscape of medicine as it makes its way into clinical practice.

From big data analysis to personalized medicine for all: challenges and opportunities.

PubMed

Alyass, Akram; Turcotte, Michelle; Meyre, David

2015-06-27

Recent advances in high-throughput technologies have led to the emergence of systems biology as a holistic science to achieve more precise modeling of complex diseases. Many predict the emergence of personalized medicine in the near future. We are, however, moving from two-tiered health systems to a two-tiered personalized medicine. Omics facilities are restricted to affluent regions, and personalized medicine is likely to widen the growing gap in health systems between high and low-income countries. This is mirrored by an increasing lag between our ability to generate and analyze big data. Several bottlenecks slow-down the transition from conventional to personalized medicine: generation of cost-effective high-throughput data; hybrid education and multidisciplinary teams; data storage and processing; data integration and interpretation; and individual and global economic relevance. This review provides an update of important developments in the analysis of big data and forward strategies to accelerate the global transition to personalized medicine.

Personalized medicine in thrombosis: back to the future

PubMed Central

Nagalla, Srikanth

2016-01-01

Most physicians believe they practiced personalized medicine prior to the genomics era that followed the sequencing of the human genome. The focus of personalized medicine has been primarily genomic medicine, wherein it is hoped that the nucleotide dissimilarities among different individuals would provide clinicians with more precise understanding of physiology, more refined diagnoses, better disease risk assessment, earlier detection and monitoring, and tailored treatments to the individual patient. However, to date, the “genomic bench” has not worked itself to the clinical thrombosis bedside. In fact, traditional plasma-based hemostasis-thrombosis laboratory testing, by assessing functional pathways of coagulation, may better help manage venous thrombotic disease than a single DNA variant with a small effect size. There are some new and exciting discoveries in the genetics of platelet reactivity pertaining to atherothrombotic disease. Despite a plethora of genetic/genomic data on platelet reactivity, there are relatively little actionable pharmacogenetic data with antiplatelet agents. Nevertheless, it is crucial for genome-wide DNA/RNA sequencing to continue in research settings for causal gene discovery, pharmacogenetic purposes, and gene-gene and gene-environment interactions. The potential of genomics to advance medicine will require integration of personal data that are obtained in the patient history: environmental exposures, diet, social data, etc. Furthermore, without the ritual of obtaining this information, we will have depersonalized medicine, which lacks the precision needed for the research required to eventually incorporate genomics into routine, optimal, and value-added clinical care. PMID:26847245

A Synopsis of Personalized Medicine Projects Within the United States Air Force

DTIC Science & Technology

2017-06-16

MDW/SGVU SUBJECT: Professional Presentation Approval 17 MAY 2017 1. Your paper, entitled A Synopsis of Personalized Medicine Projects within the...3039 must be submitted for review and approval.) 6. TITLE OF MA TE RIAL TO BE PUBLISHED OR PRESENTED: A SYNOPSIS OF PERSONALIZED MEDICINE PROJECTS ...PERSONALIZED MEDICINE PROJECTS WITHIN THE UNITED STATES AIR FORCE Sandra Valtier, Ph.D., G. Jilani Chaudry, Ph.D., Lisa Lott, Ph.D., Manuel Caballero

The faces of personalized medicine: a framework for understanding its meaning and scope.

PubMed

Redekop, W Ken; Mladsi, Deirdre

2013-01-01

The objective of this article was to provide a framework for understanding the different definitions of the term "personalized medicine." The term personalized medicine is used regularly but interpreted in different ways. This article approaches the term by starting with a broad view of clinical medicine, where three components can be distinguished: the questions (e.g., what is the diagnosis?), the methods used to answer them (e.g., a test), and the available actions (e.g., to give or not give a particular drug). Existing definitions of personalized medicine disagree about which questions, methods, and actions fall within its domain. Some define the term narrowly, referring to the use of a diagnostic test to predict drug response, thereby clarifying whether or not a patient will benefit from that drug. An example of this combination is the HER2/neu test to predict the effectiveness of trastuzumab in breast cancer. Many who adopt this definition associate the concept of personalized medicine with fields such as genetics, genomics, and other types of "-omics." In contrast, others view personalized medicine as a concept that has always existed, because medicine has always considered the needs of the individual. One definition of personalized medicine that accommodates both interpretations is "the use of combined knowledge (genetic or otherwise) about a person to predict disease susceptibility, disease prognosis, or treatment response and thereby improve that person's health." This predictive ability can increase over time through innovations in various technologies, resulting in further improvements in health outcomes. Moreover, these developments can lead to a better understanding of the underlying causes of disease, which can eventually lead to breakthroughs in the treatment of individual patients. In that sense, a truly personalized form of medicine can also be seen as an ideal, a goal that will be achieved only after multiple advances in science. Although the term

'Personalized medicine': what's in a name?

PubMed

Pokorska-Bocci, Anna; Stewart, Alison; Sagoo, Gurdeep S; Hall, Alison; Kroese, Mark; Burton, Hilary

2014-03-01

Over the last decade genomics and other molecular biosciences have enabled new capabilities that, according to many, have the potential to revolutionize medicine and healthcare. These developments have been associated with a range of terminologies, including 'precision', 'personalized', 'individualized' and 'stratified' medicine. In this article, based on a literature review, we examine how the terms have arisen and their various meanings and definitions. We discuss the impact of the new technologies on disease classification, prevention and management. We suggest that although genomics and molecular biosciences will undoubtedly greatly enhance the power of medicine, they will not lead to a conceptually new paradigm of medical care. What is new is the portfolio of modern tools that medicine and healthcare can use for better targeted approaches to health and disease management, and the sociopolitical contexts within which these tools are applied.

Personalized Herbal Medicine? A Roadmap for Convergence of Herbal and Precision Medicine Biomarker Innovations.

PubMed

Thomford, Nicholas Ekow; Dzobo, Kevin; Chimusa, Emile; Andrae-Marobela, Kerstin; Chirikure, Shadreck; Wonkam, Ambroise; Dandara, Collet

2018-06-01

While drugs remain the cornerstone of medicine, herbal medicine is an important comedication worldwide. Thus, precision medicine ought to face this clinical reality and develop "companion diagnostics" for drugs as well as herbal medicines. Yet, many are in denial with respect to the extent of use of traditional/herbal medicines, overlooking that a considerable number of contemporary therapeutic drugs trace their discovery from herbal medicines. This expert review underscores that absent such appropriate attention on both classical drug therapy and herbal medicines, precision medicine biomarkers will likely not stand the full test of clinical practice while patients continue to use both drugs and herbal medicines and, yet the biomarker research and applications focus only (or mostly) on drug therapy. This asymmetry in biomarker innovation strategy needs urgent attention from a wide range of innovation actors worldwide, including governments, research funders, scientists, community leaders, civil society organizations, herbal, pharmaceutical, and insurance industries, policymakers, and social/political scientists. We discuss the various dimensions of a future convergence map between herbal and conventional medicine, and conclude with a set of concrete strategies on how best to integrate biomarker research in a realm of both herbal and drug treatment. Africa, by virtue of its vast experience and exposure in herbal medicine and a "pregnant" life sciences innovation ecosystem, could play a game-changing role for the "birth" of biomarker-informed personalized herbal medicine in the near future. At this critical juncture when precision medicine initiatives are being rolled out worldwide, precision/personalized herbal medicine is both timely and essential for modern therapeutics, not to mention biomarker innovations that stand the test of real-life practices and implementation in the clinic and society.

Scientific-practical and legal problems of implementation of the personalized medicine.

PubMed

Bezdieniezhnykh, N O; Reznikova, V V; Rossylna, O V

2017-09-01

The article is devoted to the comprehensive analysis of scientific, practical and legal issues of personalized medicine that is a rapidly developing science-driven approach to healthcare. It is concluded that there is lack of general legal framework for the encouragement of scientific researches and practical implementation in this field. The article shows foreign experience and prospects for the introduction of personalized medicine as a key concept of healthcare system, which is based on a selection of diagnostic, therapeutic and preventive measures that would be the most effective for a particular person in view of individual characteristics. The conclusions and proposals to improve the current legislation and development of personalized medicine in Ukraine are suggested.

Person-Centered Planning: Strategies to Encourage Participation and Facilitate Communication

ERIC Educational Resources Information Center

Wells, Jenny C.; Sheehey, Patricia H.

2012-01-01

Person-centered planning is a process that allows individuals, family members, and friends an opportunity to share information to develop a personal profile and a future vision for an individual. This article describes strategies and technology that teachers can use to promote parents' participation and facilitate communication while maintaining…

Where Personalized Medicine, Patient Engagement, and Primary Care Collide.

PubMed

Bell, Megan

2017-01-01

Personalized medicine and patient engagement have become common buzzwords in the context of health care reform. Independently both concepts have showed some promise in impacting health outcomes, but when synergistically applied, they have more power, as both are critical pieces of personalized health care (PHC). PHC is a health care model that embraces the need for patient engagement along with personalized medicine technologies to make the health care process more personalized, patient-driven, and proactive. Primary care presents an ideal setting for the application of PHC through the use of patient engagement techniques such as patient portals, patient-generated health data, and self-management programs, with the goal of supporting a preventative proactive health care approach. Copyright© South Dakota State Medical Association.

Personal and professional profile of mountain medicine physicians.

PubMed

Peters, Patrick

2003-01-01

The purpose of this study was to define and describe the personal and professional profile of mountain medicine physicians including general physical training information and to include a detailed overview of the practice of mountain sports. A group of physicians participating in a specialized mountain medicine education program filled out a standardized questionnaire. The data obtained from this questionnaire were first analyzed in a descriptive way and then by statistical methods (chi2 test, t test, and analysis of variance). Detailed results have been provided for gender, age, marital status, general training frequency and methods, professional status, additional medical qualifications, memberships in professional societies and alpine clubs, mountain sports practice, and injuries sustained during the practice of mountain sports. This study has provided a detailed overview concerning the personal and professional profile of mountain medicine physicians. Course organizers as well as official commissions regulating the education in mountain medicine will be able to use this information to adapt and optimize the courses and the recommendations/requirements as detailed by the UIAA-ICAR-ISMM (Union Internationale des Associations Alpinistes, International Commission for Alpine Rescue, International Society for Mountain Medicine).

Personalized or Precision Medicine? The Example of Cystic Fibrosis

PubMed Central

Marson, Fernando A. L.; Bertuzzo, Carmen S.; Ribeiro, José D.

2017-01-01

The advent of the knowledge on human genetics, by the identification of disease-associated variants, culminated in the understanding of human variability. With the genetic knowledge, the specificity of the clinical phenotype and the drug response of each individual were understood. Using the cystic fibrosis (CF) as an example, the new terms that emerged such as personalized medicine and precision medicine can be characterized. The genetic knowledge in CF is broad and the presence of a monogenic disease caused by mutations in the CFTR gene enables the phenotype–genotype association studies (including the response to drugs), considering the wide clinical and laboratory spectrum dependent on the mutual action of genotype, environment, and lifestyle. Regarding the CF disease, personalized medicine is the treatment directed at the symptoms, and this treatment is adjusted depending on the patient’s phenotype. However, more recently, the term precision medicine began to be widely used, although its correct application and understanding are still vague and poorly characterized. In precision medicine, we understand the individual as a response to the interrelation between environment, lifestyle, and genetic factors, which enabled the advent of new therapeutic models, such as conventional drugs adjustment by individual patient dosage and drug type and response, development of new drugs (read through, broker, enhancer, stabilizer, and amplifier compounds), genome editing by homologous recombination, zinc finger nucleases, TALEN (transcription activator-like effector nuclease), CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats-CRISPR-associated endonuclease 9), and gene therapy. Thus, we introduced the terms personalized medicine and precision medicine based on the CF. PMID:28676762

Translational research of optical molecular imaging for personalized medicine.

PubMed

Qin, C; Ma, X; Tian, J

2013-12-01

In the medical imaging field, molecular imaging is a rapidly developing discipline and forms many imaging modalities, providing us effective tools to visualize, characterize, and measure molecular and cellular mechanisms in complex biological processes of living organisms, which can deepen our understanding of biology and accelerate preclinical research including cancer study and medicine discovery. Among many molecular imaging modalities, although the penetration depth of optical imaging and the approved optical probes used for clinics are limited, it has evolved considerably and has seen spectacular advances in basic biomedical research and new drug development. With the completion of human genome sequencing and the emergence of personalized medicine, the specific drug should be matched to not only the right disease but also to the right person, and optical molecular imaging should serve as a strong adjunct to develop personalized medicine by finding the optimal drug based on an individual's proteome and genome. In this process, the computational methodology and imaging system as well as the biomedical application regarding optical molecular imaging will play a crucial role. This review will focus on recent typical translational studies of optical molecular imaging for personalized medicine followed by a concise introduction. Finally, the current challenges and the future development of optical molecular imaging are given according to the understanding of the authors, and the review is then concluded.

An interdisciplinary approach to personalized medicine: case studies from a cardiogenetics clinic.

PubMed

Erskine, Kathleen E; Griffith, Eleanor; Degroat, Nicole; Stolerman, Marina; Silverstein, Louise B; Hidayatallah, Nadia; Wasserman, David; Paljevic, Esma; Cohen, Lilian; Walsh, Christine A; McDonald, Thomas; Marion, Robert W; Dolan, Siobhan M

2013-01-01

In the genomic age, the challenges presented by various inherited conditions present a compelling argument for an interdisciplinary model of care. Cardiac arrhythmias with a genetic basis, such as long QT syndrome, require clinicians with expertise in many specialties to address the complex genetic, psychological, ethical and medical issues involved in treatment. The Montefiore-Einstein Center for CardioGenetics has been established to provide personalized, interdisciplinary care for families with a history of sudden cardiac death or an acute cardiac event. Four vignettes of patient care are presented to illustrate the unique capacity of an interdisciplinary model to address genetic, psychological, ethical and medical issues. Because interdisciplinary clinics facilitate collaboration among multiple specialties, they allow for individualized, comprehensive care to be delivered to families who experience complex inherited medical conditions. As the genetic basis of many complex conditions is discovered, the advantages of an interdisciplinary approach for delivering personalized medicine will become more evident.

Pharmacogenetics: A strategy for personalized medicine for autoimmune diseases.

PubMed

Tavakolpour, S; Darvishi, M; Ghasemiadl, M

2018-03-01

For many years, a considerable number of patients with autoimmune diseases (ADs) have suffered from a lack of drug response and drug-related toxicity. Despite the emergence of new therapeutic options such as biological agents, patients continue to struggle with these problems. Unfortunately, new challenges, including the paradoxical effects of biological drugs, have complicated the situation. In recent decades, efforts have been made to predict drug response as well as drug-related side effects. Thanks to the many advances in genetics, evaluation of markers to predict drug response/toxicity before the initiation of treatment may be an avenue toward personalizing treatments. Implementing pharmacogenetics and pharmacogenomics in the clinic could improve clinical care; however, obstacles remain to effective personalized medicine for ADs. The present study attempted to clarify the concept of pharmacogenetics/pharmacogenomics for ADs. After an overview on the pathogenesis of the most common types of treatments, this paper focuses on pharmacogenetic studies related to the selected ADs. Bridging the gap between pharmacogenetics and personalized medicine is also discussed. Moreover, the advantages, disadvantages and recommendations related to making personalized medicine practical for ADs have been addressed. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Personalized medicine, genomics, and pharmacogenomics: a primer for nurses.

PubMed

Blix, Andrew

2014-08-01

Personalized medicine is the study of patients' unique environmental influences as well as the totality of their genetic code-their genome-to tailor personalized risk assessments, diagnoses, prognoses, and treatments. The study of how patients' genomes affect responses to medications, or pharmacogenomics, is a related field. Personalized medicine and genomics are particularly relevant in oncology because of the genetic basis of cancer. Nurses need to understand related issues such as the role of genetic and genomic counseling, the ethical and legal questions surrounding genomics, and the growing direct-to-consumer genomics industry. As genomics research is incorporated into health care, nurses need to understand the technology to provide advocacy and education for patients and their families.

Decision Making on Medical Innovations in a Changing Health Care Environment: Insights from Accountable Care Organizations and Payers on Personalized Medicine and Other Technologies.

PubMed

Trosman, Julia R; Weldon, Christine B; Douglas, Michael P; Deverka, Patricia A; Watkins, John B; Phillips, Kathryn A

2017-01-01

New payment and care organization approaches, such as those of accountable care organizations (ACOs), are reshaping accountability and shifting risk, as well as decision making, from payers to providers, within the Triple Aim context of health reform. The Triple Aim calls for improving experience of care, improving health of populations, and reducing health care costs. To understand how the transition to the ACO model impacts decision making on adoption and use of innovative technologies in the era of accelerating scientific advancement of personalized medicine and other innovations. We interviewed representatives from 10 private payers and 6 provider institutions involved in implementing the ACO model (i.e., ACOs) to understand changes, challenges, and facilitators of decision making on medical innovations, including personalized medicine. We used the framework approach of qualitative research for study design and thematic analysis. We found that representatives from the participating payer companies and ACOs perceive similar challenges to ACOs' decision making in terms of achieving a balance between the components of the Triple Aim-improving care experience, improving population health, and reducing costs. The challenges include the prevalence of cost over care quality considerations in ACOs' decisions and ACOs' insufficient analytical and technology assessment capacity to evaluate complex innovations such as personalized medicine. Decision-making facilitators included increased competition across ACOs and patients' interest in personalized medicine. As new payment models evolve, payers, ACOs, and other stakeholders should address challenges and leverage opportunities to arm ACOs with robust, consistent, rigorous, and transparent approaches to decision making on medical innovations. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

MicroRNA polymorphisms: a giant leap towards personalized medicine

PubMed Central

Mishra, Prasun J

2010-01-01

“An individual’s genetic inheritance of microRNA polymorphisms associated with disease progression, prognosis and treatment holds the key to create safer and more personalized drugs and can be a giant leap towards personalized medicine.” PMID:20428464

Conceptual and Analytical Considerations toward the Use of Patient-Reported Outcomes in Personalized Medicine.

PubMed

Alemayehu, Demissie; Cappelleri, Joseph C

2012-07-01

Patient-reported outcomes (PROs) can play an important role in personalized medicine. PROs can be viewed as an important fundamental tool to measure the extent of disease and the effect of treatment at the individual level, because they reflect the self-reported health state of the patient directly. However, their effective integration in personalized medicine requires addressing certain conceptual and methodological challenges, including instrument development and analytical issues. To evaluate methodological issues, such as multiple comparisons, missing data, and modeling approaches, associated with the analysis of data related to PRO and personalized medicine to further our understanding on the role of PRO data in personalized medicine. There is a growing recognition of the role of PROs in medical research, but their potential use in customizing healthcare is not widely appreciated. Emerging insights into the genetic basis of PROs could potentially lead to new pathways that may improve patient care. Knowledge of the biologic pathways through which the various genetic predispositions propel people toward negative or away from positive health experiences may ultimately transform healthcare. Understanding and addressing the conceptual and methodological issues in PROs and personalized medicine are expected to enhance the emerging area of personalized medicine and to improve patient care. This article addresses relevant concerns that need to be considered for effective integration of PROs in personalized medicine, with particular reference to conceptual and analytical issues that routinely arise with personalized medicine and PRO data. Some of these issues, including multiplicity problems, handling of missing values-and modeling approaches, are common to both areas. It is hoped that this article will help to stimulate further research to advance our understanding of the role of PRO data in personalized medicine. A robust conceptual framework to incorporate PROs into

Deep brain stimulation, brain maps and personalized medicine: lessons from the human genome project.

PubMed

Fins, Joseph J; Shapiro, Zachary E

2014-01-01

Although the appellation of personalized medicine is generally attributed to advanced therapeutics in molecular medicine, deep brain stimulation (DBS) can also be so categorized. Like its medical counterpart, DBS is a highly personalized intervention that needs to be tailored to a patient's individual anatomy. And because of this, DBS like more conventional personalized medicine, can be highly specific where the object of care is an N = 1. But that is where the similarities end. Besides their differing medical and surgical provenances, these two varieties of personalized medicine have had strikingly different impacts. The molecular variant, though of a more recent vintage has thrived and is experiencing explosive growth, while DBS still struggles to find a sustainable therapeutic niche. Despite its promise, and success as a vetted treatment for drug resistant Parkinson's Disease, DBS has lagged in broadening its development, often encountering regulatory hurdles and financial barriers necessary to mount an adequate number of quality trials. In this paper we will consider why DBS-or better yet neuromodulation-has encountered these challenges and contrast this experience with the more successful advance of personalized medicine. We will suggest that personalized medicine and DBS's differential performance can be explained as a matter of timing and complexity. We believe that DBS has struggled because it has been a journey of scientific exploration conducted without a map. In contrast to molecular personalized medicine which followed the mapping of the human genome and the Human Genome Project, DBS preceded plans for the mapping of the human brain. We believe that this sequence has given personalized medicine a distinct advantage and that the fullest potential of DBS will be realized both as a cartographical or electrophysiological probe and as a modality of personalized medicine.

Gene expression analysis in RA: towards personalized medicine

PubMed Central

Burska, A N; Roget, K; Blits, M; Soto Gomez, L; van de Loo, F; Hazelwood, L D; Verweij, C L; Rowe, A; Goulielmos, G N; van Baarsen, L G M; Ponchel, F

2014-01-01

Gene expression has recently been at the forefront of advance in personalized medicine, notably in the field of cancer and transplantation, providing a rational for a similar approach in rheumatoid arthritis (RA). RA is a prototypic inflammatory autoimmune disease with a poorly understood etiopathogenesis. Inflammation is the main feature of RA; however, many biological processes are involved at different stages of the disease. Gene expression signatures offer management tools to meet the current needs for personalization of RA patient's care. This review analyses currently available information with respect to RA diagnostic, prognostic and prediction of response to therapy with a view to highlight the abundance of data, whose comparison is often inconclusive due to the mixed use of material source, experimental methodologies and analysis tools, reinforcing the need for harmonization if gene expression signatures are to become a useful clinical tool in personalized medicine for RA patients. PMID:24589910

Challenges in the development and reimbursement of personalized medicine-payer and manufacturer perspectives and implications for health economics and outcomes research: a report of the ISPOR personalized medicine special interest group.

PubMed

Faulkner, Eric; Annemans, Lieven; Garrison, Lou; Helfand, Mark; Holtorf, Anke-Peggy; Hornberger, John; Hughes, Dyfrig; Li, Tracy; Malone, Daniel; Payne, Katherine; Siebert, Uwe; Towse, Adrian; Veenstra, David; Watkins, John

2012-12-01

Personalized medicine technologies can improve individual health by delivering the right dose of the right drug to the right patient at the right time but create challenges in deciding which technologies offer sufficient value to justify widespread diffusion. Personalized medicine technologies, however, do not neatly fit into existing health technology assessment and reimbursement processes. In this article, the Personalized Medicine Special Interest Group of the International Society for Pharmacoeconomics and Outcomes Research evaluated key development and reimbursement considerations from the payer and manufacturer perspectives. Five key areas in which health economics and outcomes research best practices could be developed to improve value assessment, reimbursement, and patient access decisions for personalized medicine have been identified. These areas are as follows: 1 research prioritization and early value assessment, 2 best practices for clinical evidence development, 3 best practices for health economic assessment, 4 addressing health technology assessment challenges, and 5 new incentive and reimbursement approaches for personalized medicine. Key gaps in health economics and outcomes research best practices, decision standards, and value assessment processes are also discussed, along with next steps for evolving health economics and outcomes research practices in personalized medicine. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Nursing implications of personalized and precision medicine.

PubMed

Vorderstrasse, Allison A; Hammer, Marilyn J; Dungan, Jennifer R

2014-05-01

Identify and discuss the nursing implications of personalized and precision oncology care. PubMed, CINAHL. The implications in personalized and precision cancer nursing care include interpretation and clinical use of novel and personalized information including genetic testing; patient advocacy and support throughout testing, anticipation of results and treatment; ongoing chronic monitoring; and support for patient decision-making. Attention must also be given to the family and ethical implications of a personalized approach to care. Nurses face increasing challenges and opportunities in communication, support, and advocacy for patients given the availability of advanced testing, care and treatment in personalized and precision medicine. Nursing education and continuing education, clinical decision support, and health systems changes will be necessary to provide personalized multidisciplinary care to patients, in which nurses play a key role. Copyright © 2014 Elsevier Inc. All rights reserved.

Medical student preparedness for an era of personalized medicine: findings from one US medical school.

PubMed

Eden, Caroline; Johnson, Kipp W; Gottesman, Omri; Bottinger, Erwin P; Abul-Husn, Noura S

2016-03-01

The objective of this research was to assess medical student preparedness for the use of personalized medicine. A survey instrument measuring attitude toward personalized medicine, perceived knowledge of genomic testing concepts and perceived ability to apply genomics to clinical care was distributed to students in medical school (MS) years 1-4. Of 212 participants, 79% felt that it was important to learn about personalized medicine, but only 6% thought that their medical education had adequately prepared them to practice personalized medicine. Attitude did not vary across years; knowledge and ability increased after MS1, but not after MS2. While medical students support the use of personalized medicine, they do not feel prepared to apply genomics to clinical care.

Personalized Medicine and Infectious Disease Management.

PubMed

Jensen, Slade O; van Hal, Sebastiaan J

2017-11-01

A recent study identified pathogen factors associated with an increased mortality risk in Staphylococcus aureus bacteremia, using predictive modelling and a combination of genotypic, phenotypic, and clinical data. This study conceptually validates the benefit of personalized medicine and highlights the potential use of whole genome sequencing in infectious disease management. Copyright © 2017 Elsevier Ltd. All rights reserved.

What can family medicine practices do to facilitate knowledge management?

PubMed

Orzano, A John; Ohman-Strickland, Pamela A; Patel, Meghal

2008-01-01

Family medicine practices face increasing demands to enhance efficiency and quality of care. Current solutions propose major practice redesign and investment in sophisticated technology. Knowledge management (KM) is a process that increases the capacity of a practice to deliver effective care by finding and sharing information and knowledge among practice members or by developing new knowledge for use by the practice. Our preliminary research in family medicine practices has suggested improved patient outcomes with greater and more effective KM. Research in other organizational settings has suggested that KM can be facilitated by certain organizational characteristics. To identify those organizational characteristics within a family medicine practice that management can effect to enhance KM. We performed a cross-sectional secondary analysis of second-year data from 13 community family medicine practices participating in a practice improvement project. Practice KM, leaderships' promotion of participatory decision making, existence of activities supportive of human resource processes, and effective communication were derived from clinician's, nurses', and staff's responses to a survey eliciting responses on practice organizational characteristics. Hierarchical linear modeling examined relationships between individual practice members' perception of KM and organizational characteristics of the practice, controlling for practice covariates (solo-group, electronic medical record use, and perception of a chaotic practice environment) and staff-level covariates (gender, age, and role). Practices with greater participatory decision making and human resources' processes and effective communication significantly (p < .019, p < .0001, and p < .004) increased odds of reporting satisfactory KM (odds ratio = 2.48, 95% confidence interval = 1.32-4.65; odds ratio = 10.84, 95% confidence interval = 4.04-29.12; and odds ratio = 4.95, 95% confidence interval = 2.02-12.16). The sizes

Blood transcriptomics and metabolomics for personalized medicine.

PubMed

Li, Shuzhao; Todor, Andrei; Luo, Ruiyan

2016-01-01

Molecular analysis of blood samples is pivotal to clinical diagnosis and has been intensively investigated since the rise of systems biology. Recent developments have opened new opportunities to utilize transcriptomics and metabolomics for personalized and precision medicine. Efforts from human immunology have infused into this area exquisite characterizations of subpopulations of blood cells. It is now possible to infer from blood transcriptomics, with fine accuracy, the contribution of immune activation and of cell subpopulations. In parallel, high-resolution mass spectrometry has brought revolutionary analytical capability, detecting > 10,000 metabolites, together with environmental exposure, dietary intake, microbial activity, and pharmaceutical drugs. Thus, the re-examination of blood chemicals by metabolomics is in order. Transcriptomics and metabolomics can be integrated to provide a more comprehensive understanding of the human biological states. We will review these new data and methods and discuss how they can contribute to personalized medicine.

Medical student preparedness for an era of personalized medicine: findings from one US medical school

PubMed Central

Eden, Caroline; Johnson, Kipp W; Gottesman, Omri; Bottinger, Erwin P; Abul-Husn, Noura S

2016-01-01

Aim The objective of this research was to assess medical student preparedness for the use of personalized medicine. Materials & methods A survey instrument measuring attitude toward personalized medicine, perceived knowledge of genomic testing concepts and perceived ability to apply genomics to clinical care was distributed to students in medical school (MS) years 1–4. Results Of 212 participants, 79% felt that it was important to learn about personalized medicine, but only 6% thought that their medical education had adequately prepared them to practice personalized medicine. Attitude did not vary across years; knowledge and ability increased after MS1, but not after MS2. Conclusion While medical students support the use of personalized medicine, they do not feel prepared to apply genomics to clinical care. PMID:27528879

Psychiatry and Emergency Medicine: Medical Student and Physician Attitudes toward Homeless Persons

ERIC Educational Resources Information Center

Morrison, Ann; Roman, Brenda; Borges, Nicole

2012-01-01

Objective: The purpose of the study was to explore changes in medical students' attitudes toward homeless persons during the Psychiatry and Emergency Medicine clerkships. Simultaneously, this study explored attitudes toward homeless persons held by Psychiatry and Emergency Medicine residents and faculty in an attempt to uncover the "hidden…

ePatient Conference Explores Future of Personalized Medicine | NIH MedlinePlus the Magazine

MedlinePlus

... Javascript on. ePatient Conference Explores Future of Personalized Medicine Past Issues / Spring - Summer 2010 Table of Contents ... better in the digital future? What is personalized medicine? Some of the nation's top health researchers, computer ...

Path to Personalized Medicine for Type 2 Diabetes Mellitus: Reality and Hope.

PubMed

Aghaei Meybodi, Hamid Reza; Hasanzad, Mandana; Larijani, Bagher

2017-03-01

Type 2 diabetes mellitus (T2DM) is recognized as a public health problem and increasingly prevalent illness. Key elements of the guideline for diabetes care are based on evidence-based medicine approach and apply for population, not individuals. However, individualized care can improve diabetes management. Personalized medicine is otherwise called precision medicine tries to find better prediction, prevention, and intervention for T2DM individuals. Precision medicine in diabetes refers to the utility of genomics data of a patient with diabetes to provide the most effective diagnosis strategies and treatment plans. Over 100 genetic loci influence susceptibility to T2DM. Genomics data together with the potential of other "Omics" and clinical evidence-based data will lead to diabetes care improvement in the context of personalized medicine in the near future. Breakthrough of technologies enables much greater improvements in the understanding of individual variations that may alter the T2DM outcome. This article represents a comprehensive review of current knowledge on the impact of personalized medicine in T2DM.

Towards personalized medicine for patients with autoimmune diseases: Opportunities and challenges.

PubMed

Tavakolpour, Soheil

2017-10-01

There is generally no cure for autoimmune disorders, but the symptoms can be managed. Currently available drugs/treatments are more potent than those in the past decades. However, finding the right drug and right patients has remained a serious problem. We should revise our diagnosis criteria to more accurate ones. During the recent years, personalized medicine has attracted much attention. However, it needs to be well-explained for autoimmune diseases. Personalized medicine aims to find the most optimum drugs for a patient. Hence, recognizing the drugs based on genetics and molecular profile of patients, needs a comprehensive protocol. This study attempted to discuss the most practical and effective ways for identifying right patient and right drug. Patients should be divided into subpopulations. According to the last diagnosis criteria and therapeutic options, it was attempted to highlight the gaps or contradictions in current understanding and suggest what the future of research in this area may hold. Various factors could be considered, including genes variants, genes expression, epigenetic alterations, immune responses, and also basic and obvious characteristics (sex, age, ethnic, etc.). Moreover, advantages, disadvantages, obstacles, and opportunities during the personalized medicine for autoimmune diseases have been discussed in great detail. Finally, creation of a global library that covers all the aspects of personalized medicines for different types of autoimmune disease was suggested. In conclusion, revising diagnosis and treatments of autoimmune diseases toward personalized medicine could be the revolutionary step for having more effective and safer therapeutic options. Copyright © 2017 European Federation of Immunological Societies. Published by Elsevier B.V. All rights reserved.

Systems cancer medicine: towards realization of predictive, preventive, personalized and participatory (P4) medicine.

PubMed

Tian, Q; Price, N D; Hood, L

2012-02-01

A grand challenge impeding optimal treatment outcomes for patients with cancer arises from the complex nature of the disease: the cellular heterogeneity, the myriad of dysfunctional molecular and genetic networks as results of genetic (somatic) and environmental perturbations. Systems biology, with its holistic approach to understanding fundamental principles in biology, and the empowering technologies in genomics, proteomics, single-cell analysis, microfluidics and computational strategies, enables a comprehensive approach to medicine, which strives to unveil the pathogenic mechanisms of diseases, identify disease biomarkers and begin thinking about new strategies for drug target discovery. The integration of multidimensional high-throughput 'omics' measurements from tumour tissues and corresponding blood specimens, together with new systems strategies for diagnostics, enables the identification of cancer biomarkers that will enable presymptomatic diagnosis, stratification of disease, assessment of disease progression, evaluation of patient response to therapy and the identification of reoccurrences. Whilst some aspects of systems medicine are being adopted in clinical oncology practice through companion molecular diagnostics for personalized therapy, the mounting influx of global quantitative data from both wellness and diseases is shaping up a transformational paradigm in medicine we termed 'predictive', 'preventive', 'personalized', and 'participatory' (P4) medicine, which requires new strategies, both scientific and organizational, to enable bringing this revolution in medicine to patients and to the healthcare system. P4 medicine will have a profound impact on society - transforming the healthcare system, turning around the ever escalating costs of healthcare, digitizing the practice of medicine and creating enormous economic opportunities for those organizations and nations that embrace this revolution. © 2011 The Association for the Publication of the

Personalized diagnostics and biosensors: a review of the biology and technology needed for personalized medicine.

PubMed

Ahmed, Minhaz Uddin; Saaem, Ishtiaq; Wu, Pae C; Brown, April S

2014-06-01

Exploiting the burgeoning fields of genomics, proteomics and metabolomics improves understanding of human physiology and, critically, the mutations that signal disease susceptibility. Through these emerging fields, rational design approaches to diagnosis, drug development and ultimately personalized medicine are possible. Personalized medicine and point-of-care testing techniques must fulfill a host of constraints for real-world applicability. Point-of-care devices (POCDs) must ultimately provide a cost-effective alternative to expensive and time-consuming laboratory tests in order to assist health care personnel with disease diagnosis and treatment decisions. Sensor technologies are also expanding beyond the more traditional classes of biomarkers--nucleic acids and proteins--to metabolites and direct detection of pathogens, ultimately increasing the palette of available techniques for the use of personalized medicine. The technologies needed to perform such diagnostics have also been rapidly evolving, with each generation being increasingly sensitive and selective while being more resource conscious. Ultimately, the final hurdle for all such technologies is to be able to drive consumer adoption and achieve a meaningful medical outcome for the patient.

Artificial heart pumps: bridging the gap between science, technology and personalized medicine by relational medicine.

PubMed

Raia, Federica; Deng, Mario C

2017-01-01

In the US population of 300 million, 3 million have heart failure with reduced ejection fraction and 300,000 have advanced heart failure. Long-term mechanical circulatory support will, within the next decade, be recommended to 30,000 patients annually in the USA, 3000 undergo heart transplantation annually. What do these advances mean for persons suffering from advanced heart failure and their loved ones/caregivers? In this perspective article, we discuss - by exemplifying a case report of a 27-year-old man receiving a Total Artificial Heart - a practice concept of modern medicine that fully incorporates the patient's personhood perspective which we have termed Relational Medicine™. From this case study, it becomes apparent that the successful practice of modern cardiovascular medicine requires the person-person encounter as a core practice element.

Clinical phenotype network: the underlying mechanism for personalized diagnosis and treatment of traditional Chinese medicine.

PubMed

Zhou, Xuezhong; Li, Yubing; Peng, Yonghong; Hu, Jingqing; Zhang, Runshun; He, Liyun; Wang, Yinghui; Jiang, Lijie; Yan, Shiyan; Li, Peng; Xie, Qi; Liu, Baoyan

2014-09-01

Traditional Chinese medicine (TCM) investigates the clinical diagnosis and treatment regularities in a typical schema of personalized medicine, which means that individualized patients with same diseases would obtain distinct diagnosis and optimal treatment from different TCM physicians. This principle has been recognized and adhered by TCM clinical practitioners for thousands of years. However, the underlying mechanisms of TCM personalized medicine are not fully investigated so far and remained unknown. This paper discusses framework of TCM personalized medicine in classic literatures and in real-world clinical settings, and investigates the underlying mechanisms of TCM personalized medicine from the perspectives of network medicine. Based on 246 well-designed outpatient records on insomnia, by evaluating the personal biases of manifestation observation and preferences of herb prescriptions, we noted significant similarities between each herb prescriptions and symptom similarities between each encounters. To investigate the underlying mechanisms of TCM personalized medicine, we constructed a clinical phenotype network (CPN), in which the clinical phenotype entities like symptoms and diagnoses are presented as nodes and the correlation between these entities as links. This CPN is used to investigate the promiscuous boundary of syndromes and the co-occurrence of symptoms. The small-world topological characteristics are noted in the CPN with high clustering structures, which provide insight on the rationality of TCM personalized diagnosis and treatment. The investigation on this network would help us to gain understanding on the underlying mechanism of TCM personalized medicine and would propose a new perspective for the refinement of the TCM individualized clinical skills.

Impact of Biomarkers on Personalized Medicine.

PubMed

Carrigan, Patricia; Krahn, Thomas

2016-01-01

The field of personalized medicine that involves the use of measuring biomarkers in clinical samples is an area of high interest and one that has tremendous impact on drug development. With the emergence of more sensitive and specific technologies that are now able to be run in clinical settings and the ability to accurately measure biomarkers, there is a need to understand how biomarkers are defined, how they are used in clinical trials, and most importantly how they are used in conjunction with drug treatment. Biomarker approaches have entered into early clinical trials and are increasingly being used to develop new diagnostics that help to differentiate or stratify the likely outcomes of therapeutic intervention. Tremendous efforts have been made to date to discover novel biomarkers for use in clinical practice. Still, the number of markers that make it into clinical practice is rather low. In the next following chapters, we will explain the various classifications of biomarkers, how they are applied, measured, and used in personalized medicine specifically focusing on how they are used in de-risking the 10 plus years drug development process and lastly how they are validated and transformed into companion diagnostic assays.

The intersection of pharmacology, imaging, and genetics in the development of personalized medicine

PubMed Central

Gerretsen, Philip; Müller, Daniel J.; Tiwari, Arun; Mamo, David; Pollock, Bruce G.

2009-01-01

We currently rely on large randomized trials and meta-analyses to make clinical decisions; this places us at a risk of discarding subgroup or individually specific treatment options owing to their failure to prove efficacious across entire populations. There is a new era emerging in personalized medicine that will focus on individual differences that are not evident phenomenologically. Much research is directed towards identifying genes, endophenotypes, and biomarkers of disease that will facilitate diagnosis and predict treatment outcome. We are at the threshold of being able to predict treatment response, primarily through genetics and neuroimaging. In this review we discuss the most promising markers of treatment response and adverse effects emerging from the areas of pharmacogenetics and neuroimaging in depression and schizophrenia. PMID:20135894

E-Health towards ecumenical framework for personalized medicine via Decision Support System.

PubMed

Kouris, Ioannis; Tsirmpas, Charalampos; Mougiakakou, Stavroula G; Iliopoulou, Dimitra; Koutsouris, Dimitris

2010-01-01

The purpose of the present manuscript is to present the advances performed in medicine using a Personalized Decision Support System (PDSS). The models used in Decision Support Systems (DSS) are examined in combination with Genome Information and Biomarkers to produce personalized result for each individual. The concept of personalize medicine is described in depth and application of PDSS for Cardiovascular Diseases (CVD) and Type-1 Diabetes Mellitus (T1DM) are analyzed. Parameters extracted from genes, biomarkers, nutrition habits, lifestyle and biological measurements feed DSSs, incorporating Artificial Intelligence Modules (AIM), to provide personalized advice, medication and treatment.

Psychosocial job characteristics and psychological distress / well-being: the mediating role of personal goal facilitation.

PubMed

Pisanti, Renato; van der Doef, Margot; Maes, Stan; Violani, Cristiano; Lazzari, David

2016-01-01

This study examined the mediating role of personal goal facilitation through work (PGFW), defined as perceptions of the extent to which one's job facilitates the attainment of one's personal goals, in the association between psychosocial job characteristics and psychological distress and job-related well-being. Questionnaire data from 217 nurses (84% female, with a mean age of 42.7 years, SD=7.2) were analyzed. Participants completed the following measures: the Leiden Quality of Work Questionnaire for Nurses, Workplace Goal Facilitation Inventory, Maslach Burnout Inventory-Human Services Survey, and Utrecht Work Engagement Scale (short version). A cross-sectional study design was applied. Hierarchical multiple regression analyses were conducted. The results indicated that unfavorable psychosocial job characteristics (high demands, low control, and low social support) were associated with lower PGFW. Furthermore, personal goal facilitation through work explained significant additional variance (from 2 to 11%) in psychological distress (somatic complaints and emotional exhaustion) and job-related well-being (personal accomplishment, job satisfaction, and work engagement), controlling for demographic indicators and psychosocial job characteristics. Finally, the results provided support for the mediating effects of PGFW between all psychosocial job characteristics and all outcomes, except in the case of depersonalization. This study suggests that hindered personal goal facilitation may be a mechanism through which psychosocial job characteristics have a negative impact on employees' well-being.

Metabolomics and Personalized Medicine.

PubMed

Koen, Nadia; Du Preez, Ilse; Loots, Du Toit

2016-01-01

Current clinical practice strongly relies on the prognosis, diagnosis, and treatment of diseases using methods determined and averaged for the specific diseased cohort/population. Although this approach complies positively with most patients, misdiagnosis, treatment failure, relapse, and adverse drug effects are common occurrences in many individuals, which subsequently hamper the control and eradication of a number of diseases. These incidences can be explained by individual variation in the genome, transcriptome, proteome, and metabolome of a patient. Various "omics" approaches have investigated the influence of these factors on a molecular level, with the intention of developing personalized approaches to disease diagnosis and treatment. Metabolomics, the newest addition to the "omics" domain and the closest to the observed phenotype, reflects changes occurring at all molecular levels, as well as influences resulting from other internal and external factors. By comparing the metabolite profiles of two or more disease phenotypes, metabolomics can be applied to identify biomarkers related to the perturbation being investigated. These biomarkers can, in turn, be used to develop personalized prognostic, diagnostic, and treatment approaches, and can also be applied to the monitoring of disease progression, treatment efficacy, predisposition to drug-related side effects, and potential relapse. In this review, we discuss the contributions that metabolomics has made, and can potentially still make, towards the field of personalized medicine. © 2016 Elsevier Inc. All rights reserved.

Physiologically-based pharmacokinetic models: approaches for enabling personalized medicine.

PubMed

Hartmanshenn, Clara; Scherholz, Megerle; Androulakis, Ioannis P

2016-10-01

Personalized medicine strives to deliver the 'right drug at the right dose' by considering inter-person variability, one of the causes for therapeutic failure in specialized populations of patients. Physiologically-based pharmacokinetic (PBPK) modeling is a key tool in the advancement of personalized medicine to evaluate complex clinical scenarios, making use of physiological information as well as physicochemical data to simulate various physiological states to predict the distribution of pharmacokinetic responses. The increased dependency on PBPK models to address regulatory questions is aligned with the ability of PBPK models to minimize ethical and technical difficulties associated with pharmacokinetic and toxicology experiments for special patient populations. Subpopulation modeling can be achieved through an iterative and integrative approach using an adopt, adapt, develop, assess, amend, and deliver methodology. PBPK modeling has two valuable applications in personalized medicine: (1) determining the importance of certain subpopulations within a distribution of pharmacokinetic responses for a given drug formulation and (2) establishing the formulation design space needed to attain a targeted drug plasma concentration profile. This review article focuses on model development for physiological differences associated with sex (male vs. female), age (pediatric vs. young adults vs. elderly), disease state (healthy vs. unhealthy), and temporal variation (influence of biological rhythms), connecting them to drug product formulation development within the quality by design framework. Although PBPK modeling has come a long way, there is still a lengthy road before it can be fully accepted by pharmacologists, clinicians, and the broader industry.

Personalized plasma-based medicine to treat age-related diseases.

PubMed

Anitua, Eduardo; Troya, María; Zalduendo, Mar; Orive, Gorka

2017-05-01

As social and health needs are changing, new challenges to develop innovative alternatives arise to address unmet medical needs. Personalized medicine is emerging as a promising and appealing therapeutic option. The use of patient's own plasma and platelets as therapeutics is providing new avenues in the treatment of acute and chronic tissue injuries by promoting tissue repair and regeneration. Plasma and platelet-based therapies mimic the physiological repair process by releasing autologous growth factors and creating a natural, biodegradable and transient scaffold that acts as transient matrix. This review summarizes the recent advances and challenges in the field of personalized plasma-based medicine and its potential to treat age-related diseases. Copyright © 2016. Published by Elsevier B.V.

Biopharmaceutical industry perspectives on the business prospects for personalized medicine.

PubMed

Milne, Christopher-Paul; Zuckerman, Rachael

2011-09-01

Personalized medicine is entering its second decade, yet the role it will play in addressing the biopharmaceutical industry's productivity gap and the rising cost of healthcare is still a matter of speculation. So what does the biopharmaceutical industry itself say about the business prospects for personalized medicine? The authors conducted interviews with 20 science and business experts from 13 companies to find out. In this article, particular attention is paid to drug-diagnostic codevelopment, so-called companion diagnostics. The results of the interviews are discussed in light of perspectives from various stakeholders available from the literature in the public domain. In brief, biopharmaceutical acknowledges the many difficulties that plague this path to product development with particular concern for knowledge gaps in the scientific base, the timing of studies during development, as well as the regulatory, reimbursement and commercial hurdles that can thwart approval, launch and market uptake. Nonetheless, personalized medicine in general and companion diagnostics in particular are believed to be an increasingly sustainable business proposition with expectations for rapid market growth in the near term.

Health Technology Assessment and Private Payers' Coverage of Personalized Medicine

PubMed Central

Trosman, Julia R.; Van Bebber, Stephanie L.; Phillips, Kathryn A.

2011-01-01

Purpose: Health technology assessment (HTA) plays an increasing role in translating emerging technologies into clinical practice and policy. Private payers are important users of HTA whose decisions impact adoption and use of new technologies. We examine the current use of HTA by private payers in coverage decisions for personalized medicine, a field that is increasingly impacting oncology practice. Study Design: Literature review and semistructured interviews. Methods: We reviewed seven HTA organizations used by private payers in decision making and explored how HTA is used by major US private payers (n = 11) for coverage of personalized medicine. Results: All payers used HTA in coverage decisions, but the number of HTA organizations used by an individual payer ranged from one (n = 1) to all seven (n = 1), with the majority of payers (n = 8) using three or more. Payers relied more extensively on HTAs for reviews of personalized medicine (64%) than for other technologies. Most payers (82%) equally valued expertise of reviewers and rigor of evaluation as HTA strengths, whereas genomic-specific methodology was less important. Key reported shortcomings were limited availability of reviews (73%) and limited inclusion of nonclinical factors (91%), such as cost-effectiveness or adoption of technology in clinical practice. Conclusion: Payers use a range of HTAs in their coverage decisions related to personalized medicine, but the current state of HTA to comprehensively guide those decisions is limited. HTA organizations should address current gaps to improve their relevance to payers and clinicians. Current HTA shortcomings may also inform the national HTA agenda. PMID:21886515

Psychiatry and emergency medicine: medical student and physician attitudes toward homeless persons.

PubMed

Morrison, Ann; Roman, Brenda; Borges, Nicole

2012-05-01

The purpose of the study was to explore changes in medical students' attitudes toward homeless persons during the Psychiatry and Emergency Medicine clerkships. Simultaneously, this study explored attitudes toward homeless persons held by Psychiatry and Emergency Medicine residents and faculty in an attempt to uncover the "hidden curriculum" in medical education, in which values are communicated from teacher to student outside of the formal instruction. A group of 79 students on Psychiatry and 66 on Emergency Medicine clerkships were surveyed at the beginning and end of their rotation regarding their attitudes toward homeless persons by use of the Health Professionals' Attitudes Toward the Homeless Inventory (HPATHI). The HPATHI was also administered to 31 Psychiatry residents and faculty and 41 Emergency Medicine residents and faculty one time during the course of this study. For Psychiatry clerks, t-tests showed significant differences pre- and post-clerkship experiences on 2 of the 23 items on the HPATHI. No statistically significant differences were noted for the Emergency Medicine students. An analysis of variance revealed statistically significant differences on 7 out of the 23 survey questions for residents and faculty in Psychiatry, as compared with those in Emergency Medicine. Results suggest that medical students showed small differences in their attitudes toward homeless people following clerkships in Psychiatry but not in Emergency Medicine. Regarding resident and faculty results, significant differences between specialties were noted, with Psychiatry residents and faculty exhibiting more favorable attitudes toward homeless persons than residents and faculty in Emergency Medicine. Given that medical student competencies should be addressing the broader social issues of homelessness, medical schools need to first understand the attitudes of medical students to such issues, and then develop curricula to overcome inaccurate or stigmatizing beliefs.

Pre-graduate and post-graduate education in personalized medicine in the Czech Republic: statistics, analysis and recommendations.

PubMed

Polivka, Jiri; Polivka, Jiri; Karlikova, Marie; Topolcan, Ondrej

2014-01-01

The main goal of personalized medicine is the individualized approach to the patient's treatment. It could be achieved only by the integration of the complexity of novel findings in diverse "omics" disciplines, new methods of medical imaging, as well as implementation of reliable biomarkers into the medical care. The implementation of personalized medicine into clinical practice is dependent on the adaptation of pre-graduate and post-graduate medical education to these principles. The situation in the education of personalized medicine in the Czech Republic is analyzed together with novel educational tools that are currently established in our country. The EPMA representatives in the Czech Republic in cooperation with the working group of professionals at the Faculty of Medicine in Pilsen, Charles University in Prague have implemented the survey of personalized medicine awareness among students of Faculty of Medicine in Pilsen-the "Personalized Medicine Questionnaire". The results showed lacking knowledge of personalized medicine principles and students' will of education in this domain. Therefore, several educational activities addressed particularly to medical students and young physicians were realized at our facility with very positive evaluation. These educational activities (conferences, workshops, seminars, e-learning and special courses in personalized medicine (PM)) will be a part of pre-graduate and post-graduate medical education, will be extended to other medical faculties in our country. The "Summer School of Personalized Medicine in Plzen 2015" will be organized at the Faculty of Medicine and Faculty Hospital in Pilsen as the first event on this topic in the Czech Republic.

The microeconomics of personalized medicine: today's challenge and tomorrow's promise.

PubMed

Davis, Jerel C; Furstenthal, Laura; Desai, Amar A; Norris, Troy; Sutaria, Saumya; Fleming, Edd; Ma, Philip

2009-04-01

'Personalized medicine' promises to increase the quality of clinical care and, in some cases, decrease health-care costs. Despite this, only a handful of diagnostic tests have made it to market, with mixed success. Historically, the challenges in this field were scientific. However, as discussed in this article, with the maturation of the '-omics' sciences, it now seems that the major barriers are increasingly related to economics. Overcoming the poor microeconomic alignment of incentives among key stakeholders is therefore crucial to catalysing the further development and adoption of personalized medicine, and we propose several actions that could help achieve this goal.

The influence of personality traits and beliefs about medicines on adherence to asthma treatment.

PubMed

Emilsson, Maria; Berndtsson, Ina; Lötvall, Jan; Millqvist, Eva; Lundgren, Jesper; Johansson, Ake; Brink, Eva

2011-06-01

To explore the influence of personality traits and beliefs about medicines on adherence to treatment with asthma medication. Respondents were 35 asthmatic adults prescribed controller medication. They answered questionnaires about medication adherence, personality traits, and beliefs about medicines. In gender comparisons, the personality traits "Neuroticism" in men and "adherence to medication" were associated with lower adherent behaviour. Associations between personality traits and beliefs in the necessity of medication for controlling the illness were identified. Beliefs about the necessity of medication were positively associated with adherent behaviour in women. In the total sample, a positive "necessity-concern" differential predicted adherent behaviour. The results imply that personality and beliefs about medicines may influence how well adults with asthma adhere to treatment with asthma medication.

Introduction to Personalized Medicine in Diabetes Mellitus

PubMed Central

Glauber, Harry S.; Rishe, Naphtali; Karnieli, Eddy

2014-01-01

The world is facing an epidemic rise in diabetes mellitus (DM) incidence, which is challenging health funders, health systems, clinicians, and patients to understand and respond to a flood of research and knowledge. Evidence-based guidelines provide uniform management recommendations for “average” patients that rarely take into account individual variation in susceptibility to DM, to its complications, and responses to pharmacological and lifestyle interventions. Personalized medicine combines bioinformatics with genomic, proteomic, metabolomic, pharmacogenomic (“omics”) and other new technologies to explore pathophysiology and to characterize more precisely an individual’s risk for disease, as well as response to interventions. In this review we will introduce readers to personalized medicine as applied to DM, in particular the use of clinical, genetic, metabolic, and other markers of risk for DM and its chronic microvascular and macrovascular complications, as well as insights into variations in response to and tolerance of commonly used medications, dietary changes, and exercise. These advances in “omic” information and techniques also provide clues to potential pathophysiological mechanisms underlying DM and its complications. PMID:24498509

Personal, Electronic, Secure National Library of Medicine Hosts Health Records Conference

MedlinePlus

... Bar Home Current Issue Past Issues EHR Personal, Electronic, Secure: National Library of Medicine Hosts Health Records ... One suggestion for saving money is to implement electronic personal health records. With this in mind, the ...

Implementation of personalized medicine services in community pharmacies: perceptions of independent community pharmacists.

PubMed

Alexander, Katelyn M; Divine, Holly S; Hanna, Cathy R; Gokun, Yevgeniya; Freeman, Patricia R

2014-01-01

To evaluate the perceptions of independent community pharmacists within a regional independent community pharmacy cooperative on implementing personalized medicine services at their pharmacies and to gauge the pharmacists' self-reported knowledge of pharmacogenomic principles. Descriptive, exploratory, nonexperimental study. American Pharmacy Services Corporation (APSC), 2011-12. Pharmacists (n = 101) affiliated with the independent pharmacies of APSC. Single-mode survey. Independent community pharmacists' interest in implementing personalized medicine services, perceived readiness to provide such services, and perceived barriers to implementation. 101 completed surveys were returned for data analysis. The majority of pharmacists surveyed (75%) expressed interest in offering personalized medicine services. When asked to describe their knowledge of pharmacogenomics and readiness to implement such services, more than 50% said they were not knowledgeable on the subject and would not currently be comfortable making drug therapy recommendations to physicians or confident counseling patients based on results of genetic screenings without further training and education. Respondents identified cost of providing the service, reimbursement issues, current knowledge of pharmacogenomics, and time to devote to the program as the greatest barriers to implementing personalized medicine services. The majority of independent community pharmacists are interested in incorporating personalized medicine services into their practices, but they require further education before this is possible. Future initiatives should focus on the development of comprehensive education programs to further train pharmacists for provision of these services.

[Nanobiophotonics: photon-associated nanobiotechnology for laser and personalized medicine].

PubMed

Zalesskiĭ, V N; Movchan, B A

2013-01-01

Analyzed are the literature in the field of development and use nanobiophotonic technologies for laser and personalized medicine. Arguably, the origins of nanobiophotonic are closely tied in the first experimental realization of near-field optics, which enabled optical imaging beyond the diffraction limit. The information about the gist of nanobiophotonics and other photon-associations technologies (photonics, nanophotonics, biophotonics, nanooptics, plasmonics, nanospectroscopy, laser and personalized medicine) is summarized. Nanobiophotonics is the use of light to image, probe and manipulate biological materials. The particular strength of nanobiophotonics is thet in ideal case it retains of the light for permits live cell sensing. The area of nanobiophotonics technologies is too broad to possible capture all aspects nano-analitic directions and biomedical research within the last years.

Translational research: precision medicine, personalized medicine, targeted therapies: marketing or science?

PubMed

Marquet, Pierre; Longeray, Pierre-Henry; Barlesi, Fabrice; Ameye, Véronique; Augé, Pascale; Cazeneuve, Béatrice; Chatelut, Etienne; Diaz, Isabelle; Diviné, Marine; Froguel, Philippe; Goni, Sylvia; Gueyffier, François; Hoog-Labouret, Natalie; Mourah, Samia; Morin-Surroca, Michèle; Perche, Olivier; Perin-Dureau, Florent; Pigeon, Martine; Tisseau, Anne; Verstuyft, Céline

2015-01-01

Personalized medicine is based on: 1) improved clinical or non-clinical methods (including biomarkers) for a more discriminating and precise diagnosis of diseases; 2) targeted therapies of the choice or the best drug for each patient among those available; 3) dose adjustment methods to optimize the benefit-risk ratio of the drugs chosen; 4) biomarkers of efficacy, toxicity, treatment discontinuation, relapse, etc. Unfortunately, it is still too often a theoretical concept because of the lack of convenient diagnostic methods or treatments, particularly of drugs corresponding to each subtype of pathology, hence to each patient. Stratified medicine is a component of personalized medicine employing biomarkers and companion diagnostics to target the patients likely to present the best benefit-risk balance for a given active compound. The concept of targeted therapy, mostly used in cancer treatment, relies on the existence of a defined molecular target, involved or not in the pathological process, and/or on the existence of a biomarker able to identify the target population, which should logically be small as compared to the population presenting the disease considered. Targeted therapies and biomarkers represent important stakes for the pharmaceutical industry, in terms of market access, of return on investment and of image among the prescribers. At the same time, they probably represent only the first generation of products resulting from the combination of clinical, pathophysiological and molecular research, i.e. of translational research. © 2015 Société Française de Pharmacologie et de Thérapeutique.

Implementation and utilization of genetic testing in personalized medicine

PubMed Central

Abul-Husn, Noura S; Owusu Obeng, Aniwaa; Sanderson, Saskia C; Gottesman, Omri; Scott, Stuart A

2014-01-01

Clinical genetic testing began over 30 years ago with the availability of mutation detection for sickle cell disease diagnosis. Since then, the field has dramatically transformed to include gene sequencing, high-throughput targeted genotyping, prenatal mutation detection, preimplantation genetic diagnosis, population-based carrier screening, and now genome-wide analyses using microarrays and next-generation sequencing. Despite these significant advances in molecular technologies and testing capabilities, clinical genetics laboratories historically have been centered on mutation detection for Mendelian disorders. However, the ongoing identification of deoxyribonucleic acid (DNA) sequence variants associated with common diseases prompted the availability of testing for personal disease risk estimation, and created commercial opportunities for direct-to-consumer genetic testing companies that assay these variants. This germline genetic risk, in conjunction with other clinical, family, and demographic variables, are the key components of the personalized medicine paradigm, which aims to apply personal genomic and other relevant data into a patient’s clinical assessment to more precisely guide medical management. However, genetic testing for disease risk estimation is an ongoing topic of debate, largely due to inconsistencies in the results, concerns over clinical validity and utility, and the variable mode of delivery when returning genetic results to patients in the absence of traditional counseling. A related class of genetic testing with analogous issues of clinical utility and acceptance is pharmacogenetic testing, which interrogates sequence variants implicated in interindividual drug response variability. Although clinical pharmacogenetic testing has not previously been widely adopted, advances in rapid turnaround time genetic testing technology and the recent implementation of preemptive genotyping programs at selected medical centers suggest that personalized

Barriers and facilitators to implementing addiction medicine fellowships: a qualitative study with fellows, medical students, residents and preceptors.

PubMed

Klimas, J; Small, W; Ahamad, K; Cullen, W; Mead, A; Rieb, L; Wood, E; McNeil, R

2017-09-20

Although progress in science has driven advances in addiction medicine, this subject has not been adequately taught to medical trainees and physicians. As a result, there has been poor integration of evidence-based practices in addiction medicine into physician training which has impeded addiction treatment and care. Recently, a number of training initiatives have emerged internationally, including the addiction medicine fellowships in Vancouver, Canada. This study was undertaken to examine barriers and facilitators of implementing addiction medicine fellowships. We interviewed trainees and faculty from clinical and research training programmes in addiction medicine at St Paul's Hospital in Vancouver, Canada (N = 26) about barriers and facilitators to implementation of physician training in addiction medicine. We included medical students, residents, fellows and supervising physicians from a variety of specialities. We analysed interview transcripts thematically by using NVivo software. We identified six domains relating to training implementation: (1) organisational, (2) structural, (3) teacher, (4) learner, (5) patient and (6) community related variables either hindered or fostered addiction medicine education, depending on context. Human resources, variety of rotations, peer support and mentoring fostered implementation of addiction training. Money, time and space limitations hindered implementation. Participant accounts underscored how faculty and staff facilitated the implementation of both the clinical and the research training. Implementation of addiction medicine fellowships appears feasible, although a number of barriers exist. Research into factors within the local/practice environment that shape delivery of education to ensure consistent and quality education scale-up is a priority.

Proteomic Approaches to Enable Point-of-Care Testing and Personalized Medicine for Psychiatric Disorders.

PubMed

Guest, Francesca L; Guest, Paul C

2017-01-01

This chapter describes how innovations that are driven by proteomic biomarker techniques can facilitate earlier and better treatment of patients who suffer from psychiatric disorders. The application of new micro-fluidic devices along with miniaturized biosensors and transducers will enable the development of handheld point-of-care testing instruments which can analyse a drop of a blood within the time span of a single visit to the doctor's office. It is anticipated that these approaches will incorporate both biochemical and clinical information, resulting in unique profiles for each test subject. These profiles can in turn be used to drive personalized medicine approaches in this devastating disease area. In addition, smartphone applications (apps) for self-monitoring will see increasing use for improved patient outcomes.

Personalized Medicine and Customized Drug Delivery Systems: The New Trend of Drug Delivery and Disease Management.

PubMed

Soni, Abhishek; Gowthamarajan, Kuppusamy; Radhakrishnan, Arun

2018-01-01

Over the past few decades, the concept of personalized medicine has proved to play an important role in the healthcare sector. Personalized medicine modifies the current dosage forms according to the needs of the patient. Based on this improved concept, we are now able to bring out best treatment options for a particular individual leading to better therapeutic outcomes and decreased adverse effects. It also has the potential to identify the disease at an earlier stage. It links the diseased condition of a person to the basic genetic and molecular profile causing better understanding of the condition of the patient and to pick out better treatment options. This review is to enlighten the past, present, and future perspective of personalized medicine and how the personalized-medicine approach is used as customized drug delivery, as well as the regulatory aspects towards it. Personalized medicine has the potential to modify the way we recognize and manage our health problems and has already proven to have a huge impact on patient care and on clinical research. The impact of personalized medicine is expected to increase with an increased knowledge about the term and related technologies. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Watson for Genomics: Moving Personalized Medicine Forward.

PubMed

Rhrissorrakrai, Kahn; Koyama, Takahiko; Parida, Laxmi

2016-08-01

The confluence of genomic technologies and cognitive computing has brought us to the doorstep of widespread usage of personalized medicine. Cognitive systems, such as Watson for Genomics (WG), integrate massive amounts of new omic data with the current body of knowledge to assist physicians in analyzing and acting on patient's genomic profiles. Copyright © 2016 Elsevier Inc. All rights reserved.

Coaches' Perspectives on Their Roles in Facilitating the Personal Development of Student-Athletes

ERIC Educational Resources Information Center

Banwell, Jenessa; Kerr, Gretchen

2016-01-01

The purpose of this study was to investigate coaches' perspectives on the personal development student-athletes experience through interuniversity sport. Additionally, it explored the ways in which coaches understand, enable, and facilitate the personal development of student-athletes. Eight in-depth, semi-structured interviews were conducted with…

Barriers and facilitators to the quality use of essential medicines for maternal health in low-resource countries: An Ishikawa framework.

PubMed

Tran, Dan N; Bero, Lisa A

2015-06-01

An estimated 800 women die every day due to complications related to pregnancy or childbirth. Complications such as postpartum haemorrhage (PPH) and pre-eclampsia and eclampsia can be prevented by the appropriate use of essential medicines. The objective of this study was to identify the common barriers and facilitators to the availability and use of oxytocin, ergometrine, and magnesium sulfate (MgSO4) - essential medicines indicated for the prevention and treatment of PPH and pre-eclampsia and eclampsia. We analyzed seven UNFPA/WHO reports published in 2008-2010. These reports summarized country-wide rapid assessments of access to and use of essential medicines for maternal health in Mongolia, Nepal, Laos, the Democratic People's Republic of Korea (DPRK), the Philippines, Vanuatu, and the Solomon Islands. We used a "fishbone" (Ishikawa) diagram as the analytic framework to identify facilitators and barriers at four health-system levels: government/regulatory, pharmaceutical supply, health facility, and health professional. Common facilitators to the quality use of essential medicines for maternal health were observed at the government/regulatory and health professional level. A majority of countries had these medicines listed in their essential medicines lists. Awareness of the medicines was generally high among health professionals. Common barriers were identified at all health-system levels. First, standard treatment guidelines were not available, updated, or standardized. Second, there was an inadequate capacity to forecast and procure medicines. Third, a required MgSO4 antidote was often not available and the storage conditions for oxytocin were deficient. The "fishbone" Ishikawa diagram is a useful tool for describing the findings of rapid assessments of quality use of essential medicines for maternal health across countries. The facilitators and barriers identified should guide the development of tailored intervention programs to improve and expand the use

Complementary and alternative medicine used by persons with functional gastrointestinal disorders to alleviate symptom distress.

PubMed

Stake-Nilsson, Kerstin; Hultcrantz, Rolf; Unge, Peter; Wengström, Yvonne

2012-03-01

The aim of this study was to describe the complementary and alternative medicine methods most commonly used to alleviate symptom distress in persons with functional gastrointestinal disorders. People with functional gastrointestinal disorders face many challenges in their everyday lives, and each individual has his/her own way of dealing with this illness. The experience of illness often leads persons with functional gastrointestinal disorders to complementary and alternative medicine as a viable healthcare choice. Quantitative and describing design. A study-specific complementary and alternative medicine questionnaire was used, including questions about complementary and alternative medicine methods used and the perceived effects of each method. Efficacy assessments for each method were preventive effect, partial symptom relief, total symptom relief or no effect. A total of 137 persons with functional gastrointestinal disorders answered the questionnaire, 62% (n = 85) women and 38% (n = 52) men. A total of 28 different complementary and alternative medicine methods were identified and grouped into four categories: nutritional, drug/biological, psychological activity and physical activity. All persons had tried at least one method, and most methods provided partial symptom relief. Persons with functional gastrointestinal disorders commonly use complementary and alternative medicine methods to alleviate symptoms. Nurses have a unique opportunity to expand their roles in this group of patients. Increased knowledge of complementary and alternative medicine practices would enable a more comprehensive patient assessment and a better plan for meaningful interventions that meet the needs of individual patients. © 2011 Blackwell Publishing Ltd.

A review of international coverage and pricing strategies for personalized medicine and orphan drugs.

PubMed

Degtiar, Irina

2017-12-01

Personalized medicine and orphan drugs share many characteristics-both target small patient populations, have uncertainties regarding efficacy and safety at payer submission, and frequently have high prices. Given personalized medicine's rising importance, this review summarizes international coverage and pricing strategies for personalized medicine and orphan drugs as well as their impact on therapy development incentives, payer budgets, and therapy access and utilization. PubMed, Health Policy Reference Center, EconLit, Google Scholar, and references were searched through February 2017 for articles presenting primary data. Sixty-nine articles summarizing 42 countries' strategies were included. Therapy evaluation criteria varied between countries, as did patient cost-share. Payers primarily valued clinical effectiveness; cost was only considered by some. These differences result in inequities in orphan drug access, particularly in smaller and lower-income countries. The uncertain reimbursement process hinders diagnostic testing. Payer surveys identified lack of comparative effectiveness evidence as a chief complaint, while manufacturers sought more clarity on payer evidence requirements. Despite lack of strong evidence, orphan drugs largely receive positive coverage decisions, while personalized medicine diagnostics do not. As more personalized medicine and orphan drugs enter the market, registries can provide better quality evidence on their efficacy and safety. Payers need systematic assessment strategies that are communicated with more transparency. Further studies are necessary to compare the implications of different payer approaches. Copyright © 2017 Elsevier B.V. All rights reserved.

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.

PubMed

Blaus, Alison; Madabushi, Rajanikanth; Pacanowski, Michael; Rose, Martin; Schuck, Robert N; Stockbridge, Norman; Temple, Robert; Unger, Ellis F

2015-10-13

Over the past decade, personalized medicine has received considerable attention from researchers, drug developers, and regulatory agencies. Personalized medicine includes identifying patients most likely to benefit and those most likely to experience adverse reactions in response to a drug, and tailoring therapy based on pharmacokinetics or pharmacodynamic response, as well. Perhaps most exciting is finding ways to identify likely responders through genetic, proteomic, or other tests, so that only likely responders will be treated. However, less precise methods such as identifying historical, demographic, or other indicators of increased or reduced responsiveness are also important aspects of personalized medicine. The cardiovascular field has not used many genetic or proteomic markers, but has regularly used prognostic variables to identify likely responders. The development of biomarker-based approaches to personalized medicine in cardiovascular disease has been challenging, in part, because most cardiovascular therapies treat acquired syndromes, such as acute coronary syndrome and heart failure, which develop over many decades and represent the end result of several pathophysiological mechanisms. More precise disease classification and greater understanding of individual variations in disease pathology could drive the development of targeted therapeutics. Success in designing clinical trials for personalized medicine will require the selection of patient populations with attributes that can be targeted or that predict outcome, and the use of appropriate enrichment strategies once such attributes are identified. Here, we describe examples of personalized medicine in cardiovascular disease, discuss its impact on clinical trial design, and provide insight into the future of personalized cardiovascular medicine from a regulatory perspective. © 2015 American Heart Association, Inc.

Correlates of in-person and technology-facilitated sexual harassment from an online survey among young Australians.

PubMed

Douglass, Caitlin H; Wright, Cassandra J C; Davis, Angela C; Lim, Megan S C

2018-06-01

Background: Technology-facilitated sexual harassment is an emerging phenomenon. This study investigates correlates of sexual harassment among young Australians. Methods: Participants aged 15-29 were recruited for an online survey. Participants reported how often in the past year they experienced sexual harassment in person, via phone, social media and dating apps. Correlates of in-person and technology-facilitated sexual harassment were identified using logistic regression. Results: Of all participants (n=1272, 70% female), two-thirds reported sexual harassment in person, 34% through social media and 26% via phone. Of participants who used a dating app in the past year (n=535), 57% experienced sexual harassment. Sexual harassment in person was correlated with being female (aOR=9.2, CI=6.9-12.2), trans and gender diverse (aOR=2.6, CI=1.2-5.7) and being aged 20-24 years (aOR=1.5, CI=1.1-2.1). Heterosexual identity reduced the odds of sexual harassment in person (aOR=0.7, CI=0.5-0.9). Technology-facilitated sexual harassment was correlated with female (aOR=3.5, CI=2.6-4.6) and trans and gender diverse identities (aOR=3.0, CI=1.4-6.5). Older age [25-29 years (aOR=0.5, CI=0.4-0.8)] and heterosexual identity (aOR=0.7, CI=0.5-0.9) significantly reduced the odds of technology-facilitated sexual harassment. Conclusion: Young people identifying as female, trans and gender diverse and non-heterosexual are at risk of in-person and technology-facilitated sexual harassment. Service and technology providers, academics, and policy makers must respond with innovative strategies.

Barriers and facilitators to the implementation of person-centred care in different healthcare contexts.

PubMed

Moore, Lucy; Britten, Nicky; Lydahl, Doris; Naldemirci, Öncel; Elam, Mark; Wolf, Axel

2017-12-01

To empower patients and improve the quality of care, policy-makers increasingly adopt systems to enhance person-centred care. Although models of person-centredness and patient-centredness vary, respecting the needs and preferences of individuals receiving care is paramount. In Sweden, as in other countries, healthcare providers seek to improve person-centred principles and address gaps in practice. Consequently, researchers at the University of Gothenburg Centre for Person-Centred Care are currently delivering person-centred interventions employing a framework that incorporates three routines. These include eliciting the patient's narrative, agreeing a partnership with shared goals between patient and professional, and safeguarding this through documentation. To explore the barriers and facilitators to the delivery of person-centred care interventions, in different contexts. Qualitative interviews were conducted with a purposeful sample of 18 researchers from seven research studies across contrasting healthcare settings. Interviews were transcribed, translated and thematically analysed, adopting some basic features of grounded theory. The ethical code of conduct was followed and conformed to the ethical guidelines adopted by the Swedish Research Council. Barriers to the implementation of person-centred care covered three themes: traditional practices and structures; sceptical, stereotypical attitudes from professionals; and factors related to the development of person-centred interventions. Facilitators included organisational factors, leadership and training and an enabling attitude and approach by professionals. Trained project managers, patients taking an active role in research and adaptive strategies by researchers all helped person-centred care delivery. At the University of Gothenburg, a model of person-centred care is being initiated and integrated into practice through research. Knowledgeable, well-trained professionals facilitate the routines of narrative

Crowdfunding for Personalized Medicine Research.

PubMed

Fumagalli, Danielle C; Gouw, Arvin M

2015-12-01

Given the current funding situation of the National Institutes of Health, getting funding for rare disease research is extremely difficult. In light of the enormous potential for research in the rare diseases and the scarcity of research funding, we provide a case study of a novel successful crowdfunding approach at a non-profit organization called Rare Genomics Institute. We partner with biotechnology companies willing to donate their products, such as mouse models, gene editing software, and sequencing services, for which researchers can apply. First, we find that personal stories can be powerful tools to seek funding from sympathetic donors who do not have the same rational considerations of impact and profit. Second, for foundations facing funding restrictions, company donations can be a valuable tool in addition to crowdfunding. Third, rare disease research is particularly rewarding for scientists as they proceed to be pioneers in the field during their academic careers. Overall, by connecting donors, foundations, researchers, and patients, crowdfunding has become a powerful alternative funding mechanism for personalized medicine.

Crowdfunding for Personalized Medicine Research

PubMed Central

Fumagalli, Danielle C.; Gouw, Arvin M.

2015-01-01

Given the current funding situation of the National Institutes of Health, getting funding for rare disease research is extremely difficult. In light of the enormous potential for research in the rare diseases and the scarcity of research funding, we provide a case study of a novel successful crowdfunding approach at a non-profit organization called Rare Genomics Institute. We partner with biotechnology companies willing to donate their products, such as mouse models, gene editing software, and sequencing services, for which researchers can apply. First, we find that personal stories can be powerful tools to seek funding from sympathetic donors who do not have the same rational considerations of impact and profit. Second, for foundations facing funding restrictions, company donations can be a valuable tool in addition to crowdfunding. Third, rare disease research is particularly rewarding for scientists as they proceed to be pioneers in the field during their academic careers. Overall, by connecting donors, foundations, researchers, and patients, crowdfunding has become a powerful alternative funding mechanism for personalized medicine. PMID:26604866

[Circulating tumor cells: cornerstone of personalized medicine].

PubMed

Rafii, A; Vidal, F; Rathat, G; Alix-Panabières, C

2014-11-01

Cancer treatment has evolved toward personalized medicine. It is mandatory for clinicians to ascertain tumor biological features in order to optimize patients' treatment. Identification and characterization of circulating tumor cells demonstrated a prognostic value in many solid tumors. Here, we describe the main technologies for identification and characterization of circulating tumor cells and their clinical application in gynecologic and breast cancers. Copyright © 2014. Published by Elsevier Masson SAS.

Development and Validation of a Personality Assessment Instrument for Traditional Korean Medicine: Sasang Personality Questionnaire

PubMed Central

Chae, Han; Lee, Siwoo; Park, Soo Hyun; Jang, Eunsu; Lee, Soo Jin

2012-01-01

Objective. Sasang typology is a traditional Korean medicine based on the biopsychosocial perspectives of Neo-Confucianism and utilizes medical herbs and acupuncture for type-specific treatment. This study was designed to develop and validate the Sasang Personality Questionnaire (SPQ) for future use in the assessment of personality based on Sasang typology. Design and Methods. We selected questionnaire items using internal consistency analysis and examined construct validity with explorative factor analysis using 245 healthy participants. Test-retest reliability as well as convergent validity were examined. Results. The 14-item SPQ showed acceptable internal consistency (Cronbach's alpha = .817) and test-retest reliability (r = .837). Three extracted subscales, SPQ-behavior, SPQ-emotionality, and SPQ-cognition, were found, explaining 55.77% of the total variance. The SPQ significantly correlated with Temperament and Character Inventory novelty seeking (r = .462), harm avoidance (r = −.390), and NEO Personality Inventory extraversion (r = .629). The SPQ score of the So-Eum (24.43 ± 4.93), Tae-Eum (27.33 ± 5.88), and So-Yang (30.90 ± 5.23) types were significantly different from each other (P < .01). Conclusion. Current results demonstrated the reliability and validity of the SPQ and its subscales that can be utilized as an objective instrument for conducting personalized medicine research incorporating the biopsychosocial perspective. PMID:22567034

Personalized Medicine Based on Theranostic Radioiodine Molecular Imaging for Differentiated Thyroid Cancer.

PubMed

Ahn, Byeong-Cheol

2016-01-01

Molecular imaging based personalized therapy has been a fascinating concept for individualized therapeutic strategy, which is able to attain the highest efficacy and reduce adverse effects in certain patients. Theranostics, which integrates diagnostic testing to detect molecular targets for particular therapeutic modalities, is one of the key technologies that contribute to the success of personalized medicine. Although the term "theranostics" was used after the second millennium, its basic principle was applied more than 70 years ago in the field of thyroidology with radioiodine molecular imaging. Differentiated thyroid cancer, which arises from follicular cells in the thyroid, is the most common endocrine malignancy, and theranostic radioiodine has been successfully applied to diagnose and treat differentiated thyroid cancer, the applications of which were included in the guidelines published by various thyroid or nuclear medicine societies. Through better pathophysiologic understanding of thyroid cancer and advancements in nuclear technologies, theranostic radioiodine contributes more to modern tailored personalized management by providing high therapeutic effect and by avoiding significant adverse effects in differentiated thyroid cancer. This review details the inception of theranostic radioiodine and recent radioiodine applications for differentiated thyroid cancer management as a prototype of personalized medicine based on molecular imaging.

Personal Spaces in Public Repositories as a Facilitator for Open Educational Resource Usage

ERIC Educational Resources Information Center

Cohen, Anat; Reisman, Sorel; Sperling, Barbra Bied

2015-01-01

Learning object repositories are a shared, open and public space; however, the possibility and ability of personal expression in an open, global, public space is crucial. The aim of this study is to explore personal spaces in a big learning object repository as a facilitator for adoption of Open Educational Resources (OER) into teaching practices…

Intelligent Techniques Using Molecular Data Analysis in Leukaemia: An Opportunity for Personalized Medicine Support System

PubMed Central

Adelson, David; Brown, Fred; Chaudhri, Naeem

2017-01-01

The use of intelligent techniques in medicine has brought a ray of hope in terms of treating leukaemia patients. Personalized treatment uses patient's genetic profile to select a mode of treatment. This process makes use of molecular technology and machine learning, to determine the most suitable approach to treating a leukaemia patient. Until now, no reviews have been published from a computational perspective concerning the development of personalized medicine intelligent techniques for leukaemia patients using molecular data analysis. This review studies the published empirical research on personalized medicine in leukaemia and synthesizes findings across studies related to intelligence techniques in leukaemia, with specific attention to particular categories of these studies to help identify opportunities for further research into personalized medicine support systems in chronic myeloid leukaemia. A systematic search was carried out to identify studies using intelligence techniques in leukaemia and to categorize these studies based on leukaemia type and also the task, data source, and purpose of the studies. Most studies used molecular data analysis for personalized medicine, but future advancement for leukaemia patients requires molecular models that use advanced machine-learning methods to automate decision-making in treatment management to deliver supportive medical information to the patient in clinical practice. PMID:28812013

Intelligent Techniques Using Molecular Data Analysis in Leukaemia: An Opportunity for Personalized Medicine Support System.

PubMed

Banjar, Haneen; Adelson, David; Brown, Fred; Chaudhri, Naeem

2017-01-01

The use of intelligent techniques in medicine has brought a ray of hope in terms of treating leukaemia patients. Personalized treatment uses patient's genetic profile to select a mode of treatment. This process makes use of molecular technology and machine learning, to determine the most suitable approach to treating a leukaemia patient. Until now, no reviews have been published from a computational perspective concerning the development of personalized medicine intelligent techniques for leukaemia patients using molecular data analysis. This review studies the published empirical research on personalized medicine in leukaemia and synthesizes findings across studies related to intelligence techniques in leukaemia, with specific attention to particular categories of these studies to help identify opportunities for further research into personalized medicine support systems in chronic myeloid leukaemia. A systematic search was carried out to identify studies using intelligence techniques in leukaemia and to categorize these studies based on leukaemia type and also the task, data source, and purpose of the studies. Most studies used molecular data analysis for personalized medicine, but future advancement for leukaemia patients requires molecular models that use advanced machine-learning methods to automate decision-making in treatment management to deliver supportive medical information to the patient in clinical practice.

The financial hazard of personalized medicine and supportive care.

PubMed

Carrera, Pricivel M; Olver, Ian

2015-12-01

Personalized medicine is revolutionizing the delivery of oncological care, promising benefits both at the patient and health system levels. The cost of targeted therapies, unfortunately, is becoming more expensive and unaffordable. Where supportive care in cancer concerns the prevention and management of the adverse effects of cancer and its treatment and is the thrust of the Multinational Association of Supportive Care in Cancer, financing of and value in personalized medicine is an important area of research and engagement for the association. Discussing patients' concerns with and identifying those at most risk for the financial hazard of cancer treatment and offering financial counseling and assistance and/or referral to support networks are potential key areas for (exploring and providing) better supportive care. The time is now to turn the concern of patients and their carers, providers, and other advocates regarding the affordability of cancer treatment into a collective cause towards coordinated action.

Personalized health care: from theory to practice.

PubMed

Snyderman, Ralph

2012-08-01

The practice of medicine stands at the threshold of a transformation from its current focus on the treatment of disease events to an emphasis on enhancing health, preventing disease and personalizing care to meet each individual's specific health needs. Personalized health care is a new and strategic approach that is driven by personalized health planning empowered by personalized medicine tools, which are facilitated by advances in science and technology. These tools improve the capability to predict health risks, to determine and quantify the dynamics of disease development, and to target therapeutic approaches to the needs of the individual. Personalized health care can be implemented today using currently available technologies and know-how and thereby provide a market for the rational introduction of new personalized medicine tools. The need for early adoption of personalized health care stems from the necessity to reduce the egregious and wasteful burden of preventable chronic diseases, which is not effectively addressed by our current approach to care. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Enhancing provision of written medicine information in Australia: pharmacist, general practitioner and consumer perceptions of the barriers and facilitators.

PubMed

Hamrosi, Kim K; Raynor, David K; Aslani, Parisa

2014-04-23

Written medicine information can play an important role in educating consumers about their medicines. In Australia, standardised, comprehensive written information known as Consumer Medicine Information (CMI) is available for all prescription medicines. CMI is reportedly under-utilised by general practitioners (GPs) and community pharmacists in consultations, despite consumer desire for medicine information. This study aimed to determine consumers', GPs' and community pharmacists' preferences for CMI provision and identify barriers and facilitators to its use. Structured questionnaires were developed and administered to a national sample of Australian consumers (phone survey), community pharmacists and GPs (postal surveys) surrounding utilisation of CMI. Descriptive and comparative analyses were conducted. Half of consumers surveyed wanted to receive CMI for their prescription medicine, with spoken information preferable to written medicine information for many consumers and healthcare professionals. GPs and pharmacists remained a preferred source of medicine information for consumers, although package inserts were appealing to many among all three cohorts. Overall pharmacists were the preferred provider of CMI primarily due to their medicine expertise, accessibility and perceived availability. GPs preferred CMI dissemination through both the GP and pharmacist. Some consumers preferred GPs as the provider of medicines information because of their knowledge of the patients' medicines and/or medical history, regularity of seeing the patient and good relationship with the patient. Common barriers to CMI provision cited included: time constraints, CMI length and perceptions that patients are not interested in receiving CMI. Facilitators to enhance provision included: strategies to increase consumer awareness, longer consultation times and counseling appointments, and improvements to pharmacy software technology and workflow. Medicine information is important to

Use of indigenous and indigenised medicines to enhance personal well-being: a South African case study.

PubMed

Cocks, Michelle; Møller, Valerie

2002-02-01

An estimated 27 million South Africans use indigenous medicines (Mander, 1997, Medicinal plant marketing and strategies for sustaining the plant supply in the Bushbuckridge area and Mpumalanga Province. Institute for Natural Resources, University of Natal. Pietermaritzburg, South Africa). Although herbal remedies are freely available in amayeza stores, or Xhosa chemists, for self-medication, little is known about the motivations of consumers. According to African belief systems, good health is holistic and extends to the person's social environment. The paper makes a distinction between traditional medicines which are used to enhance personal well-being generally and for cultural purposes, on the one hand, and medicines used to treat physical conditions only, on the other. Drawing on an eight-month study of Xhosa chemists in Eastern Cape Province, South Africa, in 1996, the paper identifies 90 medicines in stock which are used to enhance personal well-being. Just under one-third of all purchases were of medicines to enhance well-being. Remedies particularly popular included medicines believed to ward off evil spirits and bring good luck. The protection of infants with medicines which repel evil spirits is a common practice. Consumer behaviours indicate that the range of medicines available is increased by indigenisation of manufactured traditional medicines and cross-cultural borrowing. Case studies confirm that self- and infant medication with indigenous remedies augmented by indigenised medicines plays an important role in primary health care by allaying the fears and anxieties of everyday life within the Xhosa belief system. thereby promoting personal well-being.

Translating Personality Psychology to Help Personalize Preventive Medicine for Young-Adult Patients

PubMed Central

Israel, Salomon; Moffitt, Terrie E.; Belsky, Daniel W.; Hancox, Robert J.; Poulton, Richie; Roberts, Brent; Thomson, W. Murray; Caspi, Avshalom

2014-01-01

The rising number of newly insured young adults brought on by healthcare reform will soon increase demands on primary-care physicians. Physicians will face more young-adult patients which presents an opportunity for more prevention-oriented care. In the current study, we evaluated whether brief observer reports of young adults’ personality traits could predict which individuals would be at greater risk for poor health as they entered midlife. Following the Dunedin Study cohort of 1,000 individuals, we show that very brief measures of young adults’ personalities predicted their midlife physical health across multiple domains (metabolic abnormalities, cardiorespiratory fitness, pulmonary function, periodontal disease, and systemic inflammation). Individuals scoring low on the traits of Conscientiousness and Openness-to-Experience went on to develop poorer health even after accounting for preexisting differences in education, socioeconomic status, smoking, obesity, self-reported health, medical conditions, and family medical history. Moreover, personality ratings from peer informants who knew participants well, and from a nurse and receptionist who had just met participants for the first time, predicted health decline from young adulthood to midlife despite striking differences in level of acquaintance. Personality effect sizes were on par with other well-established health-risk factors such as socioeconomic status, smoking, and self-reported health. We discuss the potential utility of personality measurement to function as an inexpensive and accessible tool for healthcare professionals to personalize preventive medicine. Adding personality information to existing healthcare electronic infrastructures could also advance personality theory by generating opportunities to examine how personality processes influence doctor-patient communication, health service use, and patient outcomes. PMID:24588093

Cancer Immunotherapy and Personalized Medicine: Emerging Technologies and Biomarker-Based Approaches.

PubMed

Maciejko, Laura; Smalley, Munisha; Goldman, Aaron

2017-09-01

The vision and strategy for the 21st century treatment of cancer calls for a personalized approach in which therapy selection is designed for each individual patient. While genomics has led the field of personalized cancer medicine over the past several decades by connecting patient-specific DNA mutations with kinase-targeted drugs, the recent discovery that tumors evade immune surveillance has created unique challenges to personalize cancer immunotherapy. In this mini-review we will discuss how personalized medicine has evolved recently to accommodate the emerging era of cancer immunotherapy. Moreover, we will discuss novel platform technologies that have been engineered to address some of the persisting limitations. Beginning with early evidence in personalized medicine, we discuss how biomarker-driven approaches to predict clinical success have evolved to account for the heterogeneous tumor ecosystem. In the emerging field of cancer immunotherapy, this challenge requires the use of a novel set of tools, distinct from the classic approach of next-generation genomic sequencing-based strategies. We will introduce new techniques that seek to tailor immunotherapy by re-programming patient-autologous T-cells, and new technologies that are emerging to predict clinical efficacy by mapping infiltration of lymphocytes, and harnessing fully humanized platforms that reconstruct and interrogate immune checkpoint blockade, ex-vivo . While cancer immunotherapy is now leading to durable outcomes in difficult-to-treat cancers, success is highly variable. Developing novel approaches to study cancer immunotherapy, personalize treatment to each patient, and achieve greater outcomes is penultimate to developing sustainable cures in the future. Numerous techniques are now emerging to help guide treatment decisions, which go beyond simple biomarker-driven strategies, and are now we are seeking to interrogate the entirety of the dynamic tumor ecosystem.

Getting personal: can systems medicine integrate scientific and humanistic conceptions of the patient?

PubMed

Vogt, Henrik; Ulvestad, Elling; Eriksen, Thor Eirik; Getz, Linn

2014-12-01

The practicing doctor, and most obviously the primary care clinician who encounters the full complexity of patients, faces several fundamental but intrinsically related theoretical and practical challenges - strongly actualized by so-called medically unexplained symptoms (MUS) and multi-morbidity. Systems medicine, which is the emerging application of systems biology to medicine and a merger of molecular biomedicine, systems theory and mathematical modelling, has recently been proposed as a primary care-centered strategy for medicine that promises to meet these challenges. Significantly, it has been proposed to do so in a way that at first glance may seem compatible with humanistic medicine. More specifically, it is promoted as an integrative, holistic, personalized and patient-centered approach. In this article, we ask whether and to what extent systems medicine can provide a comprehensive conceptual account of and approach to the patient and the root causes of health problems that can be reconciled with the concept of the patient as a person, which is an essential theoretical element in humanistic medicine. We answer this question through a comparative analysis of the theories of primary care doctor Eric Cassell and systems biologist Denis Noble. We argue that, although systems biological concepts, notably Noble's theory of biological relativity and downward causation, are highly relevant for understanding human beings and health problems, they are nevertheless insufficient in fully bridging the gap to humanistic medicine. Systems biologists are currently unable to conceptualize living wholes, and seem unable to account for meaning, value and symbolic interaction, which are central concepts in humanistic medicine, as constraints on human health. Accordingly, systems medicine as currently envisioned cannot be said to be integrative, holistic, personalized or patient-centered in a humanistic medical sense. © 2014 The Authors. Journal of Evaluation in Clinical

Science, humanism, judgement, ethics: person-centered medicine as an emergent model of modern clinical practice.

PubMed

Miles, Andrew

2013-01-01

The Medical University of Plovdiv (MUP) has as its motto 'Committed to humanity". But what does humanity in modern medicine mean? Is it possible to practise a form of medicine that is without humanity? In the current article, it is argued that modern medicine is increasingly being practised in a de-personalised fashion, where the patient is understood not as a unique human individual, a person, but rather as a subject or an object and more in the manner of a complex biological machine. Medicine has, it is contended, become distracted from its duty to care, comfort and console as well as to ameliorate, attenuate and cure and that the rapid development of medicine's scientific knowledge is, paradoxically, principally causative. Signal occurrences in the 'patient as a person' movement are reviewed, together with the emergence of the evidence-based medicine (EBM) and patient-centered care (PCC) movements. The characteristics of a model of medicine evolving in response to medicine's current deficiencies--person-centered healthcare (PCH)--are noted and described. In seeking to apply science with humanism, via clinical judgement, within an ethical framework, it is contended that PCH will prove to be far more responsive to the needs of the individual patient and his/her personal circumstances than current models of practice, so that neither a reductive anatomico-pathological, disease-centric model of illness (EBM), nor an aggressive patient-directed, consumerist form of care (PCC) is allowed continued dominance within modern healthcare systems. In conclusion, it is argued that PCH will enable affordable advances in biomedicine and technology to be delivered to patients within a humanistic framework of clinical practice that recognises the patient as a person and which takes full account of his/her stories, values, preferences, goals, aspirations, fears, worries, hopes, cultural context and which responds to his/her psychological, emotional, spiritual and social necessities

A Web-Based Lifestyle Medicine Curriculum: Facilitating Education About Lifestyle Medicine, Behavioral Change, and Health Care Outcomes.

PubMed

Frates, Elizabeth Pegg; Xiao, Ryan C; Sannidhi, Deepa; McBride, Yasamina; McCargo, Tracie; Stern, Theodore A

2017-09-11

Lifestyle medicine is the science and application of healthy lifestyles as interventions for the prevention and treatment of disease, and has gained significant momentum as a specialty in recent years. College is a critical time for maintenance and acquisition of healthy habits. Longer-term, more intensive web-based and in-person lifestyle medicine interventions can have a positive effect. Students who are exposed to components of lifestyle medicine in their education have improvements in their health behaviors. A semester-long undergraduate course focused on lifestyle medicine can be a useful intervention to help adopt and sustain healthy habits. To describe a novel, evidence based curriculum for a course teaching the concepts of Lifestyle Medicine based on a web-based course offered at the Harvard Extension School. The course was delivered in a web-based format. The Lifestyle Medicine course used evidence based principles to guide students toward a "coach approach" to behavior change, increasing their self-efficacy regarding various lifestyle-related preventive behaviors. Students are made to understand the cultural trends and national guidelines that have shaped lifestyle medicine recommendations relating to behaviors. They are encouraged to engage in behavior change. Course topics include physical activity, nutrition, addiction, sleep, stress, and lifestyle coaching and counseling. The course addressed all of the American College of Preventive Medicine/American College of Lifestyle Medicine competencies save for the competency of office systems and technologies to support lifestyle medicine counseling. The course was well-received, earning a ranking of 4.9/5 at the school. A novel, semester-long course on Lifestyle Medicine at the Harvard Extension School is described. Student evaluations suggest the course was well-received. Further research is needed to evaluate whether such a course empowers students to adopt behavior changes. ©Elizabeth Pegg Frates, Ryan C

The evolution of personalized cancer genetic counseling in the era of personalized medicine.

PubMed

Vig, Hetal S; Wang, Catharine

2012-09-01

Practice changes in cancer genetic counseling have occurred to meet the demand for cancer genetic services. As cancer genetics continues to impact not only prevention strategies but also treatment decisions, current cancer genetic counseling models will need to be tailored to accommodate emerging clinical indications. These clinical indications include: surgical prophylactic bilateral mastectomy candidates, PARP-inhibitor candidates, patients with abnormal tumor screening results for Lynch syndrome, and post-test counseling patients (after genetic testing is ordered by another healthcare provider). A more personalized, multidisciplinary approach to selecting the best framework, for a given clinical indication, may become increasingly necessary in this era of personalized medicine.

Molecular Imaging in the Era of Personalized Medicine

PubMed Central

Jung, Kyung-Ho; Lee, Kyung-Han

2015-01-01

Clinical imaging creates visual representations of the body interior for disease assessment. The role of clinical imaging significantly overlaps with that of pathology, and diagnostic workflows largely depend on both fields. The field of clinical imaging is presently undergoing a radical change through the emergence of a new field called molecular imaging. This new technology, which lies at the intersection between imaging and molecular biology, enables noninvasive visualization of biochemical processes at the molecular level within living bodies. Molecular imaging differs from traditional anatomical imaging in that biomarkers known as imaging probes are used to visualize target molecules-of-interest. This ability opens up exciting new possibilities for applications in oncologic, neurological and cardiovascular diseases. Molecular imaging is expected to make major contributions to personalized medicine by allowing earlier diagnosis and predicting treatment response. The technique is also making a huge impact on pharmaceutical development by optimizing preclinical and clinical tests for new drug candidates. This review will describe the basic principles of molecular imaging and will briefly touch on three examples (from an immense list of new techniques) that may contribute to personalized medicine: receptor imaging, angiogenesis imaging, and apoptosis imaging. PMID:25812652

Molecular imaging in the era of personalized medicine.

PubMed

Jung, Kyung-Ho; Lee, Kyung-Han

2015-01-01

Clinical imaging creates visual representations of the body interior for disease assessment. The role of clinical imaging significantly overlaps with that of pathology, and diagnostic workflows largely depend on both fields. The field of clinical imaging is presently undergoing a radical change through the emergence of a new field called molecular imaging. This new technology, which lies at the intersection between imaging and molecular biology, enables noninvasive visualization of biochemical processes at the molecular level within living bodies. Molecular imaging differs from traditional anatomical imaging in that biomarkers known as imaging probes are used to visualize target molecules-of-interest. This ability opens up exciting new possibilities for applications in oncologic, neurological and cardiovascular diseases. Molecular imaging is expected to make major contributions to personalized medicine by allowing earlier diagnosis and predicting treatment response. The technique is also making a huge impact on pharmaceutical development by optimizing preclinical and clinical tests for new drug candidates. This review will describe the basic principles of molecular imaging and will briefly touch on three examples (from an immense list of new techniques) that may contribute to personalized medicine: receptor imaging, angiogenesis imaging, and apoptosis imaging.

Inflammatory bowel disease: towards a personalized medicine

PubMed Central

Flamant, Mathurin; Roblin, Xavier

2018-01-01

The management of inflammatory bowel disease (IBD) has been transformed over the last two decades by the arrival of tumor necrosis factor (TNF) antagonist agents. Recently, alternative drugs have been approved, directed at leukocyte-trafficking molecules (vedolizumab) or other inflammatory cytokines (ustekinumab). New therapeutics are currently being developed in IBD and represent promising targets as they involve other mechanisms of action (JAK molecules, Smad 7 antisense oligonucleotide etc.). Beyond TNF antagonist agents, these alternative drugs are needed for early-stage treatment of patients with aggressive IBD or when the disease is resistant to conventional therapy. Personalized medicine involves the determination of patients with a high risk of progression and complications, and better characterization of patients who may respond preferentially to specific therapies. Indeed, more and more studies aim to identify factors predictive of drug response (corresponding to a specific signaling pathway) that could better manage treatment for patients with IBD. Once treatment has started, disease monitoring is essential and remote patient care could in some circumstances be an attractive option. Telemedicine improves medical adherence and quality of life, and has a positive impact on health outcomes of patients with IBD. This review discusses the current application of personalized medicine to the management of patients with IBD and the advantages and limits of telemedicine in IBD. PMID:29383027

Incorporating imaging into personalized medicine for the detection of prostate cancer: Pharmacological research-Urogenital pharmacology.

PubMed

Mertan, Francesca; Turkbey, Baris

2016-12-01

Imaging has played an important role in the administration of personalized medicine. From diagnosing diseases to guiding therapies, imaging has become an all-encompassing modality. With respect to prostate cancer, personalized management of the disease has been transformed by imaging. Specifically, multiparametric magnetic resonance imaging has emerged as a vital player in the detection, characterization, and localization of the disease thus making the incorporation of imaging in personalized prostate cancer management integral. In this review, the current role of imaging in personalized medicine for the management of prostate cancer is discussed. Copyright © 2016. Published by Elsevier Ltd.

Enhancing provision of written medicine information in Australia: pharmacist, general practitioner and consumer perceptions of the barriers and facilitators

PubMed Central

2014-01-01

Background Written medicine information can play an important role in educating consumers about their medicines. In Australia, standardised, comprehensive written information known as Consumer Medicine Information (CMI) is available for all prescription medicines. CMI is reportedly under-utilised by general practitioners (GPs) and community pharmacists in consultations, despite consumer desire for medicine information. This study aimed to determine consumers’, GPs’ and community pharmacists’ preferences for CMI provision and identify barriers and facilitators to its use. Method Structured questionnaires were developed and administered to a national sample of Australian consumers (phone survey), community pharmacists and GPs (postal surveys) surrounding utilisation of CMI. Descriptive and comparative analyses were conducted. Results Half of consumers surveyed wanted to receive CMI for their prescription medicine, with spoken information preferable to written medicine information for many consumers and healthcare professionals. GPs and pharmacists remained a preferred source of medicine information for consumers, although package inserts were appealing to many among all three cohorts. Overall pharmacists were the preferred provider of CMI primarily due to their medicine expertise, accessibility and perceived availability. GPs preferred CMI dissemination through both the GP and pharmacist. Some consumers preferred GPs as the provider of medicines information because of their knowledge of the patients’ medicines and/or medical history, regularity of seeing the patient and good relationship with the patient. Common barriers to CMI provision cited included: time constraints, CMI length and perceptions that patients are not interested in receiving CMI. Facilitators to enhance provision included: strategies to increase consumer awareness, longer consultation times and counseling appointments, and improvements to pharmacy software technology and workflow. Conclusion

Personalized medicine in rheumatology

PubMed Central

Kłak, Anna; Kwiatkowska, Brygida; Raciborski, Filip

2016-01-01

In the era of the 21st century, rheumatoid arthritis (RA) is still poorly characterized. Rheumatoid arthritis is a common but heterogeneous disease, not only in the course and clinical symptoms, but also in the clinical response to treatment. Now it is known that early, correct diagnosis and starting treatment with disease-modifying drugs (DMARDs), of which methotrexate (MTX) remains the gold standard in the treatment of RA, is crucial in order to prevent joint destruction, functional disability and an unfavourable disease outcome. Early diagnosis of rheumatoid arthritis is significant in so much as the primary treatment can be started better. Pharmacogenetic and pharmacogenomic studies, which help determine the genetic profile of individual patients, may bring us closer to personalized medicine. Further studies on RA should allow for the identification of disease-specific genes at the stage when their tolerance by the organism is still preserved (before auto-aggression develops). PMID:27826172

Persons with allergy symptoms use alternative medicine more often.

PubMed

Kłak, Anna; Raciborski, Filip; Krzych-Fałta, Edyta; Opoczyńska-Świeżewska, Dagmara; Szymański, Jakub; Lipiec, Agnieszka; Piekarska, Barbara; Sybilski, Adam; Tomaszewska, Aneta; Samoliński, Bolesław

2016-01-01

The aim of the study is to indicate the relation between the use of alternative medicine and the occurrence of allergic diseases in the Polish population of adults in the age of 20-44 years. Moreover the additional aim of the study is to define the relation between the sex, age and place of living and the use of alternative medicine. The data from the project Epidemiology of Allergic Diseases in Poland (ECAP) has been used for analysis. This project was a continuation of the European Community Respiratory Health Survey II. The questions on alternative medicine were asked to the group of 4671 respondents in the age of 20-44 years. Additionally outpatient tests were performed in order to confirm the diagnosis of allergic diseases. The total of 22.2% of respondents that participated in the study have ever used alternative medicine (n = 4621). A statistically significant relation between the use of alternative medicine and declaration of allergic diseases and asthma symptoms has been demonstrated (p &amp;amp;amp;amp;amp;lt; 0.001). No statistically significant relation between the use of alternative medicine by persons diagnosed by a doctor with any form of asthma or seasonal allergic rhinitis (p &amp;amp;amp;amp;amp;gt; 0.05) has been demonstrated. The occurrence of allergic diseases and asthma influences the frequency of alternative medicine use. However the frequency of alternative medicine use does not depend on allergic disease or asthma being confirmed by a doctor.

G-DOC: A Systems Medicine Platform for Personalized Oncology1

PubMed Central

Madhavan, Subha; Gusev, Yuriy; Harris, Michael; Tanenbaum, David M; Gauba, Robinder; Bhuvaneshwar, Krithika; Shinohara, Andrew; Rosso, Kevin; Carabet, Lavinia A; Song, Lei; Riggins, Rebecca B; Dakshanamurthy, Sivanesan; Wang, Yue; Byers, Stephen W; Clarke, Robert; Weiner, Louis M

2011-01-01

Currently, cancer therapy remains limited by a “one-size-fits-all” approach, whereby treatment decisions are based mainly on the clinical stage of disease, yet fail to reference the individual's underlying biology and its role driving malignancy. Identifying better personalized therapies for cancer treatment is hindered by the lack of high-quality “omics” data of sufficient size to produce meaningful results and the ability to integrate biomedical data from disparate technologies. Resolving these issues will help translation of therapies from research to clinic by helping clinicians develop patient-specific treatments based on the unique signatures of patient's tumor. Here we describe the Georgetown Database of Cancer (G-DOC), a Web platform that enables basic and clinical research by integrating patient characteristics and clinical outcome data with a variety of high-throughput research data in a unified environment. While several rich data repositories for high-dimensional research data exist in the public domain, most focus on a single-data type and do not support integration across multiple technologies. Currently, G-DOC contains data from more than 2500 breast cancer patients and 800 gastrointestinal cancer patients, G-DOC includes a broad collection of bioinformatics and systems biology tools for analysis and visualization of four major “omics” types: DNA, mRNA, microRNA, and metabolites. We believe that G-DOC will help facilitate systems medicine by providing identification of trends and patterns in integrated data sets and hence facilitate the use of better targeted therapies for cancer. A set of representative usage scenarios is provided to highlight the technical capabilities of this resource. PMID:21969811

Asthma pharmacogenetics and the development of genetic profiles for personalized medicine

PubMed Central

Ortega, Victor E; Meyers, Deborah A; Bleecker, Eugene R

2015-01-01

Human genetics research will be critical to the development of genetic profiles for personalized or precision medicine in asthma. Genetic profiles will consist of gene variants that predict individual disease susceptibility and risk for progression, predict which pharmacologic therapies will result in a maximal therapeutic benefit, and predict whether a therapy will result in an adverse response and should be avoided in a given individual. Pharmacogenetic studies of the glucocorticoid, leukotriene, and β2-adrenergic receptor pathways have focused on candidate genes within these pathways and, in addition to a small number of genome-wide association studies, have identified genetic loci associated with therapeutic responsiveness. This review summarizes these pharmacogenetic discoveries and the future of genetic profiles for personalized medicine in asthma. The benefit of a personalized, tailored approach to health care delivery is needed in the development of expensive biologic drugs directed at a specific biologic pathway. Prior pharmacogenetic discoveries, in combination with additional variants identified in future studies, will form the basis for future genetic profiles for personalized tailored approaches to maximize therapeutic benefit for an individual asthmatic while minimizing the risk for adverse events. PMID:25691813

Realizing the promise of personalized medicine.

PubMed

Aspinall, Mara G; Hamermesh, Richard G

2007-10-01

Scientific advances have begun to give doctors the power to customize therapy for individuals. However, adoption of this approach has progressed slowly and unevenly because the trial-and-error treatment model still governs how the health care system develops, regulates, pays for, and delivers therapies. Aspinall, the president of Genzyme Genetics, and Hamermesh, chair of a Harvard Business School initiative to improve leadership in health care organizations, discuss the barriers to personalized medicine and suggest ways to overcome them. The blockbuster model for developing drugs, the authors point out, is still what most major pharmaceutical companies follow, even though its days are numbered. What the industry must embrace in its place is a business model based on a larger portfolio of targeted--and therefore more effective and profitable--treatments, not a limited palette of one-size-fits-all drugs. The current regulatory environment overemphasizes large-scale clinical trials of broad-based therapies. Instead, the focus should be on enrolling subpopulations, based on diagnostic testing, in trials of targeted drug treatments and on monitoring and assessing effectiveness after drugs are approved. A dysfunctional payment system complicates matters by rewarding providers for performance of procedures rather than for accurate diagnosis and effective prevention. Aspinall and Hamermesh call for coordinating regulation and reimbursement so that incentives are provided for the right outcomes. Finally, the authors urge changing physicians' habits through education about genomics, diagnostic testing, and targeted therapies. They say that medical schools and physician organizations must become committed advocates of personalized medicine so that patients and the medical industry can get all the benefits it offers.

Genetic Knowledge Among Participants in the Coriell Personalized Medicine Collaborative.

PubMed

Schmidlen, Tara J; Scheinfeldt, Laura; Zhaoyang, Ruixue; Kasper, Rachel; Sweet, Kevin; Gordon, Erynn S; Keller, Margaret; Stack, Cathy; Gharani, Neda; Daly, Mary B; Jarvis, Joseph; Christman, Michael F

2016-04-01

Genetic literacy is essential for the effective integration of genomic information into healthcare; yet few recent studies have been conducted to assess the current state of this knowledge base. Participants in the Coriell Personalized Medicine Collaborative (CPMC), a prospective study assessing the impact of personalized genetic risk reports for complex diseases and drug response on behavior and health outcomes, completed genetic knowledge questionnaires and other surveys through an online portal. To assess the association between genetic knowledge and genetic education background, multivariate linear regression was performed. 4 062 participants completed a genetic knowledge and genetic education background questionnaire. Most were older (mean age: 50), Caucasian (90 %), female (59 %), highly educated (69 % bachelor's or higher), with annual household income over $100 000 (49 %). Mean percent correct was 76 %. Controlling for demographics revealed that health care providers, participants previously exposed to genetics, and participants with 'better than most' self-rated knowledge were significantly more likely to have a higher knowledge score (p < 0.001). Overall, genetic knowledge was high with previous genetic education experience predictive of higher genetic knowledge score. Education is likely to improve genetic literacy, an important component to expanded use of genomics in personalized medicine.

(13)C breath tests in personalized medicine: fiction or reality?

PubMed

Modak, Anil S

2009-11-01

The concept of personalized medicine is gathering momentum as various biomarkers are being discovered and developed to lead to genotype and phenotype diagnostic tests, which will enable physicians to individualize therapy. Noninvasive, rapid (13)C breath tests have the potential to serve as clinically significant diagnostic tools, especially for evaluating the enzyme activity of polymorphic enzymes. This would enable physicians to rapidly identify responders/nonresponders to various drugs primarily metabolized by these enzymes prior to initiation of therapy. With the information on enzyme activity, the physician can prescribe the right drug, at the right dose, at the right time, to the right individual, for the right clinical outcome. However, the promise of the era of personalized medicine, including the novel (13)C breath tests, will have to overcome several regulatory, business and financial hurdles for diagnostic tests to become part of routine mainstream clinical practice over the next decade.

Semantically enabling pharmacogenomic data for the realization of personalized medicine

PubMed Central

Samwald, Matthias; Coulet, Adrien; Huerga, Iker; Powers, Robert L; Luciano, Joanne S; Freimuth, Robert R; Whipple, Frederick; Pichler, Elgar; Prud’hommeaux, Eric; Dumontier, Michel; Marshall, M Scott

2014-01-01

Understanding how each individual’s genetics and physiology influences pharmaceutical response is crucial to the realization of personalized medicine and the discovery and validation of pharmacogenomic biomarkers is key to its success. However, integration of genotype and phenotype knowledge in medical information systems remains a critical challenge. The inability to easily and accurately integrate the results of biomolecular studies with patients’ medical records and clinical reports prevents us from realizing the full potential of pharmacogenomic knowledge for both drug development and clinical practice. Herein, we describe approaches using Semantic Web technologies, in which pharmacogenomic knowledge relevant to drug development and medical decision support is represented in such a way that it can be efficiently accessed both by software and human experts. We suggest that this approach increases the utility of data, and that such computational technologies will become an essential part of personalized medicine, alongside diagnostics and pharmaceutical products. PMID:22256869

Emerging genomic technologies and the concept of personalized medicine.

PubMed

Glinskii, Victoria G; Glinsky, Gennadi V

2008-08-01

With the completion of the Human Genome Project in May 2006, genetic testing for every American is rapidly becoming a reality. As the advanced technology fuels the path towards personalized medicine, genetic nondiscrimination legislation follows closely behind. It seems that the 2007 Genetic Information Nondiscrimination Act (GINA) will finally pass through both chambers of Congress and will be signed by the President, but questions remain. On May 1, 2008, the House passed GINA by a vote of 414 to 1. Why is this the year that genetic nondiscrimination legislation could finally become the reality? Is this the beginning of a new relationship between science and policy, where policy is finally catching up? We examine the answers to these questions through a look at the history of genetic nondiscrimination legislation and where it stands today, including arguments for and against the bill. We conclude by discussing how we can achieve a future of safe personalized medicine for the populous, which would require continuous productive interactions between policymakers and scientists.

Taking Bioinformatics to Systems Medicine.

PubMed

van Kampen, Antoine H C; Moerland, Perry D

2016-01-01

Systems medicine promotes a range of approaches and strategies to study human health and disease at a systems level with the aim of improving the overall well-being of (healthy) individuals, and preventing, diagnosing, or curing disease. In this chapter we discuss how bioinformatics critically contributes to systems medicine. First, we explain the role of bioinformatics in the management and analysis of data. In particular we show the importance of publicly available biological and clinical repositories to support systems medicine studies. Second, we discuss how the integration and analysis of multiple types of omics data through integrative bioinformatics may facilitate the determination of more predictive and robust disease signatures, lead to a better understanding of (patho)physiological molecular mechanisms, and facilitate personalized medicine. Third, we focus on network analysis and discuss how gene networks can be constructed from omics data and how these networks can be decomposed into smaller modules. We discuss how the resulting modules can be used to generate experimentally testable hypotheses, provide insight into disease mechanisms, and lead to predictive models. Throughout, we provide several examples demonstrating how bioinformatics contributes to systems medicine and discuss future challenges in bioinformatics that need to be addressed to enable the advancement of systems medicine.

Integrating personal medicine into service delivery: empowering people in recovery.

PubMed

MacDonald-Wilson, Kim L; Deegan, Patricia E; Hutchison, Shari L; Parrotta, Nancy; Schuster, James M

2013-12-01

Illness management and recovery strategies are considered evidence-based practices. The article describes how a web-based application, CommonGround, has been used to support implementation of such strategies in outpatient mental health services and assess its impact. The specific focus of this article is Personal Medicine, self-management strategies that are a salient component of the CommonGround intervention. With support from counties and a not-for-profit managed care organization, CommonGround has been introduced in 10 medication clinics, one Assertive Community Treatment (ACT) team, and one peer support center across Pennsylvania. Methods include analysis of data from the application's database and evaluation of health functioning, symptoms, and progress toward recovery. Health functioning improved over time and use of self-management strategies was associated with fewer concerns about medication side effects, fewer concerns about the impact of mental health medicine on physical health, more reports that mental health medicines were helping, and greater progress in individuals' recovery. Using Personal Medicine empowers individuals to work with their prescribers to find a "right balance" between what they do to be well and what they take to be well. This program helps individuals and their service team focus on individual strengths and resilient self-care strategies. More research is needed to assess factors that may predict changes in outcomes and how a web-based tool focused on self-management strategies may moderate those factors. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Facilitating ADLs by Caregivers of Persons with Dementia: The C3P Model

PubMed Central

Amella, Elaine J.; Batchelor-Aselage, Melissa B.

2015-01-01

The purpose of this paper is to explicate a change model for caregivers of persons with dementia to assist them in facilitating meals in the home, at community-based programs and in institutional settings. Building on a Social Ecological Model, the C3P Model—Change the Person, Change the People, Change the Place offers a clear method to adapt care strategies to foster independence while providing appropriate support as the person with dementia cognitively and functionally declines. Meals are highly embedded within a culture and are ritualized events within a family requiring an individualized approach when modifications are needed. PMID:24354332

Molecular classification of idiopathic pulmonary fibrosis: personalized medicine, genetics and biomarkers.

PubMed

Hambly, Nathan; Shimbori, Chiko; Kolb, Martin

2015-10-01

Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive fibrotic lung disease associated with high morbidity and poor survival. Characterized by substantial disease heterogeneity, the diagnostic considerations, clinical course and treatment response in individual patients can be variable. In the past decade, with the advent of high-throughput proteomic and genomic technologies, our understanding of the pathogenesis of IPF has greatly improved and has led to the recognition of novel treatment targets and numerous putative biomarkers. Molecular biomarkers with mechanistic plausibility are highly desired in IPF, where they have the potential to accelerate drug development, facilitate early detection in susceptible individuals, improve prognostic accuracy and inform treatment recommendations. Although the search for candidate biomarkers remains in its infancy, attractive targets such as MUC5B and MPP7 have already been validated in large cohorts and have demonstrated their potential to improve clinical predictors beyond that of routine clinical practices. The discovery and implementation of future biomarkers will face many challenges, but with strong collaborative efforts among scientists, clinicians and the industry the ultimate goal of personalized medicine may be realized. © 2015 Asian Pacific Society of Respirology.

Navigating legal constraints in clinical data warehousing: a case study in personalized medicine.

PubMed

Jefferys, Benjamin R; Nwankwo, Iheanyi; Neri, Elias; Chang, David C W; Shamardin, Lev; Hänold, Stefanie; Graf, Norbert; Forgó, Nikolaus; Coveney, Peter

2013-04-06

Personalized medicine relies in part upon comprehensive data on patient treatment and outcomes, both for analysis leading to improved models that provide the basis for enhanced treatment, and for direct use in clinical decision-making. A data warehouse is an information technology for combining and standardizing multiple databases. Data warehousing of clinical data is constrained by many legal and ethical considerations, owing to the sensitive nature of the data being stored. We describe an unconstrained clinical data warehousing architecture, some of the legal constraints that have led us to reconsider this architecture, and the legal and technical solutions to these constraints developed for the clinical data warehouse in the personalized medicine project p-medicine. We also propose some changes to the legal constraints that will further enable clinical research.

Navigating legal constraints in clinical data warehousing: a case study in personalized medicine

PubMed Central

Jefferys, Benjamin R.; Nwankwo, Iheanyi; Neri, Elias; Chang, David C. W.; Shamardin, Lev; Hänold, Stefanie; Graf, Norbert; Forgó, Nikolaus; Coveney, Peter

2013-01-01

Personalized medicine relies in part upon comprehensive data on patient treatment and outcomes, both for analysis leading to improved models that provide the basis for enhanced treatment, and for direct use in clinical decision-making. A data warehouse is an information technology for combining and standardizing multiple databases. Data warehousing of clinical data is constrained by many legal and ethical considerations, owing to the sensitive nature of the data being stored. We describe an unconstrained clinical data warehousing architecture, some of the legal constraints that have led us to reconsider this architecture, and the legal and technical solutions to these constraints developed for the clinical data warehouse in the personalized medicine project p-medicine. We also propose some changes to the legal constraints that will further enable clinical research. PMID:24427531

Personalized medicine and access to genetic technologies.

PubMed

den Exter, André

2010-01-01

Personalized medicine started after the Human Genome Project and is a relatively new concept that will dramatically change clinical practice. It offers clear clinical advantages by applying genetic diagnostic tests and then treating the patient with targeted medicines based on his or her genetic make-up. Its potential seems promising but there are quite a few legal concerns. One of these questions deals with the right to health care and access to genetic technologies. In this paper, the author explains the meaning of such a right to health care under international human rights law, its relevance for making genetic services eligible for public funding, how to cope with quality concerns of commercial testing, and finally, the patentability controversy and clinical access to genetic information. Apart from more traditional human rights concerns (consent, privacy, confidentiality) and genetics, States should be aware of the meaning of the equal access concept under international law and its consequences when introducing new technologies such genetic testing and services.

From Metabonomics to Pharmacometabonomics: The Role of Metabolic Profiling in Personalized Medicine

PubMed Central

Everett, Jeremy R.

2016-01-01

Variable patient responses to drugs are a key issue for medicine and for drug discovery and development. Personalized medicine, that is the selection of medicines for subgroups of patients so as to maximize drug efficacy and minimize toxicity, is a key goal of twenty-first century healthcare. Currently, most personalized medicine paradigms rely on clinical judgment based on the patient's history, and on the analysis of the patients' genome to predict drug effects i.e., pharmacogenomics. However, variability in patient responses to drugs is dependent upon many environmental factors to which human genomics is essentially blind. A new paradigm for predicting drug responses based on individual pre-dose metabolite profiles has emerged in the past decade: pharmacometabonomics, which is defined as “the prediction of the outcome (for example, efficacy or toxicity) of a drug or xenobiotic intervention in an individual based on a mathematical model of pre-intervention metabolite signatures.” The new pharmacometabonomics paradigm is complementary to pharmacogenomics but has the advantage of being sensitive to environmental as well as genomic factors. This review will chart the discovery and development of pharmacometabonomics, and provide examples of its current utility and possible future developments. PMID:27660611

Eliminating barriers to personalized medicine

PubMed Central

2014-01-01

With the emergence of high-throughput discovery platforms, robust preclinical small-animal models, and efficient clinical trial pipelines, it is becoming possible to envision a time when the treatment of human neurologic diseases will become personalized. The emergence of precision medicine will require the identification of subgroups of patients most likely to respond to specific biologically based therapies. This stratification only becomes possible when the determinants that contribute to disease heterogeneity become more fully elucidated. This review discusses the defining factors that underlie disease heterogeneity relevant to the potential for individualized brain tumor (optic pathway glioma) treatments arising in the common single-gene cancer predisposition syndrome, neurofibromatosis type 1 (NF1). In this regard, NF1 is posited as a model genetic condition to establish a workable paradigm for actualizing precision therapeutics for other neurologic disorders. PMID:24975854

The impact of mind-body medicine facilitation on affirming and enhancing professional identity in health care professions faculty.

PubMed

Talisman, Nicholas; Harazduk, Nancy; Rush, Christina; Graves, Kristi; Haramati, Aviad

2015-06-01

Georgetown University School of Medicine (GUSOM) offers medical students a course in mind-body medicine (MBM) that introduces them to tools that reduce stress and foster self-awareness. Previous studies reported decreases in students' perceived stress and increases in mindfulness-changes that were associated with increased empathic concern and other elements of professional identity formation. However, no reports have described the impact of an MBM course on the facilitators themselves. To explore whether MBM facilitation is associated with changes in professional identity, self-awareness, and/or perceived stress, 62 facilitators, trained by the GUSOM MBM program, were invited to complete two validated surveys: the Freiburg Mindfulness Inventory (FMI) and the Perceived Stress Scale (PSS). Forty-two participants also completed a six-item open-ended questionnaire addressing their experience in the context of their professional identity. Facilitators' scores were significantly lower on PSS and higher on FMI compared with normative controls (P < .05), and the two parameters were inversely correlated (-0.46, P < .01). Qualitative analysis revealed three main themes: (1) aspects of professional identity (with subthemes of communication; connections and community; empathy and active listening; and self-confidence); (2) self-care; and (3) mindful awareness. Preliminary findings will be extended with larger studies that examine longitudinal quantitative assessment of communication, connection, and self-confidence outcomes in MBM facilitators, and the impact of MBM facilitation on burnout and resilience.

Personalized medicine and the role of health economics and outcomes research: issues, applications, emerging trends, and future research.

PubMed

O'Donnell, John C

2013-01-01

The decade since the completion of the sequencing of the human genome has witnessed significant advances in the incorporation of genomic information in diagnostic, treatment, and reimbursement practices. Indeed, as case in point, there are now several dozen commercially available genomic tests routinely applied across a wide range of disease states in predictive or prognostic applications. Moreover, many involved in the advancement of personalized medicine would view emerging approaches to stratify patients in meaningful ways beyond genomic information as a signal of the progress made. Yet despite these advances, there remains a general sense of dissatisfaction about the progress of personalized medicine in terms of its contribution to the drug development process, to the efficiency and effectiveness of health care delivery, and ultimately to the provision of the right treatment to the right patient at the right time. Academicians, payers, and manufacturers alike are struggling not only with how to embed the new insights that personalized medicine promises but also with the fundamental issues of application in early drug development, implications for health technology assessment, new demands on traditional health economic and outcomes research methods, and implications for reimbursement and access. In fact, seemingly prosaic issues such as the definition and composition of the term "personalized medicine" are still unresolved. Regardless of these issues, practitioners are increasingly compelled to find practical solutions to the challenges and opportunities presented by the evolving face of personalized medicine today. Accordingly, the articles comprising this Special Issue offer applied perspectives geared toward professionals and policymakers in the field grappling with developing, assessing, implementing, and reimbursing personalized medicine approaches. Starting with a framework with which to characterize personalized medicine, this Special Issue proceeds to

Human iPSC-derived neurons and lymphoblastoid cells for personalized medicine research in neuropsychiatric disorders.

PubMed

Gurwitz, David

2016-09-01

The development and clinical implementation of personalized medicine crucially depends on the availability of high-quality human biosamples; animal models, although capable of modeling complex human diseases, cannot reflect the large variation in the human genome, epigenome, transcriptome, proteome, and metabolome. Although the biosamples available from public biobanks that store human tissues and cells may represent the large human diversity for most diseases, these samples are not always sufficient for developing biomarkers for patient-tailored therapies for neuropsychiatric disorders. Postmortem human tissues are available from many biobanks; nevertheless, collections of neuronal human cells from large patient cohorts representing the human diversity remain scarce. Two tools are gaining popularity for personalized medicine research on neuropsychiatric disorders: human induced pluripotent stem cell-derived neurons and human lymphoblastoid cell lines. This review examines and contrasts the advantages and limitations of each tool for personalized medicine research.

Genetic and molecular alterations in pancreatic cancer: implications for personalized medicine.

PubMed

Fang, Yantian; Yao, Qizhi; Chen, Zongyou; Xiang, Jianbin; William, Fisher E; Gibbs, Richard A; Chen, Changyi

2013-10-31

Recent advances in human genomics and biotechnologies have profound impacts on medical research and clinical practice. Individual genomic information, including DNA sequences and gene expression profiles, can be used for prediction, prevention, diagnosis, and treatment for many complex diseases. Personalized medicine attempts to tailor medical care to individual patients by incorporating their genomic information. In a case of pancreatic cancer, the fourth leading cause of cancer death in the United States, alteration in many genes as well as molecular profiles in blood, pancreas tissue, and pancreas juice has recently been discovered to be closely associated with tumorigenesis or prognosis of the cancer. This review aims to summarize recent advances of important genes, proteins, and microRNAs that play a critical role in the pathogenesis of pancreatic cancer, and to provide implications for personalized medicine in pancreatic cancer.

[Personalized molecular medicine: new paradigms in the treatment of cochlear implant and cancer patients].

PubMed

Zenner, H P; Pfister, M; Friese, N; Zrenner, E; Röcken, M

2014-07-01

To evaluate present options for the indication of cochlear implants (CI) and new forms of treatment for head and neck cancer, melanomas and basal cell carcinomas, with emphasis on future perspectives. A literature search was performed in the PubMed database. Search parameters were "personalized medicine", "individualized medicine" and "molecular medicine". Personalized medicine based on molecular-genetic evaluation of functional proteins such as otoferlin, connexin 26 and KCNQ4 or the Usher gene is becoming increasingly important for the indication of CI in the context of infant deafness. Determination of HER2/EGFR mutations in the epithelial growth factor receptor (EGFR) gene may be an important prognostic parameter for therapeutic decisions in head and neck cancer patients. In basal cell carcinoma therapy, mutations in the Hedgehog (PCTH1) and Smoothened (SMO) pathways strongly influence the indication of therapeutic Hedgehog inhibition, e.g. using small molecules. Analyses of c-Kit receptor, BRAF-600E and NRAS mutations are required for specific molecular therapy of metastasizing melanomas. The significant advances in the field of specific molecular therapy are best illustrated by the availability of the first gene therapeutic procedures for treatment of RPE65-induced infantile retinal degradation. The aim of personalized molecular medicine is to identify patients who will respond particularly positively or negatively (e.g. in terms of adverse side effects) to a therapy using the methods of molecular medicine. This should allow a specific therapy to be successfully applied or preclude its indication in order to avoid serious adverse side effects. This approach serves to stratify patients for adequate treatment.

Implementing Personalized Medicine in a Cancer Center

PubMed Central

Fenstermacher, David A.; Wenham, Robert M.; Rollison, Dana E.; Dalton, William S.

2011-01-01

In 2006, the Moffitt Cancer Center partnered with patients, community clinicians, industry, academia, and seventeen hospitals in the United States to begin a personalized cancer care initiative called Total Cancer Care™ . Total Cancer Care was designed to collect tumor specimens and clinical data throughout a patient’s lifetime with the goal of finding “the right treatment, for the right patient, at the right time.” Because Total Cancer Care is a partnership with the patient and involves collection of clinical data and tumor specimens for research purposes, a formal protocol and patient consent process was developed and an information technology platform was constructed to provide a robust “warehouse” for clinical and molecular profiling data. To date, over 76,000 cancer patients from Moffitt and consortium medical centers have been enrolled in the protocol. The TCC initiative has developed many of the capabilities and resources that are building the foundation of personalized medicine. PMID:22157297

Personalized Medicine and Adverse Drug Reactions: The Experience of An Italian Teaching Hospital.

PubMed

La Russa, Raffaele; Finesch, Vittorio; Di Sanzo, Mariantonia; Gatto, Vittorio; Santurro, Alessandro; Martini, Gabriella; Scopetti, Matteo; Frati, Paola

2017-01-01

The personalized medicine is a model of medicine based on inherent difference given by the genetic heritage that characterizes us, diversity that can affect also our response to administered therapy. Nowadays, the term "adverse drug reaction" is identified with any harmful effect involuntary resulting from the use of a medicinal product; pharmacogenomics, in this field, has the aim to improve the drug response and to reduce the adverse reaction. We analyzed all reports of adverse reaction collected in the Pharmacovigilance Centre database of an Italian University Hospital, at the Sant'Andrea Hospital Sapienza University of Rome, in a period of two years. Comparing the data result from our analysis with several studies found in literature, it is evident that adverse drug reactions represent an important problem in the management of a health care system. However, the development of pharmacogenetics and pharmacogenomics, allowing a personalized treatment, can improve clinical practice. This study highlights the great potential of pharmacogenomics in reducing adverse reactions and suggests the need for further pharmacogenomic clinical trials to better personalize drug treatment and to refine the current pharmacovigilance strategies. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

p-Medicine: From data sharing and integration via VPH models to personalized medicine.

PubMed

Rossi, S; Christ-Neumann, Ml; Rüping, S; Buffa, Fm; Wegener, D; McVie, G; Coveney, Pv; Graf, N; Delorenzi, M

2011-01-01

The Worldwide innovative Networking in personalized cancer medicine (WIN) initiated by the Institute Gustave Roussy (France) and The University of Texas MD Anderson Cancer Center (USA) has dedicated its 3rd symposium (Paris, 6-8 July 2011) to discussion on gateways to increase the efficacy of cancer diagnostics and therapeutics (http://www.winconsortium.org/symposium.html).Speakers ranged from clinical oncologist to researchers, industrial partners, and tools developers; a famous patient was present: Janelle Hail, a 30-year breast cancer survivor, founder and CEO of the National Breast Cancer Foundation, Inc. (NBCF).The p-medicine consortium found this venue a perfect occasion to present a poster about its activities that are in accordance with the take home message of the symposium.In this communication, we summarize what we presented with particular attention to the interaction between the symposium's topic and content and our project.

p-Medicine: From data sharing and integration via VPH models to personalized medicine

PubMed Central

Rossi, S; Christ-Neumann, ML; Rüping, S; Buffa, FM; Wegener, D; McVie, G; Coveney, PV; Graf, N; Delorenzi, M

2011-01-01

The Worldwide innovative Networking in personalized cancer medicine (WIN) initiated by the Institute Gustave Roussy (France) and The University of Texas MD Anderson Cancer Center (USA) has dedicated its 3rd symposium (Paris, 6–8 July 2011) to discussion on gateways to increase the efficacy of cancer diagnostics and therapeutics (http://www.winconsortium.org/symposium.html). Speakers ranged from clinical oncologist to researchers, industrial partners, and tools developers; a famous patient was present: Janelle Hail, a 30-year breast cancer survivor, founder and CEO of the National Breast Cancer Foundation, Inc. (NBCF). The p-medicine consortium found this venue a perfect occasion to present a poster about its activities that are in accordance with the take home message of the symposium. In this communication, we summarize what we presented with particular attention to the interaction between the symposium’s topic and content and our project. PMID:22276060

An Unfulfilled Promise: Changes Needed to the Drug Approval Process to Make Personalized Medicine a Reality.

PubMed

Riley, Margaret Foster

2015-01-01

The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recently, there is renewed interest; personalized medicine is much in the news. Legislation has been considered with the goal of smoothing, shortening and incentivizing the approval process for therapeutic products. President Obama mentioned the need for new initiatives to achieve such goals in the State of the Union address. But most of these initiatives do not consider the fundamental changes that personalized medicine demands. It requires a statutory structure designed for the development of products applicable for small subpopulations that is very different from our current model which is designed for the development of products for large populations. The current approval process is purposely not designed to consider individual efficacy. It is designed to incentivize reduced variation in clinical trials rather than embracing variation. In addition, it is based on twentieth-century notions of disease focused on phenotype rather than on pathophysiologic pathways. Current foci on the development of companion diagnostics, orphan drugs and post-approval study are important but insufficient. FDA does not have the authority to require the type of standardization, clinical trial design and extensive data reporting and sharing that. is needed to achieve the goals for personalized medicine. In addition, FDA's current drug approval process is too lengthy and cumbersome to deal with the iterative responses personalized medicine entails. If we are serious about wanting to achieve these goals, we will need to entertain such fundamental changes in authority.

Index case finding facilitates identification and linkage to care of children and young persons living with HIV/AIDS in Malawi.

PubMed

Ahmed, Saeed; Sabelli, Rachael A; Simon, Katie; Rosenberg, Nora E; Kavuta, Elijah; Harawa, Mwelura; Dick, Spencer; Linzie, Frank; Kazembe, Peter N; Kim, Maria H

2017-08-01

Evaluation of a novel index case finding and linkage-to-care programme to identify and link HIV-infected children (1-15 years) and young persons (>15-24 years) to care. HIV-infected patients enrolled in HIV services were screened and those who reported untested household members (index cases) were offered home- or facility-based HIV testing and counselling (HTC) of their household by a community health worker (CHW). HIV-infected household members identified were enrolled in a follow-up programme offering home and facility-based follow-up by CHWs. Of the 1567 patients enrolled in HIV services, 1030 (65.7%) were screened and 461 (44.8%) identified as index cases; 93.5% consented to HIV testing of their households and of those, 279 (64.7%) reported an untested child or young person. CHWs tested 711 children and young persons, newly diagnosed 28 HIV-infected persons (yield 4.0%; 95% CI: 2.7-5.6), and identified an additional two HIV-infected persons not enrolled in care. Of the 30 HIV-infected persons identified, 23 (76.6%) were linked to HIV services; 18 of the 20 eligible for ART (90.0%) were initiated. Median time (IQR) from identification to enrolment into HIV services was 4 days (1-8) and from identification to ART start was 6 days (1-8). Almost half of HIV-infected patients enrolled in treatment services had untested household members, many of whom were children and young persons. Index case finding, coupled with home-based testing and tracked follow-up, is acceptable, feasible and facilitates the identification and timely linkage to care of HIV-infected children and young persons. © 2017 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

[Management of Personal Information in Clinical Laboratory Medicine:--Chairmen's Introductory Remarks].

PubMed

Yoshida, Hiroshi; Shimetani, Naoto

2014-11-01

The Japanese Society of Laboratory Medicine has been running its own Medical Safety Committee, and holding a symposium on medical safety during the annual meeting. The medical world is filled with a considerable amount of personal information, including genetic information, the ultimate personal information. We, as medical staff, have to manage such personal information not only in times of peace but also during disasters or emergency situations. In Japan, the Act on the Protection of Personal Information is currently being implemented, but a number of problems remain. Human beings have entered the information technology era, including electrical medical record systems, which is useful for research and education besides medical practice. This is why personal information must be more effectively protected from leakage, misconception, and abuse. We should create a sound system to manage personal information, with the spirit of protecting patient information that originated from the Oath of Hippocrates.

The role of the pathologist in translational and personalized medicine.

PubMed

Perl, Daniel P

2007-04-01

Over the years, pathologists have served to make morphologic diagnoses for clinicians when provided with a biopsy or surgically resected tissue specimen. Traditionally, pathologists have used a series of morphologic techniques and relied on the microscopic appearance of resected tissues to determine a pathologic diagnosis and, with respect to neoplastic lesions, provide predictions of the potential growth pattern that might be anticipated. With the introduction of the techniques of molecular biology in medicine, the role of the pathologist has changed as have the tools available for characterizing pathologic specimens. With the pathologist's unique perspective on disease processes and access to tissue specimens from the operating room, he has become a key player in the area of translational and personalized medicine and the development of new approaches to diagnosis and translational research. Copyright (c) 2007 Mount Sinai School of Medicine.

Addressing phenoconversion: the Achilles' heel of personalized medicine

PubMed Central

Shah, Rashmi R; Smith, Robert L

2015-01-01

Phenoconversion is a phenomenon that converts genotypic extensive metabolizers (EMs) into phenotypic poor metabolizers (PMs) of drugs, thereby modifying their clinical response to that of genotypic PMs. Phenoconversion, usually resulting from nongenetic extrinsic factors, has a significant impact on the analysis and interpretation of genotype-focused clinical outcome association studies and personalizing therapy in routine clinical practice. The high phenotypic variability or genotype–phenotype mismatch, frequently observed due to phenoconversion within the genotypic EM population, means that the real number of phenotypic PM subjects may be greater than predicted from their genotype alone, because many genotypic EMs would be phenotypically PMs. If the phenoconverted population with genotype–phenotype mismatch, most extensively studied for CYP2D6, is as large as the evidence suggests, there is a real risk that genotype-focused association studies, typically correlating only the genotype with clinical outcomes, may miss clinically strong pharmacogenetic associations, thus compromising any potential for advancing the prospects of personalized medicine. This review focuses primarily on co-medication-induced phenoconversion and discusses potential approaches to rectify some of the current shortcomings. It advocates routine phenotyping of subjects in genotype-focused association studies and proposes a new nomenclature to categorize study populations. Even with strong and reliable data associating patients' genotypes with clinical outcome(s), there are problems clinically in applying this knowledge into routine pharmacotherapy because of potential genotype–phenotype mismatch. Drug-induced phenoconversion during routine clinical practice remains a major public health issue. Therefore, the principal challenges facing personalized medicine, which need to be addressed, include identification of the following factors: (i) drugs that are susceptible to phenoconversion

Culturomics: A New Kid on the Block of OMICS to Enable Personalized Medicine.

PubMed

Kambouris, Manousos E; Pavlidis, Cristiana; Skoufas, Efthymios; Arabatzis, Michael; Kantzanou, Maria; Velegraki, Aristea; Patrinos, George P

2018-02-01

This innovation analysis highlights the underestimated and versatile potential of the new field of culturomics and examines its relation to other OMICS system sciences such as infectiomics, metabolomics, phenomics, and pharmacomicrobiomics. The advent of molecular biology, followed by the emergence of various disciplines of the genomics, and most importantly metagenomics, brought about the sharp decline of conventional microbiology methods. Emergence of culturomics has a natural synergy with therapeutic and clinical genomic approaches so as to realize personalized medicine. Notably, the concept of culturomics expands on that of phenomics and allows a reintroduction of the culture-based phenotypic characterization into the 21st century research repertoire, bolstered by robust technology for automated and massive execution, but its potential is largely unappreciated at present; the few available references show unenthusiastic pursuit and in narrow applications. This has not to be so: depending on the specific brand of culturomics, the scope of applications may extend to medicine, agriculture, environmental sciences, pharmacomicrobiomics, and biotechnology innovation. Moreover, culturomics may produce Big Data. This calls for a new generation of data scientists and innovative ways of harnessing and valorizing Big Data beyond classical genomics. Much more detailed and objective classification and identification of microbiota may soon be at hand through culturomics, thus enabling precision diagnosis toward truly personalized medicine. Culturomics may both widen the scope of microbiology and improve its contributions to diagnostics and personalized medicine, characterizing microbes and determining their associations with health and disease dynamics.

Infrastructure for Personalized Medicine at Partners HealthCare

PubMed Central

Weiss, Scott T.; Shin, Meini Sumbada

2016-01-01

Partners HealthCare Personalized Medicine (PPM) is a center within the Partners HealthCare system (founded by Massachusetts General Hospital and Brigham and Women’s Hospital) whose mission is to utilize genetics and genomics to improve the care of patients in a cost effective manner. PPM consists of five interconnected components: (1) Laboratory for Molecular Medicine (LMM), a CLIA laboratory performing genetic testing for patients world-wide; (2) Translational Genomics Core (TGC), a core laboratory providing genomic platforms for Partners investigators; (3) Partners Biobank, a biobank of samples (DNA, plasma and serum) for 50,000 Consented Partners patients; (4) Biobank Portal, an IT infrastructure and viewer to bring together genotypes, samples, phenotypes (validated diagnoses, radiology, and clinical chemistry) from the electronic medical record to Partners investigators. These components are united by (5) a common IT system that brings researchers, clinicians, and patients together for optimal research and patient care. PMID:26927187

Impact of the US Patent System on the promise of personalized medicine.

PubMed

Solomon, Louis M; Sieczkiewicz, Gregory J

2007-09-01

The biotechnology revolution promises unfathomable future scientific discovery. One of the potential benefits is the accelerated introduction of new diagnostics and treatments to the general public. The right medication for the right patient is the goal of personalized medicine, which directly benefits from many of biotechnology's biggest and most recent advances. The US patent system rewards innovation in medicine and other arts and sciences by granting innovators, for a period of time, the right to exclude others from using what was invented. One of the purposes of the patent system is to trade that right to exclude, and in its stead obtain the patent holder's obligation to fully and publicly disclose the essence of the innovations so that they can be improved, thus advancing the common welfare. A tension exists between personalized medicine's need for access to and use of scientific advances and the patent system's reward of exclusive use or nonuse to innovators. This tension may result in fewer diagnostic and therapeutic tools brought to the market and generally adopted. The risk seems particularly acute with respect to the diagnostic and therapeutic tools arising from genetic testing that hold specific value for a subset of the population. The judicial system has introduced ethical exceptions that overcome a patent holder's right to exclude; these judicial overrides relate to the provision of certain types of medical procedures and the development of certain types of new drugs, and not, apparently, to the use of diagnostic and therapeutic tools essential to the success of personalized medicine. A serious question exists as to whether legislative action is necessary to increase public access to genetic testing.

Lifestyle medicine course for family medicine residents: preliminary assessment of the impact on knowledge, attitudes, self-efficacy and personal health.

PubMed

Malatskey, Lilach; Bar Zeev, Yael; Tzuk-Onn, Adva; Polak, Rani

2017-09-01

The WHO estimates that by 2020 two-thirds of the diseases worldwide will be the result of unhealthy lifestyle habits. Less than half of primary care physician graduates feel prepared to give lifestyle behaviour counselling. Our objective was to evaluate the impact of lifestyle medicine (LM) course on self-reported knowledge, attitudes, self-efficacy and health behaviour of family medicine residents. Based on the Israeli syllabus for the study of LM, we delivered five face to face 20 H courses. Pre/post data were collected by knowledge, attitudes, self-efficacy and personal health survey: RESULTS: A total of 112 family medicine residents participated in one of the five courses, of which 91 (81.3%) filled both pre and post surveys. Participates showed an improvement in self-reported knowledge and capacity to manage patients in regard to smoking, weight management and physical activity. An improvement was noted in personal health behaviour of overweight participant's in regard to self-reported physical activity. A comprehensive LM syllabus based course has a positive impact on family medicine residents LM counselling abilities. We suggest that LM course should be considered as a potential permanent addition to the family medicine residency programme. 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/.

Feasibility of CRISPR-Cas9-Based In Vitro Drug Target Identification for Personalized Prostate Cancer Medicine

DTIC Science & Technology

2017-09-01

AWARD NUMBER: W81XWH-16-1-0502 TITLE: Feasibility of CRISPR -Cas9-Based In Vitro Drug Target Identification for Personalized Prostate Cancer Medicine...CONTRACT NUMBER Feasibility of CRISPR -Cas9-Based In Vitro Drug Target Identification for Personalized Prostate Cancer Medicine 5b. GRANT NUMBER...Approved for Public Release; Distribution Unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT This study tests the feasibility of using CRISPR -Cas9 to

Barriers, Facilitators, and Solutions to Optimal Patient Portal and Personal Health Record Use: A Systematic Review of the Literature

PubMed Central

Zhao, Jane Y.; Song, Buer; Anand, Edwin; Schwartz, Diane; Panesar, Mandip; Jackson, Gretchen P.; Elkin, Peter L.

2017-01-01

Patient portal and personal health record adoption and usage rates have been suboptimal. A systematic review of the literature was performed to capture all published studies that specifically addressed barriers, facilitators, and solutions to optimal patient portal and personal health record enrollment and use. Consistent themes emerged from the review. Patient attitudes were critical as either barrier or facilitator. Institutional buy-in, information technology support, and aggressive tailored marketing were important facilitators. Interface redesign was a popular solution. Quantitative studies identified many barriers to optimal patient portal and personal health record enrollment and use, and qualitative and mixed methods research revealed thoughtful explanations for why they existed. Our study demonstrated the value of qualitative and mixed research methodologies in understanding the adoption of consumer health technologies. Results from the systematic review should be used to guide the design and implementation of future patient portals and personal health records, and ultimately, close the digital divide. PMID:29854263

[OMICS AND BIG DATA, MAJOR ADVANCES TOWARDS PERSONALIZED MEDICINE OF THE FUTURE?].

PubMed

Scheen, A J

2015-01-01

The increasing interest for personalized medicine evolves together with two major technological advances. First, the new-generation, rapid and less expensive, DNA sequencing method, combined with remarkable progresses in molecular biology leading to the post-genomic era (transcriptomics, proteomics, metabolomics). Second, the refinement of computing tools (IT), which allows the immediate analysis of a huge amount of data (especially, those resulting from the omics approaches) and, thus, creates a new universe for medical research, that of analyzed by computerized modelling. This article for scientific communication and popularization briefly describes the main advances in these two fields of interest. These technological progresses are combined with those occurring in communication, which makes possible the development of artificial intelligence. These major advances will most probably represent the grounds of the future personalized medicine.