Roundtable on Translating Genomic-Based Research on Health's Books

Sharing Clinical Research Data

Workshop Summary

By: Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health,National Cancer Policy Forum,Forum on Neuroscience and Nervous System Disorders,Forum on Drug Discovery, Development, and Translation

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Sharing Clinical Research Data

Workshop Summary

Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

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157

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National Academies Press

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ISBN 10

0309268745

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9780309268745

Direct-to-Consumer Genetic Testing

Summary of a Workshop

By: National Research Council,Institute of Medicine,Board on Health Care Services,National Cancer Policy Forum,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health,Forum on Drug Discovery, Development, and Translation,Division on Earth and Life Studies,Board on Life Sciences,Policy and Global Affairs,Committee on Science, Technology, and Law

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Direct-to-Consumer Genetic Testing

Summary of a Workshop

Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they offer demonstrate a public appetite for this information and where the future of genetics may be headed; they also demonstrate the need for serious discussion about the regulatory environment, patient privacy, and other policy implications of direct-to-consumer (DTC) genetic testing. Rapid advances in genetic research already have begun to transform clinical practice and our understanding of disease progression. Existing research has revealed a genetic basis or component for numerous diseases, including Parkinson's disease, Alzheimer's disease, diabetes, heart disease, and several forms of cancer. The availability of the human genome sequence and the HapMap, plummeting costs of high-throughput screening, and increasingly sophisticated computational analyses have led to an explosion of discoveries of linkages between patterns of genetic variation and disease susceptibility. While this research is by no means a straight path toward better public health, improved knowledge of the genetic linkages has the potential to change fundamentally the way health professionals and public health practitioners approach the prevention and treatment of disease. Realizing this potential will require greater sophistication in the interpretation of genetic tests, new training for physicians and other diagnosticians, and new approaches to communicating findings to the public. As this rapidly growing field matures, all of these questions require attention from a variety of perspectives. To discuss some of the foregoing issues, several units of the National Academies held a workshop on August 31 and September 1, 2009, to bring together a still-developing community of professionals from a variety of relevant disciplines, to educate the public and policy-makers about this emerging field, and to identify issues for future study. The meeting featured several invited presentations and discussions on the many technical, legal, policy, and ethical questions that such DTC testing raises, including: (1) overview of the current state of knowledge and the future research trajectory; (2) shared genes and emerging issues in privacy; (3) the regulatory framework; and (4) education of the public and the medical community.

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106

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National Academies Press

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ISBN 10

0309162165

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9780309162166

Diffusion and Use of Genomic Innovations in Health and Medicine

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Diffusion and Use of Genomic Innovations in Health and Medicine

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Until fairly recently, genetic information was used primarily in the diagnosis of relatively rare genetic diseases, such as cystic fibrosis and Huntington's Disease, but a transformation in the use of genetic and genomic information is underway. While many predictions have been made that genomics will transform medicine, to date few of these promising discoveries have resulted in actual applications in medicine and health. The Institute of Medicine's Roundtable on Translating Genomic-Based Research for Health, established in 2007, held its first workshop to address the following questions: 1. Are there different pathways by which new scientific findings move from the research setting into health care? 2. If so, what are the implications of those different pathways for genomics? 3. What can we learn from the translation of other new technologies as we seek to understand the translation of genome science into health care? Information obtained from the workshop was then used to further discussion and exploration of the answers to these questions. This book summarizes speaker presentations and discussions. Any conclusions reported should not be construed as reflecting a group consensus; rather they are the statements and opinions of presenters and participants.

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116

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National Academies Press

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ISBN 10

0309116767

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9780309116763

Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Newborn screening samples are used to test more than 4 million infants each year for life-threatening diseases that are treatable if found at birth. These specimens also represent a potentially invaluable resource for public health and biomedical research. The IOM held a workshop to examine issues surrounding the use of residual specimens for translational research.

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0309159547

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9780309159548

Applying an Implementation Science Approach to Genomic Medicine

Workshop Summary

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Applying an Implementation Science Approach to Genomic Medicine

Workshop Summary

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Although it is becoming increasingly more common for clinicians to use genomic data in their practices for disease prevention, diagnosis, and treatment, the process of integrating genomic data into the practice of medicine has been a slow and challenging one. Some of the major barriers impeding the incorporation of new genomic technology into clinical practice are: the difficulty of changing routine medical practices to account for the use of genetic testing, the limited knowledge of patients and providers about genomic medicine, assessing sufficient evidence to support the use of genetic tests, privacy and data security issues, and uncertainty about reimbursement. The field of implementation science may be able to provide insights concerning efficient ways to incorporate genomic applications into routine clinical practice. The focus of implementation science studies is to identify integration bottlenecks and optimal approaches for a given setting and ultimately to promote the up-take of research findings. To explore the potential of implementation science to improve the integration of genomics into medicine, the National Academies of Sciences, Engineering, and Medicine held a workshop in Washington, DC, in November 2015. Participants explored the challenges and opportunities of integrating genomic advances into the clinic through the lens of implementation science. This report summarizes the presentations and discussions from the workshop.

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137

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ISBN 10

0309437792

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9780309437790

Genomics-Enabled Learning Health Care Systems

Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Genomics-Enabled Learning Health Care Systems

Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

The inclusion of genomic data in a knowledge-generating health care system infrastructure is one promising way to harness the full potential of that information to provide better patient care. In such a system, clinical practice and research influence each other with the goal of improving the efficiency and effectiveness of disease prevention, diagnosis, and treatment. To examine pragmatic approaches to incorporating genomics in learning health care systems, the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health hosted a workshop which convened a variety of stakeholder groups, including commercial developers, health information technology professionals, clinical providers, academic researchers, patient groups, and government and health system representatives, to present their perspectives and participate in discussions on maximizing the value that can be obtained from genomic information. The workshop examined how a variety of systems are capturing and making use of genomic data to generate knowledge for advancing health care in the 21st century. It also sought to evaluate the challenges, opportunities, and best practices for capturing or using genomic information in knowledge-generating health care systems. Genomics-Enabled Learning Health Care Systems summarizes the presentations and discussion of the workshop.

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105

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0309371155

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9780309371155

Conflict of Interest and Medical Innovation

Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Conflict of Interest and Medical Innovation

Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together. Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.

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0309301718

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9780309301718

Genome-Based Therapeutics

Targeted Drug Discovery and Development: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Genome-Based Therapeutics

Targeted Drug Discovery and Development: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

The number of new drug approvals has remained reasonably steady for the past 50 years at around 20 to 30 per year, while at the same time the total spending on health-related research and development has tripled since 1990. There are many suspected causes for this trend, including increases in regulatory barriers, the rising costs of scientific inquiry, a decrease in research and development efficiency, the downstream effects of patient expirations on investment, and the lack of production models that have successfully incorporated new technology. Regardless, this trajectory is not economically sustainable for the businesses involved, and, in response, many companies are turning toward collaborative models of drug development, whether with other industrial firms, academia, or government. Introducing greater efficiency and knowledge into these new models and aligning incentives among participants may help to reverse the trends highlighted above, while producing more effective drugs in the process. Genome-Based Therapeutics explains that new technologies have the potential to open up avenues of development and to identify new drug targets to pursue. Specifically, improved validation of gene-disease associations through genomics research has the potential to revolutionize drug production and lower development costs. Genetic information has helped developers by increasing their understanding of the mechanisms of disease as well as individual patients' reactions to their medications. There is a need to identify the success factors for the various models that are being developed, whether they are industry-led, academia-led, or collaborations between the two. Genome-Based Therapeutics summarizes a workshop that was held on March 21, 2012, titled New Paradigms in Drug Discovery: How Genomic Data Are Being Used to Revolutionize the Drug Discovery and Development Process. At this workshop the goal was to examine the general approaches being used to apply successes achieved so far, and the challenges ahead.

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ISBN 10

0309260248

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9780309260244

The Value of Genetic and Genomic Technologies

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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The Value of Genetic and Genomic Technologies

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Knowing one's genetic disposition to a variety of diseases, including common chronic diseases, can benefit both the individual and society at large. The IOM's Roundtable on Translating Genomic-Based Research for Health held a workshop on March 22, 2010, to bring together diverse perspectives on the value of genetic testing, and to discuss its use in clinical practice.

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108

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National Academies Press

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ISBN 10

0309157714

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9780309157711

Innovations in Service Delivery in the Age of Genomics

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Innovations in Service Delivery in the Age of Genomics

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

New discoveries in genomics-that is, the study of the entire human genome-are changing how we diagnose and treat diseases. As the trend shifts from genetic testing largely being undertaken for rare genetic disorders to, increasingly, individuals being screened for common diseases, general practitioners, pediatricians, obstetricians/gynecologists, and other providers need to be knowledgeable about and comfortable using genetic information to improve their patients' health. To address these changes, the Roundtable on Translating Genomic-Based Research for Health held the public workshop "Innovations in Service Delivery in the Age of Genomics" on July 27, 2008.

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ISBN 10

0309177588

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9780309177580

Assessing Genomic Sequencing Information for Health Care Decision Making

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Assessing Genomic Sequencing Information for Health Care Decision Making

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Rapid advances in technology have lowered the cost of sequencing an individual's genome from the several billion dollars that it cost a decade ago to just a few thousand dollars today and have correspondingly greatly expanded the use of genomic information in medicine. Because of the lack of evidence available for assessing variants, evaluation bodies have made only a few recommendations for the use of genetic tests in health care. For example, organizations, such as the Evaluation of Genomic Applications in Practice and Prevention working group, have sought to set standards for the kinds of evaluations needed to make population-level health decisions. However, due to insufficient evidence, it has been challenging to recommend the use of a genetic test. An additional challenge to using large-scale sequencing in the clinic is that it may uncover "secondary," or "incidental," findings - genetic variants that have been associated with a disease but that are not necessarily related to the conditions that led to the decision to use genomic testing. Furthermore, as more genetic variants are associated with diseases, new information becomes available about genomic tests performed previously, which raises issues about how and whether to return this information to physicians and patients and also about who is responsible for the information. To help develop a better understanding of how genomic information is used for healthcare decision making, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine held a workshop in Washington,DC in February 2014. Stakeholders, including clinicians, researchers, patients, and government officials, discussed the issues related to the use of genomic information in medical practice. Assessing Genomic Sequencing Information for Health Care Decision Making is the summary of that workshop. This report compares and contrasts evidence evaluation processes for different clinical indications and discusses key challenges in the evidence evaluation process.

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0309304970

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9780309304979

Integrating Large-Scale Genomic Information into Clinical Practice

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Integrating Large-Scale Genomic Information into Clinical Practice

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

The initial sequencing of the human genome, carried out by an international group of experts, took 13 years and $2.7 billion to complete. In the decade since that achievement, sequencing technology has evolved at such a rapid pace that today a consumer can have his or her entire genome sequenced by a single company in a matter of days for less than $10,000, though the addition of interpretation may extend this timeframe. Given the rapid technological advances, the potential effect on the lives of patients, and the increasing use of genomic information in clinical care, it is important to address how genomics data can be integrated into the clinical setting. Genetic tests are already used to assess the risk of breast and ovarian cancers, to diagnose recessive diseases such as cystic fibrosis, to determine drug dosages based on individual patient metabolism, and to identify therapeutic options for treating lung and breast tumors, melanoma, and leukemia. With these issues in mind and considering the potential impact that genomics information can have on the prevention, diagnosis, and treatment of disease, the Roundtable on Translating Genomic-Based Research for Health hosted a workshop on July 19, 2011, to highlight and identify the challenges and opportunities in integrating large-scale genomic information into clinical practice. Integrating Large-Scale Genomic Information into Clinical Practice summarizes the speaker presentations and the discussions that followed them. This report focuses on several key topics, including the analysis, interpretation, and delivery of genomic information plus workforce, ethical, and legal issues.

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112

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National Academies Press

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ISBN 10

0309220343

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9780309220347

Deriving Drug Discovery Value from Large-Scale Genetic Bioresources

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Roundtable on Genomics and Precision Health

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Deriving Drug Discovery Value from Large-Scale Genetic Bioresources

Proceedings of a Workshop

The process of discovering and developing a new drug or therapy is extremely costly and time consuming, and recently, it has been estimated that the creation of a new medicine costs on average more than $2 billion and takes 10 years to reach patients. The challenges associated with bringing new medicines to market have led many pharmaceutical companies to seek out innovative methods for streamlining their drug discovery research. One way to increase the odds of success for compounds in the drug development pipeline is to adopt genetically guided strategies for drug discovery, and recognizing the potential benefits of collecting genetic and phenotypic information across specific populations, pharmaceutical companies have started collaborating with healthcare systems and private companies that have curated genetic bioresources, or large databases of genomic information. Large-scale cohort studies offer an effective way to collect and store information that can be used to assess geneâ€"environment interactions, identify new potential drug targets, understand the role of certain genetic variants in the drug response, and further elucidate the underlying mechanisms of disease onset and progression. To examine how genetic bioresources could be used to improve drug discovery and target validation, the National Academies of Sciences, Engineering, and Medicine hosted a workshop in March 2016. Participants at the workshop explored the current landscape of genomics-enabled drug discovery activities in industry, academia, and government; examined enabling partnerships and business models; and considered gaps and best practices for collecting population data for the purpose of improving the drug discovery process. This publication summarizes the presentations and discussions from the workshop.

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115

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ISBN 10

030944781X

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9780309447812

Drug Repurposing and Repositioning

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Drug Repurposing and Repositioning

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Drug development can be time-consuming and expensive. Recent estimates suggest that, on average, it takes 10 years and at least $1 billion to bring a drug to market. Given the time and expense of developing drugs de novo, pharmaceutical companies have become increasingly interested in finding new uses for existing drugs - a process referred to as drug repurposing or repositioning. Historically, drug repurposing has been largely an unintentional, serendipitous process that took place when a drug was found to have an offtarget effect or a previously unrecognized on-target effect that could be used for identifying a new indication. Perhaps the most recognizable example of such a successful repositioning effort is sildenafil. Originally developed as an anti-hypertensive, sildenafil, marketed as Viagra and under other trade names, has been repurposed for the treatment of erectile dysfunction and pulmonary arterial hypertension. Viagra generated more than $2 billion worldwide in 2012 and has recently been studied for the treatment of heart failure. Given the widespread interest in drug repurposing, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine hosted a workshop on June 24, 2013, in Washington, DC, to assess the current landscape of drug repurposing activities in industry, academia, and government. Stakeholders, including government officials, pharmaceutical company representatives, academic researchers, regulators, funders, and patients, were invited to present their perspectives and to participate in workshop discussions. Drug Repurposing and Repositioning is the summary of that workshop. This report examines enabling tools and technology for drug repurposing; evaluates the business models and economic incentives for pursuing a repurposing approach; and discusses how genomic and genetic research could be positioned to better enable a drug repurposing paradigm.

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0309302072

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9780309302074

Genome-Based Diagnostics

Clarifying Pathways to Clinical Use: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Genome-Based Diagnostics

Clarifying Pathways to Clinical Use: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

The sequencing of the human genome and the identification of associations between specific genetic variants and diseases have led to an explosion of genomic-based diagnostic tests. These tests have the potential to direct therapeutic interventions, predict risk or onset of disease, or detect residual disease. As research progresses and an increasing number of associations are found, further tests will be developed that can aid in providing personalized treatment options for patients. However, the adoption of genomic diagnostic tests by health care providers has been limited due to a lack of evidence regarding the clinical utility of many tests. Health funders and practitioners lack the data necessary to distinguish which tests can improve practice or the clinical settings in which tests will provide the greatest value. The Roundtable on Translating Genomic-Based Research for Health held a workshop in November 2010 to determine what evidence is needed and how it is viewed by different stakeholders in order to develop genomic diagnostic tests of clinical value. Genome-Based Diagnostics summarizes the presentations and discussions that took place throughout the workshop. Two presentations, in particular, sparked extensive discussion. One presentation proposed that all genomic diagnostic tests be reviewed and approved by the Food and Drug Administration. The other observed that venture capitalists are no longer investing substantially in the development of genomic diagnostic tests because of a lack of clarity surrounding regulatory and reimbursement pathways. Both presentations suggested the need for major changes in the systems used to develop, regulate, and reimburse genomic diagnostic tests. The report also presents the perspectives of different stakeholders in the development of genomic diagnostic tests. Each stakeholder group has a different set of needs and issues of importance, yet commonalities among them are apparent, such as the need to put patients and health outcomes at the center of discussion and action.

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104

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0309253977

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9780309253970

Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

With the advent of genome-wide association studies, numerous associations between specific gene loci and complex diseases have been identified-for breast cancer, coronary artery disease, and asthma, for example. This rapidly advancing field of genomics has stirred great interest in "personalized" health care from both the public and private sectors. The hope is that using genomic information in clinical care will lead to reduced health care costs and improved health outcomes as therapies are tailored to the genetic susceptibilities of patients. A variety of genetically based health care innovations have already reached the marketplace, but information about the clinical use of these treatments and diagnostics is limited. Currently data do not provide information about how a genomic test impacts clinical care and patient health outcomes-other approaches are needed to garner such information. This volume summarizes a workshop to address central questions related to the development of systems to evaluate clinical use of health care innovations that stem from genome-based research: What are the practical realities of creating such systems? What different models could be used? What are the strengths and weaknesses of each model? How effectively can such systems address questions about health outcomes?

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103

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0309147417

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9780309147415

Genomics-Enabled Learning Health Care Systems

Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Genomics-Enabled Learning Health Care Systems

Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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105

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0309371155

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9780309371155

The Economics of Genomic Medicine

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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The Economics of Genomic Medicine

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

The sequencing of the human genome and the identification of links between specific genetic variants and diseases have led to tremendous excitement over the potential of genomics to direct patient treatment toward more effective or less harmful interventions. Still, the use of whole genome sequencing challenges the traditional model of medical care where a test is ordered only when there is a clear indication for its use and a path for downstream clinical action is known. This has created a tension between experts who contend that using this information is premature and those who believe that having such information will empower health care providers and patients to make proactive decisions regarding lifestyle and treatment options. In addition, some stakeholders are concerned that genomic technologies will add costs to the health care system without providing commensurate benefits, and others think that health care costs could be reduced by identifying unnecessary or ineffective treatments. Economic models are frequently used to anticipate the costs and benefits of new health care technologies, policies, and regulations. Economic studies also have been used to examine much more specific issues, such as comparing the outcomes and cost effectiveness of two different drug treatments for the same condition. These kinds of analyses offer more than just predictions of future health care costs. They provide information that is valuable when implementing and using new technologies. Unfortunately, however, these economic assessments are often limited by a lack of data on which to base the examination. This particularly affects health economics, which includes many factors for which current methods are inadequate for assessing, such as personal utility, social utility, and patient preference. To understand better the health economic issues that may arise in the course of integrating genomic data into health care, the Roundtable on Translating Genomic-Based Research for Health hosted a workshop in Washington, DC, on July 17-18, 2012, that brought together economists, regulators, payers, biomedical researchers, patients, providers, and other stakeholders to discuss the many factors that may influence this implementation. The workshop was one of a series that the roundtable has held on this topic, but it was the first focused specifically on economic issues. The Economics of Genomic Medicine summarizes this workshop.

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129

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0309269733

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9780309269735

Integrating Large-Scale Genomic Information into Clinical Practice

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Integrating Large-Scale Genomic Information into Clinical Practice

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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0309220343

ISBN 13

9780309220347

Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Many drug developers have examined new strategies for creating efficiencies in their development processes, including the adoption of genomics-based approaches. Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and has the potential to significantly reduce the cost of clinical trials by reducing the number of patients that must be enrolled in order to demonstrate safety and efficacy. A key component of the approval of targeted therapeutics is the ability to identify the population of patients who will benefit from treatment, and this has largely hinged on the co-development and co-submission to the FDA of a companion diagnostic test.The co-development process, or the development of the test and drug for the simultaneous submission to FDA, has led to a major alteration in the way that drugs are being developed, with traditionally separate entities-pharmaceutical and diagnostic companies-now working in close collaboration. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests is the summary of a workshop held by the Roundtable on Translating Genomic-Based Research for Health on February 27, 2013 to examine and discuss challenges and potential solutions for the codevelopment of targeted therapeutics and companion molecular tests for the prediction of drug response. Prior to the workshop, key stakeholders, including laboratory and medical professional societies, were individually asked to provide possible solutions to resolve the concerns raised about co-development of companion diagnostic tests and therapies. Workshop speakers were charged with addressing these solutions in their presentations by providing insight on (1) whether the proposed solutions address the problems described, (2) whether there are other solutions to propose, and (3) what steps could be taken to effectively implement the proposed solutions.

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National Academies Press

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ISBN 10

0309298245

ISBN 13

9780309298247

Assessing Genomic Sequencing Information for Health Care Decision Making

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By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Assessing Genomic Sequencing Information for Health Care Decision Making

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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104

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National Academies Press

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ISBN 10

0309304970

ISBN 13

9780309304979

Innovations in Service Delivery in the Age of Genomics

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By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Innovations in Service Delivery in the Age of Genomics

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By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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ISBN 10

0309132142

ISBN 13

9780309132145

Genome-Based Diagnostics

Clarifying Pathways to Clinical Use: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Genome-Based Diagnostics

Clarifying Pathways to Clinical Use: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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104

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National Academies Press

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ISBN 10

0309253977

ISBN 13

9780309253970

The Value of Genetic and Genomic Technologies

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By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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The Value of Genetic and Genomic Technologies

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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108

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National Academies Press

Published Date

ISBN 10

0309157714

ISBN 13

9780309157711

Diffusion and Use of Genomic Innovations in Health and Medicine

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Diffusion and Use of Genomic Innovations in Health and Medicine

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By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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116

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National Academies Press

Published Date

ISBN 10

0309178312

ISBN 13

9780309178310

Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health

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By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health

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By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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103

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National Academies Press

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ISBN 10

0309147417

ISBN 13

9780309147415

Conflict of Interest and Medical Innovation

Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Conflict of Interest and Medical Innovation

Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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ISBN 10

0309301718

ISBN 13

9780309301718

Genome-Based Therapeutics

Targeted Drug Discovery and Development: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Genome-Based Therapeutics

Targeted Drug Discovery and Development: Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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ISBN 10

0309260248

ISBN 13

9780309260244

Applying an Implementation Science Approach to Genomic Medicine

Workshop Summary

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Applying an Implementation Science Approach to Genomic Medicine

Workshop Summary

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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137

Publisher

National Academies Press

Published Date

ISBN 10

0309437792

ISBN 13

9780309437790

Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

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Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development

Workshop Summary

By: Institute of Medicine,Board on Health Sciences Policy,Roundtable on Translating Genomic-Based Research for Health

Despite the many basic research discoveries in genetics, relatively few gene-based treatments, drugs, or preventative measures have been developed. One way to bridge this gap may be for industry, academia, and government to develop partnerships that share resources while distributing risk. However, intellectual property protections and other barriers can inhibit collaborative efforts. The Institute of Medicine held a workshop on July 22, 2010, to explore these issues and develop solutions.

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