Roundtable on Translating Genomic-Based Research for Health 2012 Annual Report (2013) / Chapter Skim
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Roundtable on Translating Genomic-Based Research for Health: 2012 Annual Report
Roundtable on Translating Genomic-Based Research for Health: 2012 Annual Report
Pages 1-12
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BOARD ON HEALTH SCIENCES POLICY Roundtable on Translating Genomic-Based Research for Health 2012 Annual Report
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However, many important questions must be addressed to ensure that this new technology is used responsi bly. Decreasing genome sequencing costs and innovative science have placed genomics and related molecular tools at the center of biomedical research; but translation into health care applications remains difficult due to a currently underdeveloped evidence base, a misalignment between basic research and clinical needs, and the lack of a robust knowledge generating system that incorporates genomic information from both basic and clinical research.
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The Roundtable hosted a public workshop to investigate how genetic and genomic information is currently being used and how it will be used in the future to improve the process of drug development. The goal of the workshop was to examine the current investment in, use of, and utility of genetic and genomic data in drug development strategies.
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The Roundtable co-hosted a workshop with the Center for Medical Technology Policy to discuss research methodologies related to demonstrating and assessing the clinical validity and utility of molecular diagnostics for oncology. The presentations and discussions explored the challenges in and identified potential opportunities for advancing the development and use of molecular diagnostic tests for guiding the treatment and management of oncology patients.
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and the National Institutes of Health, disease advocacy groups, and other stakeholders. The workshop featured invited presentations and discussions that examined the benefits of and barriers to sharing clinical research data, specifically clinical trial data, and strategies for enhancing sharing within and among sectors to facilitate the research and development of effective, safe, and needed products.
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Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: A Workshop (February 27, 2013) Genome information can identify new drug targets for both common and rare diseases, can identify patients who 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 to demonstrate safety and efficacy.
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The Roundtable will host a workshop to assess the current landscape of drug-repurposing activities in industry, academia, and government; examine enabling tools and technology; and evaluate the business models and economic incentives for drug-repurposing programs. Stakeholders, including government officials, pharmaceutical company representatives, academic researchers, regulators, funders, and patients, will be invited to present their perspectives and participate in discussions during the workshop.
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Members examine issues such as the economic impact of genomic medicine, the educational needs of the health care workforce, and the intersection between bioinformatics and clinical practice. May 24 Challenges and Opportunities November 17 in Using Newborn Screening Generating Evidence for Samples for Translational July 23 Genomic Diagnostic Test February 22-23 Research Workshop; Meeting 10 Meeting 11 Development Workshop Meeting 13 2011 July 22 November 18 Establishing Precompetitive Collaborations to Stimulate Meeting 12 Genomics-Driven Drug Development Workshop
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Diagnostic Applications The Roundtable established the Diagnostic Applications working group to discuss issues related to the development and use of molecular diagnostics. Genome-Based Diagnostics: This group has focused its discussions on three key Clarifying Pathways to Clinical Use: elements in the development and adoption of clini- Workshop Summary cally useful genome-based diagnostic applications: evidence gaps, regulatory policy, and reimbursement for genomic tests.
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Duke University Director Duke University March 21 New Paradigms in Drug Discovery: December 3 How Genomic Data Are Being Used July 17-18 Improving the Efficiency and to Revolutionize the Drug Discovery Assessing the Economics of Effectiveness of Genomic Science and Development Process Workshop Genomic Medicine Workshop Translation Workshop 2013 May 24 October 4-5 March 22 July 18 December 4 Meeting 16 Evidence for Clinical Utility of Molecular Meeting 17 Sharing Clinical Research Meeting 18 Diagnostics in Oncology Workshop Data Workshop
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February 27 Refining Processes for the Co-Development of Genome-Based June 24 Therapeutics and Companion Genomics-Enabled Drug Repurposing December 4-5 Diagnostic Tests Workshop and Repositioning Workshop Meeting 21 2014 February 28 June 25 Meeting 19 Meeting 20
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As a convening mechanism for interested parties with different perspectives to meet and discuss complex issues of mutual concern in a neutral setting, the Roundtable fosters dialogue across sectors and institutions and facilitates collaboration among stakeholders. To achieve its objectives, the Roundtable conducts structured discussions, workshops, and symposia, and publishes workshop summaries.
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