A newly created team of experts in precision medicine and large clinical research studies will seek public input from the large and diverse stakeholder community interested in the development of the President’s Precision Medicine Initiative and articulate the vision for building the national participant group for the Initiative. They will help define what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design, and what success would look like five and 10 years out. Formed as a Working Group of the Advisory Committee to the NIH Director (ACD), the team of experts will deliver a preliminary report in September 2015 that will inform efforts to accelerate the understanding of individual differences that play a role in health, with the goal of informing better prevention and treatment strategies tailored for each person.
President Obama launched the new initiative on Jan. 30, 2015, and called for initial funding of $215 million in his FY2016 budget. Of this total, $130 million would be dedicated to beginning the process of building the group of 1 million or more research participants who will volunteer to share their biological, environmental, lifestyle and behavioral information and tissue samples with qualified researchers in a way that protects participant privacy. Participant input through representation on the working group, workshops and other feedback mechanisms will be central to the design and implementation of the study. We look forward to working with Congress to implement the President’s Budget.
“Establishing a 1 million person cohort is an audacious endeavor,” said NIH Director Francis S. Collins, M.D., Ph.D. “But the results from studying such a large group of Americans will build the scientific evidence necessary for moving precision medicine from concept to reality. I’m confident that we’ve pulled together the best of the best in this working group to put us on the right path forward. And we look forward to broad input from a wide cross-section of stakeholders as this process moves forward.”
NIH held a two-day workshop on February 11-12, 2015, which helped to shape the objectives of the working group. To fulfill its charge, the working group will gather additional input from patient and scientific stakeholder groups through a combination of public workshops on precision medicine topics, including privacy, electronic health records, mobile health technologies, existing research cohorts, participant preferences, and inclusion of minority and underserved populations. Information about these events, as well as opportunities for members of the public to offer input, will be provided on the NIH Precision Medicine Initiative web page.
External working group on building a research cohort for precision medicine:
- Richard Lifton, M.D., Ph.D., Chair, Department of Genetics, Sterling Professor of Genetics and Professor of Medicine, Founder and Executive Director, Yale Center for Genomic Analysis, Investigator, Howard Hughes Medical Institute, Yale University School of Medicine, New Haven, Connecticut
- Bray Patrick-Lake, M.F.S., Director of Stakeholder Engagement, Clinical Trial Transformation Initiative, Duke University, Durham, North Carolina
- Kathy Hudson, Ph.D., Deputy Director of Science, Outreach, and Policy, National Institutes of Health
- Esteban Gonzalez Burchard, M.D., M.P.H., Harry Wm. and Diana V. Hind Distinguished Professor in Pharmaceutical Sciences Professor and Vice Chair, Departments of Bioengineering & Therapeutic Sciences and Medicine Director, Center for Genes, Environments & Health University of California, San Francisco
- Tony Coles, M.D., M.P.H., Chairman and CEO, Yumanity Therapeutics, Cambridge, Massachusetts
- Rory Collins, FMedSci, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, U.K.
- Andrew Conrad, Ph.D., Head of Life Sciences Team, Google X, Mountain View, California
- Josh Denny, M.D., Associate Professor of Biomedical Informatics and Medicine, Vanderbilt University, Nashville, Tennessee
- Susan Desmond-Hellmann, M.D., M.P.H., CEO, Gates Foundation, Seattle
- Eric Dishman, Intel Fellow & General Manager, Health & Life Sciences, Intel, Santa Clara, California
- Kathy Giusti, M.B.A., Founder and Executive Chairman, Multiple Myeloma Research Foundation, Norwalk, Connecticut
- Sekar Kathiresan, M.D., Director, Preventive Cardiology, Massachusetts General Hospital, Boston; Institute Member, Broad Institute, Cambridge; Associate Professor of Medicine, Harvard Medical School, Boston
- Sachin Kheterpal, M.D., M.B.A., Associate Professor, Department of Anesthesiology, University of Michigan Medical School, Ann Arbor
- Shiriki Kumanyika, PhD, MPH, Emeritus Professor of Epidemiology, University of Pennsylvania Perelman School of Medicine
- Spero M. Manson, Ph.D., Distinguished Professor and Director, Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado, Denver
- P. Pearl O’Rourke, M.D., Director, Human Research Affairs, Partners Health Care System, Inc., Boston
- Richard Platt, M.D., Professor and Chair of the Harvard Medical School Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston
- Jay Shendure, M.D., Ph.D., Associate Professor, Genome Sciences, University of Washington, Seattle
- Sue Siegel, CEO, GE Ventures & Healthymagination, Menlo Park, CA
The working group will also include ex-officio members from the U.S. Department of Defense, U.S. Department of Veteran Affairs, U.S. Food and Drug Administration, Health and Human Services Office of the National Coordinator for Health Information Technology, and White House Office of Science and Technology Policy. For more information about the ACD, go to: http://acd.od.nih.gov. For more information about the Precision Medicine Initiative, go to: http://www.nih.gov/precisionmedicine.
The ACD advises the NIH Director on policy matters important to the NIH mission of conducting and supporting biomedical and behavioral research, research training, and translating research results for the public.
The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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