An Update on the Precision Medicine Initiative Cohort Program

Since September 17, 2015, when I accepted the framework for shaping the Cohort Program as part of implementing the President’s Precision Medicine Initiative (PMI)(link is external), my team has been moving swiftly to lay the foundation for building a national research cohort of one million or more volunteers that will expand our understanding of the ways we can improve health and treat disease.

I’m excited that the first set of funding opportunities is on the street. These projects will build a solid infrastructure for the PMI Cohort Program, including a coordinating center, biobank, network of healthcare provider organizations, and participant mobile technologies. I am excited to see the innovative ideas that will be submitted by the scientific community. We also have announced a funding opportunity to develop a pilot program to inform the creation of the direct volunteer enrollment component of the cohort, and a funding opportunity to devlop a communication infrastructure that will be vital to conveying the importance of this research effort.
We are well along in putting together an expert group of outside advisors, the PMI Cohort Program Advisory Panel. Panel members will provide on-going guidance and oversight of the cohort, while contributing significantly to the evolution of the program’s vision, scientific and clinical goals, and operations. The panel has deep and diverse expertise to advise on this unprecedented initiative. Additional members will be named over time.
We have also launched a nationwide search for an outstanding leader to take the helm as the permanent director of the PMI Cohort Program. In the meantime, Dr. Josephine Briggs, the Director for the National Center for Complementary and Integrative Health, will continue her capable leadership of the current efforts as interim program director.

In addition, the White House Office of Science and Technology Policy recently issued the PMI Privacy and Trust Principles(link is external) to ensure that privacy is built into the foundation of the Initiative. The principles articulate a set of core values and responsible strategies for sustaining public trust and maximizing the benefits of precision medicine and will be key to the development of all aspects of the cohort program. The White House is engaging in a similar effort with input from internal and external experts in data security to develop the optimal framework for maintaining data security in PMI.

Pending Congressional appropriations, NIH will begin building the infrastructure for this historic, first-of-its-kind study so enrollment in the cohort can begin in 2016. It will take volunteers from all walks of life to build a resource that will help scientists answer a wide range of important health questions to improve treatments for a broad range of diseases and to prevent them in the first place, so we hope we can count on you when we’re ready to enroll. If you would like to be alerted to our progress over the coming weeks, I encourage you to sign up for updates on the NIH PMI Cohort Program website.

You can learn more about the President’s vision for the PMI and its promise in revolutionizing the way we work together to develop individualized treatments by visiting the White House PMI website(link is external).

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health

PMI Cohort Program Advisory Panel
Lon Cardon, Ph.D., Senior Vice President, Alternative Discovery & Development, GlaxoSmithKline
Alta Charo, J.D., Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin Law and School of Medicine & Public Health
Tony Coles, M.D., M.P.H., Chairman and Chief Executive Officer, Yumanity Therapeutics
Sir Rory Collins, FRS., Professor of Medicine & Epidemiology and Head, Nuffield Department of Population Health, University of Oxford
Eric Dishman, Intel Fellow & General Manager, Health & Life Sciences, Intel Corporation
Alejandra Gepp, M.A., Associate Director, National Council of La Raza, Institute of Hispanic Health
Sachin Kheterpal, M.D., M.B.A., Associate Professor, Department of Anesthesiology, University of Michigan Medical School
Marie Lynn Miranda, Ph.D., Howard R. Hughes Provost and Professor of Statistics, Rice University, Adjunct Professor of Pediatrics at Duke University, University of Michigan, and Baylor College of Medicine
Bray Patrick-Lake, M.F.S., Director of Stakeholder Engagement, Clinical Trials Transformation Initiative; Director of Patient Engagement, CTSA, Duke University
Gregory Simon, M.D., M.P.H., Senior Investigator & Psychiatrist, Group Health Research Institute; Chair, Scientific Advisory Board, Depression and Bipolar Support Alliance.
Sharon Terry, M.A., President and Chief Executive Officer, Genetic Alliance
David Williams, M.P.H., Florence and Laura Norman Professor of Public Health; Professor of African and African American Studies and Sociology, Harvard University
Ex Officio Members
Rob Califf, M.D., Deputy Commissioner for Medical Products and Tobacco, U.S. Food and Drug Administration
Karen DeSalvo, M.D., M.P.H., M.Sc., Acting Assistant Secretary for Health, National Coordinator for Health Information Technology, Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services
Michael Gaziano, M.D., M.P.H., Principal Investigator, Million Veterans Program; Chief, Division of Aging, Brigham and Women’s Hospital; Profession of Medicine, Harvard Medical School