Precision Medicine Initiative (PMI) Working Group

Background

On January 20, 2015, President Obama launched a new U.S. initiative, the Precision Medicine Initiative (PMI), to accelerate our understanding of individual variability and its effect on disease onset, progression, prevention, and treatment. There are two components to the PMI, one focused on expanding current efforts in cancer genomics and testing methods for prevention and treatment of cancers in a more precise way; this component will be managed by the National Cancer Institute. The second is to create a large research cohort of one million or more participants who choose to share many types of data (e.g., biomedical, behavioral, and lifestyle) to advance research. The creation of this research cohort will provide unprecedented opportunities to discover and quantify factors that contribute to illness, and to test approaches that can preserve health and treat disease.

In the fiscal year 2016 budget, the President proposed that $215 million be devoted to the PMI. Of this, $130 million will be used to start building the PMI research cohort. To help plan for the creation and management of the PMI research cohort in fiscal year 2016 and beyond, a working group of the Advisory Committee to the NIH Director (ACD) will be established. This group includes experts from many disciplines and sectors (see Roster).

Charge

The ACD Working Group on the Precision Medicine Initiative will develop a vision for how to harness the advances in technology, scientific understanding, and participant engagement to develop a platform for precision medicine research. To ensure that the Working Group's contributions can be incorporated into the funding plan for fiscal year 2016, in the short term, this group will develop a plan for creating and managing a large research cohort with data and specimens that can be accessed by all researchers for studies to understand the variables that contribute to health and disease and ultimately translate that knowledge into treatments tailored to individuals. A report will be delivered to the ACD in September 2015.

In developing the report, the Working Group will:

  • Articulate the vision for the PMI research cohort, including what can be learned from a study at this scale and what success might look like five and ten years out.
  • Detail the issues that will need to be examined in developing the study design.
  • Consider how to incorporate rapidly evolving technology into the cohort design
    • Develop criteria for the inclusion of mobile health technologies into the cohort, both for baseline and ongoing data collection.
    • Outline a path forward for getting the EHRs associated with the cohort interoperable or for standardizing data that can be extracted in response to a query.
    • Consider what laboratory components can be incorporated, including various — omics and imaging approaches
  • Assess ways to recruit visionary experts from multiple disciplines to join the PMI, including potential support of pilots to test new ideas and new technologies
  • Identify the pros and cons of different models for enrolling participants into the cohort, including consideration of methods for ensuring that underserved populations are included.
  • Review existing models of participant engagement and recommend a path for establishing the best strategy for ensuring participants are involved in the planning, building, and management of the cohort.
  • Identify any gaps in existing policies on data privacy, security, and misuse that must be filled to support the PMI cohort, and propose a route to develop appropriate solutions.
  • Recommend approaches to work with the International community, both for learning as we build the cohort and for possible collaborations.
  • Describe methods for evaluating the success and utility of the cohort for all parties — participants, researchers, healthcare providers, funders, etc.

In carrying out its charge, the working group will need to engage with many individuals from different disciplines and backgrounds — through public meetings on issues critical to the design and vision for the cohort.ta science challenges facing the biomedical research enterprise.

Final Reports

Roster

  • Kathy Hudson, PhD (co-chair)
    Deputy Director for Science,
    Outreach, and Policy
    National Institutes of Health
  • Richard Lifton, MD, PhD (co-chair)
    Chair, Department of Genetics
    Sterling Professor of Genetics
    and Internal Medicine
    Founder and Executive Director
    Yale Center for Genome Analysis
    Yale University School of Medicine
  • Bray Patrick-Lake, MFS (co-chair)
    Director of Stakeholder Engagement
    Clinical Trials Transformation
    Initiative Director of Patient
    Engagement
    CTSA
    Duke University
  • Esteban Gonzalez Burchard,
    MD, MPH
    Harry Wm. and Diana V. Hind
    Distinguished Professor in
    Pharmaceutical Sciences
    Professor and Vice Chair
    Departments of Bioengineering
    & Therapeutic Sciences
    Medicine Director, Center for
    Genes, Environments & Health
    University of California,
    San Francisco
  • Tony Coles, MD
    Chairman and Chief Executive
    Officer
    Yumanity Therapeutics LLC
  • Rory Collins, FMedSci
    Professor of Medicine &
    Epidemiology
    Nuffield Department of
    Population Health
    University of Oxford
  • Andrew Conrad, PhD
    Head of Life Sciences
    Google
  • Josh Denny, MD
    Associate Professor of Biomedical
    Informatics
    Vanderbilt University
  • Susan Desmond-Hellmann,
    MD, MPH
    Chief Executive Officer
    Bill & Melinda Gates Foundation
  • Eric Dishman
    Intel Fellow & General Manager
    Health & Life Sciences
    Intel Corporation
  • Kathy Giusti, MBA
    Founder/Executive Chairman
    Multiple Myeloma Research Foundation
  • Sekar Kathiresan, MD
    Director, Preventive Cardiology
    Massachusetts General Hospital
    Institute Member, Broad Institute
    Associate Professor of Medicine
    Harvard Medical School
  • Sachin Kheterpal, MD, MBA
    Associate Professor
    Department of Anesthesiology
    University of Michigan Medical School
  • Shiriki Kumanyika, PhD, MPH
    Emeritus Professor of Epidemiology
    University of Pennsylvania Perelman School of Medicine
  • Spero M. Manson, PhD
    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, MD
    Director, Human Research Affairs
    Director, Embryonic Stem Cell Research Oversight
    Partners HealthCare
  • Richard Platt, MD
    Professor and Chair
    Harvard Medical School Department of Population Medicine
    Harvard Pilgrim Health Care Institute
  • Jay Shendure, MD, PhD
    Associate Professor
    Department of Genome Sciences
    University of Washington
  • Sue Siegel
    Chief Executive
    GE Ventures and Healthymagination

EX OFFICIO MEMBERS

  • Robert Califf, MD
    Deputy Commissioner for Medical Products and Tobacco
    US Food and Drug Administration
  • Karen DeSalvo, MD, MPH, MSc
    National Coordinator for Health Information Technology
    Office of the National Coordinator
    US Department of Health and Human Services
  • Jo Handelsman, PhD
    Associate Director for Science
    Office of Science and Technology Policy
    The White House
  • Timothy O'Leary, MD
    Chief Research and Development Officer
    US Department of Veterans Affairs
  • Terry M. Rauch, PhD
    Director
    Research & Development Policy & Oversight
    Office of the Assistant Secretary Of Defense
    US Department of Defense

This page last reviewed on February 12, 2011