The Sentinel Stakeholder Engagement Workgroup

January 30, 2018 | The mission of the Sentinel Stakeholder Engagement workgroup was to develop messages to inform engagement partners about the Sentinel System, letting them know what a valuable tool it is and how it works, and to remind them of the FDA’s commitment to protect patient privacy. The workgroup was led by a Patient Representative to the Sentinel Planning Board. Workgroup members included representatives of the patient community, health advocacy groups, providers, health plan members, the Sentinel System staff, and the FDA.

Workgroup Leaders

  • Steve Mikita JD, Spinal Muscular Atrophy Foundation and Patient Representative to the Sentinel Planning Board, Salt Lake City, UT
  • Richard Platt MD, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
  • David Tyler Coyle MD, MS, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Workgroup Members

  • Barbara Evans JD, MPH, University of Houston Law Center and Member of Sentinel Privacy Panel, Houston TX
  • Bray Patrick-Lake MA, Duke Clinical Research Institute, Durham, NC
  • Sharon Terry, Genetic Alliance and Patient Representative to Sentinel Planning Board, Washinigton D.C.
  • Nancy Kurilla Falk, Kaiser Foundation Health Plan, Oakland, CA
  • Consuelo H. Wilkins MD, MSCI, Meharry-Vanderbilt Alliance, Nashville, TN
  • Jamie Brocki BA, Anthem, Inc., Cincinnati, OH
  • Amy B. Cadwallader PhD, Barry D. Dickinson PhD, American Medical Association, Chicago, IL
  • Jamila Mwidau RN, BSN, MPH, Michael Nguyen MD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
  • David Martin MD, MPH, Office of Center Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
  • Anna Staton, Office of Communications, U.S. Food and Drug Administration, Silver Spring, MD
  • Katherine Freitas BA, Susan Forrow BA, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

 

March 1, 2019 | This project will reconvene the Sentinel Stakeholder Engagement Workgroup to develop and disseminate enhanced messaging concerning Sentinel’s expanded role in supporting FDA’s regulatory mission and assessing the efficacy of medical products, and will clarify Sentinel’s value to important constituencies, including patients, providers, data partner members, and the public.

Workgroup Leaders

  • Steve Mikita JD, Spinal Muscular Atrophy Foundation and Patient Representative to the Sentinel Planning Board, Salt Lake City, UT
  • Richard Platt MD, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
  • Michael Nguyen MD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Workgroup Members

  • Bray Patrick-Lake MA, Duke Clinical Research Institute, Durham, NC
  • Consuelo H. Wilkins MD, MSCI, Meharry-Vanderbilt Alliance, Nashville, TN
  • Jamie Brocki BA, Anthem, Inc., Cincinnati, OH
  • Amy B. Cadwallader PhD, American Medical Association, Chicago, IL
  • Katherine Chiu MPH, Susan Forrow BA, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA