FDA Sentinel Initiative Strategic Review
Three years ago, the U.S. Food and Drug Administration (FDA) launched the Sentinel Initiative, making significant progress in developing a system for conducting active surveillance of medical products. On September 26-27, the Engelberg Center hosted an event to reflect on the progress of the Initiative to date, and to consider its future direction and sustainability.
This event brought together a diverse set of stakeholders to reflect on the progress of the Initiative made to date, and consider its future direction to ensure sustainability of the system and reliability of results generated, including:
- Potential pathways that others outside of FDA (e.g., industry, academic safety scientists, etc) can access the resources and tools developed through the Mini-Sentinel pilot;
- Alignment of national priorities for safety science methods research and development, and training opportunities for the next generation of safety scientists; and
- Development of a national resource for evidence development by identifying synergies with related initiatives
Agenda
Welcome, Overview, and Conference Objectives
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Perspectives on the Progress of the Sentinel Initiative: Protecting Public Health
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Paul Stang
Johnson & Johnson and the Observational Medical Outcomes Partnership
Francesca Cunningham
Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management Services
Marcus D. Wilson
President - HealthCore
Michael McCaughan
Prevision Policy LLC and The RPM Report
Lessons Learned from Recent Mini-Sentinel Assessments
Melissa Robb
U.S. Food and Drug Administration
Jeffrey Brown
Harvard Pilgrim Health Care Institute and Harvard Medical School
Alec Walker
World Health Information Science Consultants, LLC
Brian J. Kelly
Aetna
Day 1: Wrap Up
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Day 2: Welcome and Overview
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
Supporting Industry-Sponsored Phase IV Studies
Nancy C. Santanello
Vice President and Head of Epidemiology
Elliott Levy
Bristol-Myers Squibb
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Paul Stang
Johnson & Johnson and the Observational Medical Outcomes Partnership
Arnold Chan
OptumInsight Life Sciences
John Santa
Consumer Reports Health Ratings Center
Supporting Safety Science Methods Research and Development
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
Garry Neil
Johnson & Johnson
Ronald Lee Krall
University of Pennsylvania Center for Bioethics
Ellen Sigal
Chairperson and Founder - Friends of Cancer Research
Creating Sentinel as a National Resource for Evidence Development
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Patrick Miller
University of New Hampshire and All-Payer Claims Database Council
Dave Knutson
U.S. Department of Health and Human Services
Joe Selby
Executive Director - Patient-Centered Outcomes Research Institute
Rich Elmore
Office of the National Coordinator for Health Information Technology
Closing Remarks
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
More Information
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