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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
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September 26
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Welcome, Overview, and Conference Objectives
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke UniversityJWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
Perspectives on the Progress of the Sentinel Initiative: Protecting Public Health
RPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstitutePSPaul Stang Johnson & Johnson and the Observational Medical Outcomes PartnershipFCFrancesca Cunningham Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management ServicesMDWMarcus D. Wilson President - HealthCoreMMMichael McCaughan Prevision Policy LLC and The RPM Report -
Lessons Learned from Recent Mini-Sentinel Assessments
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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 UniversityRSRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLC -
Supporting Industry-Sponsored Phase IV Studies
NCSNancy C. Santanello Vice President and Head of EpidemiologyBMBriggs MorrisonELElliott Levy Bristol-Myers SquibbRPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstitutePSPaul Stang Johnson & Johnson and the Observational Medical Outcomes PartnershipACArnold Chan OptumInsight Life SciencesJSJohn Santa Consumer Reports Health Ratings Center -
Supporting Safety Science Methods Research and Development
RSRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLCGNGarry Neil Johnson & JohnsonRLKRonald Lee Krall University of Pennsylvania Center for BioethicsESEllen Sigal Chairperson and Founder - Friends of Cancer ResearchRHRalph Horwitz -
Creating Sentinel as a National Resource for Evidence Development
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke UniversityPMPatrick Miller University of New Hampshire and All-Payer Claims Database CouncilDKDave Knutson U.S. Department of Health and Human ServicesRERich Elmore Office of the National Coordinator for Health Information TechnologySRTSean R. Tunis -
Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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