Brookings Active Surveillance Implementation Council Meeting #1
During the first BASIC meeting, Council members received updates on several ongoing pilot activities including the Observational Medical Outcomes Partnership (OMOP), Mini-Sentinel, the Exploring and Understanding Adverse Drug Reactions (EU-ADR) Project, and the Vaccine Safety Datalink.
Recognizing similarities among these pilot activities, the Council considered potential opportunities for sharing findings and minimizing overlap. Following a presentation by McKinsey & Company on lessons learned from public-private partnerships and complex alliances in other industries, the Council discussed governance of the Sentinel System. Specifically, Council members explored the merits of potential organizational models focusing on governance for multiple users and multiple uses, economic sustainability, and ensuring participation of appropriate stakeholders.
Agenda
Welcome, Introduction, Charge to the Council, and Meeting Objectives
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Remarks from FDA Leadership
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Rachel Behrman
Director, Office of Medical Policy, Center for Drug Evaluation and Research
Session I: U.S.-Based Medical Product Active Surveillance Pilot Projects
Paul Stang
Johnson & Johnson and the Observational Medical Outcomes Partnership
Judy Racoosin
Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research
Francesca Cunningham
Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management Services
Trinka Coster
Pharmacovigilance Center, United States Army, Office of the Surgeon General
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Council Discussion
Arnold Chan
OptumInsight Life Sciences
Myrl Weinberg
Chief Executive Officer - National Health Council
Session II: Other Initiatives That Can Inform Development of the Sentinel System
Miriam Sturkenboom
Department of Medical Informatics and Epidemiology, Erasmus University Medical Center
Chesley Richards
Office of Prevention through Healthcare, Office of the Director for Policy, Centers for Disease Control and Prevention
Jean Slutsky
Center for Outcomes and Evidence, Agency for Healthcare Research and Quality
Session III: Organization Models for the Sentinel System
Navjot Singh
MicKinsey & Company
Robert M. Califf
Duke Translational Medicine Institute
Alec Walker
World Health Information Science Consultants, LLC
Stanley B. Watson
Kaiser Foundation Research Institute
Discussion Summary and Next Steps
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
More Information
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