Sentinel Initiative Public Workshop - Eighth Annual

Project Title Sentinel Initiative Public Workshop - Eighth Annual
Date
Wednesday, February 3, 2016
Description

The Duke-Margolis Center for Health Policy hosted the 8th Annual Sentinel Initiative Public Workshop at the Renaissance Washington, DC Dupont Circle Hotel. This annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the development of the Sentinel Initiative. With the passage of the Food and Drug Administration Amendments Act of 2007, Congress mandated that the U.S. Food and Drug Administration (FDA) develop a national electronic system to track the safety of regulated medical products. In response to this charge, FDA launched the Sentinel Initiative in 2008. Mini-Sentinel, a pilot project of the Sentinel Initiative, utilizes electronic health care data for postmarket risk identification and analysis of medical product safety. Since 2008, Mini-Sentinel has continued to develop with great interest from the stakeholder community and recently transitioned from pilot project to the full Sentinel System to help expand and enhance the FDA’s surveillance capabilities.

Specific topics that were addressed during the workshop include:

  • An overview of the current state of Sentinel safety surveillance activities;
  • Uses of Sentinel in medical product evaluations;
  • Development of current and future Sentinel tools and methods;
  • Sentinel’s role as a national resource for evidence generation; and
  • Stakeholder feedback on opportunities to enhance and modernize the Sentinel System.

Funding for this conference was made possible in part by a cooperative agreement from the Food and Drug Administration, Center for Drug Evaluation Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.

The workshop was captured on video and the segments displayed below are as follows:

Part 1: Welcome and Overview; Keynote Address; The Sentinel Initiative: Perspective from FDA’s Leadership; State of Sentinel Safety Surveillance Activities 

Part 2: Selected Sentinel Medical Product Evaluations; Current and Future Development of the Sentinel System

Part 3: Developing a National Resource for Evidence Generation

Part 4: Stakeholder Perspectives on Opportunities to Enhance and Modernize Postmarket Drug Safety Surveillance; Closing Remarks

Host

Mark McClellan, MD, PhD, Duke-Robert J. Margolis Center for Health Policy and Robert J. Margolis Professor of Business, Medicine and Health Policy, Duke University; Greg Daniel, PhD, MPH, Deputy Director, Duke-Robert J. Margolis Center for Health Policy and Clinical Professor, Fuqua School of Business, Duke University

Location
Presenters

Steven Anderson, PhD, MPP, Director, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration; Kathleen Blake, MD, MPH, Vice President, Performance Improvement, American Medical Association; Jeff Brown, PhD, Associate Professor, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute; Patrizia A. Cavazzoni, MD, Senior Vice President, Worldwide Development Operations, Pfizer, Inc.; Francesca Cunningham, PharmD, Associate Chief Consultant, Medication Safety, PBM, and Director, Center for Medication Safety, U.S. Department of Veterans Affairs; Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Bruce Fireman, Biostatistician, Division of Research, Kaiser Permanente Northern California; Susan Hariri, PhD, Scientific Deputy, Prevention Branch, Division of Viral Hepatitis, U.S. Centers for Disease Control and Prevention; Troy McCall, PhD, Chief Implementation Officer, Reagan-Udall Foundation for the FDA; Catherine M. Meyers, MD, Director, Office of Clinical and Regulatory Affairs, National Center for Complementary and Integrative Health, National Institutes of Health; J. Stephen Mikita, JD, Planning Board Member, Sentinel, Lead, Sentinel Engagement Partners Workgroup, Patient Representative, Duke Clinical Trials Transformation Initiative; Gregory Pappas, MD, PhD, Associate Director for National Device Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Doris Peter, PhD, Director, Health Ratings Center, Consumer Reports; Richard Platt, MD, MSc, Professor and Chair, Department of Population Medicine, Harvard Medical School, Executive Director, Harvard Pilgrim Health Care Institute; Marsha E. Reichman, PhD, Senior Advisor and Scientific Lead for Surveillance Programs, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Commander (CDR) Melissa Robb, Associate Director for Regulatory Affairs, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Joe Selby, MD, MPH, Executive Director, Patient-Centered Outcomes Research Institute; Azadeh Shoaibi, PhD, MHS, Sentinel Lead, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration; Paul Wallace, MD, Chief Medical Officer and Senior Vice President, Clinical Translation, Optum Labs; Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.