Nov 15

Past Event

Developing Systems to Support Pharmacovigilance of Biologic Products

Summary

Biologic products show great promise as treatments for a variety of illnesses, including cancer and autoimmune diseases. However, the complexity of these products creates unique challenges for monitoring their safety in the postmarket setting. Specifically, variations between similar biologic products and batches of the same product may be associated with significant adverse events. As such, pharmacovigilance systems must be able to distinguish between products with a high level of specificity.

On November 15, the Engelberg Center for Health Care Reform convened an expert workshop, “Developing Systems to Support Pharmacovigilance of Biologic Products” to explore strategies that support the identification of products for safety surveillance and monitoring. Participating stakeholders included safety surveillance experts, the biologics industry, patient advocacy groups, clinicians, pharmacists, provider systems, payers, academia, and regulators. These stakeholders shared their input on pharmacovigilance issues associated with biologics, explored lessons from international regulatory experiences, and examined mechanisms to identify biologics to support safety surveillance.  

Event Agenda

  • 8:30

    Registration

  • 9:00

    Welcome and Introduction

  • 9:30

    Session I: Current Pharmacovigilance Systems' Capabilities and Limitations

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Robert Ball

      U.S. Food and Drug Administration

    • Huifeng Yun

      University of Alabama at Birmingham School of Medicine

    • Meghan Baker

      Harvard Pilgrim Health Care Institute & Harvard Medical School

    • Kathryn Starzyk

      Quintiles

  • 10:30

    Break

  • 10:45

    Session II: International Experience and Lessons Learned with Biologics and Biosimilars

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Mark McCamish

      Sandoz

    • Geoffrey Eich

      Amgen

    • Judith K. Jones

      The Degge Group, Ltd.

  • 11:45

    Lunch

  • 1:00

    Session III: Potential Strategies to Identify Biologics for Safety Surveillance

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Angela Long

      U.S. Pharmacopeial Convention

    • Cynthia Hake

      Centers for Medicare & Medicaid Services

    • David Gaugh

      Generic Pharmaceutical Association

    • Sara Radcliffe

      Biotechnology Industry Organization

    • Richard Dolinar

      Alliance for Safe Biologic Medicines

  • 2:30

    Closing Remarks

Details

November 15, 2013

8:30 AM - 2:45 PM EST

Brookings Institution

Saul/Zilkha Rooms

1775 Massachusetts Avenue NW

Map

For More Information

Brookings Office of Communications

202.797.6105