Dec 15

Past Event

Expert Workshop: Expedited Drug Development for Promising Therapies

Event Materials


On December 15, the Engelberg Center convened an expert workshop to discuss expedited drug development for promising therapies.

This workshop brought together a diverse set of stakeholders who discussed the following issues:

  • Existing tools for facilitating expedited market access;
  • Opportunities for improving and expanding upon these tools;
  • Therapeutic areas most in need of an expedited development pathway and how promising therapies can be defined;
  • Methodological approaches to enable a compressed drug development timeline; and
  • Potential evidence gaps that may result in the post-market environment for products approved through an expedited pathway.


Event Agenda

  • Welcome

  • Panel 1: Existing Approaches for Expedited Market Access

  • Panel 2: Opportunities to Improve and Expand Existing Pathways

    • Moderator: Jeff Allen

      Friends of Cancer Research

    • Janet Woodcock

      U.S. Food and Drug Administration

    • James C. Greenwood

      Biotechnology Industry Organization

    • Jonathan Leff

      Warburg Pincus LLC

    • Garry Neil

      Johnson & Johnson

  • Panel 3: Focus Areas for Expedited Drug Development Informed by Patient and Public Health Needs

    • Moderator

    • Daniel Perry

      Alliance for Aging Research

    • Naomi Aronson

      Blue Cross and Blue Shield Association Technology Evaluation Center

    • Russell Katz

      U.S. Food and Drug Administration

  • Panel 4: Innovative Methodologies for Expedited Evidence Development

    • Moderator

    • Robert Califf

      Duke University Medical Center and Duke Translational Medicine Institute

    • Donald Berry

      University of Texas MD Anderson Cancer Center

    • Jeffrey Murray

      U.S. Food and Drug Administration

  • Panel 5: Post-Market Considerations to Ensure Safe Use and Continued Evidence Development Following Expedited Development and Approval

    • Moderator

    • Brian Solow


    • Ellen Sigal

      Friends of Cancer Research

    • Kathleen Hewitt

      American College of Cardiology

    • Louis Jacques

      Centers for Medicare & Medicaid Services

    • Richard Platt

      Harvard Medical School and Harvard Pilgrim Health Care Institute

  • Closing Remarks


December 15, 2011

8:30 AM - 2:30 PM EST

The Brookings Institution

Falk Auditorium

1775 Massachusetts Ave., NW


For More Information

Brookings Office of Communications

(202) 797-6105