Dec 15

Past Event

Expert Workshop: Expedited Drug Development for Promising Therapies

Event Materials

Summary

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.

 

Details

December 15, 2011

8:30 AM - 2:30 PM EST

The Brookings Institution

Falk Auditorium

1775 Massachusetts Ave., NW

Map

For More Information

Brookings Office of Communications

(202) 797-6105

Event Agenda

  • Welcome

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

      View Bio

  • Panel 1: Existing Approaches for Expedited Market Access

    • Moderator

      Portrait: Greg Daniel

      Gregory W. Daniel

      Managing Director for Evidence Development & Innovation

      Economic Studies

      View Bio

    • Rachel Sherman

      U.S. Food and Drug Administration

    • Margo Heath-Chiozzi

      Bristol-Myers Squibb

  • 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

      Portrait: Greg Daniel

      Gregory W. Daniel

      Managing Director for Evidence Development & Innovation

      Economic Studies

      View Bio

    • 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

      mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

      View Bio

    • 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

      mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

      View Bio

    • Brian Solow

      OptumRx

    • 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

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

      View Bio

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