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Past Event

Expert Workshop: Expedited Drug Development for Promising Therapies

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.

 

Agenda

Welcome

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

Panel 1: Existing Approaches for Expedited Market Access

R

Rachel Sherman

Principal, Drug and Biological Drug Products - Greenleaf Health LLC

Panel 2: Opportunities to Improve and Expand Existing Pathways

J

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

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

Panel 4: Innovative Methodologies for Expedited Evidence Development

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

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

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

E

Ellen Sigal

Chairperson and Founder - Friends of Cancer Research

R

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

Closing Remarks

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

More Information

Contact
(202) 797-6105

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