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
Director, Margolis Center for Health Policy - Duke University
Panel 1: Existing Approaches for Expedited Market Access
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
Margo Heath-Chiozzi
Bristol-Myers Squibb
Panel 2: Opportunities to Improve and Expand Existing Pathways
Moderator: Jeff Allen
Friends of Cancer Research
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
James C. Greenwood
Biotechnology Industry Organization
Jonathan Leff
Partner - Deerfield Management
Garry Neil
Johnson & Johnson
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
Director, Margolis Center for Health Policy - Duke University
Robert M. Califf
Duke Translational Medicine Institute
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
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Ellen Sigal
Chairperson and Founder - Friends of Cancer Research
Kathleen Hewitt
American College of Cardiology
Louis Jacques
Centers for Medicare & Medicaid Services
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Closing Remarks
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
More Information
Contact
(202) 797-6105
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