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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
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December 15
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Welcome
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Panel 1: Existing Approaches for Expedited Market Access
GWDGregory W. Daniel Former Brookings Expert, HealthCoreRSRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLCMHMargo Heath-Chiozzi Bristol-Myers Squibb -
Panel 2: Opportunities to Improve and Expand Existing Pathways
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Panel 3: Focus Areas for Expedited Drug Development Informed by Patient and Public Health Needs
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Panel 4: Innovative Methodologies for Expedited Evidence Development
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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 UniversityBSBrian SolowESEllen Sigal Chairperson and Founder - Friends of Cancer ResearchKHKathleen Hewitt American College of CardiologyLJLouis Jacques Centers for Medicare & Medicaid ServicesRPRichard 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
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