Technology Policy & Regulation
Why and how should we regulate the use of AI in health care?
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
MJAModerator: Jeff Allen Friends of Cancer ResearchJWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug AdministrationJCGJames C. Greenwood Biotechnology Industry OrganizationJLJonathan Leff Partner - Deerfield ManagementGNGarry Neil Johnson & Johnson -
Panel 3: Focus Areas for Expedited Drug Development Informed by Patient and Public Health Needs
GWDGregory W. Daniel Former Brookings Expert, HealthCoreDPDaniel Perry Alliance for Aging ResearchRKRussell Katz U.S. Food and Drug Administration -
Panel 4: Innovative Methodologies for Expedited Evidence Development
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke UniversityRMCRobert M. Califf Duke Translational Medicine InstituteJMJeffrey 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 UniversityESEllen 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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