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Breakthrough Therapy: One Candle on the Birthday Cake - Are Innovators Enjoying Sweet Success or Is the Pathway Not Baked Yet?
Session Chair(s)
Nancy Bradish Myers, JD
CEO and Founder
Catalyst Healthcare Consulting, Inc, United States
What has been accomplished in the first year of Breakthrough Therapy? This forum will explore experiences, lessons learned and how these lessons could inform new regulatory changes intended to spur innovation.
Learning Objective : Identify lessons learned under FDA’s new Breakthrough Therapy designation; Recognize how to apply these lessons and plan for changes as it evolves in its second year of implementation
Speaker(s)
Patient Advocacy Perspective on Breakthrough Therapy at One Year
Jeff Allen, PhD
Friends of Cancer Research, United States
President and Chief Executive Officer
Industry/Manufacturing Perspective on Breakthrough Therapy at One Year
Earl S. Dye, PhD
Genentech, A Member of the Roche Group, United States
Director, Technical Regulatory Policy
Industry Perpective on Breakthrough Therapy at One Year
Urte Gayko, PhD
Pharmacyclics, United States
Senior Vice President, Global Regulatory Affairs
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