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Breakthrough Therapy: One Candle on the Birthday Cake - Are Innovators Enjoying Sweet Success or Is the Pathway Not Baked Yet?
Program Code:
277
Date:
Tuesday, June 25, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Nancy Bradish Myers,
Esq, JD (SCHNON), President,
Catalyst Healthcare Consulting, Inc, United States
Nancy Bradish Myers, JD is President of Catalyst Healthcare Consulting. She served as Senior Strategic Advisor in FDA’s Office of the Commissioner and has held senior positions at PhRMA and BIO. She is a past President of the Alliance for a Stronger FDA and received FDA’s Distinguished Alumni Award
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SPEAKER
(S):
Jeff Allen,
PhD (SPKSUP), Executive Director,
Friends of Cancer Research, United States
Jeff Allen, Ph.D., serves as the Executive Director of Friends of Cancer Research, a cancer research think tank based in Washington, D.C. that through policy and education brings together key stakeholders to overcome the barriers standing between patients and the most promising cancer treatments.
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Earl S. Dye, III, PhD (SPKNON), Director, Technical Regulatory Policy, Genentech, A Member of the Roche Group, United States
Urte Gayko, PhD (SPKNON), Senior Vice President, Global Regulatory Affairs, Pharmacyclics, United States
Description
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.