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Breakthrough Therapy Designation: One Year After
Session Chair(s)
Martine Zimmermann, PHARMD
Senior Vice President, Head of Global Regulatory Affairs, Ipsen , France
This session will discuss the impact of breakthrough therapy designation on the development of new medicines for serious conditions. An industry representative will present a real case study, and a regulatory agency view will also be shared.
Learning Objective : Discuss which products can apply for breakthrough designation; Discuss the benefit of breakthrough therapy designation for products targeted for serious conditions.
Speaker(s)
Richard Moscicki, MD
Chief Medical Officer and Executive Vice President, Science and Regulatory, PhRMA, United States
FDA Perspective
Paul Tomkins, PHD
Senior Director, HIV and Liver Disease Regulatory Affairs, Gilead Sciences, Inc., United States
Sovaldi for HCV: Case Study on Breakthrough Therapy
Karen Jones
Head of Regulatory Innovation, Accumulus Synergy , United States
The Forecast for Breakthrough Therapy Designations and Lessons Learned from Oncology
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