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Breakthrough Therapy Designation: One Year After
Session Chair(s)
Martine Zimmermann, PharmD
Senior Vice President, Head of Global Regulatory Affairs, R&D Quality
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)
FDA Perspective
Richard Moscicki, MD
PhRMA, United States
Chief Medical Officer and Executive Vice President, Science and Regulatory
Sovaldi for HCV: Case Study on Breakthrough Therapy
Paul Tomkins, PhD
Gilead Sciences, Inc., United States
Senior Director, HIV and Liver Disease Regulatory Affairs
The Forecast for Breakthrough Therapy Designations and Lessons Learned from Oncology
Karen Jones
Accumulus Synergy , United States
Head of Regulatory Innovation
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