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Breakthrough Therapy Designation: One Year After

Track:
Regulatory Affairs and Submissions

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
267

Room Number:
6F

Level:
Intermediate

Type:
Session

Title:
Breakthrough Therapy Designation: One Year After

Chair(s):
Martine Zimmermann, PharmD
Vice President, Global Regulatory Affairs
Alexion Pharma International Sàrl, Switzerland

Description:
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(s):
Discuss which products can apply for breakthrough designation; Discuss the benefit of breakthrough therapy designation for products targeted for serious conditions.

Presentation(s) & Speaker(s):
FDA Perspective
Richard Moscicki, MD
Deputy Center Director for Science Operations, CDER
FDA, United States

Sovaldi for HCV: Case Study on Breakthrough Therapy
Paul Tomkins, PhD
Senior Director, HIV and Liver Disease Regulatory Affairs
Gilead Sciences, Inc., United States

The Forecast for Breakthrough Therapy Designations and Lessons Learned from Oncology
Karen Jones
Genentech, A Member of the Roche Group, United States