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CMC Development of Breakthrough Therapies
Session Chair(s)
Sarah Pope Miksinski, PHD
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
This session will focus on regulatory considerations regarding drug development of breakthrough therapies, with an emphasis on the relationship of CMC development data to overall patient benefit-risk as well as innovative approaches to consider for submission of CMC information in breakthrough (or otherwise expedited) submissions.
Learning Objective : Discuss CMC regulatory considerations and development challenges for breakthrough products; Define possible innovations and points to consider for CMC dossiers for breakthrough products; Outline potential strategies for CMC submissions that support breakthrough products.
Speaker(s)
G.K. Raju, PHD, MS
Chairman and Chief Executive Officer, Light Pharma Inc., United States
Quality and Benefit Risk Management for Breakthrough Therapies
Brian Kelley
Vice President, Bioprocess Development, Genentech, A Member of the Roche Group, United States
Impact of Accelerated Launch in the Development Pathway for Large Molecules
Ramesh K. Sood, PHD
Senior Scientific Advisor (Acting), Office of New Drug Products, CDER, FDA, United States
Quality Considerations for Breakthrough Drugs: FDA Perspective
Angelica Dorantes, PHD, MSC
Biopharmaceutics Branch Chief (acting), Office of Pharmaceutical Quality, CDER, FDA, United States
Panelist
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