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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)
Quality and Benefit Risk Management for Breakthrough Therapies
G.K. Raju, PhD, MS
Light Pharma Inc., United States
Chairman and Chief Executive Officer
Impact of Accelerated Launch in the Development Pathway for Large Molecules
Brian Kelley
Genentech, A Member of the Roche Group, United States
Vice President, Bioprocess Development
Quality Considerations for Breakthrough Drugs: FDA Perspective
Ramesh K. Sood, PhD
FDA, United States
Senior Scientific Advisor (Acting), Office of New Drug Products, CDER
Panelist
Angelica Dorantes, PhD, MSc
FDA, United States
Biopharmaceutics Branch Chief (acting), Office of Pharmaceutical Quality, CDER
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