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CMC Development of Breakthrough Therapies

Pharmaceutical Quality

Day & Time:
June 17, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:

Room Number:



CMC Development of Breakthrough Therapies

Sarah Pope Miksinski, PhD
Acting Director, Division II, Office of New Drug Quality Assessment, OPS, CDER
FDA, 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(s):
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.

Presentation(s) & Speaker(s):
Quality and Benefit Risk Management for Breakthrough Therapies
G.K. Raju, PhD, MS
Chairman and Chief Executive Officer
Light Pharma Inc., United States

Impact of Accelerated Launch in the Development Pathway for Large Molecules
Brian Kelley, PhD
Vice President, Bioprocess Development
Genentech, A Member of the Roche Group, United States

Quality Considerations for Breakthrough Drugs: FDA Perspective
Ramesh K. Sood, PhD
Deputy Office Director, Office of New Drug Quality Assessment, CDER
FDA, United States

Angelica Dorantes, PhD, MSc
Biopharmaceutics Team Leader, ONDQA, OPS, CDER
FDA, United States