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Session 5 Track B: Opportunities and Challenges for Developing ATMP Products
Session Chair(s)
Judy Chou, PhD
President and CEO
AltruBio, Inc., United States
Advanced Therapeutic Medicinal Products (ATMPs) present therapeutic advantage for patients and the development opportunities for pharmaceutical industry. With the inherent technical challenges from R&D all the way to manufacturing, the strategy as well as the approaches for ATMPs need to be in place ahead of time. The experiences from three companies will be shared and discussed in this session.
Speaker(s)
Speaker
Judy Chou, PhD
AltruBio, Inc., United States
President and CEO
Challenges and Considerations for Large Scale Manufacture of an AAV-Based Gene Therapy Product
Robert Baffi
Biomarin, United States
Executive Vice President of Technical Operations
Regulation of Advanced Therapies: Cell and Gene Therapy Products
Raj K. Puri, MD, PhD
FDA, United States
Director, Division of Cellular and Gene Therapies, OTAT, CBER