Development of Points to Consider: Comparability Considerations for Advanced Therapy Medicinal Products Subject to Changes in their Manufacturing Process

3:00 PM - 4:00 PM (PDT), Wednesday, June 15, 2022

This session will focus on considerations for evaluating the comparability of cell and gene therapy (CGT) products before and after changes are made in their manufacturing processes.  Industry members representing a variety of CGT modalities will discuss innovative approaches that may be relevant when assessing the impact of manufacturing process changes on quality, safety, and efficacy of the final product.   Case studies will also be presented to frame the discussion.

Vice President, Quality and Regulatory Compliance, QI&I, Nov
Novo Nordisk
Head of Regulatory, PT Cell & Gene Therapeutics
Genentech, A Member of the Roche Group
Acting Director, Cellular and Gene Therapies
The U.S. Food and Drug Administration
Sr. Director, CMC Regulatory Affairs