Leveraging Past Learnings For Future-Focused Solutions To Clinical Manufacturing

The ThinkLive Cell and Gene Therapy Summit 2024 provided a forum for industry experts to explore leveraging past insights for future-focused solutions in clinical manufacturing. Moderated by Christian Schneider, Vice President and Head of Biopharma Excellence at PharmaLex, part of Cencora, the panel session featured accomplished professionals such as Dan O’Connor, Director, Regulatory and Early Access Policy at the Association of the British Pharmaceutical Industry (ABPI), Lisa Freeman, Vice President, Head of Regulatory Affairs at CRISPR Therapeutics, Christopher McMahon, Senior Director, Discovery, Research, at Fujifilm Cellular Dynamics, and Tamara T. Monesmith, Senior Vice President, Technical Development at Editas Medicine.

The discussion touched upon aligning CMC development with clinical timelines, navigating EMA and FDA requirements, and optimizing regulatory strategies through joint scientific advice. Panelists discussed challenges like potency assurance, regulatory changes, and the role of bioinformatics in product characterization. They also explored the collaborative relationship between industry and regulators in shaping efficient pathways for novel therapies.

Watch the full recording to learn more about early regulatory engagement, platform approaches, and health economics integration for successful drug development.