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2020 ISPE Annual Meeting & Expo

SES411 - Supply Security in Cell and Gene Therapy Manufacturing

Nov 6, 2020 11:30am ‐ Nov 6, 2020 1:00pm

Expiration Date: Nov 30, 2021


Supply chain complexity in advanced therapies is driven by the three "Ps" of Patient, Process, and Product, with highly variable starting materials (patients), highly complex manufacturing (process) and highly regulated therapies and medicines (product). This session will bring a variety of perspectives from well-known presenters in the field, covering the challenges of establishing, managing, and executing a highly dynamic supply chain in a rapidly evolving industry. The panelists have significant experience in CMC , patient material collection and qualification, and clinical material manufacturing, from biopharma, clinical center manufacturing, and the tissue and blood banking industry. Key takeaways will include anticipating and scaling manufacturing supply chains for cell and gene therapies, the pitfalls of advanced therapy manufacturing, and strategies to assure success at all phases of clinical development through commercial manufacturing.

Session Leader(s):



  • Mark Davis, MS, MBA, Founder and Principal, NegotiumBio

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