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Session 1: Regulatory Framework and GMP Requirements for ATMPs
Session Chair(s)
Eliana Clark, PHD
Senior Vice President Technical Operations and Quality, Intellia Therapeutics, Inc., United States
Cell and gene therapy products and other advanced-therapy medicinal products (ATMPs) are different from biologics and small molecules due to their inherent complexity, with many novel manufacturing processes, use of complex starting materials, multiple banking requirements, and complex analytical methods. The regulatory framework and classifications are different between regions, as are GMP requirements for manufacturing of ATMPs. This session will cover case studies in regulatory and manufacturing approaches for gene therapy, gene editing, and autologous and allogeneic cell therapies.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand regulatory CMC requirements for ATMPs, including Drug Substance, Drug Product and Starting Material definitions
- Understand phase appropriate GMP requirements for ATMPs in different regions
- Discuss opportunities for harmonization of CMC requirements for ATMPs
Speaker(s)
Steven Oh, PHD
Acting Director, Division of Cell Therapy 1 & 2, FDA, United States
Speaker
Alexandra Beumer Sassi, PHARMD, PHD, RAC
Global Head of CMC&QA, Voisin Consulting Life Sciences, United States
Speaker
Dana Alexander, MBA
Senior Vice President, Technical Operations, AlloVir, United States
Speaker
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