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Session 4: Starting and Raw Materials in Cell and Gene Therapy
Session Chair(s)
Sofia Buch, PHD, MSC
Vice President for Cell Therapy CMC, Novo Nordisk A/S, Denmark
Starting- and raw materials are an important part of the cell and gene therapy products and can be highly complex in nature. This session will focus on gene edited cells as starting material, approaches to selection and qualification of raw materials and differences in regulations from different countries.
Learning Objective : At the conclusion of this session, participants should be able to:
- Have an increased understanding of cells as starting material that are gene edited
- Have increased understanding of approaches to raw materials
- Have a general overview regulatory landscape for raw materials
Speaker(s)
Benjamin Fryer, PHD
CEO, Pluristyx, Inc., United States
Overview of Regulatory Landscape for Raw Materials
Sara Mills
Senior Consultant, Dark Horse Consulting Group, United States
A Risk-Based Approach to Raw Material Applications Throughout Clinical Development of Advanced Therapies
Andrew Ramelmeier, PHD
Executive Vice President, Technical Operations, Sangamo Therapeutics, United States
The Intricacies of Cell Therapy’s Starting Materials
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