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📄 New in Cytotherapy: ‘Accelerating The Development of Genetically Engineered Cellular Therapies: A Framework for Extrapolating Data Across Related Products’ by Mark Stewart, Jeff Allen et al. Advancements in cellular therapy, particularly CAR-T cell treatments, have revolutionized oncology by demonstrating significant clinical benefits, prompting the need for expedited development strategies. A risk-based approach to data extrapolation across genetically engineered cellular therapies offers promise beyond CAR-T cells, potentially reshaping clinical development and regulatory pathways, thus accelerating the delivery of innovative treatments to cancer patients. Read the full paper now: https://lnkd.in/g-QGR8vb #Cytotherapy

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Timothy Kline, Ph.D., RAC

Senior Director, Global Regulatory Affairs at GSK

5mo

This is exactly how regulatory needs to be at the innovation table with our cross-functional stakeholders. Congratulations to my colleague Carsten Goessl as well.

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