Consultants' Network

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Consultants' Network

From CMC Challenges to Regulatory Strategy: Navigating Cell Therapy Development and Manufacturing | June 22 11:00 EDT | Virtual

Participate in the virtual Consultants' Network. This session brings together two critical perspectives: an in-depth look at how persistent CMC challenges—ranging from variable patient starting material and rising critical material costs to antigen escape and the complexities of solid tumors—are reshaping autologous cell therapy manufacturing and product design; and a strategic overview of global regulatory pathways, highlighting expedited programs, key FDA and EMA frameworks, and the implications of manufacturing models on compliance and speed to market. Registration for this free opportunity closes June 19, 2026.

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Consultants are a key component of CASSS membership. The purpose of the CASSS Consultants' Network is to facilitate discussions among consultants.

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For more information, contact Anne Ornelas.

Abstract | June 22

This session brings together two critical perspectives: an in-depth look at how persistent CMC challenges—ranging from variable patient starting material and rising critical material costs to antigen escape and the complexities of solid tumors—are reshaping autologous cell therapy manufacturing and product design; and a strategic overview of global regulatory pathways, highlighting expedited programs, key FDA and EMA frameworks, and the implications of manufacturing models on compliance and speed to market. Attendees will gain practical insights into comparability, process changes, inspection readiness, and lifecycle management, equipping consultants with the knowledge needed to navigate increasingly complex, globally aligned cell therapy development.

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2026 Speaker Presentations

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Save your spot for the virtual Consultants' Network Discussion on June 22, 2026. Registration for this free opportunity closes June 19, 2026.

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