From IND to BLA: building defensible analytical strategies for cell therapy

“...anticipate unexpected questions, take a hard look at your data, and try to assemble some experts to pick it apart before submission.”

Early analytical decisions in cell therapy can influence the entire development pathway, from IND readiness and CDMO transfer to BLA submission and commercial scale‑up. In this expert panel discussion, leaders from Thermo Fisher Scientific, Cabaletta Bio, Resolution Therapeutics, and Roche Genentech examine common risks, evolving regulatory expectations, and how to build phase‑appropriate strategies that last.

Michael Brewer, Regulatory Global Principal Consultant, Thermo Fisher Scientific, Chien‑Chung Chen, Senior Director of Analytical Development, Cabaletta Bio, Damian Marshall, Vice President of Analytical Development, Resolution Therapeutics, and Max Tejada, Executive Director of Analytical Development and Quality Control, Roche Genentech, assembled to discuss the regulatory risks shaping cell therapy development, strategies for building resilient analytical packages, and how teams can avoid costly missteps as expectations evolve.

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