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

“Phase‑appropriate does not mean sloppy.”

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.

The panel discusses the regulatory risks shaping cell therapy development, strategies for building resilient analytical packages, and how teams can avoid costly missteps as expectations evolve.

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

Max Tejada
Executive Director of Analytical Development and Quality Control, Roche Genentech

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