Stephan Krause
Executive Director, Analytical Science and Technology, Cell Therapy Quality,
Bristol Myers Squibb
Dr. Stephan Krause is the Executive Director, Analytical Strategy, Cell Therapy Global Quality at Bristol Myers Squibb. Stephan is a recognized industry leader for advancing best practices for analytical method lifecycle steps to support acceleration of product development. He is currently immediate past chair of PDA’s ATMP Advisory Board (since 2021), chair of the ANSI task force for standardizing analytical lifecycle steps and conditions (since 2022), chair of PDA Technical Report ATMP for phase-appropriate QMS (since 2024), and ISPE/ICH Q2R2/Q14 working group (formal training slides). He has won numerous innovation, advocating, and publication awards. Based on his high-impact publications and advocacy, Stephan was invited multiple times in recent years to present an industry perspective to the FDA, other major regulatory agencies, and USP to support the implementation of ICH Q2(R2), Q12, and Q14.
Sessions
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20-Jan-2027Theatre 2Session 6: Cell therapy product characterization and QC