Dr. Stephan Krause is the Executive Director, Analytical Strategy, Cell Therapy Global Quality at Bristol Myers Squibb. Stephan stands out as a recognized industry leader, particularly for his efforts in advancing best practices to support enhanced and accelerated product development. Throughout his career, Stephan has held several notable advocacy roles. He is the immediate past chair of PDA’s ATMP Advisory Board, chair of the PDA/ANSI task force for standardizing analytical lifecycle steps and conditions (since 2022), and, he is chair of PDA’s Technical Report working group for phase-appropriate GMP and QMS. Stephan’s dedication and innovative leadership have earned him numerous awards for innovation, advocacy, and publications. His influential work has led to multiple invitations in recent years to present industry perspectives to the FDA and other major regulatory agencies, supporting the implementation of ICH Q2(R2), Q12, and Q14. His reputation for high-impact publications and advocacy continues to make a meaningful difference in the field.