Stephan Krause
Executive Director, Analytical Science , Technology & Cell Therapy Quality Bristol Myers Squibb
Stephan O. Krause, Ph.D., is Executive Director, Analytical Science and Technology, Cell Therapy Global Quality at Bristol Myers Squibb, where he leads analytical strategy and quality lifecycle execution for global cell therapy products. He is a member of PDA’s Board of Directors, chair of PDA’s ATMP Advisory Board, and chair of the ANSI task force (ANS-007) for analytical lifecycle steps. Dr. Krause is an accomplished advocate for advancing industry best practices and has received numerous awards for innovation and leadership.
Seminars
Tuesday 15th September 2026
Panel Discussion: Weighing the Pros & Cons of Automated Manufacturing
9:30 am
- Exploring the adoption of automated manufacturing process to enhance consistency, output and decrease variability
- Examining integration and flexibility challenges in automation to inform realistic implementation strategies
- Analyzing the impact of automation on cost of goods to optimize resource allocation and support sustainable clinical and commercial manufacturing
Thursday 17th September 2026
Defining Phase-Appropriate Control Strategies for Diverse Cell Therapy Products
11:25 am
- Exploring how phase-appropriate control strategies differ across CAR-T products, to ensure fit-for-purpose development strategies
- Evaluating potency and functional assays tailored to each modality to guide safe and effective transition from first-in-human through later clinical phases
- Discussing the evolution of control strategies from FIH to BLA to establish regulatory confidence
- Considerations for post-license control strategy revisions
