Stephan Krause
Executive Director - Analytical 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
Automated manufacturing is emerging as the industry’s clearest path to lower COGs, broader patient access and sustainable commercial success.
In this focused session, evaluate where automation delivers the greatest value in your manufacturing process, how to integrate it into your existing framework and how to align with regulations. Through case studies and in-depth discussions, combining industry leaders involved in automated manufacturing and key regulatory experts, gain insight into the decisions, trade-offs and lessons shaping automated manufacturing programmes to de-risk execution and ensure a smooth and economical road to market.
- Analyzing the impact of automation on cost of goods to optimize resource allocation and support sustainable clinical and commercial manufacturing
- Integrating automated platforms within GMP manufacturing and quality systems while maintaining data integrity and oversight
- Interpreting updated cell therapy GMP and advanced manufacturing technology expectations to leverage regulatory flexibility without compromising compliance
- 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
- 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
