Stephan Krause
Executive Director, Analytical Strategy, Cell Therapy Global Quality Bristol Myers Squibb
Stephan O. Krause, Ph.D., is Executive Director, Analytical Strategy and Quality, Cell Therapy Global Quality at Bristol Myers Squibb, where he leads analytical strategy and lifecycle execution for global cell therapy products. He is the immediate past chair of PDA’s ATMP Advisory Board, chair of the ANSI task force (ANS-007) for analytical lifecycle steps, and chair of PDA’s Technical Report working group for phase-appropriate GMP/QMS for ATMPs. Dr. Krause is an external industry/agency liaison and accomplished advocate for advancing industry best practices. He has received numerous industry awards for innovation and leadership.
Seminars
Meet the Scientific Advisory Board whose expertise has helped shape a highly relevant, industry focused agenda for this year’s meeting.
They will be exploring topics such as:
- Defining priorities that shift analytical development from support function to core risk management
- Identifying where challenges are similar and different across modalities and what that means for teams
- Clarifying practical gaps that still limit progress across analytical development and QC
- Using an enhanced analytical development program via appropriate analytical target profiles (ATP) and development staging opportunities to optimize analytical performance.
- Aligning analytical development, manufacturing, and QC controls strategy conditions.
- Pre-/post-commercial capacity expansion and validation considerations for QC operations for autologous cell therapies.
