Stephan Krause

Company: Bristol Myers Squibb

Job title: Executive Director, Analytical Science & Technology, Cell Therapy Quality, Bristol Myers Squibb

Seminars:

Optimizing Analytical Validation for Commercialization Success in Product Development 9:30 am

Exploring methods to strategically validate assays, minimizing the number required for commercialization while ensuring regulatory compliance. Discussing the transition towards PAT to accelerate testing timelines, with a focus on stability assessments and early data acquisition. Investigating innovative approaches to obtain stability data earlier in the manufacturing process, enabling expedited release of the final drug product.Read more

day: Conference Day Two

Industry Leaders’ Fireside Chat: Pioneering Analytical Frontiers to Overcome the Complexities of Cell Therapy Products – Insights from Cell Therapy’s Foremost Analytical Minds 8:40 am

Delve into the key obstacles and complexities currently facing analytical development in cell therapy: Representative material for method development Regulatory expectations and phase appropriateness Comparability challenges across analytical methods Discuss the latest advancements and innovations in analytical techniques and methodologies and their applications in cell therapy development. Share insights and strategies for overcoming current challenges…Read more

day: Conference Day One