Going from Zero to 100: The Bemdaneprocel Journey to Phase 3 and Beyond! | BMWS25 Keynote

In this BMWS keynote, leaders from Bayer and BlueRock Therapeutics share the real-world journey of advancing bemdaneprocel from early clinical development to Phase 3—highlighting the manufacturing challenges, collaboration, and comparability work that make large-scale readiness possible. Tina Self, SVP of Global Biologics Manufacturing and Berkeley Site Head at Bayer, and Craig Beasley, Chief Technology Officer at BlueRock Therapeutics, reflect on the end-to-end journey of bringing bemdaneprocel from Phase 1 to Phase 3 and preparing for commercial launch. They discuss what RMAT designation means operationally, the challenges overcome along the way, and how the team is demonstrating comparability to ensure seamless transitions across development stages. Key insights include: What RMAT really means for manufacturing as programs advance to Phase 3 Key lessons from the bemdaneprocel journey—from early development to launch readiness Challenges overcome to prepare for Phase 3 and commercial scale How comparability is demonstrated to enable smooth transitions across stages How Bayer and BlueRock Therapeutics collaborate to bring this therapy to patients About BMWS: The Biomanufacturing World Summit brings together senior manufacturing, technical operations, quality, and bioprocessing leaders to share insights, explore innovation, and advance the future of global biopharma production. Learn more at https://www.executiveplatforms.com/bmws/