11:00am Chair Introduction

Cynthia Pussinen, Chief Technology Officer, Spark Therapeutics

11:05am Presentation: Developing allogeneic CAR-T cell products from iPSCs

• Notch is focused on small footprint, suspension-based manufacturing solutions for iPSC-derived T cells
• Products require early generation of well-characterized and commercially compatible GMP iPSC lines, gene editing and manufacturing processes
• Uniform and well characterized products will meet CMC regulatory standards and reduce clinical variability

Emily Titus, Senior Vice President, Technical Operations, Notch Therapeutics

11:20am Presentation: Implementing A 1-hour Mycoplasma Test for Immune-Effector Cells

• Addressing the current challenges faced in product release
• Benefits of an ultra-rapid and simplified assay to face scarcity of highly skilled workforce
• Validation approach for multiple products

Zankar Desai, Assistant Technical Director, Cell Therapy Testing Lab, Dana-Farber Cancer Institute

11:35am Presentation: Incorporation of QbD Early Into Development

• Importance of Assay Validation:
  • Phase appropriate advancement of assay validation
  • The Phases of Development
  • Case Study: Cell Count Qualification Across Multiple Devices
  • Continual Verification

Donna Rill, Chief Technical Officer, Triumvira Immunologics

11:50am Presentation: Garbage in, Garbage Out… Importance of QC Testing in Cell Therapy Manufacturing

• Addressing potential sources of variability in starting materials
• Utilizing flow cytometry in-process to make real-time actionable decisions with your drug product
• Simplifying QC release w/ automation to improve reproducibility
• How automation can help address the talent shortage in QC

Matt Li, Director, Cell Therapy CMC, Tome Biosciences

&

Pete Cotter, Associate Director, Analytical Development, Verve Therapeutics

12:05pm Closing Panel with Q&A

With all session participants