April 20, 2023, 11:00 am – 1:30 pm ET, Online and Interactive

The complexity and rapid growth of autologous and allogeneic cell therapies presents significant new CMC challenges companies must address and overcome. Our experts share their personal experiences and insight to help anticipate challenges and implement better CMC strategies to accelerate success.

Developing and engineering recombinant protein expression platforms are not for the faint of heart. Many variables must be considered during the development process. When cell line challenges arise, scientists must engineer solutions to overcome. In this interactive virtual event, our experts share their personal experiences and insight to help you identify and overcome today’s cell line challenges. Topics include cell therapy analytical challenges, identifying & overcoming cell therapy CMC challenges, flow cytometry assay development, and more.

Meeting Agenda (all times ET and subject to change)

11:00 am – 11:15 am Welcome + Meet and Greet Networking

11:15 – 11:40am: Conversation #1: Identifying and Overcoming Cell Therapy CMC Challenges - Yeh-chuin Poh, senior director, cell therapy process development, Beam Therapeutics Inc.

  • Balancing continuous process innovation and the FDA
  • Implementing a proper comparability strategy
  • When to make pivotal product changes
  • QbD – finding the right balance of expertise
  • Process standardization – what’s possible, what’s appropriate

11:40 – 12:05pm: Conversation #2: Key Analytical Challenges for Cell Therapies
Bruce Thompson, vice president and technical lead, cell therapy franchise, Resilience

  • Identifying proper analytical development timelines
  • Understanding product biology to develop proper potency assays
  • Staying current on the rapid safety testing landscape
  • The latest iterations and most exciting new analytical techniques

12:05 – 12:30pm: Conversation #3: Flow Cytometry Assay Development Strategies for Cell Therapies
Akshata Ijantkar, Senior Principal Scientist, CMC Team Lead, Gene and Cell Therapy, Bristol Myers Squibb

  • What is/isn’t phase appropriate
  • Understanding regulatory implications
  • FMO controls - why you need them
  • Qualification attributes – How many experiments is enough
  • Assay choices for Phase I (and beyond)

12:30 pm – 1:30 pm Deep Dive Networking