7:00 am Registration & Coffee Rooms Open

8:30 am Chair’s Opening Remarks

8:45 am Industry Leader’s Fireside Chat

Synopsis

  • Highlighting the greatest challenges to innate immune cell therapy development and where the opportunity lies
  • Considering the competitive cell therapy landscape and how the innate immune-based therapeutics will compete
  • Discussing the role of innate immune cells in crafting an allogeneic future for cell therapies
  • Meeting investor expectations for timelines and budgets while performing true discovery science

9:30 am Driving Progress in Solid Tumors: Outlining Barriers to Success and Next-Generation Approaches to Breach the Next Frontier in Cell Therapy

  • Heather Raymon Vice President Early Development & Program Management, Artiva Bio

Synopsis

  • Describing barriers to efficacy in solid tumors for innate killer immune cells such as exhaustion, inhibition, persistence, and homing
  • Examining the natural innate immune cell armoury against solid tumors, and features that can be enhanced by engineering or combination therapies
  • Sharing early development strategies to breach solid tumor barriers with innate immune cell therapies

10:00 am Developing iPSCs as an ‘Infinite’, Pre-Engineered Cell Source for Consistent, Scalable, ‘Off-the-Shelf’ Innate Killer Therapies

Synopsis

  • Considering if iPSCs are good cell products, the desirable attributes conferred, and future improvements to be made
  • Describing the persistence of iPSC derived cells and early clinical responses
  • Reviewing the manufacturing challenges, advantages, and considerations for iPSC-derived NK cell therapies such as batchto-batch variability, engineering steps, safety data, and scalability
  • Discussing pre-clinical plans to target solid tumors

10:30 am Morning Refreshments & Structured Networking

11:00 am

12:30 pm Lunch & Networking

1:30 pm

3:00 pm Afternoon Poster Session & Networking

‘Into the Clinic’ Roundtable Session to Expedite Lab to GMP Development
Moderator: Christina Coughlin, CEO, Cytoimmune Therapeutics

4:00 pm Improving GMP Manufacturing of Allogeneic NK Cell Therapies: Assessment of NK Activation and Expansion Technologies

  • Philip Lee Chief Technology Officer, Senti Biosciences

Synopsis

  • Sharing experience of setting up GMP grade manufacturing for cell therapies
  • Discussing the need for feeder cells, safety precautions, and how to demonstrate safety and purity
  • Highlighting the key considerations and lessons learned in taking a product from preclinical development to GMP manufacturing and remaining areas of improvement

4:30 pm Sharing a Step-by-Step Guide to Bring Cell Therapies from the Lab to IND

Synopsis

  • Communicating translational studies with regulators to secure first-in-human trials
  • Outlining what is required in FDA packages for first-in-human dose and how to determine dosing strategy for cell therapies
  • Highlighting critical preclinical data to communicate to regulators
  • Reflecting on experiences with non-human primate models and how to prepare toxicity studies for IND filing
  • Sharing details of how to prepare for IND filing, key details to include in packages, and why they are important when you first enter the clinic

5:00 pm Navigating Regulatory Interactions to Bring Genetically Modified Cell Therapies to IND

  • Melody Eble Vice President Global Regulatory Affairs, Century Therapeutics

Synopsis

  • Identifying innovative or platform focused elements to obtain early interactions (CATT/INTERACT)
  • How to get the most out of your pre-IND meeting: key questions to ask and how to communicate with regulators
  • Highlighting how cell therapy INDs differ from small molecule sections

5:30 pm Open Q&A with Mastermind speakers

6:00 pm Chair’s Closing Remarks

6:15 pm End of Day 1