Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy (PICI) hosted a public meeting to explore opportunities to advance next-generation therapies, including innovative approaches in cell therapy development. As genetically modified cell-based therapies expand toward treating different types of cancers and diseases and leverage new modalities, this meeting will convene academics, regulatory and industry experts, and patient advocates to examine opportunities to accelerate their development. Discussions focused on modernizing first-in-human clinical trials, operationalizing risk-based chemistry manufacturing and controls (CMC) flexibility, and exploring models to maintain global competitiveness without compromising patient safety or product quality. Sessions addressed practical considerations for investigational new drug (IND) readiness and early-phase trial design, phase-appropriate validation and comparability strategies, and longer-term structural opportunities to reinforce the cell therapy ecosystem. 

9:30AM | Networking Breakfast (in-person only)

10:00AM | Welcome & Opening Remarks 

• Ellen Sigal, Friends of Cancer Research

10:05AM | Presentation – Regulatory and Operational Considerations in Cell Therapy Development (Presentation Slides)

• Mark Stewart, Friends of Cancer Research

10:15AM | Session 1 – Modernizing Early Phase Clinical Development Approaches

Session 1 explored the application of expectations for early phase clinical development and where greater clarity could improve predictability without compromising safety. Panelists discussed IND readiness, patient population selection, and early-phase trial design considerations that can influence downstream evidentiary strategies and late phase trial design.

• Lola Fashoyin-Aje, Clinical-Regulatory Strategy Consulting – Moderator
• Steven Fleischer, FDA 
• Vijay Kumar, FDA
• M Travis Quigley, Kelonia Therapeutics 
• Rosanna Ricafort, Bristol Myers Squibb
• Nirali N. Shah, NCI
• Chris White, Friends Advisory Advocate 

11:15AM | Break 

11:30AM | Session 2 – Operationalizing Risk-Based CMC Flexibility Across the Product Lifecycle 

Session 2 examined existing CMC flexibilities from IND through licensure, with a focus on risk-based approaches to validation, comparability, and release specifications, and the role of platform knowledge in supporting process evolution.

• John Connolly, Parker Institute for Cancer Immunotherapy – Moderator
• Ben Beneski, Allogene Therapeutics
• Marc Better, Pharmefex
• Magdi Elsallab, Harvard Medical School 
• Arvind Natarajan, Iovance Biotherapeutics
• Alexandra Beumer Sassi, AstraZeneca 
• Kimberly Schultz, FDA 

12:30PM | Lunch & Networking 

1:00PM | Fireside Chat – Predictability in Drug Development in an Evolving Policy Environment

This conversation explored how broader policy dynamics are shaping predictability in drug development and investment. The discussion considered how regulatory, legislative, and funding environments influence innovation and long-term sustainability. 

• Jeff Allen, Friends of Cancer Research – Moderator
• Christopher R. Heery, Arcellx, Inc 
• David Kaufman, Third Rock Ventures 
• Julie Tierney, Leavitt Partners 

1:30PM | Session 3 – Strengthening the Future of Cell-Based Gene Therapy Development

Session 3 focused on longer-term policy and regulatory science opportunities to strengthen the cell therapy ecosystem, including areas that may benefit from structural alignment, pilot efforts, or legislative engagement, to support sustained innovation and patient access.

• Lizzy Lawrence, STAT – Moderator
• George Eastwood, Emily Whitehead Foundation
• Grace Graham, FDA 
• Priti Hegde, Kite, a Gilead Company
• Timothy Hunt, Alliance for Regenerative Medicine
• Carl June, University of Pennsylvania

2:25PM | Closing Remarks 

• Jeff Allen, Friends of Cancer Research

2:30PM | Meeting Adjourned