Friday, May 9, 2025
10AM – 2PM ET
The Ritz Carlton
1150 22nd St NW, Washington, DC 20037
Conference will also be streamed virtually
Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy (PICI) are proud to announce our upcoming joint public meeting, Unlocking Next-Generation Therapies: Exploring Innovative Development and Manufacturing Models for Cell Therapies.
Cell therapies have demonstrated remarkable success in treating certain cancers and, given their personalized nature, hold particular promise for rare cancers and other difficult-to-treat diseases, especially when conventional therapies may be insufficient or unavailable. However, current development and manufacturing models often face challenges related to regulatory uncertainty, timeliness, accessibility, and production costs, which can be especially limiting for rare disease applications. Overcoming these challenges will be necessary to create a sustainable pathway that ensures patients—particularly those with rare diseases—benefit from these promising therapies.
To explore solutions, Friends and PICI launched a multi-stakeholder working group to develop a practical framework for advancing regulatory and manufacturing approaches that can enable timely access to promising therapies while ensuring quality and safety. This includes regulatory flexibilities to facilitate therapy development in small populations, cost recovery considerations to engage payors earlier in the process and scalable manufacturing approaches, including decentralized models. This initiative will examine operational, safety, and quality control strategies to support flexible, risk-adjusted manufacturing approaches while maintaining rigorous standards.
Through collaboration, this effort aims to identify sustainable approaches and innovative policies that expand the availability of cell therapies.
Agenda
9:30 AM | Networking Breakfast
10:00 AM | Welcoming Remarks
- Jeff Allen, President & CEO, Friends of Cancer Research
10:05 AM | Session 1: Advancing Regulatory Frameworks for Cell-Based Therapies
This session will explore the challenges in developing cell-based therapies for small patient populations and discuss potential solutions to address gaps in development and access. Panelists will examine frameworks that could facilitate cost recovery and evidence generation in the pre-market space, while also discussing regulatory pathways for approval that balance flexibility with ensuring sufficient data to support patient access.
Session 1 Panel Discussion and Q&A
- Moderator: Michael Kalos, Next Pillar Consulting
- Lee Fleisher, Rubrum Advising
- Kristen Hege, Independent Board of Directors Member
- Holly Fernandez Lynch, Perelman School of Medicine, University of Pennsylvania
- Crystal Mackall, Stanford University
- Nicole Verdun, U.S. FDA
11:30 AM | Networking Lunch
12:10 PM | Lunch Keynote
- Moderator: Kate Rawson, Prevision Policy
- George Eastwood, Emily Whitehead Foundation
- Saar Gill, University of Pennsylvania
- Lynelle Hoch, Bristol Myers Squibb
12:40 PM | Session 2: Manufacturing Strategies to Support Access to Cell-Based Therapies
Manufacturing remains a critical challenge for advancing cell-based therapies, particularly when both low throughput and commercial viability are concerns. This session will explore proposals that could reduce production costs, foster sustainable partnerships between non-profits, academia, and industry, and support scalable, adaptable manufacturing models.
Session 2 Panel Discussion and Q&A
- Moderator: John Connolly, Parker Institute for Cancer Immunotherapy
- Ben Beneski, Allogene
- Boro Dropulic, Caring Cross
- Steven Feldman, Stanford University
- Natasha Kekre, Ottawa Hospital Research Institute
- David Mitchell, CAR-T patient & Patients For Affordable Drugs
- Kimberly Schultz, U.S. FDA
1:55 PM | Closing Remarks
- John Connolly, Parker Institute for Cancer Immunotherapy
2:00 PM | Meeting Adjournment
Agenda is subject to change
