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Unlocking Complex Cell-based Gene Therapies

Unlocking Complex Cell-based Gene Therapies

Unlocking Complex Cell-based Gene Therapies

Monday, May 6th, 2024
10:00AM – 2:15PM ET
The Ritz Carlton
1150 22nd St NW
Washington, DC 20037

Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy (PICI) are proud to announce our upcoming joint public meeting, Unlocking Complex Cell-based Gene Therapies. Discussions among key stakeholders at the meeting will enable the next generation of proposals in the rapidly changing cell and gene therapy space, reimagining trials and treatments for patients. Register above and scroll through below to read more about the meeting.

Draft Agenda

10:00AM – Welcoming Remarks

10:05AM – Opening Keynote Conversation

  • Moderator: Laurie McGinley, fmr. Washington Post Reporter
  • Namandjé Bumpus, Principal Deputy Commissioner, U.S. FDA
  • Peter Marks, Director, CBER, U.S. FDA

10:30AM – Session 1: Shaping the Future of Cell and Gene Therapies: Challenges & Opportunities

To date, the U.S. Food and Drug Administration (FDA) has approved seven autologous cell-based immunotherapies that have demonstrated remarkable efficacy in a limited set of cancer types. However, to expand their use to a wider range of cancers, the next generation of engineered cellular therapies will require innovative scientific approaches that build upon learnings from existing products to further enhance their safety and efficacy. To advance these novel therapies, several scientific and operational challenges need to be addressed, including overcoming biological constraints, and reducing both the cost and duration of manufacturing and clinical development.

Session Highlights:
  • The Evolution of Cell and Gene Therapies: Current Advances and Challenges
  • Opportunities to Enhance Adoptive T Cell Therapies using CRISPR Gene Editing
  • Panel Discussion and Q&A
12:05PM – Lunch
12:50PM – Session 2: Discovering & Developing the Next Generation of Cell-based Gene Therapies: Considerations for First-in-Human Trials

CRISPR screens, a type of gene-editing test, have identified hundreds of promising gene candidates for tackling critical challenges in treating solid tumors with autologous T cell products. However, nonclinical models fall short in accurately prioritizing gene modifications for human testing. There is an urgent need to explore ways to simultaneously test multiple gene modifications in human clinical trials, while ensuring patient safety. Given the complexity of these novel investigational products, it is crucial to reevaluate and enhance appropriate safety measures.

Session Highlights:

  • Novel Methods to Evaluate CAR-T Investigational Products in Human Trials
  • Panel Discussion and Q&A
2:05PM – The Path Forward: Key Takeaways

2:15PM – Meeting Adjourns

Draft agenda is subject to change