Thermo Fisher Live Event Shorts

1. Future Proof Process Design Through Risk-Focused Decisions, Automation Readiness, And Regulatory Pragmatism 10/29/2025

   In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene share that future proofing begins with deep process understanding.

2. Streamlining Tech Transfer And Advancing Next Generation CAR T Therapies 10/29/2025

   In this final segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene, Luman emphasizes that early engagement between R&D, process development, and manufacturing teams is critical for smooth tech transfer to CDMOs, including using scale-down models, documenting processes thoroughly, and collaborating closely with CDMO staff.

3. Balancing Innovation And Flexibility In Early Cell Therapy Manufacturing Technologies 10/29/2025

   In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene, Luman explains that introducing advanced analytics, automation, and digital tools early can strengthen process control and sterility, but startups must weigh innovation against practical constraints.

4. The Importance Of Early Manufacturing Choices And Simple Flexible Process Design 10/29/2025

   In this first segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene explore how early manufacturing decisions influence long-term success in cell therapy development.

5. Why Academic Centers Reach The Clinic Faster 10/29/2025

   In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene, Luman explains that academic institutions often move faster in Phase 1 because many trials are investigator-initiated, allowing streamlined oversight and quicker regulatory engagement, though similar pathways for sponsor-led programs don’t yet exist in the U.S. or EU.

6. Early Development Choices Define Scalability And Product Quality In CGT 10/29/2025

   In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene stress that early-stage process decisions have lasting downstream effects on product quality, scalability, and speed to clinic.

7. Building Strong Data Foundations And Smart Logistics For Scalable CGT Development 10/29/2025

   In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene emphasize that early investment in analytics and structured data collection is essential to guide scale-up and regulatory success. 

8. 2025 CGT Regulatory Outlook | Audience Q&A 4/8/2025

   Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) answer questions from the audience. They covered key regulatory topics, including the FDA’s process for finalizing draft guidances, the status of INTERACT meetings, and the use of the term “critical component” in manufacturing regulations.

9. Navigating Global Regulations, Equity Challenges, And The Future Of Patient Access 4/8/2025

   Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) continue the discussion to explore the complexities of expanded access programs (EAPs) in CGT, highlighting global regulatory differences, ethical concerns, and accessibility challenges.

10. How The FDA's 2024 Draft Guidances Will Influence CGT Regulation In 2025 4/8/2025

    Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) share why the FDA’s 2024 draft guidance documents are expected to shape regulatory standards for cell and gene therapy in 2025, with topics ranging from safety testing of allogeneic cells to manufacturing practices and the use of human and animal-derived materials.