Regulatory Guidance And Enabling Compliance

31. CAR-T Innovation: Balancing Allogeneic And Autologous Cell Therapy 6/30/2025

    Join experts as they discuss strategies for optimizing allogeneic and autologous therapies, aiming for balanced development and wider patient accessibility by 2030.

32. CMC Comparability: Transitioning to Commercial Manufacturing with Dr. Nicole Verdun 1/30/2024

    In this segment, Dr. Nicole Verdun shares some of the challenges demonstrating CMC comparability during late-stage product development (i.e., pivotal or Phase 3 clinical trial) that occur while transitioning to commercial manufacturing.

33. Focal Points for 2024: Dr. Verdun and Dr. Marks Talk Regulatory Challenges for Cell-Based Therapies 1/30/2024

    Dr. Verdun and Dr. Marks provide detailed feedback on the regulatory challenges facing cell therapy and explain the Agency’s most important focal points for 2024, patient accessibility, and more.

34. Why Clinical Requirements Change: Dr. Peter Marks on Pre-IND Meeting Pathways 1/30/2024

    Learn how clinical requirements change after the FDA and a company agree on a pathway during a pre-IND meeting and how the company might recover as a result.

35. Best Practices For Effective Donor Management 5/6/2024

    Starting with high quality donor material is critical for allogeneic cell therapy drug manufacturing, and this requires laying the groundwork for a high-touch, end-to-end donor pool management strategy.

36. A Successful Journey To Cell Therapy Manufacturing 5/29/2025

    Learn about the three main areas to consider when you're preparing to commercialize a cell therapy, including starting/raw material, the controlled manufacturing process, as well as testing safety and quality.

37. Patient Data's Impact On CMC Robustness 1/30/2024

    When CGT products demonstrate dramatic improvements with minimal safety concerns in a Phase 2 study, sponsors may want to modify the protocol mid-study to increase patient enrollment.

38. What's New for 2024: Dr. Nicole Verdun Offers a Look Inside The Office Of Therapeutic Products 1/30/2024

    What is the Office of Therapeutic Products, where did it originate, and what's on its regulatory agenda for 2024?

39. Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials 1/24/2024

    Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.

40. Advancing Vaccine Development With Novel Chromatography Solutions & Quality Testing 6/24/2025

    Learn more on novel chromatography solutions that can help improve the downstream processes of different vaccine types such as mRNA, recombinant proteins, and Virus-Like Particles (VLPs).