Regulatory Guidance And Enabling Compliance

31. Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing 1/30/2024

    In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.

32. Innovations In Mycoplasma And Sterility Testing For Biopharma 5/22/2025

    In this webinar, our expert speakers will discuss the types of analytical testing that can be effectively employed in the early stages of therapeutic development and subsequently scaled to meet production challenges.

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. 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.

35. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

36. mRNA For Cancer Immunotherapy 2024 Outlook | Audience Q&A 1/29/2024

    During our Cell & Gene Live, mRNA For Cancer Immunotherapy 2024 Outlook, our expert panelists answered audience questions regarding patient safety, foreseeable challenges in mRNA cancer immunotherapy for solid tumors, and much more.

37. Tackling Cell And Gene Therapies' Top 3 Regulatory Impediments: Audience Q&A 1/30/2023

    During each Cell & Gene Live, our audience has the opportunity to submit real-time questions for our expert panelists. Watch and listen as Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio provide detailed, insightful responses to our audience questions on everything from regulatory timelines to successful and unsuccessful strategies needed to convince the regulators that current regulation requirements are either inappropriate or alternatively excessively burdensome for cell and gene-based therapies.

38. Simple In-House Mycoplasma Testing Method For Regulatory Expectations And Rapid, Confident, And Actionable Results 5/29/2025

    In this webinar, we present an overview of worldwide regulatory guidance for mycoplasma testing, as well as a mycoplasma testing method that has been accepted by regulatory authorities worldwide across various therapeutic modalities.

39. A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems 11/10/2025

    In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.

40. Dr. Peter Marks on the Adoption of Novel Precision Analytics 1/30/2024

    Hear advice for developers who are worried that the FDA will not accept changes in their process that include a new analytical method.