Regulatory Guidance And Enabling Compliance

1. 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.

2. Innovative Contamination Control: Enabling Integrity And Efficiency 10/15/2024

   An integrated approach can enhance contamination control, boost process efficiency, and ensure the production of high-quality cell therapy products.

3. Race To The Regulatory Finish Line: Dr. Nicole Verdun Talks Efficiencies In Platform Technologies 1/30/2024

   Could a platform approach help certain therapies make their way over the regulatory finish line more efficiently?

4. Challenge #2: Rare Or Ultra-Rare Study Design Considerations And Use Of Existing Data 1/30/2023

   There are more than 7,000 unique, rare diseases recognized in the United States, and 300 million people worldwide living with a rare disease; patients often experience a long journey to receive their diagnosis. Our expert panelists, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio, examine the regulatory requirements for safety and efficacy demonstration and identify the gaps in regulatory oversight that require clearer guidance.

5. Major Trends Impacting Allogeneic Cell Therapies For Oncology 5/6/2024

   We kicked off this Cell & Gene Live, Unlocking the Future of Allogeneic Cell Therapy for Oncology by discussing the major trends impacting allogeneic cell therapies for oncology.

6. 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.

7. Challenge #3: Lack Of Animal Models 1/30/2023

   Many cell and gene therapies are intended for diseases and conditions that primarily impact pediatric patients, requiring the prospect of direct benefit to individual subjects enrolled in the trial.  In the absence of good animal models, there may be challenges demonstrating the prospect of direct benefit.  During this segment of Cell & Gene Live, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO discusses novel approaches to consider going forward.

8. Leveraging dPCR r Techniques To Quantitate Lentivirus Particles 5/28/2025

   Discover how digital PCR can streamline lentiviral vector characterization to reduce variability and improve analytical sensitivity. Learn how this approach can help you comply with regulatory guidance.

9. 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.

10. 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.