Regulatory Guidance And Enabling Compliance

  1. Successful Microbial Testing And Identification 5/27/2025

    In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.

  2. Navigating Global Regulatory Landscapes In An Evolving Biopharma Industry 4/15/2025

    Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management, supplier collaboration, and future market trends.

  3. Understanding AI And Machine Learning's Impact On CGT with Dr. Peter Marks and Dr. Nicole Verdun 1/30/2024

    During this segment, Dr. Peter Marks and Dr. Nicole Verdun share their take on how AI and machine learning will impact FDA regulation in 2024.

  4. ResDNASEQ Workflow Solution 5/22/2025

    Explore the Applied Biosystems resDNASEQ workflow solutions. Starting with the sample preparation kit, to purification, quantitating residual host-cell DNA, and analyzing resDNASEQ assays.

  5. Introducing The Applied Biosystems Resdnaseq Quantitative DNA System 11/20/2025

    Thermo Fisher Scientific's portfolio of resDNASEQ solutions is here to meet your specific needs enabling you to test for residual host cell DNA and release your biotherapeutics with confidence in safety and confidence in product quality.

  6. Defining The CMC / Clinical Relationship For Allogeneic Cell Therapies 5/6/2024

    During this segment, Nguyen and Wagner define why the relationship between CMC and Clinical is so critical, and they also explain what a mutually beneficial partnership between CMC and Clinical looks like.

  7. 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.

  8. Other CGT Regulatory Challenges 1/30/2023

    During this segment of Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio detail their own experiences with roadblocks with regulators and how they and their teams worked to overcome them.

  9. Interview With Nico Chow And Sandi True, Field Applications Specialists 11/6/2025

    Hear Nico Chow and Sandi True, Field Applications Specialists, discuss working with customers to help them evaluate and implement Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.

  10. 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?