Regulatory Videos

  1. Developing An In Vivo CAR-T With Interius BioTherapeutics' Sianny Christanti and Babu Medi, Ph.D. 8/12/2025

    On this episode of Better Biopharma, Interius BioTherapeutics’ Sianny Christanti and Babu Medi, Ph.D., explain how the company is re-engineering a lentiviral vector to enable INT2104, its off-the-shelf, in vivo CAR T-cell therapy. They discuss the vector's design and its manufacturability, as well as the analytical and regulatory challenges of bringing this first-in-human therapy to the clinic.

  2. Unfiltered: The Great PFAS Debate 8/7/2025

    Explore the global concern over persistent “forever chemicals” linked to health and environmental risks, as well as learn about regulatory debates, global restrictions, and why urgent action is needed.

  3. Streamline Production With A Final Filling Single-Use Set 8/7/2025

    Streamline your production with a Final Filling Single-Use Set that installs in under 10 minutes to eliminate cleaning and sterilization while ensuring Annex 1 compliance and full customization.

  4. FDA Fridays: Advancing Communication and Consistency in CGT Regulation with Kaye Spratt 8/7/2025

    This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kaye Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting.

  5. How To Be A Policy Advocate For Biotech With NewYorkBIO's Jennifer Hawks Bland 6/25/2025

    On this week's episode of the Business of Biotech, Jennifer Hawks Bland, CEO of NewYorkBIO, shares insights on New York State's life sciences ecosystem while reflecting on her journey from Capitol Hill to biotech advocacy.

  6. FDA Trials And Tribulations With Connect Biopharma's Barry Quart 6/19/2025

    On this week's episode of the Business of Biotech, Barry Quart, CEO of Connect Biopharma, weighs in on the current state of engagement between drug developers and the FDA, and how that key relationship continues to evolve under new leadership. Barry also discusses moving the company from China to San Diego, why a U.S. financial reporting structure helps attract investors, and how Connect is finding the white spaces in respiratory disease -- the company's lead candidate is a biologic drug targeting acute asthma and COPD exacerbations.

  7. Extracellular Vesicle Breakthroughs with Aegle Therapeutics' Dr. Gloria Matthews 6/17/2025

    In this episode of Cell & Gene: The Podcast, Host Erin Harris interviews Dr. Gloria Matthews, Chief Medical Officer of Aegle Therapeutics, a clinical-stage regenerative medicine company focused on developing therapies for rare and severe dermatologic and immunologic disorders.

  8. Bridging Development and Regulation in CGT with Halloran Consulting Group's Monika Swietlicka 6/3/2025

    On this episode of Cell & Gene: The Podcast, Host Erin Harris welcomes Monika Swietlicka, Principal, Regulatory Strategy at Halloran Consulting Group to discuss the key regulatory challenges facing cell and gene therapy companies.

  9. Psychedelics For Mental Health Disorders With atai's Srinivas Rao, M.D., Ph.D. 5/28/2025

    On this week's Business of Biotech episode, Dr. Srinivas Rao, co-founder and CEO at atai Life Sciences, explains how his engineering background led him to the development of psychedelic compounds for treating depression, anxiety, and other mental health disorders. Internal drug development efforts at atai are focused on short-duration psychedelics that can work within existing healthcare infrastructure, with the potential to transform the treatment of mental health disorders.

  10. BoB@JPM: Kasper Roet, Ph.D., QurAlis 3/12/2025

    On this episode of the Business of Biotech, Life Science Leader's Ben Comer joins to co-host a conversation with Dr. Roet that goes deep on his company's genetic medicine approach to ALS, and even deeper into his opinions on, and growing influence over, the regulatory environment.