Regulatory Videos

  1. Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka 3/24/2026

    On episode 125 of Cell & Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group's Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach.

  2. Unlocking The Therapeutic Power Of Fibroblasts With Pete O'Heeron And Hamid Khoja, Ph.D. 2/24/2026

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by FibroBiologics’ CEO and Founder, Pete O’Heeron, and chief scientific officer, Hamid Khoja, Ph.D.

  3. Inside a Breakthrough HER2 Immunotherapy for PMO with OS Therapies' Paul Romness 2/10/2026

    In episode 122 of Cell & Gene: The Podcast, Host Erin Harris talks to Paul Romness, CEO of OS Therapies, to learn the company’s mission to address the severe unmet need in pulmonary metastatic osteosarcoma (PMO), a rare pediatric cancer with no established standard of care once it metastasizes.

  4. Bringing Curative Cell Therapies To Market with Kite Pharma's Cindy Perettie 2/6/2026

    On this week's episode of the Business of Biotech, we're speaking with Cindy Perettie, Executive Vice President and Global Head at Kite Pharma, a Gilead-owned company focused on curing cancer with cell therapies.

  5. Putting Pressure On CDMOs With Herman Bozenhardt 1/27/2026

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance.

  6. Data Governance And Regulations For AI Use In GMP With Peter Baker 1/13/2026

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Peter Baker, former FDA investigator and president of Live Oak Quality Assurance.

  7. The Editors' Roundtable: A 2025 Retrospective of the Life Sciences Industry 1/8/2026

    We’re sharing this episode on Cell & Gene: The Podcast because Better Biopharma is a sister podcast within the Life Science Connect family. This conversation speaks directly to the challenges and opportunities our Cell & Gene: The Podcast audience is navigating right now.

  8. Select Your Best Downstream Process Intensification Strategy 1/7/2026

    Intensified and connected processing can cut costs and eliminate bottlenecks in mAb manufacturing. Discover how to identify the most efficient chromatography methods and future-proof your operations.

  9. Compliance In Conversation: A Fill And Finish Regulatory Roundtable 1/7/2026

    Explore Annex 1 expectations, PFAS legislation, and contamination control strategies in this expert-led discussion, as well as practical insights on risk mitigation, validation, and inspection readiness.

  10. The Editors' Roundtable: A 2025 Retrospective Of The Life Science Industry 12/26/2025

    In this special edition of “Better Biopharma,” host Tyler Menichiello is joined by fellow chief editors from across the Life Science Connect ecosystem to reflect on the year and share their industry outlooks for 2026.