Regulatory Videos

  1. Where Organ On Chips Will Add The Most Value In 3–5 Years 5/19/2026

    Panelists emphasized that CROs and CDMOs will be essential to scaling organ on chip adoption, but only if they commit to standardized, commercial execution rather than treating these systems as experimental add ons. As Don Ingber put it plainly, CROs “need to start buying these commercial systems and start scaling” them to make organ on chip studies operationally viable for industry.

  2. How FDA Policy And NCATS Are Supporting Organs On Chips 5/19/2026

    Christine Happle explains how FDA and NIH efforts are converging to move organ‑on‑chip and microphysiological systems from innovation toward regulatory credibility. She outlines how FDA has clarified expectations for new approach methodologies (NAMs) through structured qualification pathways, most notably the ISTAND program, which has now become a permanent mechanism for evaluating non‑animal methods within a defined context of use.

  3. Validation Challenges Facing Advanced Single-Use Technologies 5/18/2026

    In this episode of "Better Biopharma," host Tyler Menichiello is joined by BioPlan Associates’ director of research, Katrina Cordovado, as well as Joshua Nelson, Ph.D., a senior material qualification specialist at Takeda, and Paul Priebe, a consultant and single-use expert, to continue their conversation from the Bioprocess Online Live event, "Closing The Adoption Gap For Advanced Single-Use Materials."

  4. The Impact Of FDA Risk On Biotech Rewards With CFO And Board Director Allan Shaw 4/16/2026

    On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and how that uncertainty is reshaping clinical trial strategy, investor behavior, and the innovation ecosystem.

  5. Why Requalify? 4/14/2026

    Qualification is not a one-and-done activity in regulated environments. Learn when requalification is required and how lifecycle-based testing helps ensure equipment performance and compliance.

  6. Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D. 4/9/2026

    On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes.

  7. 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.

  8. 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.

  9. 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.

  10. 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.