Regulatory Videos

1. Cell Therapy Without The Cells: Building A Therapeutic Secretome With Noveome Biotherapeutics' Larry Brown, Sc.D. 6/16/2026

   In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Larry Brown, Sc.D., chief scientific officer at Noveome Biotherapeutics, to discuss ST266, a first-of-its-kind secretome therapy.

2. Cell & Gene: The Podcast Presents: Better Biopharma's Editors' Roundtable — A Midyear Look at the 2026 Life Sciences Industry 6/15/2026

   For episode 131 of Cell & Gene: The Podcast, we’re sharing a recent "Better Biopharma" roundtable that Erin Harris had the opportunity to join alongside her Life Science Connect editorial colleagues.

3. The Editors' Roundtable: A Midyear Look At The 2026 Life Sciences Industry 6/5/2026

   On this week's episode of the Business of Biotech, Tyler Menichiello, chief editor at Bioprocess Online, host of the Better Biopharma podcast, and my Life Science Connect (LSC) colleague, convenes the broader LSC editorial team once again for a midyear discussion on what's happening now in the life sciences industry, and what's to come in the second half of the year.

4. The Editors' Roundtable: A Midyear Look At The 2026 Life Sciences Industry 6/2/2026

   In this special edition of “Better Biopharma,” host Tyler Menichiello is joined by chief editors from across the Life Science Connect ecosystem to discuss what’s shaping the pharmaceutical industry in 2026. The editors reflect on recent developments in their respective spaces and make predictions on what the rest of the year has in store.

5. 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.

6. 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.

7. 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."

8. 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.

9. 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.

10. 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.