Cell and Gene Regulatory

31. Precigen Secures FDA Approval For PAPZIMEOS And Redefines RRP Treatment 8/27/2025

    Precigen has received FDA approval for PAPZIMEOS, the first therapy for recurrent respiratory papillomatosis, marking a major advance in patient care.

32. Delivering Biologics To The Brain With Adaptin Bio's Michael Roberts, Ph.D., and Duke University's Mustafa Khasraw, MD 8/26/2025

    In this episode of "Better Biopharma," host Tyler Menichiello is joined by Adaptin Bio's CEO, co-founder, and president, Michael Roberts, Ph.D., and Duke University's Mustafa Khasraw, MD to discuss Adaptin's Brain Bispecific T-cell Engager (BRiTE) platform.

33. Navigating Regulatory Complexity In Cell And Gene Therapy 8/26/2025

    This is a recap of the first three episodes of FDA Fridays, a special four-week series from Cell & Gene: The Podcast. These conversations shed light on the current challenges, best practices, and forward-looking strategies shaping the CGT regulatory environment.

34. Barriers, Breakthroughs, and Building Access in Pediatric CGTs with Bambi Grilley, Ph.D. 8/21/2025

    This is Episode 3 of "FDA Fridays," a 4-week special series from Cell & Gene: The Podcast. Host Erin Harris talks to Bambi Grilley, Ph.D., Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine and Chief Regulatory Officer for ISCT, a leading expert at the forefront of pediatric cell and gene therapy.

35. Audit Trails And Transparency: Changes In Clinical Data 8/18/2025

    Audit trails are not only a regulatory necessity but a strategic tool to ensure data reliability and accelerate high-quality clinical research outcomes.

36. Overview Of FDA's Expedited Program For Serious Conditions 8/15/2025

    Review more details on the FDA expedited review programs, the incentives for obtaining such designations, and the required information/data to better position your investigational product for success.

37. Understanding cGMPs For Phase 1 Investigational Drugs 8/15/2025

    Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.

38. Understand Your Stability Programs 8/14/2025

    A stability program evaluates how pharmaceutical and biologic products maintain potency, purity, and quality over time, which ensures safety, effectiveness, and regulatory compliance.

39. 2025 Global Report For In-Vivo CAR Cell Therapy 8/14/2025

    Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.

40. LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations 8/14/2025

    Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.