Cell and Gene Regulatory

  1. 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.

  2. Supporting Cell Therapy Development From Concept To Clinic 4/9/2026

    Streamline gene-edited therapy development with population-informed genotoxicity assessments. Learn to navigate on- and off-target risks through orthogonal assays for regulatory-ready success.

  3. Understanding The EU Regulatory Landscape For Cell And Gene Therapies 4/9/2026

    EU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.

  4. How Australia's Leading CRO Is Driving Biotech's Acceleration From First-In-Human To Global Markets 4/8/2026

    The next era of clinical trials will be defined by global expansion across the Asia-Pacific region, rapid and cost-effective pathways to regulatory approval, and reliable, patient-centric leadership.

  5. From Fermentation To Vaccination 4/8/2026

    Non-animal-origin squalene is gaining momentum in vaccine adjuvants. See how fermentation-derived squalene delivers comparable performance, strong stability, and regulatory alignment.

  6. Real-World Evidence Revisited 4/6/2026

    Explore how the latest regulatory updates transform real-world data into a credible evidentiary pathway. Learn the new standards for data reliability and hybrid study design.

  7. General Wellness Isn't A Vibe Anymore: What The 2026 FDA Update Means 4/6/2026

    The FDA’s 2026 guidance has put an end to "wellness by disclaimer." Learn how new standards for wearables and apps impact study design, participant safety, and the evolving ethical role of the IRB.

  8. Clinical Decision Support Software: Clear Expectations For Research Oversight 4/6/2026

    The FDA’s 2026 CDS guidance signals a shift to settled policy. IRBs must now demand greater transparency regarding automation bias and clinician independence to accurately assess study risk.

  9. The FDA's Final BIMO "Processes And Practices" Guidance 4/6/2026

    Gain a clear roadmap for investigators, sponsors, and IRBs. This shift toward transparency replaces regulatory guesswork with predictable standards for every partner in the research ecosystem.

  10. What Does The FDA's 2025 Safety Reporting Guidance Mean For You? 4/6/2026

    New FDA guidance aligns IND safety reports with unanticipated problems, shifting the focus from administrative definitions to proactive participant protection and trial integrity.