Cell and Gene Regulatory

  1. 6 Key Implications Of EU Clinical Trials Regulation 1/7/2026

    Centralized submissions, greater transparency, and stronger patient protections reshape EU clinical trials, impacting timelines, costs, and strategies for sponsors and CROs.

  2. Psychiatric Drug Development Renaissance: With Familiar Risks 1/6/2026

    Emerging psychiatric therapies bring hope, but progress is fragile. Biomarker-driven, mechanism-first approaches help overcome biological, regulatory, and commercial barriers.

  3. Clinical Research Trends And IRB Expectations For 2026 1/6/2026

    Oversight in 2026 requires adaptability as AI, consent standards, and regulatory uncertainty challenge sponsors and IRBs to balance ethics with innovation through proactive planning and collaboration.

  4. How Global Shifts Are Reshaping ATMP Logistics Beyond Borders 12/29/2025

    Global economic shifts, regulatory changes, and evolving trade dynamics are transforming ATMP logistics, demanding resilient strategies to ensure uninterrupted delivery of advanced therapies worldwide.

  5. 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. 

  6. Vendor Selection Bias: Why Structured Decisions Often Fail 12/22/2025

    Learn how subtle influences derail decisions and discover proven safeguards that promote transparency, accountability, and shared ownership for better trial outcomes.

  7. Overcoming Regulatory Hurdles In AAV Production 12/16/2025

    Demonstrating residual reagent clearance is a critical regulatory requirement in AAV manufacturing. Explore how specialized assays and strategic partnerships streamline compliance.

  8. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

  9. Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D. 12/12/2025

    On this week's episode of the Business of Biotech, Bruce Culleton, M.D., CEO at ProKidney, talks about moving from academic research to industry and the role a key mentor played in his career path.

  10. Product Carbon Footprints: The Next Frontier In Sustainable Innovation 12/12/2025

    Product Carbon Footprints reveal true lifecycle emissions, enabling collaboration, innovation, and informed decisions. Learn why moving from estimates to evidence is essential for reducing Scope 3 impact.