Articles

  • From pirates to powerhouse

    The evolution from imitation to innovation has created an ecosystem designed to reward novel science and transformative treatment approaches — and Swiss companies are now claiming their stake.
    Tuesday, February 24, 2026
  • Swimming upstream

    Rare and ultra-rare disease patients have long been forced to struggle upstream.
    Wednesday, February 18, 2026
  • 2026 cell and gene therapy predictions

    As advanced therapies transition from promising science to industrial maturity, investors will increasingly favor late-stage programs with strong data, proven scalability and credible paths to adoption.
    Monday, February 09, 2026
  • From centralized to decentralized

    A decentralized model for cell-based products offers various benefits including fresh tissues and drug products, reduced costs, and shorter treatment times.
    Wednesday, February 04, 2026
  • Narrowing the CGT access gap

    There is significant opportunity to expand the applications of cell therapy further into rare diseases as well as to tackle widespread conditions.
    Tuesday, January 27, 2026
  • What sponsors should know about FDA’s platform technology designation

    Sponsors with a licensed gene therapy can use the same vector platform to reference manufacturing, analytical and safety data for other candidates.
    Tuesday, January 20, 2026
  • Little fish, big waves

    A powerful shift is underway within the rare disease space. It started as a handful of inspiring stories of parents stopping at nothing to save the lives of their children. But while this patient advocacy-driven movement is compelling — it shouldn’t have to exist.
    Tuesday, January 13, 2026
  • Changes: A turbulent year for FDA oversight

    Characterizing 2025 from a regulatory perspective is uniquely challenging. Perhaps David Bowie said it best when he said, “I don’t know where I’m going from here, but I promise it won’t be boring.”
    Friday, January 02, 2026
  • Ensuring viral safety in advanced therapies

    Viral clearance studies, long a cornerstone of biologics production, are now being reevaluated and adapted for genetically engineered viral vectors and vector-derived products.
    Wednesday, October 15, 2025
  • How digital can ease the burden of cell and gene therapy long-term follow-up

    Because CGTs are designed to have lasting and lifelong effects, regulatory bodies often mandate 15-year, long-term follow-up. Fortunately, collaborative groups are creating resources and recommendations for these emerging studies.
    Wednesday, September 17, 2025
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