Featured Articles

  • From pirates to powerhouse

    Tuesday, February 24, 2026
    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. read more

  • Swimming upstream

    Wednesday, February 18, 2026
    Rare and ultra-rare disease patients have long been forced to struggle upstream. read more

  • 2026 cell and gene therapy predictions

    Monday, February 09, 2026
    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. read more

  • From centralized to decentralized

    Wednesday, February 04, 2026
    A decentralized model for cell-based products offers various benefits including fresh tissues and drug products, reduced costs, and shorter treatment times. read more

  • Narrowing the CGT access gap

    Tuesday, January 27, 2026
    There is significant opportunity to expand the applications of cell therapy further into rare diseases as well as to tackle widespread conditions. read more

  • What sponsors should know about FDA’s platform technology designation

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

  • Little fish, big waves

    Tuesday, January 13, 2026
    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 ... read more

  • Changes: A turbulent year for FDA oversight

    Friday, January 02, 2026
    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.” read more

  • Ensuring viral safety in advanced therapies

    Wednesday, October 15, 2025
    Viral clearance studies, long a cornerstone of biologics production, are now being reevaluated and adapted for genetically engineered viral vectors and vector-derived products. read more

  • How digital can ease the burden of cell and gene therapy long-term follow-up

    Wednesday, September 17, 2025
    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. read more

  • Rethinking iPSC development

    Wednesday, September 10, 2025
    A robust CMC strategy cannot be retrofitted; it should guide decisions from the very beginning. For developers aiming to bring iPSC-based therapies to the commercial market, the starting point is not the laboratory bench, it is the ... read more

  • Navigating cell therapy's maze of risks

    Wednesday, September 03, 2025
    Biopharma companies advancing cell therapies must confront a range of key considerations and risks. A strategic, collaborative approach can accelerate development and ensure patients reliably access safe and effective cell therapy products. read more
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