Featured Insights

  1. Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ 1/6/2025

    The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

  2. Partnering With Health Systems: Essential Tips For CGT Commercialization 12/5/2025

    Successful cell and gene therapy commercialization requires early, detailed manufacturer collaboration with health systems to ensure scalable operations and seamless patient access beyond the clinical trial.

  3. Addressing A Critical Drug Shortage 4/20/2026

    A critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered operational readiness in three months.

  4. Streamlining European Expansion With Integrated PV, Regulatory, And Commercial Expertise 4/17/2026

    See how a single-provider model integrated pharmacovigilance with regulatory and commercialization support to support a scalable, audit-ready system that strengthened compliance and freed internal resources for growth.

  5. 5 Operational Gaps To Avoid CGT Patient Risks 5/27/2026

    Examine five critical supply chain gaps in cell and gene therapy logistics that put patients at risk, from invisible operational burdens to reactive monitoring and fragmented coordination strategies.

  6. Cell And Gene Therapy Commercialization Handbook 11/24/2025

    Bringing advanced therapeutics to market requires overcoming hurdles in regulation, logistics, and reimbursement. Learn how to coordinate supply chains and implement adaptive strategies for long-term commercial success.

  7. Inside The Payer Perspective On Cell And Gene Therapy Coverage 3/2/2026

    Find out what 19 US payer organizations revealed about CGT coverage decisions, pre-approval engagement timelines, and the clinical evidence they need most to approve high-cost therapies.

  8. A Thoughtful Copay Program Design That Increased Patient Engagement 11/26/2024

    Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.

  9. Navigating The Cell And Gene Regulatory Landscape 10/3/2024

    Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.

  10. 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.