Featured Insights

  1. Pharmacovigilance Is Not A Checkbox: Rethinking Safety Monitoring From Day One 9/10/2026

    Cell and gene therapies demand a pharmacovigilance approach built from the ground up, not adapted from frameworks designed for conventional drug products.

  2. A Year Of Reflection And Preparation 1/3/2025

    The Trial Master File (TMF) landscape in 2025 will require companies to stay attuned to the evolving ICH E6(R3) guidelines and the full implementation of the CTIS.

  3. Specialist PV Support Transforms Safety For Orphan Medicinal Products 4/17/2026

    Learn how a UK-based company developing two orphan-designated, centrally authorized therapies successfully navigated operational challenges after transitioning from a prior provider.

  4. 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.

  5. 9 Logistics And Distribution Recommendations For CGTs 5/6/2026

    Cell and gene therapy commercialization requires tailored logistics strategies. Explore nine recommendations covering site readiness, reimbursement gaps, packaging, testing, and coordination.

  6. 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.

  7. Transforming PSP Enrollment To Enhance User Experiences And Optimize Workflows 2/18/2026

    Lengthy enrollment calls burden patients and PSP teams alike. See how a digital-first intake approach cut onboarding time and improved outcomes for everyone involved.

  8. The Need For Adaptive Distribution Partners For Cell And Gene Therapies 1/6/2026

    Optimize your commercial strategy by exploring how adaptive distribution models navigate reimbursement challenges and improve patient access. Partner early to align workflows and ensure operational success.

  9. Evolving And Expanding Global Consulting With Local Expertise 2/3/2025

    Experts discuss global market expansion, emphasizing regulatory complexities, product lifecycle investments, and integrating local expertise to ensure successful product launches and long-term market sustainability.

  10. 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.