Featured Insights

  1. 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.

  2. Pre-Launch Checklist - A Roadmap To Success 6/21/2024

    The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.

  3. Navigating The CGT Supply Chain: Key Logistical Challenges And Solutions 7/16/2025

    Commercializing cell and gene therapies requires overcoming complex logistical hurdles. Customized strategies for temperature control, compliance, and end-to-end delivery are crucial to prevent supply chain issues.

  4. 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.

  5. 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.

  6. 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.

  7. Boosting Quality And Reducing Complexity With A Single-Provider PV Solution 4/17/2026

    Discover how a German biopharmaceutical company successfully managed growing global pharmacovigilance complexity across more than 2,300 marketing authorizations and a broad partner network.

  8. 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.

  9. Navigating The Complex Regulatory World Of ATMPs/CGTs 1/15/2026

    Discover how shifting definitions for ATMPs and CGTs impact global development strategies, from CMC validation requirements to navigating the latest European pharmaceutical legislation and expedited regulatory pathways.

  10. Sterility Assurance With Louise Ui Fhatharta 1/17/2025

    This discussion explores critical aspects of maintaining sterility in pharmaceutical manufacturing, from facility design and environmental monitoring to regulatory compliance and common misconceptions.