Featured Insights

  1. Best Practices For Managing The Logistics And Distribution Of CGTs 2/23/2026

    Site infrastructure, formulary timelines, and storage capabilities create barriers between approval and patient access. Planning for these operational realities separates successful launches from stalled ones.

  2. Navigating EU Regulatory Challenges With Cell And Gene Therapies 2/23/2026

    EU regulatory changes affecting advanced therapies demand new approaches to scientific advice, evidence generation, and health technology assessment for cell and gene therapy developers.

  3. 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.

  4. The Value Of Real-World Evidence In Canadian Drug Commercialization 2/18/2026

    Leveraging real-world evidence (RWE) across the product lifecycle enables manufacturers to fill the evidence gap beyond RCTs to help guide local commercial strategic planning and market access strategy.

  5. Digitized Solutions To Increase Visibility And Streamline Communication Between A PSP And Manufacturer 2/18/2026

    When email-based escalation management creates compliance and visibility gaps, a centralized digital solution helps manufacturer and PSP teams act faster and with greater accountability.

  6. Evolving Landscape Of Payer Coverage For CGTs: Trends And Insights 1/20/2026

    Examine how proactive payer engagement and robust clinical evidence regarding comparative effectiveness and durability of response can overcome significant reimbursement barriers and enhance patient access.

  7. 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.

  8. The Growing Case For AI To Support Pharmacovigilance 1/14/2026

    Insights from the World Drug Safety Congress reveal how automation and AI streamline signal management and safety reporting while maintaining essential human oversight and ensuring regulatory compliance.

  9. Why Flexible, Collaborative Distribution Partners Matter For CGTs 1/9/2026

    Learn how collaborative distribution models manage reimbursement hurdles and complex delivery requirements to ensure patient access and long-term commercial success.

  10. 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.