Featured Insights

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Unlock The Future Of Market Access In 2026: A Guide To Navigating A Shifting Healthcare Landscape 11/24/2025

    Navigating the future healthcare landscape requires early strategic planning and organizational agility to manage policy shifts. From AI implementation to global pricing dynamics, understanding these trends is essential for ensuring timely patient access.

  7. Tips For Partnering With Health Systems: A Critical Step For CGT Commercialization 11/3/2025

    Collaborating with health systems is key to CGT commercialization. Learn how to address operational and financial challenges to ensure processes are scalable and patient access is streamlined.

  8. Essential Strategies For Mastering CMC And Avoiding CRLs For CGTs 10/16/2025

    CGT developers face rising regulatory challenges around potency, stability, and process control. Find out how proactive planning, expert guidance, and early FDA engagement are key to avoiding delays.

  9. Why CMC Is A Key Sticking Point For CGTs And How To Meet FDA Expectations 10/2/2025

    FDA scrutiny of CMC for cell and gene therapies is high. Learn common pitfalls—like issues with potency and comparability—and gain actionable strategies to meet regulatory expectations and reduce risk.

  10. Navigating Commercial Logistics: Key Considerations For Emerging CGT Manufacturers 8/27/2025

    A successful cell and gene therapy launch requires a logistics strategy that keeps patients at the center, plans for disruptions, and prepares for future growth and global expansion.