Featured Insights

  1. 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.

  2. Overcoming Regulatory, Pharmacovigilance, And Market Access Roadblocks To European Expansion 7/7/2026

    With 30 national HTA bodies, an EU-QPPV requirement, and MFN pricing now linking European reimbursement rates to U.S. drug prices, launching in Europe demands a coordinated global strategy.

  3. 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.

  4. 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.