Regulatory Insights

  1. Unlock Oncology Success With A Comprehensive Commercialization Guide 8/22/2025

    Navigate the complex process of bringing an oncology therapy to market, from regulatory planning to patient access and supply chain logistics, with this comprehensive handbook for developers.

  2. Audit Trails And Transparency: Changes In Clinical Data 8/18/2025

    Audit trails are not only a regulatory necessity but a strategic tool to ensure data reliability and accelerate high-quality clinical research outcomes.

  3. 2025 Global Report For In-Vivo CAR Cell Therapy 8/14/2025

    Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.

  4. LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations 8/14/2025

    Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.

  5. Understanding Immunogenicity In AAV Gene Therapy 8/14/2025

    As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

  6. Gene Therapy Studies Rose While Financing Declined In Q2 2025 8/13/2025

    There were three new approvals across the therapeutic landscape in the second quarter of 2025, but despite those positive signs, overall dealmaking was flat for the quarter.

  7. Demanding More From AI Governance In Drug Safety 8/13/2025

    Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

  8. Navigating Global Health Policy In A Time Of Disruption 8/12/2025

    The healthcare industries in the U.S. and EU are undergoing significant regulatory and legislative changes. Learn how to better position yourself to navigate this complex environment.

  9. Thinking Ahead: How Integrated Development Plans Improve Product Success 8/12/2025

    How can integrated development planning reduce development timelines and increase your chances of commercialization success? Industry experts reveal how this approach helps avoid common pitfalls.

  10. How PIE Streamlines Biopharma And Payer Communication 8/12/2025

    Navigating pre-approval information exchange (PIE) with healthcare decision-makers is essential for market success. Learn what information can be shared and the best strategies for communication.