Regulatory Insights

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Building A High-Quality IND From Scratch With Strategic Gap Analysis 8/12/2025

    A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

  7. NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission 8/12/2025

    A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

  8. Advancing Oncology Innovation With Adaptive Trial Designs 8/12/2025

    When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.

  9. Rescuing A Global Program For NDA Success 8/12/2025

    Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

  10. 5 Ways To Get Ready For IRT Regulatory Inspections 7/31/2025

    Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.