Insights on Clinical Trials

  1. Collaboration Leads To CGT Progress At Astellas' West Coast Innovation Center 3/13/2025

    Yoshi Shitaka, outgoing CSO and Richard Wilson, SVP, Primary Focus Lead (Genetic Regulation) at Astellas share how the company's West Coast Innovation Center serves as a central hub for AI, digital transformation, and more.

  2. Multi-Regional Clinical Trials: The Latest Guidance From FDA 3/12/2025

    Conducting multi-regional clinical trials (MRCTs) is essential for accelerating oncology drug development and ensuring broader patient access. However, differences across regions can impact findings.

  3. The Strategic Backbone Of Marketing Application Success 3/12/2025

    Through proactive timeline management and strategic oversight, organizations can achieve their regulatory goals with confidence.

  4. Taking A Statistics-Driven Approach To Clinical Trial Planning 3/12/2025

    Clinical trials are inherently complex, and even well-structured studies may struggle to achieve statistical significance due to challenges in study design, patient selection, and data variability.

  5. Navigating Patient Access Challenges In Commercializing Your CGT Product 3/10/2025

    Learn how to effectively break down barriers to patient access in cell and gene therapy by enhancing provider education, streamlining coordination, and expanding patient support.

  6. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

    Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

  7. Hepatitis B - Global Clinical Trial Landscape 3/6/2025

    As Hepatitis B virus (HBV) clinical trials advance, refining therapeutic endpoints and integrating novel treatment strategies are essential to transforming Hepatitis B management.

  8. Informed Consent In Clinical Trials Involving Neurologic Disorders 3/4/2025

    Informed consent is essential in clinical research. However, when participants lose decisional capacity, a Legally Authorized Representative (LAR) is needed to provide consent and uphold ethical standards.

  9. The "Unique" Opportunity Presented by Southeast Asia 2/26/2025

    Southeast Asia has emerged as a pivotal region for vaccine clinical trials, driven by rapid recruitment, cost efficiency, and robust immunization infrastructure.

  10. Navigating The Future Of Clinical Trials: Expert Insights For 2025 2/26/2025

    The biopharmaceutical industry is undergoing transformative changes to develop more dynamic and efficient frameworks that prioritize patient outcomes in 2025.