Regulatory Insights

  1. Balancing Science With Intellectual Property 5/16/2025

    Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.

  2. Why ePROs In Oncology Are Perfect For Capturing The Patient's Voice 5/15/2025

    Recently released FDA guidance showcases why electronic patient-reported outcomes (ePROs) are ideal for capturing the “voice” of the patient. See how ePRO eases oncology trials.

  3. The Role Of FDA Initiatives In Early-Phase Oncology Trials 5/15/2025

    Project FrontRunner represents a paradigm shift in oncology drug development, championing earlier-line studies to bring novel treatments to patients sooner.

  4. Why Biotech Leaders Can't Afford Delays In Document Review 5/15/2025

    Document review is a hidden bottleneck in biopharma. Learn how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.

  5. ISPOR 2024-2025 Top 10 HEOR Trends 5/14/2025

    This report outlines ten defining HEOR trends influencing global health decision-making.

  6. Infectious Diseases - Global Clinical Trial Landscape (2025) 5/14/2025

    The global infectious disease clinical trial landscape has rapidly expanded between 2020 and 2024, driven by the urgency of emerging threats, technological innovation, and evolving regulatory frameworks.

  7. Europe Has A Platform For Driving More Flexible Clinical Trials 5/13/2025

    Despite recent setbacks, Europe possesses inherent strengths in clinical research, and a concerted effort is needed to transform its potential into a thriving and competitive environment.

  8. Regulatory Opportunities For Decentralized Clinical Trials 5/13/2025

    Project SHASTA, a pioneering effort to measure the benefits of decentralized trial elements, reveals significant regulatory opportunities that could shape the future of clinical research.

  9. Developing Drugs For Rare Diseases: A New Approach To Generating Clinical Evidence 5/13/2025

    For rare diseases, scientific breakthroughs often stall before reaching patients. A new approach to generating clinical evidence could change that trajectory.

  10. How To Build Partnerships For Sustainable Healthcare 5/13/2025

    Effective partnerships are essential to address the multifaceted challenges of the healthcare sector, yet collaborative efforts often face persistent barriers.