Clinical Guest Contributors

  1. AI At The FDA: Legal Implications And Strategic Considerations For Drug Developers 1/19/2026

    AI-assisted reviews are changing FDA submissions. In part one of this two-part series, familiarize yourself with the FDA's use of AI and key legal concerns it raises.

  2. Site Management And Oversight Become Must-Haves For Successful Sites 1/15/2026

    Site management and site oversight are often used interchangeably in clinical research, but they mean different things. Explore their roles and importance in ensuring successful sites and trials.

  3. Could Moving To This Swiss Life Sciences Hub Be In Your Company's Future? 1/15/2026

    Basel Area Business & Innovation CEO Christof Klöpper discusses how the Basel Area Life Sciences Supercluster supports discovery through commercialization.

  4. Confronting "Time Toxicity" In Global Oncology And Rare Disease Trials For Operational Excellence And Patient Retention 1/14/2026

    Time is the only truly finite resource in a clinical trial. Consultant Leila Cupersmith discusses how sponsors can better design trials with a lower time burden to boost enrollment, retention, and overall operational excellence.

  5. From Lab To Launch: Navigating The Transition To Commercial Readiness 1/13/2026

    Many clinical-stage companies start thinking about commercialization too late. FTI Consulting experts team up to provide guidance on getting started early.

  6. Working (Well) With Patient Advocates: The Sponsor POV 1/12/2026

    Aeovian CEO Allison Hulme reflects on Aeovian Pharmaceuticals' partnership with the TSC Alliance and how it’s informed research and development of their first-in-class selective mTORC1 inhibitor. 

  7. Virtual Reality Endpoints Improve Measurement Of Patients' Real-World Benefit 1/12/2026

    Opus Genetics CEO George Magrath, MD, discusses how the company introduced virtual reality-enabled assessments and relied on digital endpoints to better measure participants’ vision changes.

  8. Working (Successfully) With Pharma: A PAG's Perspective 1/12/2026

    TSC Alliance President and CEO Kari Rosbeck details the patient advocacy group's unique and fruitful relationship with Aeovian Pharmaceuticals in developing the company's first-in-class selective mTORC1 inhibitor for TSC-related refractory epilepsy.

  9. Making Medical Innovation Matter To Patients With Simplified Trial Design 1/9/2026

    To be a leader in today’s environment, Lexicon Pharmaceuticals CMO Craig Granowitz, MD, Ph.D., says companies must embrace simplified clinical trial designs, which can reduce regulatory risks, lower R&D costs, and shorten clinical timelines.

  10. How Should Scientific Focus Change In 2026? Researchers Weigh In 1/8/2026

    To kick off 2026, clinical researchers share how they think research should change in the new year.