Clinical Guest Contributors

  1. Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials 4/23/2026

    Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today. 

  2. Philanthropy Empowers And Accelerates Testing Of Drug Combinations In T1D 4/23/2026

    City of Hope’s Alberto Pugliese, MD, discusses how philanthropic gifts helped launch a landmark multi-center trial to test a combination therapy using repurposed drugs for the treatment of Type 1 Diabetes.

  3. The Patient-Centered Trial Paradigm For Knee Osteoarthritis 4/22/2026

    Although PROs can complicate a trial design, they're essential to reflecting a patient’s true knee OA experience and producing meaningful evidence, explains Katie Mowry, Ph.D., VP of R&D at Organogensis.

  4. Navigating Elsa's AI Transition: Practical Guidance To Safeguard Confidential Information (Part 3) 4/22/2026

    With FDA's Claude-to-Gemini transition underway within Elsa, Kimberly Chew, Esq., and Michael Yang, Esq., offer advice for proactive risk management to safeguard trade secrets and regulatory outcomes in part three of this series on Elsa's AI transition.

  5. Caregivers: The Missing Line Item In Trial Budgets 4/21/2026

    More than 60 million Americans are caregivers, holding up a system and clinical research enterprise, yet they are mostly uncompensated for their efforts. That needs to change, says Denise N. Bronner and Marsha Calloway-Campbell.

  6. A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis 4/21/2026

    A new biomarker risk score developed by the Pulmonary Fibrosis Foundation's PROLIFIC consortium could serve as the latest prognostic or predictive tool in clinical trials and care. for those diagnosed with idiopathic pulmonary fibrosis (IPF).

  7. Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center 4/20/2026

    For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.

  8. Reminder: FDA Approval Is Not Synonymous With Commercial Success 4/17/2026

    Life sciences expert Rena Roseberg, Ph.D., warns that research and commercial efforts cannot operate within a vacuum. Here, she shares best practices on developing a therapeutic product with solid understanding of its commercial viability. 

  9. What Sites, Sponsors, Vendors, And CROs Can All Agree On 4/17/2026

    Experts representing sponsors, sites, vendors, and CROS discussed at Life Sciences Future SW the pain points and the opportunities that lie ahead in clinical research.

  10. AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research 4/16/2026

    Companies that successfully use AI are those that understand technology magnifies accountability. Anyone that fails to internalize that lesson could find themselves defending the very systems they relied on to bring those products to market.