Clinical Guest Contributors

  1. ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity 4/30/2026

    Coya Therapeutics' Fred Grossman dives into innovative trial design elements and a novel biomarker that might better account for clinical and functional progression in Coya's ALS trial studying a dual immunomodulatory therapy.

  2. Clinical Failures Persist Because They're Structural, Not Random 4/29/2026

    Clinical failures are no longer contained within a single program but happen across portfolios, companies, and therapeutic areas. Advisor Mikail Evteev suggests the reason is a failure to learn from past mistakes.

  3. Human-In-The-Loop In AI Validation And Control: From Principle To Practice 4/28/2026

    Explores how human-in-the-loop oversight can move from principle to practice. with a risk-based framework for determining when HITL is required, how the human role should be defined, and what organizational factors influence its effectiveness.

  4. Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support 4/27/2026

    Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.

  5. Breaking Barriers In Rare Disease Clinical Trials 4/27/2026

    Priovant Therapeutics CEO Ben Zimmer shares lessons learned from rare disease VALOR trial exploring a new therapy for the treatment of dermatomyositis.

  6. Reimagining Data Governance For The AI Era 4/24/2026

    Understand the persistent governance challenges that undermine AI initiatives and walk away with a robust blueprint for building a resilient, scalable, and ethically sound framework.

  7. 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. 

  8. 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.

  9. 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.

  10. 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.