Clinical Guest Contributors

  1. Small Biotech Survival: Navigating Risk And Capital Scarcity With AI 5/8/2026

    Maxine Opperman discusses the challenge and the necessity of small biotech's using AI, citing its pros, cons, and strategies for use.

  2. 5 Critical Risks With The FDA's Real-Time Trial Monitoring 5/8/2026

    Life science legal experts Kimberly Chew and Odette Hauke cover the FDA proof-of-concept real-time clinical trials (RTCTs) and expose five major issues that must be addressed before the pilot expands.

  3. Executive Order For Psychedelics 5/8/2026

    We caught up with Joseph Tucker, Ph.D., CEO of Enveric Biosciences, to discuss the executive order for psychedelics.

  4. Aligning AI Use Clinical Trials With FDA And EMA Expectations 5/7/2026

    For any trial conducted in the EU/EEA, regulators want to know that AI used across clinical trial planning, conduct, and analysis is transparent, controlled, and fit for purpose. Jessica Cordes explains how even U.S.-based teams must meet EMA expectations.

  5. Precision Medicine Needs Better Infrastructure — And We Already Have The Models For It 5/6/2026

    Standard methods for evaluating clinical trial representativeness perform poorly when the trial population differs from the broader disease population in a patient registry. June Cha, Ph.D., MPH, explains how the right metrics can make a difference.

  6. Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24 5/5/2026

    FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

  7. A Biomarker Playbook For Building Faster, Smarter Clinical Trials 5/1/2026

    Not every trial needs a biomarker, but every development leader should be assessing whether they can be effectively used to improve trial design, boost enrollment, reduce operational waste, and increase the likelihood that a study will answer the question it was built to answer.

  8. 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.

  9. 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.

  10. 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.