Clinical Guest Contributors

31. Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic 2/20/2026

    Pilatus Biosciences CEO Raven Lin shares learnings from his company's early-stage oncology program.

32. Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease 2/19/2026

    The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.

33. The Problem With Excluding Children From GLP-1 Trials In The U.S. 2/19/2026

    In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.

34. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

    Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

35. How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows 2/17/2026

    Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.

36. 4 Steps For Representative Enrollment In Rare Disease Trials 2/16/2026

    Discover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.

37. When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs 2/13/2026

    Learn how to account for AI-related costs under evolving U.S. Generally Accepted Accounting Principles (GAAP).

38. FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now 2/13/2026

    On December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.

39. How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2) 2/12/2026

    Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.

40. How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1) 2/12/2026

    Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.