GUEST COLUMNISTS

• Patient-Powered Drug Trials Are Getting The FDA Greenlight

  Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.

• When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down

  Regulators want one thing during inspections — to see how the data flows, says Just In Time GCP's Donna Dorozinsky. Here, she explores the importance of data oversight and where sponsors sometimes go wrong.

• How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026

  Deep learning is reshaping clinical trial design, execution, and analysis. Learn how to deploy it safely, measurably, and at scale with help from life sciences consultant and MIT industry advisor Partha Anbil.

• The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development

  Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

• Avoid Clinical Alignment Breakdowns With "Lateral Agility"

  Internal misalignment can stall the clinical timeline, erode the window of patent protection, and jeopardize funding. Learn why leadership can no longer be and instead must exhibit "lateral agility" across the enterprise.

• Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes

  The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.

• The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board

  Tufts CSDD’s Beth Harper shares findings from the org's latest Impact Report and discusses how companies might better define risk, measure success, and understand central monitoring. 

• FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs

  The FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.