GUEST COLUMNISTS

• ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity

  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.

• Clinical Failures Persist Because They're Structural, Not Random

  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.

• Human-In-The-Loop In AI Validation And Control: From Principle To Practice

  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.

• Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support

  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.

• Breaking Barriers In Rare Disease Clinical Trials

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

• Reimagining Data Governance For The AI Era

  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.

• Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials

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

• Philanthropy Empowers And Accelerates Testing Of Drug Combinations In T1D

  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.