GUEST COLUMNISTS

• 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.

• The Patient-Centered Trial Paradigm For Knee Osteoarthritis

  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.

• Navigating Elsa's AI Transition: Practical Guidance To Safeguard Confidential Information (Part 3)

  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.

• Caregivers: The Missing Line Item In Trial Budgets

  More than 60 million Americans are caregivers, holding up a system and clinical research enterprise, yet they are mostly uncompensated for their efforts. That needs to change, says Denise N. Bronner and Marsha Calloway-Campbell.

• A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis

  A new biomarker risk score developed by the Pulmonary Fibrosis Foundation's PROLIFIC consortium could serve as the latest prognostic or predictive tool in clinical trials and care. for those diagnosed with idiopathic pulmonary fibrosis (IPF).