GUEST COLUMNISTS

• 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).

• Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center

  For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.

• Reminder: FDA Approval Is Not Synonymous With Commercial Success

  Life sciences expert Rena Roseberg, Ph.D., warns that research and commercial efforts cannot operate within a vacuum. Here, she shares best practices on developing a therapeutic product with solid understanding of its commercial viability.