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In this episode of Denatured, you'll be listening to Indu Navar, CEO and founder of EverythingALS and Dr. Olga Uspenskaya, chief medical officer at VectorY Therapeutics. We'll be speaking about patient-pharma collaborations accelerating trials and hope, advances in ALS biology understanding and biomarker-driven endpoints.

Original title: “ALS Advances Unite Patients and Pharma on Novel Targets, Biomarker Breakthroughs”

The pharmaceutical industry has long grappled with the cognitive dissonance of drug development—the tension between data-driven insights and the deeply ingrained gut feelings of experienced trial designers. As clinical trials grow in complexity, the reliance on fragmented digital tools and ... The pharmaceutical industry has long grappled with the cognitive dissonance of drug development—the tension between data-driven insights and the deeply ingrained gut feelings of experienced trial designers. As clinical trials grow in complexity, the reliance on fragmented digital tools and legacy benchmarks has often led to operational bottlenecks and unpredictable recruitment cycles. Innovating Biothreat Therapies: An Interview with Head of GigaGen · Moe Alsumidaie · Johnson & Johnson’s Innovative Approach to Enhancing Diversity in Clinical Trials · Moe Alsumidaie · Navigating Complexities in Obesity Clinical Trials: Insights from Skye Bioscience · Moe Alsumidaie · How To Leverage eClinical Technology to Enhance Sponsor-Site Collaboration · Moe Alsumidaie · How to Navigate Rare Disease Clinical Trial Recruitment · Strategic Navigation for Clinical Trials in Mid-Size Biopharma: Insights from Almirall · Moe Alsumidaie · Navigating the Future of Endometriosis Diagnostics · Moe Alsumidaie · How Sangamo is Navigating the Future of Gene Therapy for Rare Diseases · Moe Alsumidaie · Redefining Clinical Imaging: How a Site-First Approach is Setting a New Standard for Transparency and Data Integrity ... Building Trust Through Transparency: Apellis Pharma’s Steph Viscomi on Lean TMF and Site Collaboration ... Veeva and OpenEvidence Form Strategic AI Partnership to Revolutionize Trial Access and Therapeutic Adoption

Original title: “Bridging the Cognitive Gap: How Novo Nordisk is Virtualizing Clinical Trial Decisions”

Clinical research scientist explains why structural barriers make randomized trials on nutraceuticals far harder than most consumers appreciate. When Elise Felicione tried to design a clinical trial for a supplement, 5 things got in the way. It’s a lesson for the industry. Peer-reviewed trials are rare for branded products, and when they exist, they are often underpowered, methodologically limited, or uninterpretable. The National Institutes of Health advises consumers against assuming that supplements can reverse the course of disease. Companies legally cannot claim that their supplements prevent, diagnose, treat, or cure disease. If a supplement sponsor runs a trial that targets clinical endpoints or disease pathways, the FDA may interpret that as drug-like intent, especially once the results are shared publicly. In pharmaceuticals, patent exclusivity helps justify the expense of clinical trials. Botanical supplements rarely have this. Products derived from nature, such as turmeric, ashwagandha, and elderberry, are difficult to patent in ways that block competitors. If one company spends $300,000 proving its product supports sleep or immune function, every other brand using the same ingredient benefits for free.

Original title: “I tried to design a clinical trial for a supplement. 5 things got in the way”

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