Health & Veritas Greg Licholai: Breaking through the Innovation Bottleneck
May 9, 2024
Greg Licholai, a lecturer at Yale and seasoned biotech entrepreneur, joins the discussion to share insights from his diverse career. He delves into the role of contract research organizations in clinical trials, emphasizing their impact on both large and small pharmaceutical companies. Licholai highlights the optimism surrounding innovations in gene therapies and CRISPR, while addressing the challenges of access and payment. He also tackles innovation bottlenecks in the clinical trial process, advocating for improved technology to facilitate participation.
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Donut Hole Revealed Costly Mortality Impact
- Researchers used Medicare Part D enrollment month as a natural experiment to study cost-sharing effects on drug use and mortality.
- They found higher December mortality linked to earlier enrollment months, suggesting coverage lapses raised death risk.
Cost-Sharing Forces Dangerous Drug Stops
- The study showed patients stopped both high-value drugs and medicines with dangerous withdrawal effects when coverage lapsed.
- Cost-sharing therefore harms outcomes and can be more expensive in human life than the program's savings.
CROs Are The Backbone Of Drug Approval
- Contract research organizations (CROs) generate the clinical data regulators use to approve drugs.
- ICON and similar CROs run trials and supply the evidence the FDA relies on for safety and efficacy decisions.