regulatory-ai
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Pavan Kalyan Left the Lab to Make Pharma Paperwork Move at Machine Speed
An IIT Bombay researcher learned to make machines tell stories. Now he and two friends are teaching them the less glamorous, more consequential craft of regulatory documentation.
Brandon Rice Is Turning Drug Development’s Paper Trail Into Working Memory
The Weave Bio CEO began with Neanderthal genomes and ended up rebuilding one of drug development’s least glamorous systems. His wager is simple: let software carry the paperwork so experts can carry the judgment.
Steve Herne
Steve Herne is the CEO of Unlearn.AI, a San Francisco-based company building AI-powered digital twin technology to transform how clinical trials are designed and run. With over 25 years of experience across pharmaceutical R&D companies including WCG, Bioclinica, and Covance, Herne joined Unlearn in May 2024 as Chief Commercial Officer before ascending to CEO in September 2024. Under his leadership, Unlearn — backed by $130M+ in venture funding including a $50M Series C led by Altimeter Capital — is pivoting from research-led to commercially-driven product delivery, with its digital twin models now EMA-qualified and adopted by major biopharma companies to reduce placebo arm sizes by up to 38% in pivotal trials.