trial-design
(3)
Unlearn.AI
Unlearn.AI is a San Francisco biotech-AI company that builds disease-specific machine learning models to generate digital twins of clinical trial participants - longitudinal predictions of how each patient would have fared on placebo. Folded into a statistical method called PROCOVA and a trial design called TwinRCT, the approach lets sponsors shrink control arms by up to a third, so more patients receive the experimental drug while trials reach answers faster. Founded in 2017 by physicists Charles Fisher, Aaron Smith and Jon Walsh, the company has raised about $130M and earned a first-of-its-kind EMA qualification for an AI-based method to reduce sample size in pivotal trials.
Medidata Solutions
Medidata Solutions is a New York-based, cloud software company that runs the digital plumbing of modern clinical research. Its flagship Rave EDC pioneered electronic data capture in clinical trials, and today its unified platform spans data capture, patient engagement, AI analytics, imaging, and trial operations. A Dassault Systèmes company since 2019, Medidata powers trials for most of the world's largest pharmaceutical companies and has supported the development of a large share of newly approved drugs and medical devices.
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.