Unlearn.AI
Unlearn.AI builds AI-generated digital twins that improve clinical trial design and evaluation.
Founded
2017Unlearn.AI builds AI-generated digital twins that improve clinical trial design and evaluation.
Unlearn.AI differentiates on regulatory engagement for its statistical methods, including European qualification for its prognostic adjustment approach and public feedback from United States regulators. Its models are trained on extensive historical patient level data and generate per participant forecasts from baseline data alone.
The company also differentiates on therapeutic breadth, with generators spanning neurology, immunology, respiratory, cardiovascular, and metabolic conditions. Sponsor facing deployment under regulated controls supports adoption by large drug developers with strict data requirements.
Source: unlearn.ai
Demand for the company's category follows pressure on drug developers to run faster trials with fewer participants on control arms. Neurology programs in Alzheimer disease, ALS, Huntington disease, and Parkinson disease provide a natural fit because progression can be modeled from historical data.
Adoption depends on continued regulatory acceptance of AI generated comparators and on sponsors building trial plans around digital twin analyses. Partnerships with biotechnology sponsors and data access agreements with research foundations support expansion into additional indications.
Source: unlearn.ai
Unlearn.AI offers disease specific digital twin generators that forecast how an individual trial participant would progress under control or standard of care conditions. Sponsors use the forecasts in randomized designs with smaller control arms, in single arm studies as external comparators, and in interim or retrospective analyses.
The methods include prognostic covariate adjustment techniques that regulators in the United States and Europe have reviewed. Deployment options cover web based access and on premises use within sponsor controlled environments under regulated compliance standards.
Source: unlearn.ai