Unlearn has entered into a multi-year collaboration with Merck to accelerate late-stage clinical trials with novel trial designs that include Digital Twins. Initially, the collaboration will focus on advancing the regulatory approval of candidates in Merck’s immunology pipeline, with the potential to expand into other therapeutic areas.
Background
Unlearn works with pharma, biotech companies, and academic researchers to optimise human clinical trials by applying artificial intelligence methods to historical patient data. The company generates Digital Twins, which are comprehensive, longitudinal predictions of a patient’s prognosis on a control treatment.
Moving forward
Integrating Digital Twins into clinical trials is expected to reduce the required number of patients needed to be enrolled while enabling unbiased estimates of treatment effects. Unlike existing methods such as external control arms, the method Unlearn has developed does not introduce bias and maintains randomisation, two aspects critical to regulators.
Using Digital Twins’ technology, Merck plans to incorporate prognostic information from Digital Twins into its randomised controlled trials to enable smaller control groups and generate evidence suitable for supporting regulatory decisions.
Official comments
“We are very pleased to establish this collaboration with Merck KGaA, Darmstadt, Germany and to be working with its world-class team who shares our vision for how AI and other innovative technologies can expand access to new medicines. Our solution has successfully proven that it can reduce the size of control arms by 30% or more and generate reliable clinical evidence in a fraction of the time”, said Charles Fisher, Founder and CEO of Unlearn.
