Clinical trials are a costly and time-consuming aspect of drug development, with Phase 3 studies costing upwards of $55,000 per day and completed trials routinely costing tens of millions of dollars. Unlearn.ai, a startup, aims to reduce these costs and improve trial efficiency using digital twin technology, a concept initially developed by NASA. By creating 'living models' of patients, Unlearn hopes to reduce placebo exposure, accelerate drug development timelines, and identify subgroups that respond best to specific therapies.
Neural Boltzmann Machines and PROCOVA
Unlearn's technology is built upon the Neural Boltzmann Machine (NBM), which powers its digital twins. Unlike typical predictive models, the NBM can simultaneously predict numerous clinical outcomes, including lab results, vital signs, and complex biomarkers, while also capturing the relationships between these outcomes. This provides researchers with a richer understanding of a patient’s likely disease trajectory, generating a range of possible outcomes to optimize clinical trials for cost and improved power.
To further enhance its approach, Unlearn uses PROCOVA (PRObabilistic COVariate Adjustment), a method that integrates digital twin predictions into clinical trial analysis. PROCOVA has received support from major regulatory bodies, including the EMA and FDA, which is crucial for wider adoption within the pharmaceutical industry.
Addressing Data Harmonization
Developing sophisticated models like Unlearn’s requires addressing data harmonization challenges. The company focuses on creating general disease-specific models rather than study-specific ones to broaden their applicability. Data privacy is paramount, with Unlearn adhering to strict protocols to protect client information.
"We've spent about 80% of our tech stack and pipelines and work streams just on taking in data, cleaning it, harmonizing it, understanding it, and using it to build these models," explained Alyssa Vanderbeek, a product manager at Unlearn.ai.
Usability and Precision Medicine
Introducing cutting-edge AI solutions into the pharmaceutical industry presents challenges. Unlearn focuses on ease of use to encourage adoption. "Our primary customers have a role called clinical development lead or medical director. They're not technical at all. This interface really resonates with them," said Angela Dao from Unlearn.ai.
Unlearn’s vision extends beyond improving clinical trial efficiency; it aligns with the movement towards precision medicine. By leveraging digital twins, Unlearn can help identify which patients are most likely to respond to certain treatments, enabling more personalized and effective therapeutic strategies. Addressing diversity in clinical data is another critical aspect of Unlearn’s mission. By ensuring that their models are trained on diverse datasets, including varying ages, genders, ethnic backgrounds, and disease severities, Unlearn aims to improve the generalizability of clinical trial outcomes across different populations.
"Subgroup discovery in general is of great interest in the pharma space, because the hope is that even if you have a drug that did not work in your population, maybe there’s some subpopulation for whom it’s effective," said Dao.
