Opyl Ltd (ASX:OPL) has completed the first critical proof-of-concept stage of development of a machine learning, artificial intelligence-based software interface which can predict the likelihood of a clinical trial completing each phase.
The software works to optimise clinical trials across areas such as study planning, protocol design, recruitment and site location through to selection of the best CRO (contract research organisation) for particular diseases in key geographic locations based on their historical performance.
The Opyl technology is based on information from in excess of 300,000 published trials and more than 60 trial variables across a wide selection of diseases and conditions.
The application of an emerging branch of data science, ‘explainable AI’, has been used to develop the algorithm.
Reduces risk to global biopharma developers
Chief executive officer Michelle Gallaher said: “The Opyl algorithm has the potential to dramatically disrupt the clinical trial feasibility sector, reducing risk and cost to global biopharma and medtech developers.
“This technology has the potential to create more certainty in the typically risky clinical trial stage, which in turn means success worth millions if not billions to a biopharma or medtech company.
“The program has demonstrated its potential impact on specific variables on trial success such as the choice of CRO, site (hospital), academic partners and dosing strategy.
“Understanding how trial variables impact on outcome is a powerful competitive advantage for developers in designing the optimal protocol and for investors looking to reduce risk and optimise returns.”
Model to attract fund managers and investors
The Opyl model has estimated some trials as having up to a 70% chance of success, while other trials are as low as less than 1% and the technology represents a major milestone for the company as it pursues a new strategic direction in digital health.
While the primary market for the clinical trial predictor tool will be typically major biopharma and medtech developers who invest in large numbers of trials each year and seek to reduce risk, fund managers and investors will likely have a strong interest in predicting the likely success of their investments.
Gallagher continued: “We can work with all companies undertaking clinical studies across medical devices, pharmaceuticals, biologics and diagnostics to help them predict the outcome of their studies as well as improve the execution of the clinical trial through site selection, trial protocols and CRO choice.”
The tool could also give smaller developers confidence in their trial designs and may use the predictive approach to build confidence, attracting further investment and commercial partners.
Expected launch in September quarter
It is expected the Opyl model will be commercialised on a subscription basis, with additional bespoke consulting services most likely aimed at pharmaceutical, biotechnology, government, hospitals, universities and research institutes, medical device companies, CRO’s and investment houses.
The company is in preliminary discussion with several organisations in this space.
Accelerating the development of the Opyl algorithm is a key priority for the company with the vast majority of the research and development budget earmarked for the next two quarters being applied to its progression toward an expected market launch in the September quarter of 2020.