Bristol-Myers Squibb has struck a multi-year deal with Boston-based Concerto HealthAI to use artificial intelligence and real-world data to improve how it designs and conducts cancer drug studies.
Details on the agreement are sparse, but Bristol-Myers indicated it would tap Concerto's data platform to better use real-world data for regulatory purposes, and validate use of AI in clinical research.
It's the latest move by Bristol-Myers to incorporate real-world data into drug development, and comes as the big pharma's clinical trial designs in the fast-moving field of cancer immunotherapy have been called into question.
The partnership marks the New York drugmaker’s latest foray into using real-world data, a term used to describe observational data obtained during routine clinical care.
Bristol-Myers and partner Pfizer are already using real-world data to boost the profile of their oral anticoagulant Eliquis (apixaban) in an effort to unseat warfarin, the standard of care for decades.
Now, Bristol-Myers will use Concerto's platform eurekaHealth, which collects real-world data from patients at practices nationwide, in a "diverse range of cancers."
AI's potential in medicine, and particularly in drug development, have long been discussed, although examples of clear successes remain limited. In cancer research, machine learning technology could theoretically help identify patients who respond best to particular drugs or certain combinations of medicines.
The collaboration between Bristol-Myers and Concerto comes on the heels of a Food and Drug Administration effort announced in December to expand use of real-world evidence in development of drugs and biologics. The FDA said new electronic tools can now be used to better inform regulatory decisions. The 21st Century Cures Act, signed into law in December 2016, required the FDA to release a comprehensive plan for how it will advance efforts around real-world evidence.
According to the FDA, real-world data can be derived from sources like electronic health records, medical claims, product and disease registries, laboratory test results and consumer mobile devices.
Concerto CEO Jeff Elton touted the company's agreement with Bristol-Myers Squibb as a a turning point for real-world evidence. “It is not just a tool for generating insights into the current standard of care, but a field in its own right that can lead to optimization of current treatments and new therapeutic innovations," he said.