BMS and Concerto HealthAI sign real world evidence tie-up

Bristol-Myers Squibb and Concerto HealthAI, which specialises in using AI and machine learning technology to help generate ‘real world’ evidence (RWE) for trials, have announced a multi-year strategic agreement that will apply the technology to design faster and more efficient studies.

Bristol-Myers Squibb will use Concerto HealthAI’s EurekaHealth technology platform, to investigate novel health economic outcomes and clinical development synthetic control arm studies.

With this agreement, the companies will advance the use of RWE for regulatory purposes, validate clinical application of AI solutions and execute clinical studies to advance patient care.

The move follows the FDA’s 21st Century Cures Act, which called for adoption of RWE in clinical trials and post-approval studies.

In December 2018, the FDA published a framework to assess RWE in regulatory decisions and approvals.

Concerto HealthAI integrates data from sources including CancerLinQ, a platform that collects and analyses real-world data from patients at practices nationwide and delivers knowledge back to physicians and researchers.

CancerLinQ is developed and operated by CancerLinQ LLC, a non-profit subsidiary of the American Society of Clinical Oncology (ASCO). As an exclusive licensee, Concerto HealthAI works closely with CancerLinQ to broaden the use of RWE for pre- and post-approval studies.

Concerto HealthAI’s chief executive, Jeff Elton, said: “With the increasing importance of Real-World Data and Real-World Evidence, healthcare providers and regulators need to have confidence in the credibility and accuracy of the data sources and methods of evidence generation.”

“Our agreement with Bristol-Myers Squibb is a recognition that we have reached a pivot-point for RWE – 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 optimisation of current treatments and new therapeutic innovations.”

Jeff Conklin, head of business insights and analytics at Bristol-Myers Squibb said: “At Bristol-Myers Squibb, we have seen the value of Real-World Data in our efforts to discover, develop and deliver medicines for patients.

“This strategic agreement with Concerto HealthAI – a leader in AI solutions for precision oncology – reinforces our commitment to pursue data science to accelerate disease insights, advance novel study concepts and achieve precision in treatment, with the goal of improving patient outcomes.”