Bristol-Myers Squibb and Flatiron to collaborate on real-world data standards for regulatory decisions

Bristol-Myers Squibb
BMS’s partnership includes broader access to Flatiron and Foundation Medicine’s joint database of de-identified clinical and genomic data, gathered from about 20,000 patients across a variety of tumor types. (Bristol-Myers Squibb)

Bristol-Myers Squibb and Flatiron Health expanded their relationship with a new three-year agreement and plan to form a joint scientific advisory board focused on using real-world evidence in regulatory submissions.

BMS hopes to use Flatiron’s real-world data in its oncology research efforts, as well as improve its cultivation of evidence from outside clinical trials. The collaboration plans to contribute to industry standards, develop and validate real-world endpoints, and provide regulators with use cases for guidance, BMS Chief Scientific Officer Thomas Lynch said in a statement.

Earlier this year, Roche acquired Flatiron for $1.9 billion, but allowed it to continue operating as a separate legal entity—illustrating the demand for Flatiron’s cancer-focused electronic health record software and evidence repository.

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“This is an important step in our personalized healthcare strategy for Roche, as we believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments,” Roche CEO Daniel O’Day said at the time.

RELATED: Roche pens $1.9B deal to buy oncology data firm Flatiron

BMS’s partnership also includes broader access to Flatiron and Foundation Medicine’s joint database of de-identified clinical and genomic data, gathered from about 20,000 patients across a variety of tumor types.

“Bristol-Myers Squibb has been an important partner since 2014 when we first began working together on the development of our initial real-world datasets,” said Flatiron’s Amy Abernethy, chief scientific officer, chief medical officer and SVP for oncology.

“This collaboration, key legislation like the 21st Century Cures Act and an increasing focus by the Food & Drug Administration, signal a turning point where RWE is not just a promising tool, but one that is substantive and credible enough to be able to make real, outcomes-based decisions to advance medical research,” Abernethy said.