BMS looks to leverage real-world data, with Flatiron collab

Bristol-Myers Squibb has extended its existing collaboration with Flatiron Health by three years and expanded the efforts both will be making in using real-world data in cancer research.

The deal comes despite Flatiron having been acquired by Roche for $1.9 billion in February; as part of the transaction, Roche agreed to let its new partner pursue business with other pharma companies.

BMS will be using the collaboration to aid in R&D and to provide additional evidence of its cancer treatments’ efficacy beyond the structure of clinical trials.

As part of the extended collaboration, the two companies will create a Scientific Advisory Board that will, according to the press release, "advance the use of RWE for regulatory decision making".

"Our continued collaboration with Flatiron further strengthens our comprehensive RWE capabilities, an important component of our oncology drug development program, giving us greater insight into the use and impact of our cancer therapies," said Thomas J. Lynch, Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb. "We will work with Flatiron to contribute to RWE industry guidance and standards, and advance new regulatory-focused RWE use cases. Ultimately, this work will enable us to accelerate our ability to help patients."

Both Roche’s investment in Flatiron and BMS partnership reflect a growing interest in real world evidence and, as well as this, a push to make the data generated hold greater weight when it comes to regulatory applications.

Clinical trials are extraordinarily expensive, particularly in large-scale trials, so being able to supplement data generated in this manner more effectively with data that is significantly easier to accrue would be a huge bonus for the pharma industry.

"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 Amy Abernethy, Chief Scientific Officer and Chief Medical Officer, Flatiron Health. "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."

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