Bristol-Myers Squibb and Flatiron Health, a curator of regulatory-grade real-world data for cancer research and real-world evidence (RWE) generation, expanded their relationship today by announcing a three-year collaboration agreement.
Bristol-Myers Squibb will use Flatiron’s real-world data to accelerate its research and development efforts, as well as improve its ability to generate additional evidence on the use of its cancer medicines outside of clinical trials.
With the expanded collaboration, the two companies intend to form a joint Scientific Advisory Board to 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, M.D., 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.”
Bristol-Myers Squibb will use Flatiron data to generate RWE across a substantial range of tumors and will collaborate, along with other stakeholders, on the development and validation of real-world endpoints within Flatiron’s longitudinal datasets.
Additionally, the partnership includes broadened access to Flatiron and Foundation Medicine’s jointly established Clinico-Genomic Database.
Amy Abernethy, M.D., chief scientific officer, chief medical officer and SVP, oncology, Flatiron Health commented, “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.”
(Source: Bristol-Myers Squibb)
