NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb (NYSE:BMY) and Flatiron Health, a market leader in oncology-specific electronic health record software and the curation 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.
“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, M.D., chief scientific officer, chief medical officer and SVP, oncology, 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.”
About Flatiron Health
Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care. Our platform enables cancer researchers and care providers to learn from the experience of every patient. Currently, Flatiron partners with over 265 community cancer clinics, six major academic research centers and the top 15 therapeutic oncology companies. Additionally, Flatiron’s regulatory-grade real-world data is currently used by the Food & Drug Administration, National Cancer Institute, and other cancer researchers across the oncology community. These research initiatives include supporting post-marketing commitments, accelerating label expansions, informing health technology assessments, designing clinical trials, implementing external control arms, and, importantly, supporting quality monitoring and quality improvement at the point of care. For more information, visit www.flatiron.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the partnership with Flatiron Health will proceed as planned. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2017 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.