Strengthens Real-World Data Capabilities in Oncology Research at BMS
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
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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.
Flatiron Health Jenny Edelston, 707-395-7116 press@flatiron.com or Bristol-Myers Squibb Danielle Halstrom, 609-252-3403 danielle.halstrom@bms.com or Investors: Tim Power, 609-252-7509 timothy.power@bms.com orBill Szablewski, 609-252-5894 william.szablewski@bms.com