Bristol-Myers Squibb and Flatiron in RWE Pact
Drugmaker Bristol-Myers Squibb (BMS) and Flatiron Health, a privately held healthcare technology and services company – both are headquartered in New York City – have extended their existing relationship with a new three-year research collaboration agreement. As part of the deal, the two companies plan to form a joint Scientific Advisory Board to advance the use of Real World Evidence (RWE) for regulatory decision-making.
Flatiron Health, which is in the process of being acquired by Swiss pharmaceutical giant Roche, has established a reputation as a curator of regulatory-grade RWE data for cancer research as well as RWE generation. The new partnership will also include broadened access to Flatiron and Foundation Medicine’s jointly established Clinico-Genomic Database, the companies said.
To accelerate its drug R&D efforts, as well as improve its ability to generate additional evidence on the use of its cancer medicines outside of clinical trials, Bristol-Myers Squibb said it will use Flatiron’s real-world data to generate RWE across a substantial range of tumors. It will also collaborate with other stakeholders on the development and validation of real-world endpoints within Flatiron’s longitudinal datasets.
Commenting on the extended collaboration, Amy Abernethy, chief scientific officer, chief medical officer and SVP for oncology at Flatiron Health, said this pact, along with key legislation like the 21st Century Cures Act and an increasing focus by the US Food & Drug Administration (FDA) “signal a turning point for RWE.” This, she said, “is no longer 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.”
Lynch, executive vice president and chief scientific officer of BMS, said the continued collaboration with Flatiron further strengthens his company’s comprehensive RWE capabilities. An important component of the drugmaker’s oncology drug development program, “this gives us greater insight into the use and impact of its cancer therapies,” he added.