Real-World Data for Regulatory Submissions
Pharma giant Bristol-Myers Squibb (BMS) 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, inked a three-year agreement to create a joint scientific advisory board designed to use real-world evidence in regulatory submissions, according to an article by Conor Hale in Fierce Biotech.
BMS – who describes its mission as to discover, develop and deliver innovative medicines that help patients prevail over serious diseases -- plans to utilize Flatiron’s real-world data in its oncology research efforts and to improve its development of evidence from outside clinical trials. Objectives of the collaboration include contributing to industry standards, developing and validating real-world endpoints, and giving regulators cases for guidance, according to BMS Chief Scientific Officer Thomas Lynch. BMS’s partnership also entails broader access to Flatiron and Foundation Medicine’s joint Clinico-Genomic Database of de-identified clinical and genomic data, gathered from about 20,000 patients across a variety of tumor types.
Flatiron Health, a healthcare technology and services company focused on accelerating cancer research and improving patient care, has a platform that enables cancer researchers and care providers to learn from the experience of every patient. Flatiron is partnering with more than 265 community cancer clinics, six major academic research centers and the top 15 therapeutic oncology companies. Flatiron’s regulatory-grade real-world data is being used by the Food & Drug Administration, National Cancer Institute and other cancer researchers across the oncology community. Initiatives include supporting post-marketing commitments, accelerating label expansions, informing health technology assessments, designing clinical trials, implementing external control arms and supporting quality monitoring and quality improvement at the point of care.
Although Roche acquired Flatiron for $1.9 billion earlier this year, Roche permitted Flatiron to continue to operate as a separate legal entity, showing that there is great demand for Flatiron’s cancer-focused electronic health record software and evidence repository. As Roche CEO Daniel O’Day said, “This is an important step in our personalized healthcare strategy for Roche, as we believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments.”
Flatiron’s Amy Abernethy, chief scientific officer, chief medical officer, and SVP for oncology, added, “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. 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.”
Lynch concluded, “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. Ultimately, this work will enable us to accelerate our ability to help patients.”