Last February 2018, the Swiss drug giant Roche acquired Flatiron Health for $1.9billion. At the time, the New York startup said that it would still be looking for opportunities to trade with other drug companies. On the 2^nd of this month, Flatiron announced a three-year agreement with Bristol-Myers Squibb (BMS) a leading pharma company from the US. BMS is planning to use Flatiron’s expertise to expand real-world evidence to develop Bristol’s experimental cancer drugs.

“We see the Roche deal as a very positive deal for BMS, and we also envision that Roche will invest in Flatiron’s vision” said Mr. Saurabh Saha, Bristol’s head of translational medicine

Amy Abernethy, Flatiron’s chief medical officer, said that one company’s input just wouldn’t be enough when it comes to working with the FDA to figure out how RWE can be used.  “From an FDA perspective it’s important to have multiple voices and multiple companies on the table, if it’s only Roche’s voice, that’s not good. If it’s only Flatiron’s voice, that’s not good. I think BMS sees themselves as a leader in how to do this.” she added.

Congress has ordered the FDA to figure out how to use real-world evidence. The 21st Century Cures Act, a 2016 law, specifies that the FDA should consider real-world evidence for safety analyses and additional uses of drugs. One thing it leaves unclear: What exactly does real-world evidence mean?

Flatiron makes use of its own electronic medical record, used by more than 2,500 cancer doctors, to collect data on patients. Using this information, it can create virtual clinical studies to see if what happens in randomized trials matches with what happens in the real world. In one study presented earlier this year, for example, Bristol worked with Flatiron to put together a virtual control group for a single-arm study and a small study with a placebo group testing the company’s drug Opdivo in a rare form of esophageal cancer.  The drug may have benefits regarding in that rare disease.

“These kinds of data can be used in multiple ways: possibly for regulatory submissions, it also shows that a treatment has economic value and for figuring how to recruit patients to enter clinical trials” says Saha.

“I think it’s going to help push the whole industry forward in this area” Abernethy stated.