Sanofi is launching a companywide project to incorporate its real-world data platform with Aetion’s analytics system to better develop studies capable of standing up to regulatory requirements.
The drugmaker’s internal data platform, named DARWIN, compiles and analyzes de-identified data gathered from hundreds of millions of patients, according to the company. In one project, Sanofi is currently working with Sema4 on a five-year, digital longitudinal study of about 1,200 asthma patients.
Meanwhile, Aetion’s system—used by the FDA and several of the largest pharma companies—is designed to search for trends within real-world data to produce and validate answers to questions surrounding the safety, efficacy and value of drugs across different points in their development.
“Today marks another important step in Sanofi’s digital transformation,” Bernard Hamelin, Sanofi’s global head of medical evidence generation, said in a statement. “By integrating these platforms, we strive to make faster, more informed decisions with the potential to lead to first-in-class and best-in-class treatments that could change the practice of medicine.”
Additionally, Aetion’s platform can help identify subsets of the population most likely to see a benefit as well as demonstrate possible label expansions for a treatment. It also allows researchers to evaluate outcomes-based contracting, by delineating the best conditions for a potential drug.
This past February, the software developer raised an extra $27 million in financing to help expand its efforts—on top of the $36 million it brought in through its 2018 series B round. That included money from Sanofi as well as Blue Cross Blue Shield of New Jersey’s Horizon Health Services, UCB and McKesson Ventures. Previous backers included Amgen’s venture capital arm and New Enterprise Associates (NEA).
More recently, Aetion was able to recruit former FDA Commissioner Scott Gottlieb to a seat on its board of directors. Gottlieb, also an NEA partner, encouraged the use and refinement of real-world evidence during his time leading the agency.
Both Sanofi and Aetion anticipate real-world evidence will play a larger role in FDA reviews in the coming years, acting as a supplement to clinical trial data, with an agency guidance document on its use expected to be published in 2020.