Sanofi and Aetion Launch Enterprise-Wide Collaboration to Advance Regulatory Submissions Using Real-World Evidence

BRIDGEWATER, N.J. and NEW YORK, Nov. 20, 2019 /PRNewswire/ — Sanofi announced today an enterprise-wide collaboration with health care technology company Aetion that will integrate Sanofi’s real-world data platform, DARWIN, with the Aetion Evidence Platform® with the objective of advancing more efficient use of real-world evidence (RWE), facilitating regulatory-grade studies with deep transparency, and unlocking access to new real-world data.

Both companies have invested in RWE platforms, recognizing the pressing need for accurate, fast, and cost-effective research and the important role RWE could play in meeting this need. Sanofi’s DARWIN compiles and analyzes de-identified data from hundreds of millions of patients across disease states, while Aetion’s platform analyzes real-world data to produce transparent, rapid, and scientifically validated answers about the effectiveness, safety, and value of drugs. By combining these platforms, Sanofi is seeking to elevate its capabilities in conducting regulatory-grade analytics, opening new doors for the development and application of medical treatments.

“Today marks another important step in Sanofi’s digital transformation,” said Bernard Hamelin, MD, MSc, MBA, Global Head of Medical Evidence Generation, Sanofi. “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.”

Real-world evidence offers a view of clinical practice outside of the experimental setting, providing an opportunity to inform clinical trial development and supplement trial data with evidence of actual product use in the health care system.

“Our work with Sanofi further validates the value and potential for real-world evidence in drug development,” said Carolyn Magill, Chief Executive Officer of Aetion. “Our companies share a common goal of using the best available data to get the right treatment to the right patient as quickly and efficiently as possible.”

This collaboration between Sanofi and Aetion demonstrates leadership during a critical time. Real-world evidence is expected to play a key role in transforming the health care ecosystem, with the U.S. Food and Drug Administration (FDA) recently prioritizing efforts to incorporate RWE as a companion to clinical trial data to aid in regulatory decision-making. The FDA will release its draft RWE guidance before the end of 2020.

About Aetion

Aetion is a health care technology company that delivers real-world evidence for life sciences companies, payers, at-risk providers, and regulatory agencies. The Aetion Evidence Platform analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on treatments, costs, and outcomes. Founded by Harvard Medical School faculty with decades of experience in epidemiology and health outcomes research, Aetion informs health care’s most critical decisions — what works best, for whom, and when — to guide treatment development, commercialization, and payment innovation into health care’s modern era. Aetion is based in New York City, and backed by investors including New Enterprise Associates (NEA), Flare Capital Partners, Lakestar, Town Hall Ventures, McKesson Ventures, Sanofi Ventures, Amgen Ventures, UCB, and Horizon Health Services, Inc. Learn more at, and follow us at @aetioninc.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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