European Medicines Agency selects Aetion to support safety and efficacy research in Europe
The relationship covers a range of pharmacoepidemiologic studies on the utilisation, safety, and efficacy of medicines marketed across the European Union
BARCELONA, SPAIN, December 1, 2021 — The European Medicines Agency (EMA) has selected Aetion for a four-year term to support the agency’s Quality, Efficacy, and Safety Studies on Medicines. Aetion will perform pharmacoepidemiologic research for EMA, generating real-world evidence (RWE) to help measure the utilisation, safety, and efficacy of medicines used in routine clinical practice. These studies aim to generate insights on the quality, efficacy, and safety of pre- and post-authorisation medicines to support EMA decision-making.
Through this contract, Aetion’s research purview includes studies looking at health outcomes across specific time periods and within different populations; the association between exposure and health outcomes; estimation of the impact of an intervention, such as a drug or vaccine; as well as those that could improve RWE methods. Aetion partners with Cegedim Health Data to enable access to The Health Improvement Network® (THIN®) database for these analyses. THIN® currently covers large populations of over 69 million patients across several European countries.
“Aetion being evaluated and selected by EMA shows the value of the Aetion Evidence Platform® (AEP) in generating evidence that regulators trust,” said Dr. Jeremy Rassen, Co-Founder and President of Aetion. “We are proud to support—and are deeply aligned with—EMA’s strategy to leverage health care data for regulatory decision-making, including to ensure the efficacy and safety of medicines.”
Aetion is a European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) designated research centre and contributes to multiple working groups involved in EU data sources, methodological approaches for multi-source studies, and independence and transparency in the conduct of RWE research.
Global regulators and health technology assessment agencies use AEP to support their RWE efforts. The U.S. Food & Drug Administration (FDA) selected AEP to develop a system of studies that enables rapid evidence generation for COVID-19 and future pandemics. Aetion also partners with the UK’s National Institute for Health and Care Excellence (NICE) to explore how RWE can be used to study real-world clinical effectiveness.
Aetion is a health care analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyses data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members 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 product development, commercialisation, and payment innovation.
Aetion is based in New York City with offices in Boston, Los Angeles, and Barcelona. Aetion is backed by investors including New Enterprise Associates (NEA), Warburg Pincus, Flare Capital Partners, Greenspring Associates, Lakestar, B Capital, Foresite Capital, Town Hall Ventures, McKesson Ventures, Sanofi Ventures, EDBI, Johnson & Johnson Innovation—JJDC, Inc., UCB, Amgen Ventures, and Horizon Health Services, Inc. Learn more at aetion.com and follow us at @aetioninc.