Aetion issued the following announcement on Sep. 17.
Aetion, the health care technology company that delivers real-world evidence (RWE) for life sciences companies, payers, and regulatory agencies, announced that former Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb has joined its board of directors. Gottlieb will advise the company as it expands the reach and utility of the Aetion Evidence Platform™, a scientifically validated tool to assess the safety, effectiveness, and value of treatments.
Gottlieb served as the 23rd Commissioner of Food and Drugs from May 2017 to April 2019. During his tenure, Gottlieb was a champion of the FDA's use of real-world evidence, recognizing its potential to advance medical products and their development. Gottlieb's experience as a physician, regulator, and advocate will help guide the company as it furthers its science and technology.
"The widespread adoption of real-world evidence to the development and application of new treatments will improve the precision of prescribing decisions and help make drug discovery far more efficient," said Gottlieb. "As a member of Aetion's Board, I'm inspired by the opportunity to join the company's efforts to bring RWE to the forefront of drug research and development."
Gottlieb first served at the FDA under President George W. Bush as Deputy Commissioner for Medical and Scientific Affairs as well as a senior advisor to the FDA Commissioner. He is currently a Resident Fellow at the American Enterprise Institute and is an elected member of the National Academy of Medicine.
"Dr. Gottlieb has played a pivotal role in advancing the use of real-world evidence for regulatory decision-making. As a real-world evidence advocate and standard-setter, he's an ideal partner in our work to help define RWE's role in the development, delivery, and payment of treatments," said Carolyn Magill, CEO of Aetion.
Gottlieb joins the Aetion Board of Directors during a momentous year for the company. Aetion now works with 12 of the top 20 biopharma firms in the world, along with leading payers. Global health care leaders Sanofi, Amgen, UCB, McKesson Ventures, and Horizon Healthcare Services have all backed Aetion as strategic investors.
Aetion is also working with Brigham and Women's Hospital (BWH) and the FDA to help inform the use of RWE in regulatory decisions for drug approval and safety through the RCT DUPLICATE demonstration project. BWH researchers are running RWE studies in the Aetion platform to attempt to replicate the results of 30 completed randomized controlled trials (RCTs), and to predict the results of seven ongoing Phase IV trials. The company is also participating in the Friends Of Cancer Research Pilot 2.0, a key project to assess several frontline treatment regimens in patients with advanced non-small cell lung cancer (aNSCLC), and to inform FDA's acceptance of RWE.
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 aetion.com, and follow us at @aetioninc.
Original source can be found here.