Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration, has joined the board of directors of health-tech company Aetion. This marks the second board of directors the former FDA head has joined this week.
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Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration, has joined the board of directors of health-tech company Aetion. This marks the second board of directors the former FDA head has joined this week. On Monday, he joined the board of FasterCures, part of the Milken Institute.
On Wednesday, Aetion announced that the former commissioner will advise the company as it expands the reach and utility of the Aetion Evidence Platform, a tool developed to assess the safety, effectiveness, and value of treatments. In the announcement, Gottlieb said he is “inspired by the opportunity” to join Aetion’s efforts to bring real-world evidence to the “forefront of drug research and development.”
While he was commissioner of the FDA, the use of real-world evidence or real-world data was something Gottlieb championed. RWE relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. The data can be collected from a variety of sources, including electronic health records, wearable devices, lab tests and more. Before departing from his role atop the FDA, Gottlieb said that the use of RWE is a “recognition that new approaches and technologies can help expand the sources of evidence that we can use to make more reliable treatment decisions.” During that speech, Gottlieb also noted that the base of evidence collected from these “in-the-wild” sources “can continue to build and improve throughout the therapeutic life of an FDA approved drug or medical device.”
“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,” Gottlieb said in the Aetion announcement.
Gottlieb joins the Aetion Board of Directors during a significant year for the New York-based company. Aetion is now working with 12 of the top 20 biopharma firms in the world, along with leading payers. Those partners include Sanofi, Amgen, UCB, McKesson Ventures, and Horizon Healthcare Services, the company said.
Last year, Aetion partnered with Brigham and Women’s Hospital and the FDA to help inform the use of RWE in regulatory decisions for drug approval and safety through the RCT DUPLICATE demonstration project. That project uses real-world evidence to predict the results of seven ongoing Phase IV trials. This is the first time researchers will estimate the results of randomized controlled trials that have not yet concluded. BWH researchers are running RWE studies in the Aetion platform to attempt to replicate the results of 30 completed randomized controlled trials 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 and to inform FDA’s acceptance of RWE. “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,” Carolyn Magill, chief executive officer of Aetion said in a statement.
Gottlieb stepped down from his role at the FDA in April. Weeks after he left his job as commissioner, he joined the board of directors of pharmaceutical giant Pfizer. At Pfizer, Gottlieb was tapped to serve on two different board-level committees, the Regulatory and Compliance Committee and the Science and Technology Committee.
In addition to his roles on the board of directors of the multiple companies, Gottlieb is a Resident Fellow at the American Enterprise Institute and is an elected member of the National Academy of Medicine.
