Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., has added another position to his roster of board and advisory roles since leaving the agency back in March.
He'll be joining healthcare technology company Aetion’s board of directors, the company announced Tuesday. The New York-based company offers real-world evidence and analytics to drug companies, payers, life sciences companies and regulatory agencies.
Aetion closed on a $27 million extension of series B financing in February, bringing the total raised in the round to expand its platform to $63 million, according to FierceBiotech.
Sanofi, Amgen, UCB, McKesson Ventures and Horizon Healthcare Services have all backed Aetion as strategic investors, according to the company.
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 using real-world evidence, the company said in a press release.
Since he stepped down as FDA commissioner less than six months ago, Gottlieb has nabbed a partnership at a venture capital firm, New Enterprise Associates, and a think tank fellowship with American Enterprise Institute. He also joined the board of directors of pharmaceutical giant Pfizer.
Gottlieb served as the 23rd commissioner of the FDA from May 2017 to April 2019. Under his leadership, the agency has taken on the implementation of the new right-to-try law and sought to address high prescription drug prices.
Pharmaceutical trade groups also lauded his focus on innovation in drug development and review, increased competition and advancing the regulatory framework for approving novel technologies including gene therapies.
During his tenure, Gottlieb also pushed for the FDA’s use of real-world evidence, recognizing its potential to advance medical products and their development, Aetion said.
“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 a statement. “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.”
“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, CEO of Aetion, said in a statement.
Aetion works with 12 of the top 20 biopharma firms in the world, along with leading payers.
The company is working with Brigham and Women’s Hospital (BWH) and the FDA to help inform the use of real-world evidence in regulatory decisions for drug approval and safety through the RCT DUPLICATE demonstration project. BWH researchers are running real-world evidence studies in the Aetion platform to attempt to replicate the results of 30 completed randomized controlled trials and to predict the results of seven ongoing phase 4 trials.