Gottlieb on board to advance Aetion’s RWE work, guide platform development

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/Pinkypills)
(Image: Getty/Pinkypills)

Related tags: Scott Gottlieb, Fda, Aetion, Real world evidence, RWE

Aetion today announced that former FDA Commissioner Scott Gottlieb has joined its board of directors to help to advance the use of RWE in drug development and commercialization.

In this role, Gottlieb will advise the company as it further develops its tool to assess treatment safety, effectiveness, and value using real world data – the Aetion Evidence Platform.

According to the company, its ‘rapid-cycle analytics’ enables users to reduce ‘time-to-evidence’ from months to days.

Gottlieb was the US Food and Drug Administration (FDA) Commissioner from May 2017 to April 2019, during which time he advocated for the use of real-world evidence (RWE).

“Dr. Gottlieb’s experience as a physician, regulator, and advocate will help guide us as we continue to invest in the Aetion Evidence Platform, and work with our customers to advance the use of RWE in drug development and commercialization,”​ an Aetion spokesperson told us.

Said Gottlieb in a statement addressing the announcement: “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.”

“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,”​ he added.

The company’s platform is scientifically validated and produces a fully transparent audit trail, “allowing researchers to understand decisions made in the study design and implementation,”​ the spokesperson said.

“More than ever, one of the biggest challenges in health care is figuring out how to choose the best treatments for patients and determining how much we should pay for them. In many cases major care decisions are being made without high-quality evidence on whether they will work for the specific population being treated,”​ they added.

“The Aetion Evidence Platform enables analysis of relevant data from the real world and gives health care decision-makers new insights.”

Aetion works with both payers and biopharma firms, including Sanofi, Amgen, and UCB, as well as McKesson Ventures and Horizon Healthcare Services, all of which have backed Aetion as strategic investors.

Aetion’s Series B fundraising completed earlier this year​ totaled $27m, capping the NY-based company’s total Series B funding at $63m. Since launching in 2015, Aetion has raised $77m.

The company also is working with Brigham and Women’s Hospital (BWH) and the FDA as part of the RCT Duplicate demonstration project​. Using Aetion’s platform, the project aims to validate the use of RWE by replicating the results of 30 completed studies and predicting the results of seven ongoing Phase IV trials.

Additionally, Aetion is participating in the Friends Of Cancer Research Pilot 2.0 to further inform the regulator’s acceptance of RWE.

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