Congratulations to inventor Adam Gazzaley, MD, PhD, Professor, Neurology, UCSF Weill Institute for Neurosciences, whose advanced research and work with the commercialization teams at UCSF resulted in the clearance of Endeavor, and the honor of making history in two ways in the field of digital medicine last week:
(1) It was the first time a game-based therapeutic was cleared by the FDA; and
(2) It is the first digital therapeutic intended to address ADHD
What is Endeavor?
The overarching purpose of this new technology according to UCSF Innovation Ventures Office of Technology Management Licensing Officer Kathy Wilson Edell, PhD, who currently manages the UCSF-Akili partnership, is “to complement or even replace drugs with digital therapies.”
Endeavor, based on a technology developed by Gazzaley, is now a prescription treatment for kids with ADHD that is delivered through an entertaining video-game. STAT News describes it as “a delivery system for targeted algorithms that can activate and strengthen certain neural networks in the brain.”
How does it work?
The technology, called EndeavorRx, targets and activates specific neural networks in the brain that are associated with cognitive dysfunction. It provides sensory stimulation that ultimately activates the specific neural system that is involved in attention function. Further, it leverages algorithms to personalize treatment for each patient, adjusting to individual differences at the offset, and setting higher bars as the patient progresses.
Behind the 10-year commercialization process
The commercialization process took a decade in total, typical for life sciences technologies. “It was so helpful for me to work closely with experts in the Innovation Ventures office over many years and navigate a new and unfamiliar domain. The results have been so gratifying; we have had the opportunity to translate invention into treatment and directly impact many people’s lives.”
The UCSF Innovation Ventures Office of Technology Management team led the process, under the direction of Assistant Director Debbie Alexander, DPhil, and Licensing Officer Kathy Wilson-Edell, PhD. They worked closely with the inventor and other members of a broader team, as it grew toward a fully functioning company. According to Edell, Gazzaley has embraced the commercialization process. She remarked, “Dr. Gazzaley is clearly driven by a passion for ensuring that his technology would eventually make its way to those whose lives would be improved by it in profound ways. He is a remarkable scientist and manages effectively to ensure he impacts the patients he serves.”
The process began in 2010, when Gazzaley filed an initial disclosure. The UCSF Office of Technology Management team worked with him on a patent strategy, which included filing, and collaborated with him to support the ongoing research that would be needed to complete development and testing. In 2013, the year he also published a pivotal research paper in Nature, Innovation Ventures negotiated a license and the formation of a startup, Akili, based on this new UCSF technology. Dr. Gazzaley was named the scientific advisor, and the company refined and tested the game in clinical trials for another five years before seeking clearance from the FDA in 2018. In April 2020, Akili was able to release Endeavor prior to clearance after the FDA announced an enforcement discretion policy for a class of digital therapeutics, prompted by the COVID pandemic. This, shortly before it was cleared as a medical device in June, 2020. From the time clinical trials were completed, the FDA clearance process took two years. Next, the company will work with physicians so that they are aware the game can be prescribed to their patients and with insurers to cover it.
About UCSF Innovation Ventures: Innovation Ventures works to accelerate the process of bringing discoveries to patients, helping UCSF achieve its mission of transforming health care. To this end, this team leads business development, licensing, alliance creation, startup formation to translate cutting-edge science into therapies and products that benefit patients on a global basis.
About The Office of Technology Management: This UCSF Innovation Ventures team evaluates and grows new ideas, devises a commercialization and intellectual property (IP) plan including formation of a start-up, connects research with appropriate potential internal and external collaborators, and negotiates suitable licenses with appropriate commercialization partners such as existing companies, venture capitalists or other investors.