FDA accepts first AI algorithm to drug development tool pilot, with Deliberate AI’s anxiety and depression assessment

For the first time since it launched in 2020 and began accepting submissions in 2022, a program started by the FDA to provide support for unconventional drug development tools has accepted its first artificial intelligence-powered tool.

The Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot was designed to create a new pathway to FDA review for novel tools that may not fit into currently existing routes of evaluation, but that could potentially improve the development of new drugs.

The newest tool accepted into ISTAND comes from Deliberate AI. The AI-generated Clinical Outcome Assessment—AI-COA for short—uses multimodal behavioral signal processing and machine learning technology to record mental health symptoms and assess the severity of cases of anxiety and depression.

“This marks a pioneering step for the ISTAND program as the first artificial intelligence-based, digital health technology project in neuroscience to be accepted into the pilot program,” Peter Stein, M.D., director of the Office of New Drugs within the FDA’s Center for Drug Evaluation and Research, said in an agency announcement this week. “Our acceptance aligns with FDA's vision of optimizing drug development and evaluation, potentially expediting the availability of safe and effective treatments.”

With its letter of intent now accepted by the program—affirming that its tool is feasible, practical and will address a specific need in drug development—Deliberate AI will move on to the next of two more steps in the qualification process, which will see the company working with the FDA to develop a qualification plan.

Deliberate’s technology takes in a range of patient data—including facial expressions, speech behaviors and acoustics, physical movements, pupil changes and vital signs—to build a quantitative assessment of each patient’s mental health.

According to the company, those assessments can be performed throughout clinical trials of new therapeutics for depression, anxiety and other neurological conditions to more accurately track participants’ progress and the efficacy of the drugs.

“The FDA’s inclusion of AI-COA into ISTAND is a testament to its potential to revolutionize psychiatric care. Where we have historically relied on subjective and time-consuming assessments, this breakthrough is set to bring unprecedented rigor and precision to clinical assessments and research,” Rene Kahn, M.D., Ph.D., chair of psychiatry at Mount Sinai’s Icahn School of Medicine, said in Deliberate AI’s announcement Friday.

Outside of clinical trials, meanwhile, the company is also working on adapting AI-COA for use in regular clinical and psychotherapy assessments, where it could potentially provide a more objective assessment of patients’ mental health than self-reported surveys.

The FDA’s CDER and Center for Biologics Evaluation and Research kicked off the ISTAND program in 2020, aimed at broadening the scope of tools available to drugmakers. Among the categories cited by the agency as being stranded beyond traditional review pathways are those enabling remote trials; tools like tissue chips and nonclinical assays that “may advance our understanding of drugs”; and, as with Deliberate’s, those that implement AI algorithms, wearables and other digital health technologies.

Two years later, they accepted the first tool into the pilot: Integral Molecular’s Membrane Protein Array, which evaluates off-target protein binding to improve safety assessments of proposed new drugs.