The FDA has initiated a program, the Innovative Science and Technology Approaches for New Drugs (ISTAND), aimed at facilitating the development of innovative medicine tools. Recently, this program accepted its first artificial intelligence-powered tool, marking a significant milestone since its inception in 2020 and commencement of submissions in 2022.
Intended to provide an alternative pathway for cutting-edge tools that may not align with traditional evaluation methods but hold promise for advancing new drug development, the ISTAND pilot has welcomed a novel device from IntentionalAI. This AI-driven tool, known as the Clinical Outcome Assessment—AI-COA, utilizes machine learning technology and bidirectional cognitive signal processing to assess mental health symptoms related to anxiety and depression.
Dr. Peter Stein, the Director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, lauded this development as a groundbreaking step for the ISTAND program, highlighting the significance of integrating artificial intelligence-based digital health technologies into the evaluation framework. The FDA’s endorsement underscores its commitment to fostering drug development and evaluation processes, potentially expediting the availability of safe and effective therapies.
Moving forward, IntentionalAI will progress through the certification stages, collaborating with the FDA to devise a qualification plan. The company’s innovative technology leverages diverse data inputs such as facial expressions, speech patterns, bodily movements, and vital signs to deliver precise patient assessments, particularly in clinical studies focusing on depression, anxiety, and neurological conditions.
The inclusion of AI-COA in the ISTAND initiative is poised to revolutionize medical care by enhancing the accuracy and efficiency of clinical assessments. Dr. Pierre Kahn from the Icahn School of Medicine at Mount Sinai emphasized the transformative potential of this advancement in clinical research and patient care.
Furthermore, IntentionalAI plans to extend the application of AI-COA beyond clinical trials to routine medical and psychotherapy evaluations, offering an objective measure of patients’ mental well-being. The ISTAND program, established in 2020 by the FDA’s CDER and Center for Biologics Evaluation and Research, aims to broaden the spectrum of resources available to drug developers, encompassing innovative technologies like AI algorithms, wearable devices, and nonclinical assays.
In a similar vein, Integral Molecular’s Membrane Protein Array, a pivotal tool for the ISTAND program, was approved by the FDA to enhance safety evaluations of potential new drugs by assessing off-target protein binding.
