FDA Welcomes First Neuroscience and AI Collaboration in Drug Development

The FDA’s Centers for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) recently accepted a new application for the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This entry represents the first initiative in neuroscience, digital health technology, and artificial intelligence accepted for ISTAND. 

Peter Stein, M.D., director of CDER’s Office of New Drugs, said, “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.” “The FDA’s goal of streamlining drug development and evaluation and possibly accelerating the availability of safe and effective treatments is aligned with our acceptance. 

With its launch in 2020, ISTAND seeks to help create innovative drug development tools (DDTs) for new medical product regulatory applications. For DDTs that don’t fit into well-established evaluation and application pathways, such biomarkers and clinical outcome assessments, the program creates new options. 

The submission of the approved letter of intent (LOI)The purpose of this external link disclaimer is to describe an automated tool for measuring the severity of anxiety and depression that uses a variety of behavioral and physiological indices of depression in a machine learning (ML) model to generate clinician-reported outcomes for anxiety and depression based on scores from the Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Depression Rating Scale (HAM-D). This letter of intent (LOI) reflects the FDA’s significant attention on artificial intelligence (AI) and machine learning (ML) as well as digital health technology (DHT). 

The acceptance of a letter of intent (LOI) is the first step in the three-step qualification process in DDT qualification programs. It is determined by a few factors, such as the submission’s scientific merit, the DDT’s ability to address a particular drug development need, the availability of data and resources to support the proposed qualification effort, and the ability to show that the DDT is workable and practical in the intended context of use. To provide input on the applicant’s qualification plan—the next qualifying step—the FDA will now collaborate with them. 

As stated in recent publications such as “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products,” “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development,” and the most recent final guidance, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” the FDA is still committed to supporting novel approaches to drug development, including AI/ML and DHTs. 

With the first AI and DHT admittance into the pilot program, CDER and CBER are thrilled to grow the field of innovative DDT development in the future. We look forward to ISTAND’s commitment to the advancement of innovative medication development strategies and the quicker and more efficient delivery of beneficial therapies to patients. 

News Link  

Food and Drug Administration, https://www.fda.gov/drugs/drug-safety-and-availability/fdas-istand-pilot-program-accepts-submission-first-artificial-intelligence-based-and-digital-health.