FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.” Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with the Clinical Trials Transformation Initiative, will feature presentations and a panel discussion around guiding principles for the responsible use of AI in the development of safe and effective drugs and biological products.
Per the Federal Register Notice, FDA plans to discuss the following topics at the workshop:
- Optimizing model design through multidisciplinary expertise (e.g., medicine, statistics, pharmacology, data science, and engineering) to ensure the development of optimal AI models.
- Exploring strategies for overcoming common data-related challenges, such as the availability of fit-for-use data that can be used in drug development, access via federated learning, data quality issues (e.g., representativeness of data, bias, etc.), and the use of synthetic data.
- Balancing model performance, explainability, and transparency of AI models, as well as strategies for assessing the need to integrate humans into the decision-making process (i.e., “human-in-the-loop” and/or “human-on-the-loop”).
- Identifying key gaps and challenges hindering the use of AI in drug and biological product development and exploring potential strategies, collaborations, and initiatives to address these challenges and advance the responsible use of AI in developing safe, effective, and quality drugs.
As we have discussed in other Covington Digital Health posts, FDA’s interests in AI used by drug and biological product sponsors is different from FDA’s framework for regulating some AI/ML-based software functions under its medical device authorities (i.e., software as a medical device), and this FDA workshop is the latest in a series of Agency actions specific to AI deployed by biopharma sponsors. For example, FDA released two discussion papers last year that focused on the use of AI in drug and biological product development and in drug manufacturing, and more recently issued a Federal Register Notice introducing the “Emerging Drug Safety Technology Meeting” program, which will provide those involved in pharmacovigilance (PV) activities the ability to interact with CDER staff regarding the use of AI in the advancement of PV, including efforts to validate and verify relevant models. This FDA workshop also precedes anticipated draft guidance from the Agency later this year on the use of AI and machine learning to support drug development, which will be informed by insights gained from the Agency’s review of submissions containing AI elements, as well as feedback received on the two discussion papers and the upcoming workshop.
Registration is free and open to the public.