Workshop To Consider Artificial Intelligence in Drug and Biological Product Development; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop titled “Artificial Intelligence (AI) in Drug & Biological Product Development.” Convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative (CTTI), the purpose of the public workshop is to bring drug developers and AI experts together to discuss guiding principles for the responsible use of AI in the development of safe and effective drugs and biological products. The workshop format will include presentations and panel discussions.

DATES:

The public workshop will be held virtually and in-person on August 6, 2024, from 10 a.m. to 5:30 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information.

ADDRESSES:

Participants can join the public workshop either virtually using the Zoom platform or in person at the FDA Great Room, located at 10903 New Hampshire Ave., Silver Spring, MD, 20993. The link for the public workshop will be sent to registrants upon registration.

FOR FURTHER INFORMATION CONTACT:

Marsha Samson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6330, Silver Spring, MD 20993-0002, 301-837-7407, Marsha.Samson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

This public workshop will convene experts in AI including drug sponsors, academia, and technology organizations to discuss guiding principles that are being applied by innovators to promote the responsible use of AI in the development of safe and effective drugs.

II. Topics for Discussion at the Public Workshop

At the public workshop, FDA plans to convene experts in AI to discuss topics, including but not limited to:

1. Optimizing model design through multidisciplinary expertise. Specifically, discussants will explore the importance of integrating experts from diverse fields, such as medicine, statistics, pharmacology, data science, and engineering to ensure the development of optimal AI models.

2. Exploring strategies for overcoming common data-related challenges, namely, the availability of fit-for-use data that can be used in drug development. Topics will include data availability and access via federated learning, data quality issues ( i.e., representativeness of data, bias, etc.), and the use of synthetic data.

3. Balancing model performance, explainability, and transparency of AI models. Additionally, discussants will share strategies for assessing the need to integrate humans into the decision-making process (human-in-the-loop and/or human-on-the-loop).

4. 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. Considering actionable next steps to advance the responsible use of AI in developing safe, effective, and quality drugs.

III. Participating in the Public Workshop

Registration: To register for the public workshop, please visit the following website: https://duke.zoom.us/meeting/register/tJcrcu-qrTMiHdayh1J3JhkCi6XkvmAIFey6 . Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Registration is free and people interested in attending this public workshop must register to receive a link to the meeting. Registrants will receive confirmation email after they register.

If you need special accommodations due to a disability, please contact Kelly.Franzetti@duke.edu no later than July 30, 2024. Please note, closed captioning will be available automatically.