[Federal Register Volume 89, Number 132 (Wednesday, July 10, 2024)]
[Notices]
[Pages 56757-56758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0001]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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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, [email protected].

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.

[[Page 56758]]

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 [email protected] no later than July 30, 2024. Please 
note, closed captioning will be available automatically.

    Dated: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15125 Filed 7-9-24; 8:45 am]
BILLING CODE 4164-01-P