Notice2024-15125
Workshop To Consider Artificial Intelligence in Drug and Biological Product Development; Public Workshop
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 10, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 132 (Wednesday, July 10, 2024)</title>
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[Federal Register Volume 89, Number 132 (Wednesday, July 10, 2024)]
[Notices]
[Pages 56757-56758]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#f3be9281809b92dda0929e809c9db3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="15587467667d743b467478667a7b557371743b7d7d663b727a63">[email protected]</span></a>.
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: <a href="https://duke.zoom.us/meeting/register/tJcrcu-qrTMiHdayh1J3JhkCi6XkvmAIFey6">https://duke.zoom.us/meeting/register/tJcrcu-qrTMiHdayh1J3JhkCi6XkvmAIFey6</a>. 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 <a href="/cdn-cgi/l/email-protection#cd86a8a1a1b4e38bbfaca3b7a8b9b9a48da9b8a6a8e3a8a9b8"><span class="__cf_email__" data-cfemail="672c020b0b1e49211506091d0213130e2703120c0249020312">[email protected]</span></a> 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
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