[Federal Register Volume 89, Number 165 (Monday, August 26, 2024)]
[Notices]
[Pages 68394-68395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19039]


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DEPARTMENT OF COMMERCE

International Trade Administration


AI in Biopharmaceuticals Industry Roundtable

AGENCY: International Trade Administration, Department of Commerce.

ACTION: Notice.

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SUMMARY: Through this notice, the International Trade Administration 
(ITA) of the Department of Commerce announces a roundtable discussion 
with industry representatives and U.S. government officials on 
strategies to increase U.S. industry competitiveness and support 
adoption of artificial intelligence (AI) in the U.S. biopharmaceutical 
industry and the adoption of AI in drug discovery and development, 
biopharmaceutical manufacturing, clinical trial design, and supply 
chain management. ITA invites applications from industry 
representatives to participate in the roundtables. Applicants should be 
existing producers or prospective new market entrants with medicines 
that are or will be produced or developed in the United States and 
exported overseas.

DATES: 
    Events: The roundtable will be held on Wednesday, October 16, 2024, 
from 2:30 p.m. to 4:30 p.m., Eastern Daylight Time.
    Event Registration: ITA will evaluate registrations based on the 
submitted information (see below) and inform applicants of selection 
decisions, which will be made on a rolling basis until a maximum of 20 
participants have been selected.

ADDRESSES: Event: The roundtable will be held via Microsoft Teams, and 
the link for the meeting will be provided to selected and registered 
participants.

FOR FURTHER INFORMATION CONTACT: Liam Kraft at 771-216-4432 or via 
email at [email protected].

SUPPLEMENTARY INFORMATION: AI is anticipated to yield significant 
growth opportunities for the healthcare sector. With AI regulation and 
policy formation still nascent in many markets, it is important to 
understand the implications of changes in these areas for U.S. 
healthcare industry stakeholders as adoption of AI grows across the 
biopharmaceutical industry. This discussion will help position ITA to 
work with U.S. industry stakeholders in ways that can enhance U.S. 
industry competitiveness in overseas markets and reduce current or 
future trade barriers faced by companies in this space.
    The Department seeks individual input and views at the 10/16/2024 
roundtable regarding overseas competitiveness of U.S. companies using, 
or planning to incorporate, AI in how they produce and commercialize 
biopharmaceuticals. Participants will be encouraged to provide any 
relevant feedback on this issue during the roundtable, which may 
include comments on the following non-exhaustive list of possible 
topics:
     With the introduction of technologies such as foundational 
models and general-purpose AI, what regulatory and policy shifts is 
your company monitoring in global markets that might affect adoption of 
AI in the production and commercialization of biopharmaceuticals? How 
do you anticipate these changes may affect your company's global 
competitiveness?

[[Page 68395]]

     Which markets, given shifting regulatory and policy 
landscapes, present the most promising commercial environments for 
adopting AI in the biopharmaceutical industry, from your experience?
     How do you assess the potential for public-private 
partnerships (P3s) to support efforts in the healthcare sector to adopt 
AI in the development and commercialization of biopharmaceuticals in 
global markets? What would a successful P3 in this space look like?
     What kinds of strategic international engagements do you 
believe would be most effective in creating a more conducive 
environment for the U.S. biopharmaceutical industry to adopt AI and 
strengthen its competitiveness in overseas markets?
     What kinds of trade barriers are you seeing or 
anticipating that might negatively affect U.S. competitiveness? Where 
do you encounter these barriers? How do you think the barriers can be 
reduced, removed, or prevented?
    [cir] What are the implications of regulations and policies around 
health data in foreign markets for adoption of AI in the U.S. 
biopharmaceutical industry?
    [cir] What are the implications of how foreign governments are 
addressing intellectual property considerations in relation to AI-
assisted drug development?
    The event is closed to press and the public. Industry participation 
is limited to a maximum of 20 qualifying industry representatives.

Selection

    To attend, participants should submit the below information to 
[email protected] by no later than 10/9/2024. ITA will evaluate 
registrations based on the submitted information (and based on the 
criteria below) on a rolling basis until a maximum of 20 participants 
have been selected for each roundtable and inform applicants of 
selection decisions.
    Applicants are encouraged to send representatives at a sufficiently 
senior level to be knowledgeable about their company's capabilities, 
interests, and challenges in the global AI in healthcare market. Due to 
time constraints, there is a limit of one person to speak on behalf of 
each company.
    Applicants should include the following information in their 
response email:
     Name of attendee and short bio.
     Name of company and brief company description.
     A statement self-certifying how the company meets each of 
the following criteria:
    1. It is not majority owned by a foreign government entity (or 
entities).
    2. It is an existing provider or prospective new market entrant, of 
biopharmaceuticals that are or will be produced in the United States 
and that feature use of AI/ML in one or more of the following business 
areas: drug discovery/development (e.g., target identification, disease 
modeling, de novo drug design, pre-clinical development), clinical 
trials (e.g. patient recruitment, trial design), drug manufacturing 
(e.g., process optimization, drug synthesis and formulation), and 
supply chain management (e.g., predictive modeling, demand 
forecasting).
    3. The representative will be able to attend the entire roundtable.
    Selection will be based on the following criteria:
     The company's production or production plans with respect 
to AI in drug discovery/development, clinical trials, drug 
manufacturing, and supply chain management.
     The company's experience in leveraging AI to produce 
biopharmaceuticals that are exported from the United States to overseas 
markets.
     Suitability of the representative's position and biography 
to be able to engage in the conversation.
     Ability of the company to contribute to the roundtable's 
purpose of seeking individual input and views on policies and 
initiatives that strengthen U.S. industry competitiveness of U.S. 
exports.

    Dated: August 20, 2024.
Amanda Lawrence,
Acting Director, Office of Health Industries, International Trade 
Administration.
[FR Doc. 2024-19039 Filed 8-23-24; 8:45 am]
BILLING CODE 3510-DR-P