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? ( printed 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?

○ What are the implications of regulations and policies around health data in foreign markets for adoption of AI in the U.S. biopharmaceutical industry?

○ 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 HealthAI@trade.gov 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.

89 FR 68394