AI in Healthcare & Drug Development

​Discover critical strategies for navigating the intersection of artificial intelligence and regulatory science in drug and biologic development, with expert panelists Gabriel Innes, Assistant Director for Data Science and AI Policy from the U.S. Food & Drug Administration (FDA), Peter Clark, VP, Computational Drug Design at Novo Nordisk and Lauren Tobe, Director, Regulatory Policy & Strategy from Eli Lilly and moderated by Rumi Young, Director of Regulatory Policy,  Novo Nordisk. This session will provide attendees with an overview of current FDA oversight of AI, insights on effective engagement approaches with FDA to foster development and learnings on key opportunities for growth and how to approach common issues. Specific topics:

​·       Current Regulatory Oversight of AI used for drug/biologic development: Understand the application of FDA’s recent draft guidance for AI used drug and biologic development, including scope, risk-based approaches, context-of-use assessment, and expectations for the validation and credibility of AI tools. Learn of AI use cases the pharmaceutical industry is exploring to accelerate drug development (CMC, Clinical, Discovery, etc.,).  

​·       Mechanisms for FDA Engagement: Learn about formal and informal pathways for interacting with FDA, including meetings and regulatory submissions. Understand current pharmaceutical industry best practices and effective approaches using recent examples.

​·       Third-Party Considerations and Diverse AI Tool Development: Gain insights into expectations regarding the use of third-party AI models, including information about such models that should be included in a credibility assessment plan which may be proprietary (held by third-party developer). Panelists will discuss potential solutions to ensure effective development and FDA engagement.

​·       FDA’s Organizational Structure and Policy Leadership: Get insight into the organization of FDA units and teams tasked with shaping policy for AI applications. The session will spotlight key groups and their roles, providing guidance for researchers and sponsors eager to contribute to or understand FDA’s approach to AI governance and policy evolution.

​This interactive event offers attendees a rare window into the regulatory processes and decision-making that underpin AI adoption in drug and biologic development. Whether you are developing new technologies or interested in regulatory science, join us to engage directly with leaders charting the future of AI in medicine and policy.