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NURA Training - Advancing Drug Safety with AI: From Innovation to Regulatory Acceptance
Tuesday, October 06, 2026, 10:00 AM - 11:00 AM EDT
Category: Partner Webinar
Tuesday, October 6, 2026 10:00 am ET / 14:00 UTC
PRESENTER
Farhan Khodaee, PhD; Co-Founder & CEO of Absentia Labs
Dr. Khodaee will begin the webinar with a review of the recent advancements in AI-driven NAMs and their toxicology applications, validation, explainability and regulatory expectations. He will then present a case study on hepatotoxicity risk assessment using mechanistic AI which was presented to the US Food and Drug Administration (FDA).
Learning objectives:
- Describe recent advances in AI-driven New Approach Methodologies (NAMs) for toxicology, including their applications, validation strategies, explainability, and evolving regulatory expectations.
- Evaluate how mechanistic AI can be applied to assess hepatotoxicity risk through a real-world case study presented to regulatory agencies such as the FDA and EMA.
- Identify key considerations for advancing AI-based toxicology tools from scientific innovation to regulatory acceptance.
ABOUT THE PRESENTER Farhan Khodaee, PhD, is the Co-founder and CEO of Absentia Labs, where he leads the development of AI-driven technologies for drug development and safety assessment. He earned his PhD in Bioengineering from the Massachusetts Institute of Technology (MIT), where his research focused on developing fundamental computational methods for biology. His work has been published in leading scientific journals, including Nature Computational Science. He founded Absentia Labs with the mission of bringing scientifically rigorous, AI-powered solutions to pharmaceutical research and development. Absentia Labs recently became the first company to achieve FDA acceptance of AI-driven models for regulatory use in toxicology, advancing the integration of artificial intelligence into regulatory science and accelerating safer, more efficient drug development.
Visit pcrm.org/FDA for complete details on this webinar and the entire NURA FDA Series.
Contact: [email protected]
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