Seminars

A Deep Dive into the FDA NAMs Road Map with Former Senior Management of the FDA

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This video will be available for a limited time, from now through October 2, 2026.

Title: A Deep Dive into the FDA NAMs Road Map with Former Senior Management of the FDA

Interview Video Overview:

NAMs Road Map was published in April 2025. The goal in non-clinical safety studies is to transition from animal studies into NAMs within 3 to 5 years. FDA is accelerating validation and adoption of these methods, aiming to reduce animal use while improving predictive accuracy. However, pharmaceutical companies lack this information, and there are lots of uncertainties about what kinds of studies FDA will require when submitting IND/NDA files. In this video, we have delved deeper into unclear points with Dr. McGovern, a former FDA senior manager who had produced the NAMs Road Map.

Dr. McGovern shares his perspective on the direction of the FDA’s NAMs initiative and practical considerations for incorporating NAMs into drug development and IND/NDA submissions.

This interview was originally presented during Axcelead’s luncheon seminar at the 53rd Annual Meeting of the Japanese Society of Toxicology.

Key Topics:

  • How in vitro, ex vivo, and in silico methods are being implemented to strategically reduce animal testing?
  • How such models are being incorporated into IND process?
  • Will mid-sized pharmaceutical companies and academia suffer any disadvantages in the IND review process without submitting NAMs data?
  • FDA’s acceptance status on in vitro cytokine release assays and humanized animals as substitutes for monkeys.

Presenters

 

Dr. Timothy McGovern is Co-founder and Principal Consultant at White Oak Regulatory Tox, LLC, where he advises pharmaceutical and biotechnology companies on regulatory strategy and nonclinical drug development. He has more than 22 years of regulatory experience at the U.S. FDA and most recently served as Associate Director for Pharmacology and Toxicology in the Office of New Drugs at CDER. He was also a member of ICH Expert Working Groups for S1B, Q3C, Q3D, and M7 and served as President of the American College of Toxicology in 2022.

 

Dr. Hideo Fukui has extensive experience in nonclinical safety assessment and regulatory toxicology. Before joining Axcelead, he worked at Takeda Pharmaceutical Company, where he led nonclinical safety assessments for global drug development programs, addressed complex toxicology issues, supported regulatory interactions, and conducted due diligence for potential in-licensing opportunities. He is a board-certified toxicologist in both Japan and the United States and served as President of the 48th Annual Meeting of the Japanese Society of Toxicology in 2021.