FDA’s draft guidance on the validation of non-animal methods (NAMs) is reshaping how nonclinical programs are designed and justified. This webinar explores how sponsors can apply NAMs to streamline development, improve human relevance, and support IND decision-making within a weight-of-evidence framework.
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FDA’s draft guidance on the validation of New Approach Methodologies (NAMs) is reshaping how nonclinical programs are designed and justified. This webinar explores how sponsors can apply NAMs to streamline development, improve human relevance, and support IND decision-making within a weight-of-evidence framework.
We will break down FDA expectations for validation, including context of use and fit-for-purpose application, and show how to position NAMs effectively in regulatory interactions.
Through real-world case examples spanning in vitro, in silico, and data-driven approaches, attendees will gain practical insight into how NAMs can address data gaps, reduce reliance on traditional models, and strengthen nonclinical programs.
Featured Speakers
Kevin has deep expertise in nonclinical informatics, data standards, and regulatory science, with prior leadership experience at FDA/CDER as Associate Director of Nonclinical Informatics. His work has focused on advancing the regulatory use of CDISC SEND data and enabling data-driven decision-making in pharmacology/toxicology. At Certara, he guides pharmaceutical sponsors in integrating nonclinical data across development to enhance drug safety and innovation. Kevin is an active contributor to industry consortia, including CDISC, PHUSE, Pistoia Alliance, VICT3R, and BioCelerate, and a strong advocate for modernizing toxicology through data science, predictive modeling, and new approach methodologies (NAMs).
Moderator
