Streamlining Nonclinical Development with FDA NAMs

FDA’s draft guidance on the validation of New Approach Methodologies (NAMs) is reshaping how nonclinical programs are designed and justified.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.

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