From organoids to artificial intelligence, New Approach Methodologies (NAMs) promise to reinvent the way we study drugs. NAMs generate human-relevant data, reduce the reliance on animal models, and are built from the ground up to provide quantitative and actionable results in drug development. One of the major hurdles remaining in the adoption of NAMs is how these data are integrated and interpreted in regulatory submissions. From the US “Roadmap to Reducing Animal Testing in Preclinical Safety Studies” to the UK “Replacing Animals in Science” strategy, 2025 has seen a flurry of activity from regulators to define precisely how NAMs data can be accepted. At the forefront of the drive to reduce animal studies is the FDA ISTAND Program (Innovative Science and Technology Approaches for New Drugs) to qualify NAMs for regulatory use.

In this webinar, Dr. Michael Phelan, founder of InnovApproach Consulting, will describe his experiences as the lead of the first ever submission accepted into the ISTAND program. He will provide a step-by-step guide to preparing for and completing each phase of the ISTAND program. Attendees will learn how to best position their own technologies for ISTAND submission and what the impacts of qualification might be.

Complete details for this training are available at https://www.pcrm.org/FDA.

Available resources and materials from this webinar will be posted to https://www.pcrm.org/FDASubmissions and posted to the NURA On-Demand Catalog following the training.