02389nas a2200517   4500000000100000000000100001008004100002260001200043653000800055653001200063653003300075653001800108653005200126653001100178653003800189653002000227653001800247653002100265653002400286653002300310653002100333653002000354653002600374653002700400100002100427700001900448700002100467700001900488700001700507700002000524700002400544700001900568700001700587700002000604700001800624700002400642700002200666700001700688700001700705700001500722245014300737300001100880490000700891520095900898022001401857       2025                            d  c2025-0410a3Rs10aAnimals10aDrug Evaluation, Preclinical10aDrug Industry10aDrug-Related Side Effects and Adverse Reactions10aHumans10aNew Approach Methodologies (NAMs)10aRisk Assessment10acase examples10aDrug development10aindustry consortium10anonclinical safety10anonhuman primate10apharmaceuticals10aregulatory submission10areplacement of animals1 aJacintha Shenton1 aImein Bousnina1 aMichael Oropallo1 aRhiannon David1 aLucinda Weir1 aThomas K. Baker1 aHelen-Marie Dunmore1 aRemi Villenave1 aMary McElroy1 aBetty Pettersen1 aTushar Kokate1 aClaudette L. Fuller1 aKimberly A. Homan1 aEloise Hudry1 aCharles Wood1 aSam Gunter00aOpportunities and insights from pharmaceutical companies on the current use of new approach methodologies in nonclinical safety assessment  a1043280 v303 aSharing New Approach Methodology (NAM)-based regulatory experiences is crucial for improving human risk assessment and reducing animal use in drug safety testing. To foster broader adoption, the Biotechnology Innovation Organization surveyed companies about NAM usage and collected case studies showcasing NAM-based regulatory filings for biotherapeutics, where NAMs replaced large animal studies for safety assessment. These scientifically justified approaches were generally accepted by global health authorities, particularly in the context of species relevance limitations, prior target modulation experience, and/or when addressing severe disease. Despite successes with NAM-based global regulatory filings, there are concerns from companies about global regulatory harmonization and clinical translatability. NAMs have the potential for greater uptake with enhanced guidance and industry-regulatory agency collaboration being key to their adoption.  a1878-5832