Abstract
New approach methodologies (NAMs) have long contributed to pharmaceutical development with growing attention now focused on their use at regulatory decision points to reduce reliance on laboratory animal models in drug safety and efficacy assessment. Yet validated NAMs remain limited to specific endpoints, and uncertainty persists regarding human translatability and health authority acceptance. In the absence of globally harmonized frameworks, validated-method databases, and clearly defined contexts of use, companies vary in how they identify, evaluate, govern, and implement NAMs. This article summarizes findings from a survey conducted by the IQ 3Rs Implementation of Replacement Working Group on industry practices for NAM identification and implementation. Forty-five companies, primarily large and mid-sized organizations headquartered across Asia, the United States, and Europe, provided insights into governance, accountability, evaluation strategies, integration across drug development, and barriers and opportunities. NAM use was most prevalent in early discovery, with opportunities for broader application at later, regulatory-driven decision points. The most frequently cited barriers were uncertainty regarding health authority acceptance and human translatability. Respondents identified a health-authority-accepted NAM database, real-world evidence of validity, and shared knowledge infrastructure as valuable enablers. These findings demonstrate meaningful adoption and identify opportunities to expand NAM application through coordinated, globally aligned action across industry, regulators, and the scientific community.