Accelerating Advanced Materials Innovation with New Approach Methodologies

Overcoming the translational gap and accelerating the development of advanced materials require enabling tools that provide reliable information to support decision-making throughout the innovation process. New Approach Methodologies (NAMs) can contribute substantially by generating relevant information while reducing reliance on conventional testing approaches. However, the reliability and relevance of many NAMs have not yet been sufficiently established across the applicability domains relevant to advanced materials. Given their diversity and complexity, formal validation of NAMs across the entire range of materials and applications is unlikely to be realistic. Instead, a fit-for-purpose approach is needed, with the level of evidence and qualification tailored to the intended use and applicability domain of the NAM. During early innovation, NAMs may support exploration, research, and iterative decision-making, where full regulatory qualification may not be necessary. In contrast, NAMs used to support regulatory decisions require more stringent qualification. This perspective paper describes the different roles NAMs can play in innovation and discusses a flexible application of existing qualification criteria according to intended use, supporting efficient and accelerated innovation especially for advanced and complex materials while maintaining confidence in NAM-derived information.