02545nas a2200253   4500000000100000008004100001260001500042653003200057653003100089653002100120653002000141653002700161100002000188700002200208700002100230700002200251700001800273245010200291856007200393300001100465490000600476520179500482022001402277       2025                            d  c2025-01-0110aAnimal-free Risk Assessment10anew approach methodologies10aRoutes to Impact10aSocietal impact10aStakeholder Engagement1 aTessel B. Wijne1 aWouter P. C. Boon1 aAnne S. Kienhuis1 aEllen H. M. Moors1 aJarno Hoekman00aPursuing societal impact in research projects on NAM development: An analysis of routes to impact  uhttps://www.sciencedirect.com/science/article/pii/S3050620425000454  a1000500 v13 aNew Approach Methodologies (NAMs) for risk assessment of chemicals and pharmaceuticals are widely regarded as essential for phasing out animal testing and advancing next-generation risk assessment. However, despite substantial public investments in research and development (R&D) to develop these NAMs, concerns persist about the limited societal impact of these projects. This study addresses this concern by examining how societal impact is pursued in sixteen large-scale, publicly-funded European R&D projects focused on developing NAMs that integrate in silico and in vitro methods. Drawing on an in-depth analysis of 197 publicly available documents and seven semi-structured interviews, we identify 25 impact activities typically pursued in these projects, which vary in the stakeholders targeted as well as levels of engagement ranging from one-way communication to more interactive approaches such as deliberation and co-production. From these findings, we derive five routes to impact focused on community and capacity building, changing policy and regulation, advancing scientific developments, commercialization and industrial partnerships, and mobilizing civil society. We then analyze how these routes function within projects with a focus on perceived barriers and trade-offs between them. Based on this we offer practical and strategic recommendations for pursuing impact in NAM R&D projects. In particular, we recommend that project coordinators and partners be more reflexive on the pursuit of multiple impact routes in a single project and adopt more co-productionist approaches to stakeholder engagement, beyond those already used in case-study development. We also recommend a stronger focus on engaging civil society, which remains underrepresented in NAM R&D projects.  a3050-6204