From vivarium to NAM-centred laboratory: A practical framework for managing infrastructure, expertise and organisational transition.

Abstract

Political, Regulatory and Scientific developments are propelling the use of New Approach Methodologies (NAMs) across regulatory toxicology and drug development, creating challenges for organisations operating animal-testing facilities. High clinical attrition rates driven by lack of efficacy and toxicity continue to stimulate interest in more human-predictive approaches. The FDA Modernization Acts and UK and EU initiatives to phase out animal testing are also influencing future testing strategies. Universities, pharmaceutical companies and contract research organisations (CROs) have made substantial investments in facilities, equipment, support services and highly skilled personnel. Increasing adoption of NAMs forces existing infrastructure redevelopment, whilst preserving capital investment and retaining/repurposing scientific expertise. A practical framework is presented for organisations transitioning from animal-based testing towards NAM-centred operations, addressing infrastructure redevelopment, workforce transition, expertise retention and capital investment preservation. Infrastructure requirements, support services, workforce development, business sustainability and role-specific staff retraining are examined. Retaining institutional knowledge and recognising the continuing value of technical, scientific and regulatory expertise developed through animal-testing programmes as organisations transition towards NAMs are prioritised. Contexts of Use (CoUs) and Adverse Outcome Pathways (AOPs) help connect historical animal-study knowledge with future NAM applications. Successful transition is presented as a managed organisational process involving people, infrastructure, knowledge and investment rather than simply the replacement of one experimental model with another.