Research and harmonization activities to promote acceptance of advanced animal-free new approach methods (NAM) and data therefrom in different stakeholder communities

CAAT-Europe has recently joined 3R network in Baden-Württemberg (3R-Netzwerk BW) with the project NAM-ACCEPT for the promotion of both animal welfare and research.

The project NAM-ACCEPT will pursue activities that will facilitate the application and acceptance of novel approach methods (NAM) in industry, for regulatory purposes and for biomedical research.

As part of a large research consortia on NAM, CAAT-Europe has worked closely with relevant partners, as the European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM).

In this context, major limitations to a broader implementation of NAM have been identified: difficulties to translate in vitro results to the human situation; methods’ standardization; and a lack of systematic assessment of a method’s readiness for e.g. regulatory implementation.

The NAM-accept project aims to specifically advance the understanding of in vitro-to-in vivo extrapolations of drug concentrations.

Additionally, the project will promote the international harmonization and development of principles for test method descriptions and data reporting standards to allow confident use of NAMs. CAAT-Europe’s international network and contacts will be used to couple the 3Rs network BW to international organizations, e.g. the US FDA or EFSA. CAAT-Europe will enhance its efforts to better harmonize formats and accessibility of NAM data on international platforms.

All research groups of the 3R network will benefit from these activities, independently from the particular models and approaches that are developed.

The platform financed with 3.8 million euros by the Ministry for Science, Research and Art in Baden-Württemberg will be evaluated for its performance after 3 and 5 years.