NAMs: Where Do European Experts Stand? Lessons from the NAMWISE Project

WP 2.4

As part of the European NAMWISE project, funded by Horizon Europe, 25 interviews with experts (academic, industrial & regulators) from the pharmaceutical & chemical sectors were consulted between July 2025 and January 2026. The goal was to map current perceptions of New Methodological Approaches (NAMs) and identify levers to accelerate their adoption.

The key findings indicate that he biological relevance of NAMs is now defined as a “fit-for-purpose” (the ability to provide reliable and relevant data) attribute rather than as an intrinsic property. Models based on human cells (organoids, micro physiological systems) are widely recognized as more predictive and superior to animal models for capturing a large panel of specific human mechanisms. However, one expert cautions: “You can tweak your model for 1,000 years, but you will always end up with a model that has limitations, until we develop a perfect human-on-a-chip or a human-in-silico.”

In terms of reliability, integrated approaches (IATA) [NB4] (framework that combines multiple sources of information to assess the safety or hazards of a substance) appear to offer the highest level of confidence. Yet a structural barrier persists, as one participant aptly summarized: “The major problem is that new methods have historically been calibrated against animal data, even though animal models are only partially relevant to humans.” When available, clinical data should be the data gold standard. When it comes to industrial adoption, the “fail fast, fail early” approach is already well established among major pharmaceutical companies. However, even within these companies, standardization remains incomplete. One expert puts it bluntly: “One issue with standardizing NAMs is that within the same company, you may find different teams creating their own little organoids, with each using their own specific cells, media, culture conditions, and so on.” Obstacles remain in terms of lack of harmonized and shared protocols, international validation timelines of 5 to 10 years, and difficulties in translating academic models into an industrial setting.

On the regulatory front, encouraging signs are emerging. The EMA has launched a training program dedicated to the 3Rs and NAMs, while an informal group now comprising six international agencies (the EMA, the FDA, Japan’s PMDA, Australia’s TGA, Swiss medic, and Health Canada) is working to harmonize acceptance criteria and build mutual trust. In the United States, the FDA has launched the ISTAND program specifically dedicated to the development of NAMs. These institutional dynamics, driven in part by societal pressure in favor of the 3Rs, are creating an unprecedented “top-down” momentum, although regulatory conservatism remains the main obstacle identified by experts.

The conclusion clearly stated that the paradigm shift is less a matter of technological innovation than of regulatory translation. Harmonized frameworks and enhanced collaboration between developers and evaluators are now essential.