New Approach Methodologies (NAM) for biomedical research

Costanza Rovida
CAAT Europe, Konstanz University, Germany


New Approach Methodologies (NAMs) indicate a complex system that joins together many different techniques to support a decision on the effect of a substance on the human health. The acronym “NAM” was initially used for Non Animal Methodologies as it started to test toxicological properties avoiding the use of vertebrate animals. It was soon acknowledged that the new approach was well-structured, deserving a broader definition.

NAMs are opposed to the traditional mode mainly based on in vivo studies as is, with a new system that has the ambitious to elucidate the pathways of toxicity leading to a specific adverse event. Any technique may contribute within the NAM, ranging from basic physical-chemical methods, to simple cell culture up to sophisticated reconstructed 3D human tissues. Computational methods are fundamental for modelling the biochemical behaviour, for combining the experimental results or for scaling the in vitro concentration to the real exposure in the organism, representing a crucial role in the system.

The principle of NAM is expanded also to basic biomedical research, in particular in the area where the animal model fails in mimicking a particular human disease. The most promising technique arrives from the development of organoids starting from human iPSC (induced pluripotent stem cells) derived from fibroblasts of adult volunteers. Other applications include the use of lower organisms, such as insects, fish embryo or worms. NAMs can be exploited to understand the development of the disease and study the efficacy of a new drug, with important opportunities during investigative toxicology.