CN Bio notes that the EMA has announced a new voluntary data submission pilot designed to help regulators gain experience with New Approach Methodologies (NAMs), including microphysiological systems, organoids, and computational approaches.

CN Bio is a leading Organ-on-a-chip (OOC) company that enables scientists to improve the accuracy and efficiency of preclinical drug discovery. Our PhysioMimix® Core microphysiological system, 3D-validated cells, consumable plates, and Contract Research Services facilitate the prediction of human responses to drug exposure, in the presence or absence of disease, so that new medicines can be brought to market more rapidly, cost-effectively and using fewer animals. Utilizing primary cells, our perfused single (Lung, Liver), and multi-organ (Gut/Liver, Lung/Liver) models recapitulate the microarchitecture, microenvironment, and function of their human counterparts in vitro. The approach provides a viable alternative to animal models where translatability to humans is predicted to be poor and for testing advanced drug modalities where human-specific targets and pathways are required. They generate physiologically relevant, human-translatable, mechanistic data that enables researchers to progress only the safest and most efficacious drugs into in vivo animal studies and be better prepared for clinical trials. Please follow us for regular updates. Let's change the game, together!

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