NAMs in developmental toxicity testing

NAMs in developmental toxicity testing: how can we move the needle towards regulatory use?

New Approach Methodologies (NAMs) for developmental toxicity testing are being used for derisking and for exploring mechanisms of toxicity by pharmaceutical and chemical companies for more than 20 years now, but they are only seldomly used in regulatory submissions despite the fact that the updated regulatory guidelines for chemicals and pharmaceuticals have created some opportunities to do so. This may be in part due to the need for a better understanding of the biological relationship between the currently available NAMs and the in vivo outcome, and the fact that these NAMs do not cover the complete scope of embryofetal development. The Health and Environmental Sciences Institute’s Developmental and Reproductive Toxicology (HESI DART) Committee has established a collaborative effort between academia, regulators, and industry to better understand the hesitance of industry towards using developmental toxicity NAMs for regulatory use. This presentation will highlight the outcome of a HESI DART workshop to increase the confidence in the use of NAMs in both the pharmaceutical and chemical regulatory areas.