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NAMs in Predictive Safety: From Genotoxicity to Endocrine Disruption
Harness New Approach Methodologies Across Toxicological Endpoints
The future of safety testing is evolving, and it’s designed with you in mind. New Approach Methodologies (NAMs) are moving from concept to practice, delivering faster, human-relevant insights while reducing reliance on animal studies. For developers of biopharma, as well as agrochemical and industrial chemical products, this means making earlier, more confident decisions with data that more accurately reflects human biology.
In genetic toxicology, microphysiological systems (MPS), including Liver-on-Chip models, enable simultaneous detection of multiple genotoxic endpoints, providing precise and predictive insights. Annie Hamel, M.S., Scientific Director of Genetic Toxicology at Charles River, is leading these advances and presented her work at WC13 RIO, one of the industry’s leading conferences.
NAMs for Predictive Genotoxicity using MPS
The New Alternative Method (NAM) for predictive genotoxicity employing MPS is being recognized as a more predictive, ethical, and efficient alternative to conventional animal testing.
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NAMs are also transforming endocrine disruptor screening across pharmaceutical, chemical, and sectors. Mira Wenker, PhD, Director of Discovery and Environmental Sciences at Charles River, presented her work at Eurotox, demonstrating predictive in silico and in vitro assays for estrogen, androgen, thyroid, and steroidogenesis pathways. These approaches align with regulatory frameworks such as REACH, and incorporating toxicokinetics, and metabolism further strengthens biological relevance.
The NIH’s $87 million Standardized Organoid Modeling (SOM) Center highlights the growing adoption of NAMs as the future foundation of regulatory toxicology. Standardized organoid models are designed to provide consistent, human-relevant data, reduce reliance on animal testing, and reinforce predictive safety strategies.
Role of NAMs in Evolving Endocrine Disruptors
New Approach Methodologies (NAMs) are changing how we identify and assess endocrine disruptors (EDs), shifting from traditional animal-based testing.
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Advancing with NAMs
Insights from these presentations and the latest microphysiological approaches demonstrate how science is progressing toward more predictive, human-relevant safety testing. Our work in this field helps clients navigate these changes and discover new ways to improve the development of safer, more sustainable products. We are proud to lead this transformation, advancing science, shaping regulatory discussions, and helping clients across industries adopt a safer, more predictive, and sustainable future.
Discover how we can help you integrate NAMs into your development plan today.
*Note: Annie Hamel presented this data as an oral presentation at WC13 RIO, and Deborah Lenart has presented this information in other formats at leading genetic toxicology conferences worldwide.