This symposium will explore how emerging New Approach Methodologies (NAMs) contribute to reducing animal use and transforming chemical hazard assessment and human exposure studies, aligning with the principles of the 3Rs. Biological models are essential in biomedical and pharmaceutical research to elucidate molecular functions and disease mechanisms. Recent advancements in tissue engineering and stem cell research have blurred the line between traditional in vitro models and complex animal systems.

This session will showcase cutting-edge in vitro innovations, such as organoids (miniaturized tissue models that mimic organ structure and function) and organ-on-chip systems (devices replicating organ microenvironments to enable dynamic, human-relevant drug testing). These models provide precise and human-centered insights into toxicological responses that were previously assessable only through animal testing. Such advances herald a new era in biomedical and pharmaceutical sciences, minimizing animal experimentation. A focus will be placed on cell counting methodologies, a key element in these new models, particularly for cells in suspension and within 3D structures. Given the structural complexities of 3D models and the need for reliable, reproducible results, we will address how cell counting techniques influence data accuracy in toxicity studies.

Additionally, we will discuss high-throughput, scalable testing approaches incorporating microfluidics and multi-omics, which enable high-fidelity toxicological evaluations while reducing ethical and environmental impacts. Emphasis will be placed on the standardization and harmonization of these methodologies across sectors to ensure data reliability, regulatory compliance, and public health safeguards. The symposium will bring together academia, industry representatives, metrological agencies, and policymakers in biotechnology and pharmaceuticals. Through international and interdisciplinary participation, we aim to foster dialogue on the technical, ethical, and regulatory requirements for the broader adoption of NAMs, advancing the field through collaboration and innovation.

Topic(s): Human Health