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 crucial in biomedical and pharmaceutical research for elucidating 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, including organoids (miniaturized tissue models that mimic organ structure and function) and organ-on-chip systems (devices that replicate organ microenvironments to enable dynamic, human-relevant drug testing). These models provide precise and human-centered insights into toxicological responses that were previously accessible only through animal testing. Such advances herald a new era in biomedical and pharmaceutical sciences, thereby minimizing the need for 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 and reproducible results, we will examine how cell counting techniques affect data accuracy in toxicity studies.

Additionally, we will discuss high-throughput, scalable testing approaches that incorporate microfluidics and multi-omics, enabling high-fidelity toxicological evaluations while reducing ethical and environmental impacts. Emphasis will be placed on standardizing and harmonizing these methodologies across sectors to ensure data reliability, regulatory compliance, and public health safeguards. The symposium will bring together academics, industry representatives, metrological agencies, and policymakers in the fields of biotechnology and pharmaceuticals. Through international and interdisciplinary collaboration, we aim to foster dialogue on the technical, ethical, and regulatory requirements for the broader adoption of NAMs, advancing the field through shared innovation. 
Topic(s): Human Health

Presenters:

• Chair: José Mauro Granjeiro, National Institute of Metrology, Quality and Technology
• Co-Chair: Ana Ribeiro, International Iberian Nanotechnology Laboratory ( Nanosafety Group, INL)

Invited Speakers:

• José Mauro Granjeiro (INMETRO): Impact of ISO 20391 Standards on Accurate Cell Counting in Suspension
• Ana Lopes Ribeiro (INL): Skin-on-chip models for toxicology
• Rodrigo De Vecchi (L’Oreal): Reconstructed Human Skin models
• Leandra Baptista (Gcell Startup): Spheroids and organoids as NAMs
• Thomas Hartung (CAAT/Johns Hopkins University): Next generation validation for next generation risk assessment