Bio: Thomas Hartung, MD PhD, is professor at Johns Hopkins Bloomberg School of Public Health in Environmental Health & Engineering as well as Molecular Microbiology and Immunology, the Whiting School of Engineering and the School of Medicine In Cellular and Molecular Medicine, as well as Georgetown University, Washington D.C., in Environmental Metrology and Policy, and University of Konstanz, Germany, in Pharmacology and Toxicology; he also is Director of Centers for Alternatives to Animal Testing (CAAT) in the US and Europe and Field Chief Editor of Frontiers in AI. He authored 730+ scientific publications with 52,000+ citations (h-index 124) and his COURSERA toxicology classes had 22,000+ active learners.

Abstract: Toxicology stands at a historic inflection point. In the wake of technological innovation, mounting societal demands, and a pressing need for human relevance, the discipline is undergoing a profound transformation. This keynote will reflect on the Now—the current state of toxicological science, still heavily reliant on animal testing, fragmented data, and limited human predictivity. It will then pivot to the New—emerging paradigms that redefine toxicology through new approach methodologies (NAMs), including organoid(-on-chip) systems, integrated omics, high-content imaging, and artificial intelligence. These tools are already reshaping regulatory frameworks and enabling evidence-based assessments rooted in mechanistic insights and human biology. Building trust into them and their formal validation, however, represent major challenges. Finally, the Next will be outlined: a bold vision for a predictive, preventive, and personalized toxicology. This includes the integration of microphysiological systems (MPS), exposomics, and agentic AI into a global infrastructure for health risk assessment—aiming ultimately at a Human Exposome Project and Green Toxicology, i.e., benign-by-design chemicals and early testing in product development. Emphasis will be placed on establishing reproducibility standards (e.g., GCCP 2.0, GIVReSt), trust-building in AI applications, and a shift toward probabilistic, systems-based assessments.The keynote will also highlight the organizational and cultural shifts needed to accelerate this transition—from validation bottlenecks to transdisciplinary collaboration and public-private partnerships. By connecting scientific innovation with regulatory foresight, toxicology can lead the way toward a truly 21st-century biomedical and environmental health science.