Anne Kienhuis

Professor of Toxicology in Transition & Senior Scientist, Utrecht University | RIVM

Anne Kienhuis is Professor of Toxicology in Transition at Utrecht University and a senior scientist at the National Institute for Public Health and the Environment (RIVM), the Netherlands. Her chair focuses on the transition towards human‑relevant, animal‑free safety assessment of chemicals and medicines, contributing to broader societal and scientific transitions in toxicology.

Her work centres on the development and implementation of New Approach Methodologies (NAMs) that are grounded in human biology and can reliably inform risk assessment without the use of animals. A key challenge she addresses is making these methods applicable, trusted and acceptable for regulatory decision‑making. To this end, she combines technological innovation with attention to social, institutional and cultural factors that influence uptake and acceptance by regulators, industry and society.

Within the Dutch NWO‑funded VHP4Safety project, Anne plays a central role in bridging disciplines and sectors, bringing together scientists, regulators, industry and NGOs to enable animal‑free safety assessment based on human data and models. From her position at RIVM, she brings extensive experience in regulatory toxicology and transdisciplinary collaboration at the science‑policy interface. Through her professorship, she also contributes to training the next generation of professionals in this transitioning field.

Presentation: VHP4Safety: Building the Virtual Human Platform to integrate human data for animal-free safety assessment

The Virtual Human Platform for Safety Assessment (VHP4Safety) is a Dutch NWA‑funded consortium (2021–2026) that aims to enable next‑generation, animal‑free safety assessment by integrating human‑relevant data and models within a coherent, interoperable platform. Building on rapidly expanding knowledge on health and disease and on innovative in vitro and in silico New Approach Methodologies (NAMs), VHP4Safety unites 32 partner organisations, including scientists, industry, regulators, clinicians, policy makers and NGOs.

Through a series of Designathons and Hackathons, data scientists, toxicologists and social scientists collaborate to: (1) build a FAIR data infrastructure that connects existing and newly developed data, models and services within the Virtual Human Platform (VHP); (2) populate this platform with mechanistic toxicological knowledge and NAM‑derived data; and (3) implement the platform in a way that explicitly addresses stakeholder needs, usability, transparency and acceptance.

In this presentation, Anne will introduce the VHP and illustrate how this interdisciplinary, transdisciplinary and stakeholder‑engaged approach has resulted in a modular digital infrastructure that integrates in silico and in vitro NAMs and human data into human‑centric safety assessment concepts. Using three case studies,  drug‑induced kidney function failure, lifelong exposure to chemicals and Parkinson’s disease, and thyroid‑mediated brain development, as proof of principle, the VHP demonstrates how to connect human data and NAMs into human relevant strategies for safety assessment, supporting a future in which chemical and drug safety can be reliably evaluated without reliance on animal testing.

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