Assessing the safety of chemicals and pharmaceuticals without using laboratory animals

Imagine a world in which we perform precision safety testing of chemicals and pharmaceuticals without using laboratory animals. It will become reality with the Virtual Human Platform for Safety Assessments (VHP4Safety). Wageningen University & Research, Utrecht University and University Medical Center Utrecht are part of the consortium that is developing this platform.

Current legal and regulatory frameworks for the assessment of the safety of chemicals and pharmaceuticals for human health rely predominantly on data from in vivo animal studies. However, the accuracy of animal studies to predict toxicity in humans is limited. And current animal testing regimes do not reflect human-relevant scenarios, such as differences in susceptibility due to age, sexe, timing of exposure, or disease state.

All the reason for the consortium partners, under the guidance of Utrecht University, HU University of Applied Sciences Utrecht and the Dutch National Institute for Public Health and the Environment, to develop the VHP4Safety. To improve the prediction of the potential harmful effects of chemicals and pharmaceuticals based on a holistic, interdisciplinary definition of human health. And to accelerate the transition from animal-based testing to innovative safety assessment.

Towards safety assessment based on human data

The platform integrates data on human physiology, chemical characteristics and perturbations of biological pathways, for the first time in an inclusive and integrated manner that incorporates:

1. human-relevant scenarios to discriminate vulnerable groups, such as disease state, life course exposure, gender and age
2. chemicals from different sectors: pharma, consumer products and chemical industry
3. different regulatory and stakeholder needs

The researchers address the emerging societal challenge of the transition to animal-free safety assessment, by integrating various scientific disciplines in the consortium, such as data sciences, toxicology and innovation sciences. But also by working with all stakeholders towards implementation and societal acceptance of an approach to chemical safety assessment, based on human data rather than animal data. Experts from Utrecht University Medical Center will contribute to the clinical aspects of this research and WUR will add knowledge on PBK modelling.

Research lines

The platform will be developed within three interacting research lines:

1. building the platform
2. feeding the platform with newly generated data
3. implementing the platform to ensure stakeholders’ acceptance, governance and sustainability

The project started in June 2021 and will last for the duration of 5 years.