VHP4Safety
Hi There! You have reached the public documentation pages for the Virtual
Human Platform for Safety Evaluation of Chemicals. This is a large Dutch
research project, funded by NWO. These pages contain information,
documentation, installation instructions, and demos on how to use the
software, models, and data generated in the project.
Mission and Vision
Towards safety assessment based on human data. Imagine a world in which we
perform precision safety testing of chemicals and pharmaceuticals without
using laboratory animals. Imagine that the safety of chemicals and
pharmaceuticals can be assessed for vulnerable groups such as infants, the
elderly, or the diseased. Imagine that we know how these substances interact
with human biology and physiology and how they can be used safely at home,
school, or at work during the course of our lives. This is our vision for
the future, the vision that underlies the development of the Virtual Human
Platform for Safety Assessment, VHP4Safety.
Towards Safety Assessment Based on Human Data
The mission of the Virtual Human Platform is to improve the prediction of
the potential harmful effects of chemicals and pharmaceuticals based on a
holistic, interdisciplinary definition of human health by developing the
Virtual Human Platform and accelerating the transition from animal-based
testing to innovative safety assessment. The Virtual Human 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:
-
Human-relevant scenarios to discriminate vulnerable groups, such as
disease state, life course exposure, gender, and age
-
Chemicals from different sectors: pharma, consumer products, and chemical
industry
- Different regulatory and stakeholder needs
The Virtual Human Platform addresses the emerging societal challenge of the
transition to animal-free safety assessment, by integrating various
scientific disciplines in the consortium and working with all stakeholders
towards implementation and societal acceptance of an approach to chemical
safety assessment that is based on human data rather than animal data.
Moving Away from Animal Experimentation
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. In addition, current animal testing
regimes do not reflect human-relevant scenarios, such as differences in
susceptibility due to age, sex, timing of exposure, or disease state. The
Virtual Human Platform will be developed within three interacting research
lines (RL):
- RL1: Building the platform
-
RL2: Feeding the platform with newly generated data
-
RL3: Implementing the platform to ensure stakeholders’
acceptance, governance, and sustainability
In a national and international arena urgently calling for the reduction of
animal testing, the current approach to gradually refine, reduce, and
replace animal testing has not led to the necessary and desired pace of
innovation in animal-free safety assessment. Furthermore, the opportunities
offered by state-of-the-art technologies in human health and data science
have hardly been explored in the realm of safety assessment.
VHP4Safety is a research project funded by the Dutch Research Council (NWO)
programme entitled the ‘Dutch Research Agenda: Research on Routes by
Consortia (NWA‐ORC).’ With a budget of over 10 million Euros, the project
started on June 1, 2021, and will last for the duration of 5 years.
Research Lines
The VHP will be developed within three interacting research lines (RL),
involving:
- Building the platform (RL1)
- Feeding the platform with newly generated data (RL2)
-
Implementing the platform (RL3) to ensure stakeholder acceptance,
governance, and sustainability.
Research Line 1 focuses on the technical side of building the Virtual Human
Platform by developing all the different tools and services needed for
VHP4Safety.
Research Line 2 focuses on feeding the Virtual Human Platform with in vitro
data from our own experiments and case studies.
Research Line 3 focuses on the acceptance and implementation of the Virtual
Human Platform by looking at the broader societal context.
Find more details
here.
Case Studies and Regulatory Questions
In the VHP4Safety project, three case studies and two regulatory questions
attributed to each case study are under research. Below are these case
studies and regulatory questions.
-
Kidney Disease: Disease scenario to study disease and
pharmacovigilance.
- (a) What is the safe cisplatin dose in cancer patients?
-
(b) How can we take into account variability in activity and
expression of P-glycoprotein* in patients who underwent
transplantation and were treated with tacrolimus?
*P-glycoprotein 1 (permeability glycoprotein), also known as multidrug
resistance protein 1 (MDR1) or ATP-binding cassette sub-family B member 1
(ABCB1) or cluster of differentiation 243 (CD243), is an important protein
of the cell membrane that pumps many foreign substances out of cells (UniProt:P08183).
-
Life Course Pesticide Exposure and Neurodegenerative Disease:
Life course exposure scenario to study life course exposure and
neurodegenerative disease.
- (a) Can compound X cause Parkinson’s Disease?
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(b) Can we identify groups at extra risk of developing Parkinson’s
Disease after exposure to compound Y?
-
Thyroid-Mediated Developmental Neurotoxicity: Age and sex
scenario to study health effects discriminated by age and sex on
thyroid-mediated neurodevelopment.
-
(a) What information about a compound do we need to advise women in
early pregnancy on whether the compound can be used?
-
(b) Does compound Z influence thyroid-mediated brain development in
the fetus, resulting in cognitive impairment in children?
Partners and Consortium
The VHP consortium consists of leading scientific groups from Dutch
universities, university medical centres, public health institutes, and
applied research organisations. These groups bring expertise in
technological, biological, chemical, medical, and social sciences.
Co-funders and cooperation partners ensure active involvement from academic,
regulatory, industrial, and societal stakeholders, covering the entire
safety assessment knowledge chain. This collaboration unites the necessary
and complementary expertise to build, test, and evaluate the Virtual Human
Platform.
View the
VHP4Safety Partners.
See the full list of consortium members
here.