Certara Joins EU-ToxRisk – An Integrated European ‘Flagship’ Program Driving Mechanism-based Toxicity Testing and Risk Assessment for the 21st Century

In a large (30 Million €) H2020-supported collaborative project,
academia joins forces with small and medium-sized enterprises (SMEs),
large industry, contract research organizations (CROs) and regulatory
bodies to achieve a paradigm shift in toxicology towards a more
efficient and animal-free chemical safety assessment.

PRINCETON, N.J.–(BUSINESS WIRE)–An international consortium of 39 partner organizations will be funded
by the European Commission to work on the integration of new concepts
for regulatory chemical safety assessment. These new concepts involve
cutting-edge human-relevant in vitro non-animal methods and in
silico computational technologies to translate molecular mechanistic
understanding of toxicity into safety testing strategies. The ultimate
goal is to deliver reliable, animal-free hazard and risk assessment of
chemicals.

Coordinated by Bob van de Water, Professor of Toxicology at Leiden
University (The Netherlands), EU-ToxRisk intends to become the European
flagship for animal-free chemical safety assessment. The project will
integrate advancements in cell biology, omics technologies,
systems biology and computational modeling to define the complex chains
of events that link chemical exposure to toxic outcome. The consortium
will provide proof of concept for a new mechanism-based chemical safety
testing strategy with a focus on repeated-dose systemic toxicity as well
as developmental and reproductive toxicity. Importantly, novel
mechanism-based test methods will be integrated in fit-for-purpose
testing batteries that are in line with the regulatory framework and
will meet industrial implementation. EU-ToxRisk will develop new
quantitative risk assessment approaches based on understanding of
so-called “Adverse Outcome Pathways” incorporating all mechanistic
toxicity data available in the public domain. It will also achieve a
rapid improvement of so-called “read across” approaches as the most
important data-gap filling and hence animal-saving alternative method at
present. Thus, the project strives towards faster safety evaluation of
the many chemicals used by industry and society.

“Certara is proud to participate in this international effort to develop
reliable, efficient, animal-free toxicology tests for agrochemicals,
industrial chemicals, and cosmetics,” said Certara Chief Executive
Officer Edmundo Muniz, MD, PhD. “We plan to demonstrate the pivotal role
that physiologically-based pharmacokinetic modeling and simulation can
play in improving toxicology testing.”

Dr. Susanne Hougaard Bennekou from the Danish Environmental Protection
Agency explained: “Safety evaluation is largely based on animal testing.
This is the best we have today. However, there are widely recognized
limitations, these being that the sensitivity and specificity of
animal-based safety testing could lead to wrong predictions of
chemical-induced human adversities. Whilst false-negative results
compromise human safety, false-positive animal tests and use of
unnecessarily large safety factors may lead to the loss of beneficial
and safe chemicals and drugs.” Professor Marcel Leist, head of the
Center for Alternatives to Animal Testing in Europe (CAAT-Europe) in
Konstanz, Germany, added: “Ethical issues related to the use of
experimental animals as well as economic considerations (high costs,
time delay by testing) demand a paradigm shift, away from ‘black box’
animal testing towards a toxicological assessment based on responses
observed in human cells and a comprehensive mechanistic understanding of
cause-consequence relationships of adverse chemical effects.”

EU-ToxRisk builds on testing strategies and knowledge developed in
previous national and European projects, including the SEURAT-1 program,
a cluster of seven projects in the field of animal-free safety
assessment: 2010-2015 (www.seurat-1.eu).
The EU-ToxRisk consortium includes many of Europe’s leading
toxicologists and experts in related fields such as cell and
developmental biology, genomics, computational biology, cheminformatics,
bioinformatics, biostatistics, regulatory sciences, as well as
management and dissemination, from a range of organizational backgrounds
and covering several industry sectors. This breadth of expertise will
allow EU-ToxRisk to develop efficient and innovative safety testing
strategies, covering the whole range of stakeholders, to ensure
fit-for-purpose solutions, practical routine applicability and quick
uptake of results. EU-ToxRisk will establish strong ties with the
European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM),
hosted by the Joint Research Centre (JRC), Institute
for Health and Consumer Protection, to establish novel alternative
testing strategies that are fit for regulatory purposes. In addition,
the project will strongly collaborate with ongoing safety and risk
assessment initiatives across the globe, including the Tox21 initiative
in the United States.

Dr. Rob Taalman, Science and Research Director at Cosmetics Europe, the
Brussels-based Personal Care Association, which co-funded the SEURAT-1
cluster with the European Commission, said: “We are thrilled to be part
of this strategic EU project. This joint action restates our long-held
commitment to be at the forefront of research into alternatives to
animal testing. For more than 20 years, the industry has been pushing
the boundaries of cutting-edge science to develop technologies that
would feed into novel, sustainable safety testing strategies in line
with the European regulatory framework. Since the ban on animal testing
within the cosmetics industry, there is the wish and the scientific
capabilities to improve safety assessment approaches based on
alternatives.”

Overall, EU-ToxRisk intends to evolve a new era for European safety
sciences. At the end of the project the novel risk assessment strategies
should find wide application in various regulatory contexts, across
industry sectors, and for different population groups, such as patients,
workers, consumers, and the society at large. Altogether, EU-ToxRisk
expects to have a strong impact on the future regulatory chemical safety
and risk assessment in Europe as well as the rest of world.

The EU-ToxRisk project will kick-off in January 2016 in Leiden, The
Netherlands, and will run for six years.

Project Partners

Universities

• Leiden University, The Netherlands
• Leiden University Medical Centre, The Netherlands
• Konstanz University, Germany
• Katholieke Universiteit Leuven, Belgium
• Maastricht University, The Netherlands
• Medical University of Innsbruck, Austria
• Ruprecht-Karls-Universität Heidelberg, Germany
• University of Copenhagen, Denmark
• Universitat Pompeu Fabra, Spain
• University of Vienna, Austria

Research Institutions

• Center for Alternatives to Animal Testing in the Johns Hopkins
  Bloomberg School of Public Health, United States of America
• EMBL/European Bioinformatics Institute, United Kingdom
• Forschungsgesellschaft für Arbeitsphysiologie und Arbeitsschutz
  (IFADO), Germany
• Fraunhofer Society – Fraunhofer ITEM, Germany
• Fundación para la Investigación del Hospital Universitario La Fe de la
  Comunidad Valenciana, Spain
• Institut National de l’Environnement et des Risques, France
• Istituto di Ricerche Farmacologiche Mario Negri, Italy
• Karolinska Institutet/Swedish Toxicology Sciences Research Center,
  Sweden
• TNO, The Netherlands

Large industry

• BASF, Germany
• Cosmetics Europe, Belgium
• F. Hoffmann – La Roche, Switzerland
• L’Oreal, France
• Simcyp, a Certara company, United Kingdom
• Steinbeis CAAT-Europe at the University of Konstanz, Germany
• Unilever, Safety and Environmental Assurance Centre, United Kingdom

SMEs

• ARTTIC, France
• BioDetectionSystems, The Netherlands
• BioTalentum, Hungary
• Cyprotex Discovery Ltd, United Kingdom
• Douglas Connect, Switzerland
• InSphero AG, Switzerland
• Lhasa Limited, United Kingdom
• Open PHACTS Foundation, United Kingdom
• TissUse, Germany

Regulatory bodies

• Federal Institute for Occupational Safety and Health, Germany
• Istituto Superiore di Sanità, Italy
• The Danish Environmental Protection Agency, Denmark

Research funder

• National Centre for the Replacement, Refinement & Reduction of Animals
  in Research, United Kingdom

For further information on EU-ToxRisk and the project partners see: www.eu-toxrisk.eu

For more information on the H2020 programme, visit:

http://ec.europa.eu/programmes/horizon2020/

Notes to editors

This project has received funding from the European Union’s Horizon 2020
research and innovation program under grant agreement No 681002 —
EU-ToxRisk.

Contacts

Leiden Academic Centre for Drug Research (LACDR)
Prof. Bob van de
Water, +31-71-5276223 (Office)
Secretariat: +31-71-5276270
Leiden
University
Division of Toxicology
Einsteinweg 55 / P.O. Box
9502 / 2300 RA LEIDEN / The Netherlands
b.water@lacdr.leidenuniv.nl
or
Certara
Ellen
Leinfuss, 609-216-9586
Chief Marketing Officer
or
Rana
Healthcare Solutions
Lisa Osborne, 206-992-5245
Media Contact
lisa@ranahealth.com
or
EU-ToxRisk
eu-toxrisk@eurtd.com
www.eu-toxrisk.eu