In the Spotlight
EU ToxRisk Kicks Off
At a kick-off meeting in January, the EU launched ToxRisk, a six-year, public-private partnership with 30 million euro in funding, and a mandate to eliminate animal testing in chemical safety assessment.
The international consortium is comprised of 39 member institutions – including universities, research institutions, regulatory agencies, and large and small businesses. The project is funded through the EU’s Horizon 2020 and Cosmetics Europe, and will be coordinated by Bob van de Water of Leiden University.
According to a statement on the official website, “EU-ToxRisk intends to become the European flagship for animal-free chemical safety assessment.” Building on the achievements of SEURAT-1 (which ended in December 2015), the project will integrate advances in in vitro and in silico toxicology, read-across methods, and adverse outcome pathways, and will continue to make use of the case study strategy deployed in SEURAT-1. The program aims to develop new non-animal methods, but also – especially – to facilitate their acceptance and use in regulatory contexts.
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 Johns Hopkins University Center for Alternatives to Animal Testing (CAAT) is the only consortium partner outside the EU. Director Thomas Hartung explained that CAAT-US will be “acting as an interface to similar programs and advances in regulatory sciences in the US. Besides this role as a communication and dissemination channel, CAAT-US is actively involved in work packages addressing read-across, ‘omics technologies, interpretation of big data, and with a stem-cell-derived mini-brain for neurotoxicology.”
CAAT-Europe director Marcel Leist told AltTox that his organization will have three major roles:
- Involvement in quality control, quality assurance, validation of test systems, and general procedures within the project. Here, there will be a close collaboration with the JRC’s EURL-ECVAM and with experienced validation trial project partners (such as BDS and BASF).
- Stakeholder communication and dissemination of project results. CAAT-Europe will especially use training and workshops to create tight interfaces with stakeholders; this will be in close collaboration with ARTTIC, a company with experience in similar tasks (e.g., for SEURAT-1).
- Internal training. Summer schools and courses will be organized for project participants and involved students to help forming of a new generation of toxicologists that master the technologies used in EU-ToxRisk.
Some of the other consortium members describe their participation in the ToxRisk project on their website or in a press release.
For example, the UK’s NC3Rs said their role “will involve working alongside regulators to define and review the regulatory framework of the project; to aid in the co-ordination and provision of training to regulators; to advise on how best to integrate the 3Rs into risk assessment based on the project outcomes; and support the development of OECD guidance relevant to this project.”
The Research Programme on Biomedical Informatics will participate by providing computational technologies, including “read-across and quantitative structure-activity methods, in silico pharmacokinetics, platforms for the analysis of omics information, and statistical methods for data analysis and visualization.”
Lhasa Limited said they will apply their “expertise in in silico toxicity and metabolism prediction methodologies… to increase the collective knowledge of the consortium and the wider scientific community.”
Small businesses will provide specific technological solutions, such as InSphero’s expertise in developing advanced 3D models – expected to improve biological relevance and mechanistic accuracy. Cyprotex explains their role as “the delivery of absorption, distribution, metabolism, and excretion (ADME) data to the consortium, and will also be involved in validation of some of the newly developed toxicity models.”
Maurice Whelan, head of EURL ECVAM, told ChemWatch that the center is still finalizing the details of its involvement, but “hope[s] to play a key translational role, informing the scientific research in terms of regulatory and policy needs on one hand, and facilitating the development and optimisation of novel animal-free testing and assessment methods that are fit for regulatory application.”
In Unilever’s presentation at the January kick-off meeting, Carl Westmoreland described several challenges, such as understanding how to use the new tools and in vitro data to predict safe exposures. He explained the importance of thinking now about how Tox-Risk data will be used in making safety decisions.
The ToxRisk website is still under development, but is expected to provide additional details about case studies, and related news and events.