Qualified biomarkers help to optimize drug development and patient safety, yet for the regulatory acceptance of safety biomarkers substantial sample sizes are needed to ensure adequate case and control numbers, and robust evidence sufficient for qualification. To address this challenge, a consortium of leading European research institutions and SMEs has been established. The consortium will generate exploratory and confirmatory data enabling regulatory qualification of new safety biomarkers for application in drug development; establish robust datasets on the DILI, DIKI, DIPI, DIVI and DINI biomarkers to enhance diagnosis of disease; develop and validate assays for new safety biomarkers; implement profiles of circulating miRNAs as tissue and mechanism specific diagnostic tool; have key safety biomarkers accepted as qualified drug development tools by EMA, FDA, and PMDA. Given the significant expertise available across the consortium, the group will be able to tackle the key challenges related to successful biomarker qualification. A key driving principle of the consortium is cross-linking via existing networks of top profile research institutions, as well as capitalizing on existing data and resources. The Consortium is embedded into a network of international research collaborations such as the Pro-Euro-DILI-registry, TransQST, eTRANSAFE, the i2b2 tranSMART Foundation, the CIOMS DILI working group, EPoS, LITMUS, and BBMRI. To optimize regulatory interaction, we intend to continue our successful collaboration with non-European consortia such as PSTC, the FNIH Biomarkers Consortium, and US DILIN. A key expected result of the consortium will be a “Safety Biomarker Factory”, regularly qualifying new markers, with an associated “Safety Biomarker Warehouse”, providing to the scientific community, industry, and patients detailed data and information, and knowledge across a large spectrum of advanced safety biomarkers.

The vision of the RISK-HUNT3R consortium is to develop a reliable, efficient and cost-effective chemical safety assessment approach. It will be based entirely on non-animal methods and provide improved protection of the human population against systemic health effects caused by (chronic) chemical exposure. The major innovation provided by RISK-HUNT3R is a complete and truly human-centric risk assessment strategy. RISK-HUNT3R will establish, optimize and assemble all essential safety testing elements: exposure assessment, information on chemical distribution in the body, hazard characterization, adverse outcome prediction and determination of actual risk in defined scenarios. RISK-HUNT3R integrates cutting-edge in silico (computational) and in vitro (experimental testing) technologies. Human (disease) genetics and exposome data will ensure anchoring of test results to the human situation. The project will ensure regulatory relevance by testing the applicability of the critical test systems integrated in the next generation risk assessment strategy. The ambitious overall deliverable will be a comprehensive computational framework for the prediction of human adverse outcomes, and a set of stringently evaluated assays to feed the required data into this framework. RISK-HUNT3R will engage with all key stakeholders from different industry sectors and international regulatory agencies to critically evaluate and warrant genuine acceptance of the novel safety testing framework. This unique interaction of these key stakeholders working together on real-world case studies, will result in a ready-to-apply strategy to ensure societal protection against hazardous chemicals fully in concordance with the European Commission’s “Green Deal”. Importantly, the project will push commercial exploitation of the validated safety assessment approaches, thereby ensuring sustainability of the project outcomes and fortifying the innovation capacity of the industry sectors involved.