Translational Safety Biomarker Pipeline (TransBioLine): Enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease The TransBioLine project will focus on development of biomarkers of injury for liver, kidney, pancreas, vasculature, central nervous system (CNS) and the development of non-invasive liquid biopsies. The project will have four strategic goals:1. Develop data sets enabling the implementation of emerging safety biomarkers in clinical trials and/or diagnosis of disease;2. Develop non-invasive mechanistic biomarkers of tissue damage called “liquid biopsy” that will have a potential to revolutionise drug development and diagnosis of disease;3. Develop standardised assays and technologies for detection of biomarkers and data interpretation;4. Achieve regulatory acceptance for biomarkers. Early and reliable detection and monitoring of adverse events is essential for improving of patient safety, reducing late attrition of drug candidates, and enhancing understanding of toxic mechanisms. In particular, biomarkers that provide insights into mechanisms of tissue injury have the potential to revolutionise drug development as well as diagnosis of diseases. Therefore, the development of innovative, non-invasive biomarkers of tissue injury is of great interest to drug developers, regulators and the broader scientific community. Recent progress in biomarker development including the previous SAFE-T (http://www.imi-safe-t.eu/) that identified several promising biomarker approaches as well as the latest scientific advances in analysis of circulating microRNA provide excellent opportunities for biomarker research. Furthermore, the recent progress in regulatory science of biomarker qualification achieved by the Critical Path Institute and the Foundation for the National Institutes of Health (FNIH) provides a blueprint for conduct of formal qualification of emerging biomarkers via an innovative translational paradigm that relies on tissue injury caused by diseases and only limited clinical and non-clinical studies for assessment of biomarker performance. This approach optimises resource use and accelerates biomarker development. The biomarkers developed during TransBioLine are expected to accelerate drug development by providing innovative drug development tools and also significantly improve diagnosis of disease by enabling non-invasive interrogation of disease mechanisms. The availability of qualified biomarkers as drug development tools will have a broad positive impact on patient safety in clinical trials as well. The TransBioLine will open new markets by introducing new commercially available diagnostic products and services by diagnostic companies and SMEs. This will strengthen the competiveness and industrial leadership of Europe. TransBioLine will enable the development of new innovative biomarker approaches derived from genomics applicable as non-invasive “liquid biopsies” providing tools for precision diagnosis of mechanisms of toxicity or disease at the molecular level. Although the formal qualification of biomarkers as drug development tools by regulatory agencies is the ultimate deliverable, the biomarker data produced by TransBioLine will enable the acceptance of biomarkers by regulatory agencies under individual Investigational New Drug (INDs) even before the biomarkers are fully qualified.