Generate exploratory and confirmatory data enabling regulatory qualification of new safety biomarkers for application in drug development.
Establish robust datasets on the biomarkers across relevant patient populations to enhance diagnosis and prognosis of disease for application in clinical practice.
Implement profiles of circulating microRNAs as tissue- and mechanism- specific diagnostic tools, supported by suitable bioinformatics systems, to facilitate in-depth mechanistic understanding of drug side- effects and disease, and/or to strengthen risk assessment and safety monitoring.
Develop and validate assays for new safety biomarkers, suitable for application in drug development and clinical practice.
Have key safety biomarkers accepted as qualified drug development tools by EMA, FDA, and PMDA. Support continuous improvement of biomarker qualification methodology and processes in close collaboration with key regulatory agencies.
Facilitate sustainability of the consortium’s efforts by establishing and maintaining a European expert and knowledge network for biomarker qualification, the “Safety Biomarker Factory” and “Safety Biomarker Warehouse”, allowing for future continuous feed-in and qualification of new biomarker candidates, as well as access to comprehensive safety biomarker data.