A TNO-led consortium (which includes BaseClear) recently got the final approval from “The Netherlands Organization for Health Research and Development, ‘ZonMw’ to start a challenging and promising project focusing on the early detection of the development of various diabetic complications in one single mouse model that closely mimics the human situation. This two-year project aims to deliver a predictive translational model in which the effect of potential new medicines can be evaluated at one early time point in disease development. This is a unique approach since normally for every diabetic complication a different animal model is used. This new approach will reduce time to market of potential new medicines and strongly reduce the number of animals used in preclinical R&D. Thereby this project fits into the goal for the replacement, reduction and refinement of animal studies.
The development of new medicines asks a lot of time and effort for the evaluation of their safety, PK and efficacy. Within the ZonMw funded program ’More knowledge with less animals’ TNO has started a collaboration with the Netherlands based academic centres University Medical Centre Utrecht and Radboud Proteomics Centre, the Dutch companies BaseClear B.V. and Good Biomarker Sciences, the US-based companies Seventh Wave Laboratories and KineMed, Inc, and Takeda Pharmaceutical Company Limited in Japan.
New in the approach of this consortium is that we will combine a large set of state-of-the-art technologies (such as ECM protein turnover analysis technology with deuterated water, transcriptomics by mRNAseq on a NextGen sequencer, proteomics profiling, histopathological and biomarker analyses in very small quantities of samples). It is this data integration and Systems Biology approach that will help us to find a set of markers (signatures) that predict the onset of multiple diabetic complications such as non-alcoholic steatohepatitis (NASH), diabetic nephropathy, atherosclerosis and retinopathy. The availability of such signatures is key in the early evaluation of efficacy and safety of new medicines.
To secure the applicability for the human situation, clinicians from the Amsterdam Medical Centre, Leiden University Medical Centre, University Medical Centre Utrecht and Erasmus Medical Centre will involve their expertise and provide access to biobank material, such as blood and organs. TNO initiated this project and in addition to managing the project, they will provide their unique knowledge and expertise regarding metabolic disorders and system biology, including data integration.