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Translational approaches to disease modifying therapy of type 1 diabetes: An innovative approach towards understanding and arresting Type 1 diabetes – time to harvest. (INNODIA-HARVEST)
In the previous 4 years, the INNODIA project has built a landmark sample collection network in Europe and has established the go-to platform for clinical trials in T1D intervention, aimed at achieving protection of functional beta-cell mass.In a close collaboration between basic, translational and clinical researchers, industry partners, foundations and also people living with T1D we have built a platform of biomarker analysis using standardized sample collections, sample analysis and bioinformatics assisted integration of data. Our approach allows integrated analysis of multiple biomarkers and robust modeling of disease. Sample collection in people with newly diagnosed T1D and at-risk family members is ongoing in an unprecedented manner in Europe and has established a unique living biobank.In a similar way, we have built a clinical trials network in EU, that is now the unique network for clinical trials for interventions for at risk individuals or newly diagnosed people with T1D. Now we are at a point where we can move INNODIA to the next level and harvest the seedings of the original project:-We want to consolidate the INNODIA clinical network into the network of reference for conducting intervention studies targeted at preventing or arresting T1D. This step harvests on the establishment of our clinical sample collection network. We introduce next to the one study in the original INNODIA project, at least 2 large phase 2 trials, as well as several small mechanistic trials. -We want to continuously introduce novel biomarkers into the evolving cloud of biomarkers used in the natural history study, in particular biomarkers coming from the basic research laboratories, biomarkers identified at the time of INNODIA writing, that could not be integrated due to lack of funding.-We want to harvest on our potential to introduce disruptors of the pathogenic process in T1D, targeting different players and link these disruptors to biomarker changes, thus providing the potential to arrive to earlier read-out of intervention studies and faster drug development.-We want to feed back findings from our intervention studies and biomarker signature changes to the basic laboratories, to study the impact of heterogeneity on therapeutic success and move to personalized medicine.
Date:15 Jul 2019 → 14 Jul 2021
Keywords:type 1 diabetes