Despite significant progress in preclinical type 1 diabetes research the important findings from in vitro models and animal studies could not yet be translated into novel and effective clinical interventions with earlier diagnosis and effective treatments to prevent development and progression of type 1 diabetes.
INNODIA is an international consortium of:
with the ambition to significantly improve our understanding of type 1 Diabetes and to pave the way to novel therapeutic options to prevent and cure this devastating disease.
The overall objective of INNODIA therefore is to advance in a decisive way how we predict, evaluate and prevent the onset and progression of type 1 diabetes (T1D), by creating novel tools, such as biomarkers, disease models and clinical trial paradigms. These tools will allow to distinguish and understand at the cellular and molecular level distinctive paths of ontogeny and progression in this heterogeneous disease, thus impacting on the future management of T1D patients and at risk individuals. For this goal, INNODIA will establish a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe, with complementary expertise from the areas of immunology, beta‐cell biology and biomarker research. The consortium will interact in a coordinated fashion with all major stakeholders in the process, in particular regulatory bodies and patients with T1D and their families.
INNODIA is organized into 6 Work Packages (WP´s) focusing on distinct topics with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium.
WP1 creates a clinical infrastructure to enable studies of the relationship between changes in β-cell function, immune profiles, genetic and environmental factors in new onset T1D patients and subjects at risk. The workpackage will deliver standardized collections of clinically and scientifically relevant biological samples from very large populations of new onset T1D patients and at risk subjects.
WP2 focuses on performing multi-dimensional analyses of T1D phenotypes and relate these singly or via integration to clinical outcomes and progression (WP4), with the intention of facilitating biomarker discovery (collaboration with WP3), surrogate marker development and patient stratification, and a better understanding of disease heterogeneity.
WP3 will focus on the discovery of novel and better ways to model and monitor the disease process and to evaluate the effect of new therapies under well-controlled experimental conditions. For this purpose, WP3 will use as discovery and validation tools in particular primary human tissues (e.g. human islets and immune cells); human cell lines; and humanized mouse models. Novel approaches proposed in WP3 should allow progress of our understanding of the natural history of T1D, fast translation of novel therapies from the bench to the bedside, and mechanistic explanations as to why new disease-modifying therapies in T1D succeed or fail.
WP4 supports the overarching aims of INNODIA relating to data management and development of integrative algorithmic approaches for prediction and discovery. WP4 algorithms will predict and evaluate the progression of T1D by combining and integrating data derived from other WPs via their multidisciplinary approaches to molecular genetics and functional genomics, cellular and molecular biology, proteomics, immunology, metabolomics, and β-cell biology together with the clinical phenotyping of subjects. WP4 will create the data management infrastructure supporting analysis of individual data types as well as integrative analyses working across readouts in a way that will be compatible with the data capture models adopted in other WPs.
WP5 is aiming to establish a step change in the way to evaluate novel therapeutics for newly diagnosed patients with T1D and those at risk for T1D. It will establish an EU clinical trials network, develop novel trial design models and evaluate of utility of surrogate biomarkers to accelerate clinical trial performance in T1D, moving towards prevention or cure of the disease. These strategies will be developed through an early and close engagement between the INNODIA partners (academic and industry) and stakeholders, in particular regulators and patients.
WP6 provides project Management to effectively manage the INNODIA consortium and provide governance direction to the project. It supports the dissemination and exploitation of INNODIA results and is responsible for the interaction with internal and external stakeholders and implementing all management procedures required for the successful implementation and execution of the of the INNODIA workplan.