Objective
Building upon the success of the INNODIA IMI-JU project, a new non-profit organization INNODIA is being established as a platform to access smart clinical trial expertise and data on an ability-to-pay basis.
The non-profit purpose of the INNODIA iVZW, is to establish within Europe a new self-sustaining platform to enhance and accelerate the development of a cure for type 1 diabetes.
More specifically, the Association tries to achieve this purpose by means of, among others:
- Expanding the quality of T1D clinical trial infrastructure
- Providing expertise on smart clinical trial design
- Optimizing the use of data and samples from individuals with T1D or at risk for biomarker analysis, with the aim to develop more personalized interventions
- Sharing scientific and clinical expertise within the European T1D research space
- Providing access to expert research and biomarker laboratories
- Empowering people and families living with T1D in clinical trials
- Accelerating new entrants and innovation, allowing acceleration of prevention and intervention trials
Background Rationale
We believe there is a need for a well-organized pan-European clinical trial infrastructure, to accelerate the drug development pipeline for T1D arrest and prevention.
The current state-of-the-art before or outside of the ending IMI-JU INNODIA and INNODIA HARVEST projects in Europe comprise small networks, typically with a focus on single agent therapies. The model of INNODIA iVZW, which is building further on the achievements in IMI-JU INNODIA and INNODIA HARVEST is advantageous, since we plan to operate a network at scale, that is all inclusive and collaborative.
Such a strong, Europe-wide platform will be able to execute clinical trials in people with T1D or at risk of developing the disease, with greater efficacy. Bringing in the expertise of the INNODIA and INNODIA HARVEST consortia, by providing advice on biomarker selection, biomarker detection and execution (laboratory choice), clinical trial centre selection, trial design, regulatory guidance but importantly also providing the voice of people/families living with T1D will be unique features of the new entity that will make INNODIA iVZW an appealing partner for many organizations interested in the T1D field. We believe such a platform is essential to further accelerate the development of the drug development pipeline through coordinated, collaborate actions.
Description of Project
INNODIA iVZW is an international, non-profit organization recently established, with its seat in Leuven, Belgium. The association is building further on what has been achieved within the INNODIA IMI-JU funded project, and is founded by University of Leuven, King's College London, Medical University Graz, Hannoverische Kinderheilanstalt and Università degli Studii di Siena. It provides a unique pan-European clinical trial infrastructure for type 1 diabetes (T1D).
The specific goals of INNODIA iVZW are: 1) Expand quality T1D clinical trial infrastructure, 2) Provide expertise on smart clinical trial design, 3) Optimize the use of data and samples from people with T1D and at risk individuals for biomarker analysis, 4) Share expertise within the European T1D research space, 5) Provide access to expert research and biomarker laboratories, 6) Empower people living with T1D in clinical trials, and 7) Accelerate new entrants and innovation.
INNODIA iVZW plans, amongst others, following activities: 1) Strengthening and expanding quality T1D infrastructure, by accrediting new and re-accrediting existing clinical centers throughout Europe; 2) Facilitating access to a T1D data sandbox for secure data exploitation, 3) Facilitating access to standardized analysis and biostatistics, 4) Facilitating access to biological samples; 5) Providing advise utilizing an extensive network and experience in T1D, 6) Providing expert research and biomarker laboratories, 7) Providing advice from people with T1D through a Patient Advisory Committee, 8) Serving as smart and lean mini-CRO , 9) Accompanying large pharma, in particular towards prevention and arrest of T1D, 10) Organize meetings to enhance collaborative actions, 11) Collaborate with International non-European organizations, to further accelerate the T1D field.
This INNODIA network of accredited clinical sites and specialized laboratories is expected to accelerate drug development pipeline for pharma companies, hopefully leading to faster, life-changing innovation for people living with T1D. Also clinical centers, specialized laboratories and academic researchers will benefit through the coordinated activities planned by the INNODIA iVZW.
Anticipated Outcome
The ultimate goal of INNODIA iVZW is to provide a ‘one-stop-shop’ for T1D clinical trials in Europe. We expect that this will significantly accelerate the drug development pipeline, thereby hopefully coming to a cure for people living with T1D or at risk of developing the disease, in a faster way, leading to life-changing innovations in the T1D field.
Relevance to T1D
The ultimate goal of INNODIA iVZW is to provide a ‘one-stop-shop’ for T1D clinical trials in Europe. We expect that this will significantly accelerate the drug development pipeline, thereby hopefully coming to a cure for people living with T1D or at risk of developing the disease, in a faster way, leading to life-changing innovations in the T1D field.