Topic: IMI2-2020-23-03 A platform for accelerating biomarker discovery and validation to support therapeutics development for neurodegenerative diseases
Duration: 60 months
Start date: 1 November 2021
Grant agreement: 101034344
Total request Grant by Consortium: €9,680,000
Total request Grant by BBMRI-ERIC: €313,875
Linked Third Parties/BBMRI-ERIC Framework Agreement:
Benefit/tasks for BBMRI-ERIC: BBMRI-ERIC will be participating in Work Packages 2 (Legal and Ethical Aspects), 3 (SOP development, including co-leading a task resulting in a guideline on best practices in biobanking in the context of EPND), 4 (Cohort interaction, including leading a subtask on supporting biobanking quality control by providing self-assessment surveys and remote audits), 6 (Stakeholder involvement), 7 (Sustainability and exploitation of the platform) and 8 (Participation in the EPND Regulatory Leadership Group).
Alzheimer’s disease (AD) and Parkinson’s disease (PD) are common neurodegenerative conditions, posing a major societal burden. There is a lack of treatments to slow disease progression, and therapeutic development has been impeded by a lack of biomarkers that can detect individuals early in the disease, measure treatment effects, and stratify patients.
European cohorts recruited for research on aging and neurodegeneration provide a huge potential for biomarker discovery and validation by providing bio-samples along with deep clinical and imaging phenotypes. However, these cohorts are difficult to access. An overview of the availability of data and samples is lacking, and protocols and regulations for data and sample collection, storage, and sharing vary.
The European Platform for Neurodegenerative Diseases (EPND) will tackle the above issues by developing a self-sustaining European-based platform to facilitate discovery and access of relevant bio-samples and data. EPND will be built on an existing informatics infrastructure, the AD Workbench, which EPND will adapt to support resource- and participant-level discovery, data harmonisation, central and federated data and sample storage, and data analysis. The sample and data discovery tools will be connected to a network of over 60 cohorts on AD, PD, and related disorders. Together, these cohorts will facilitate access to data and samples of over 120,000 research participants including CSF (n=30,000), plasma (n=120,000), stools (n=6,000), urine (n=27,000), saliva (n=17,000) and digital biomarkers(n=2,000). Prospective data collection will also occur during the project. This approach provides the community with a new and powerful environment for collaborative cross study analysis of harmonised biomarkers, datasets andsamples. EPND will provide visibility into the quality and standardization of the data and samples available in the platform from the cohorts available and will also provide protocols for ongoing data and sample collection. This will guarantee quality of samples available, an important factor for validation and regulatory approval for biomarkers.
EPND will be guided by ethical, legal and regulatory experts, patients, and other stakeholders to ensure responsible practices and processes underpin all discovery, sharing and access of data and samples, whilst simultaneously ensuring the platform is self-sustainable by the end of the project. Thereby, EPND will provide the community with a long-term, powerful environment to aid biomarker research for neurodegenerative disorders, enabling critical advances in the development of treatments for AD and PD.