Wide sharing of knowledge and data drives the progression of science. Shared data allows other researchers to reproduce findings and benchmark quality of experiments. Sharing data so that other researchers can Find, Access and Interoperate – i.e. integrate the data with the outcomes of their own experiments - allows Reuse and an opportunity to build the large aggregated cohorts we need to detect rare signals and manage the many confounding factors in translational research. This project will develop the guidelines and tools needed to make data FAIR. Through worked examples using IMI and EFPIA data and application and extension of existing methods we will improve the level of discovery, accessibility, interoperability and reusability of selected IMI and EFPIA data. In addition, through disseminated guidelines and tailored training for data handlers in academia, SMEs and pharmaceuticals, data management culture will change and be sustained and datasets will be reused by pharmaceutical companies, academia and SMEs. Our FAIR SME & Innovation programme will enable wide data reuse and foster an innovation ecosystem around these data that power future re-use, knowledge generation, and societal benefit. We call this approach ‘FAIRplus’.

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 and samples. 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.