Objective 1. Create a set of agreed ethical, legal, regulatory, business and sustainability principles to establish governance and operational processes to enable sharing and access to data and samples
On the ethical and legal side of this objective, WP2 has continued to gather information to support the project (internally documented as part of M12), further extending the research published in (D2.2) entitled “The Current State of Biomedical Data and Sample Sharing for Research Purposes in Europe: Perspectives from the European Neurodegenerative Disease Community”. The team has taken experience from supporting case study activities, as well as extending research into the EHDS Regulation Proposal and legal entity structures that might become impactful in the EU in the coming years. As has been the ongoing goal the team is focused on developing insights and recommendations from this research to that will inform the implementation of necessary governance processes as the project moves into its next stage.
Objective 2. Establish a network that provides central and federated access to high quality samples and data from ~70 cohorts by combining existing data discovery and sharing initiatives made interoperable as part of the AD Workbench.
Significant progress has been made towards this objective, with metadata now collected from 83 cohorts: 24 providing extensive dataset metadata and 27 offering biosample collection details via the technical hub. The delivery of the technical hub's Minimally Viable Product (MVP) will significantly increase the catalogue's content with syndicated and federated assets. The Technical Hub now enables rich descriptions, rapid discovery, and access to shareable datasets and biosample assets, and has established deep connectivity with the AD Workbench.
Objective 3. Provide visibility into the quality and standardization of the data and samples available in the platform from existing cohorts.
As rich metadata is collated for partner cohorts, the emphasis on providing visibility into quality and standardization has been a key driver. We have developed and disseminated best practice guidelines, which we continue to share with the community, while also extending our scope into the digital biomarker space. The attainment of BBMRI quality accreditation and its incorporation into the catalogue for all partnered biobanks is a significant step in enhancing the visibility of this important measure of confidence in data and sample acquisition.
Objective 4. Perform a robust evaluation of the developing EPND platform through the execution of case studies on the Amyloid-Tau-Neurodegeneration (ATN) staging.
The evaluation of the developing EPND platform through the execution of case studies has required contributions from across the entire consortium. Significant progress has been made in data harmonization and evaluating permissioning models, with datasets now available in the AD Workbench. The consortium has provided support for navigating legal and ethical bottlenecks and guidance to establish compliant processes for centralized permissioning of datasets. Additionally, there has been coordination of the logistics for data and sample transfers and the establishment of biobank quality controls. The initiation and completion of lab analyses, along with ongoing data analyses, have furthered the project's goals. Challenges encountered have been viewed as opportunities for learning, helping the consortium develop solutions to establish more robust processes
Objective 5. Embrace sustainability from the start of the project by designing and piloting exploitation strategies such that the platform is self-sustainable by the end of the project
As the project enters its fourth year, the focus is firmly on establishing a sustainable entity to leverage the efforts of the previous years. Through reinforced leadership and strong guidance from the management team, the work package contributions are showing great synergy. WP7 has finalized a clear business proposition that we believe can drive sustainability and has explored and agreed on a suitable legal entity type to support establishing a standalone not-for-profit organization to deliver on EPND's vision. This business proposition integrates the technical hub and support services, drawing on experience gained from executing current case studies to identify potential future revenue drivers.
Reflecting the sustainability-by-design mantra that drives WP1, the technical hub MVP has focused on production-grade software, robust data security and management, and interoperability. The service model is also becoming clearer as work package activities concentrate on supporting ongoing case study efforts, documenting the resource demands to facilitate data and sample sharing, and exploring guidance opportunities.
