Periodic Reporting for period 1 - MIRIADE (Multi-omics Interdisciplinary Research Integration to Address DEmentia diagnosis)
Reporting period: 2019-11-01 to 2021-10-31
- To equip 15 scientists with unique skills and strategies to target biomarker development (WP6).
- To establish a roadmap for strong stakeholder interactions to accelerate the biomarker development process (WP1-5,7).
- To develop an open integrated data platform for biomarker development in dementia (WP1).
- To develop computational tools for rational prediction of biomarker states in CSF and blood (WP1,2).
- To develop novel biomarker assays for specific types of dementia and validate these in shared biobank samples (WP1-3).
- To facilitate clinical implementation of biomarker assays by preparing market entry (WP4).
WP2: Biomarker assays in CSF and blood are developed using state-of-the-art protein technologies. The same biomarkers are developed on different technologies, for optimal synergism and comparison of the efficacies of each strategy to build a roadmap for optimised development in WP5. There is continuous interaction of WP2 with WP1 and among the ESRs in WP2 for selection of biomarkers and reagents (e.g. antibody prediction evaluation, use antibodies to increase SRM sensitivity). As such ESRs are currently developing both SRM and ELISA based assays for 3 AD markers, 5 FTD markers, 6 DLB markers and 6 markers for all dementias.
In WP3, we will clinically validate candidate biomarkers that are developed in WP1/2. We have identified several biomarkers for which assay development was successful for at least one assay type, to the level of clinical proof of concept.
The aim of WP4 is to further develop biomarker assays that have proven clinical use into biomarker assays available on the market. So far, several relevant actions for market introduction have been started for the biomarker neurofilament light (NfL), i.e. the application of EMA approval, development of reference methods and reference calibrators and standard operation procedures for blood processing, and the development of alternative assay modalities, such point of care set-ups and alternative reagents for NfL and pTau assays. In addition, NPTX2 and VAMP-2 are evaluated for their market viability.
The aim of WP5 is to provide a roadmap for innovation of the biomarker development process. This will be done by studying the different assay development strategies in WP1-4. So far, literature studies have been performed and data are being collected by performing interviews and observations of interactions between MIRIADE partners, defining the framework for the Roadmap.
Education and training (WP6) are an inherent component of the MIRIADE project. The first network-wide training week included training on biomarkers for dementia, bioinformatics, assay development, business innovation, patient perspective, entrepreneurship, and research integrity. The content of the second training week focused on the progress reports of the ESRs, reproducibility in science, dissemination of data, ethics and privacy regulations and biostatistics. In addition, the training week contained three open lectures aiming to reach scientists/interested people also outside of the MIRIADE network. In addition, our ESRs followed 70 individual courses on a wide range of topics, such as general or specific scientific project content related topics and transferable skills.
WP7, 8 and 9: Dissemination, Project management and Ethics. Our website was launched and there are 3 active social media accounts run by our ESRs: Twitter (@MIRIADE10), LinkedIn (MIRIADE E.U.) and Instagram (miriade.eu). We’ve also had media exposure through articles on our partners’ Alzheimer Europe website and newsletter and via Italian newspapers and a TV interview. MIRIADE is proud to already have published 14 open access publications with an average impact factor of 15.29. Overall project management has been efficient, coherently, and timely, despite the covid-19 pandemic. Due to the pandemic, ESR9 recruitment was moved to another beneficiary within the consortium and finalized in December 2021. As part of the ethics requirements, we have submitted 4 deliverables on human cells and tissues, protection of personal data, non-EU countries and environmental protection and safety.