Strengthening French participation to European calls is a major challenge. Applying to this MRSEI program will enable us to assess scientific visibility and benefit of the multidisciplinary network HuPlastiX on micro- and nano-plastics for a better human health risk assessment and management. Positioned at the interface between analytical chemistry, physiology, food toxicology, environmental sciences and toxicology, and circular economy, it will facilitate access and, hopefully, success to the H2020 funding program through the call SC1-BHC-03-2018 “Micro- and nano-plastics in our environment: Understanding exposures and impacts on human health”. Global plastic production has increased exponentially over the last decades. A significant proportion of the plastic produced is not disposed of properly and persists in the environment, especially the marine environment. Plastic products can be slowly degraded and fragmented into smaller pieces (defined as secondary micro-plastics when they are smaller than 5 mm and nano-plastics when they are < 1 µm). Primary micro-plastics may also be intentionally added to, for example, toothpaste and beauty products. Furthermore, plastic debris are associated with a “cocktail of contaminants” made up of chemical ingredients present originally in the plastic (additives such as bisphenols, phthalates) and chemical pollutants adsorbed to the plastic from the environment (e.g. metals, polychlorinated biphenyls (PCBs), flame retardants…). Due to their small sizes, micro-plastics are filtered into marine species’ gastrointestinal tract mechanically or they may look like food to some species, thus entering the food chain, with to date largely unknown effects. In fact, risk assessment studies and reviews carried out in recent years have concluded that there is evidence that humans are exposed to micro- and nano-plastics through their diet, drinking water or inhalation. However, understanding the fate and toxicity of these plastic particles in humans constitutes a major knowledge gap, rendering it difficult to carry out proper science-based risk assessment and management. The challenge of this call is to provide, notably through innovative approaches, policy relevant scientific data in support of improved human health hazard and risk assessment of micro- and/or nano-plastics. The following impacts are foreseen: (i) innovation in hazard characterization and health risk assessment methodologies for micro- and/or nano-plastics, (ii) better understanding of health impacts of exposure to micro- and/or nano-plastics, (iii) contribution to the health-relevant aims of the European strategy for plastics in a circular economy and of the bioeconomy strategy. Our proposal HuPlastiX aims to cover these expected impacts. As such, objectives cannot be reached on an individual country level; the targeted call thus needs intensive collaboration and synergies between scientists across disciplines. In line with this ambitious, albeit necessary, pre-requisite, we have started to build our consortium accordingly, while keeping in mind our own vision on how to tackle this cognitive and application-driven challenge on micro- and nano-plastics. By gathering specialists of the related fields, we aim to fulfill the gap between environmental and food toxicology, considering gut and its partners involved in maintaining host homeostasis. To support these biology-based findings, innovative methods will be implemented for detection and quantification of micro- and nano-sized plastics in the presence of additives and environmental pollutants. The ultimate goal will be to link the circular economy strategy of plastics with human health criteria, in order to facilitate the transition towards a modern, nutritionally sound and more sustainable society.

Since the establishment of EATRIS as an ERIC in 2014, the infrastructure has developed a growing portfolio of services and collaborative projects serving several user groups including industry (large pharma and SME), academia, research funders and patients. EATRIS has progressed from proposing a strong proof of concept service portfolio, to building and delivering innovative tools for translational research and is now advancing its strategy to further exploit these tools for the extended research and innovation community. EATRIS-CONNECT will accelerate this strategy by focusing specifically on advancing the digital readiness of EATRIS to support biomedical challenges in Europe and provide translational solutions for the benefit of personalised medicine. Through curated access to novel digital tools and services, as well as node strengthening, EATRIS-CONNECT will equip EATRIS across the entire distributed research infrastructure to address bottlenecks and challenges for the application of digital solutions in the context of use. Moreover, the project will ensure this digital transformation is environmentally sound by improving energy, resource, and material efficiency, supporting the environmental goals of the European Green Deal. The project will promote the cross-border alignment in the adoption and application of digital tools and help consolidate the European RI landscape by fostering interdisciplinary collaborations between cross-sector RI and exploring how RI can together unlock innovation in the digital domain. EATRIS-CONNECT will provide the pathway for the evolution of EATRIS. All 14 national EATRIS nodes form the central pillar of EATRIS-CONNECT, facilitating the alignment of strategic national priorities across the infrastructure and empowering EATRIS widening nodes to strengthen their digital competencies, ultimately ensuring the long-term sustainability of EATRIS.

Molecular in vitro diagnostics and biomedical research have allowed great progress in personalised medicine but further progress is limited by insufficient guidelines for pre-analytical workflow steps (sample collection, preservation, storage, transport, processing etc.) as well as by insufficient quality assurance of diagnostic practice. This allows using compromised patients’ samples with post collection changes in cellular and extra-cellular biomolecules’ profiles thus often making diagnostic test results unreliable or even impossible. To tackle this, SPIDA4P aims to generate and implement a comprehensive portfolio of 22 pan-European pre-analytical CEN/Technical Specifications and ISO/International Standards, addressing the important pre-analytical workflows applied to personalized medicine. These will also applicable to biomarker discovery, development and validation as well as to biobanks. Corresponding External Quality Assurance (EQA) Schemes will be developed and implemented as well, aiming to survey the resulting quality of samples and diagnostic practice. SPIDIA4P will ensure stakeholder organisations involvements as well as training, education, and counselling as additional major foci of the project. The consortium will closely coordinate with large European public research consortia to obtain access to research and validation studies data serving as evidence for the new standards developments and achieved improvements of diagnosis, patient stratification and prognosis of disease outcome. At this crucial moment in the development of personalised medicine, SPIDIA4P proposes a coordination and support action that reunites 19 highly experienced partners in international standardisation for in vitro diagnostics, coming from private industry including SMEs, public institutions and from one official European Standards Organisation. This strong consortium is balanced and empowered to maximise the impacts of in vitro diagnostics on personalised medicine.

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.