A definitive conclusion about the dangers associated with human or animal exposure to a particular nanomaterial can currently be made upon complex and costly procedures including complete NM characterisation with consequent careful and well-controlled in vivo experiments. A significant progress in the ability of the robust nanotoxicity prediction can be achieved using modern approaches based on one hand on systems biology, on another hand on statistical and other computational methods of analysis. In this project, using a comprehensive self-consistent study, which includes in-vivo, in-vitro and in-silico research, we address main respiratory toxicity pathways for representative set of nanomaterials, identify the mechanistic key events of the pathways, and relate them to interactions at bionano interface via careful post-uptake nanoparticle characterisation and molecular modelling. This approach will allow us to formulate novel set of toxicological mechanism-aware end-points that can be assessed in by means of economic and straightforward tests. Using the exhaustive list of end-points and pathways for the selected nanomaterials and exposure routs, we will enable clear discrimination between different pathways and relate the toxicity pathway to the properties of the material via intelligent QSARs. If successful, this approach will allow grouping of materials based on their ability to produce the pathway-relevant key events, identification of properties of concern for new materials, and will help to reduce the need for blanket toxicity testing and animal testing in the future.

The recent global burden of disease study showed that low back pain (LBP) is the most significant contributor to disability in Europe. Most patients seen in primary care with LBP have non-specific LBP (≥85%), i.e., pain that cannot reliably be attributed to a specific disease/pathology. LBP is the fourth most common diagnosis seen in primary care (after upper respiratory infection, hypertension, and coughing). Self-management in the form of physical activity and strength/stretching exercises constitutes the core component in the management of non-specific LBP; however, adherence to self-management challenging due to lack of feedback and reinforcement. This project aims to develop a decision support system - SELFBACK - that will be used by the patient him/herself to facilitate, improve and reinforce self-management of LBP. Specifically, SELFBACK will be designed to assist the patient in deciding and reinforcing the appropriate actions to manage own LBP after consulting a health care professional in primary care. The decision support will be conveyed to the patient via a smartphone app in the form of advice for self-management. The advice will be tailored to each patient based on the symptom state, symptom progression, the patients goal-setting, and a range of patient characteristics including information from a physical activity-detecting wristband worn by the patient. The second part of the project will evaluate the effectiveness of SELFBACK in a randomized controlled trial using pain-related disability as primary outcome. We envisage that patients who use SELFBACK will have 20% reduction in pain-related disability at 9 months follow-up compared to patients receiving treatment as usual. Process evaluation will be carried out as an integrated part of the trial to document the implementation and map the patients’ satisfaction with SELFBACK. A business plan with a targeted commercialisation strategy will be developed to transfer the SELFBACK technology into the market.

Gov4Nano will design and establish a well-positioned and broadly supported Nano Risk Governance Council (NRGC). Organizing, connecting and engaging are key activities in Gov4Nano and its creation of a sustainable NRGC. Gov4Nano will develop an operational trans disciplinary Nano Risk Governance Model (NRGM) for nanotechnologies, building on an established governance framework developed by the International Risk Governance Council (IRGC). Engaging stakeholders (including regulators) to proactively address nano-specific safety and seek dialogue for joint activities. NRGC and its precursor project Gov4Nano will engage, in order to support these activities, with the broad variety of stakeholders across all relevant nano-disciplines (chemical, biocides, food and feed, pharma and medical devices and materials development) and draft a review on our knowledge progress over the last decade whilst initiating dialog. To boost the quality of the dialog it will create a platform for dialogues between stakeholders in a “trusted environment” inclusive of civil society. The NRGC core business is to coordinate, guide and harmonize in order to overcome the fragmentation of current knowledge, information and needs over various sectors and disciplines (workers, consumers/patients, environmental safety) and to prepare the transfer of this knowledge. To that end, the NRGC will be equipped with a self-sustainable NanoSafety Governance Portal (NSGP) consolidating state-of-the-art and progressive nanosafety governance tools including ones for dialogues and measuring risk perception. Major efforts will be towards requirements for data harmonization and data curation to be defined and laid down in guidance on obtaining harmonized and standardized quality-scored data collections promoting a big data approach for nano-toxicology. Research activities will be initiated for regulatory sound knowledge in support of harmonized (OECD) guidance for characterization and testing of nanomaterials.

A significant challenge to ensuring sustainable production and use of nanotechnologies is to understand safety and health risks of the technology and its end-products, and to implement practical strategies to manage these risks. Knowledge is growing rapidly, but effective use of this knowledge for risk management is lagging behind. We therefore need to bridge the gap between knowledge on hazard and risk, and ‘fit-for-purpose’ risk management tools and strategies supported by measurement and control methods. EC4SafeNano will bridge this gap in an efficient and sustainable way by setting up an independent, science-based, managed Centre (hub) linked with several networks (spokes) to act at the interface between research organisations, industry, regulatory bodies, and civil society. The objectives are to: 1) understand the needs of all stakeholders along the innovation value chain for nanotechnologies, ensuring safer, marketable, regulated and accepted long-lived products; 2) identify the resources and capabilities available to address these needs, and evaluate the capacity to provide technical solutions and actions; 3) build, test and benchmark a range of services, based on selected resources that answer stakeholder needs across the innovation value chain; 4) develop mechanisms and operating procedures to facilitate periodic updating of the “needs and resources” mapping and of the service provision; 5) develop networking activities aiming to share, benchmark and promote the EC4SafeNano services thereby enhancing and harmonizing the overall expertise, at EU level and beyond; and 6) develop governance rules and a strategic plan to prepare for self-sufficient operation beyond the project lifetime. The main outcome is the definition of a legal entity with operating procedures, gathering, integrating and sharing available technology, tools, skills and processes and promoting services and capabilities to support stakeholder needs in risk management and safe innovation.