BIORIMA stands for Biomaterial Risk Management. BIORIMA aims to develop an integrated risk management (IRM) framework for nano-biomaterials (NBM) used in Advanced Therapeutic Medicinal Products (ATMP) and Medical Devices (MD). The BIORIMA RM framework is a structure upon which the validated tools and methods for materials, exposure, hazard and risk identification/assessment and management are allocated plus a rationale for selecting and using them to manage and reduce the risk for specific NBM used in ATMP and MD. Specifically, the IRM framework will consist of: (i) Risk Management strategies and systems, based on validated methodologies, tools, and guidance, for monitoring and reducing the risks together with methods for evaluating them; (ii) Validated methodologies and tools to identify the potential Exposure and Hazard posed by NBM to humans and the environment; (iii) A strategy for Intelligent Testing (ITS) and Tiered Risk Assessment for NBM used in ATMP and MD. BIORIMA workplan consists of 7 workpackages covering the major themes: Materials, Exposure, Hazard and Risk. BIORIMA will generate methods and tools for these themes for use in risk evaluation and reduction. The BIORIMA toolbox will consist of validated methods/tools for materials synthesis; reference materials bank; methods for human/environment exposure assessment and monitoring; (eco)-toxicology testing protocols; methods for prevention of accidental risks – massive release or explosion – A tiered risk assessment method for humans/environment; An intelligent testing strategy for NBM and risk reduction measures, including the safer-by-design approach. BIORIMA will deliver a web-based Decision Support System to help users, especially SME, evaluate the risk/benefit profile of their NBM products and help to shorten the time to market for NBM products.

A major challenge for the global nanotechnology sector is the development of safe and functional engineered nanomaterials (ENMs) and nano-enabled products (NEPs). In this context, the application of the Safe-by-Design (SbD) concept has been adopted recently by the nanosafety community as a means to dampen human health and environmental risks, applying preventive safety measures during the design stage of a facility, process, material or product. However and despite its importance, SbD prescriptions are still in their infancy, and are hampered among other things by the lack of comprehensive data about the performance, hazard and release potential of the great variety of NEPs in use. SbD4Nano addresses that problem creating a comprehensive new e-infrastructure to foster dialogue and collaboration between all actors in the supply chain for a knowledge-driven definition of SbD setups that optimize hazard, technical performance and economic costs. Our project developes a validated rapid hazard profiling module, coupled to a new exposure-driven modelling framework to reduce toxicity. This safe-born material also undergoes a cost-benefit analysis algorithm to find the best compromise between safety and a industrially convenient technical performance. Finally, a new software interface where product information can be exchanged between the supply chain participants is the tool that wraps up, finishing the collaborative spirit of SbD4Nano between regulators, researchers and industry. Coherently with its goals, our SbD4Nano project is international and open-scienced in essence, with the clear aim of impacting the EU policies as well as directly and clearly benefiting the citizen.

Gene therapy, most commonly using viral vectors, can be applied to inhibit or edit the expression of any gene of interest, being highly specific. However, there is an urgent need to find non-viral vectors with low toxicity and high transfection and targeting efficacies. The SUPRO-GEN project aims to design supramolecular vectors for gene delivery for applications in immunotherapy and cancer stem cell therapy. Peptide and glyco engineering of the vectors will result in high tumor targeting efficacy. Transfection and therapeutic efficacy will be tested in vitro and in vivo. Cell trafficking and biological fate of vectors will be studied by advanced imaging techniques. SUPRO-GEN is a concerted action based on multidisciplinary expertise in materials science, chemistry, genetic engineering, cancer biology, cancer therapy, and imaging. The project will bring together a talented consortium of academic groups and a high-tech SME from Spain, Italy, Israel, the United States, South Africa, Argentina and Thailand. Early Stage and Experienced researchers will receive training and conduct research in a hosting institution abroad. In addition to achieving the scientific goals, the project also aims to develop highly skilled professionals at the interface of materials science and engineering and the biological sciences.

Diseases of the posterior segment of the eye are increasing considerably, partly due to an ageing population (almost 20% of the population of Europe now over 65). Despite accounting for approximately 55% of ocular conditions, only 5% of ocular product sales target the posterior segment due to the technical difficulties in developing safe, effective and easy-to-use formulations. Age-related Macular Degeneration and Diabetic retinopathy are some of the main cause of blindness and severe impairment of vision in patients. These diseases represent a considerable burden on patients and healthcare systems throughout the world. ORBITAL has the primary objective of recruiting excellent early stage researchers (ESRs) and developing the next generation of research leaders and drivers. There is a clear unmet clinical need for efficient, safe, non-invasive and patient-friendly strategies for the treatment of prevalent diseases of the posterior segment of the eye. With a necessary collaborative network of European and global experts, from academic, clinical and industrial sectors, ESRs will be exposed to an integrated and complementary network of expertise in materials science, nanotechnology, animal modeling, enhanced in-vitro testing, analytical chemistry and drug discovery. ORBITAL will build an intersectoral consortium with extensive experience in generating innovative technologies and training new researchers. ESRs will be exposed to a broad scientific landscape of complementary disciplines. With the combined skills and knowledge of the consortium, ESRs will be provided with the network, skills and knowledge to develop their careers while the extensive mobility of researchers will lead to increased knowledge transfer and collaborative research