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.

The incidence of Cardiovascular Disease (CD) claims worldwide 17.1 million lives a year, with an estimated 31% of all deaths globally and a EU cost of 139 billion euros. Up to 40% of all deaths occur among the elderly. In spite of all medical efforts, the 5-year mortality was reduced significantly less than that of malignant diseases. This highlights the urgent need to overcome the difficulties associated with present pharmacological therapies (i.e. drug instability, and unspecific targeting) by developing new ground-breaking therapeutic strategies that go far beyond any current regimens. New approaches for safe, efficient, and heart-specific delivery of therapeutics are strongly required. CUPIDO is envisioned to meet these critical needs by providing an unconventional and effective strategy based on nanoparticle-assisted delivery of clinically available and novel therapeutics to the diseased heart. In particular, CUPIDO will develop innovative bioinspired hybrid nanoparticles formulated as biologicals delivery, which are i) biocompatible and biodegradable, ii) designed for crossing biological barriers, and iii) guidable to the heart. A combination of multidisciplinary manufacturing and validation approaches will be employed, bringing the envisioned product beyond the currently available clinical and day-to-day management of CD individuals. Scale-up production, and respect of medical regulatory requirements will allow CUPIDO to deliver a final product for future late pre-clinical and clinical studies. Altogether, CUPIDO will foster the translation of nanomedical applications toward the cardiac field, which although still in its start, offers great potential to overcome the limitations associated to the currently pharmacological treatments.