A Decision Support System for preclinical assessment of nanomaterials in medical products: the REFINE DSS

Abstract

The application of nanomaterials in medicine has led to novel pharmaceuticals and medical devices that have demonstrated a strong potential for increasing the efficacy/performance and safety of therapeutic and diagnostic procedures to address a wide range of diseases. However, the successful translation of these technologies from their inception (proof-of-concept) to clinical practice has been challenged by substantial gaps in the scientific and technical capacity of R&D companies, especially SMEs, to keep up with the ever-evolving regulatory expectations in the emerging area of nanomedicine. To address these challenges, the EU Horizon 2020 project REFINE has developed a Decision Support System (DSS) to support developers of nanotechnology-enabled health products in bringing their products to the clinic. The REFINE DSS has been developed to support experts, innovators, and regulators in the implementation of intelligent testing strategies (ITS) for efficient preclinical assessment of nanotechnology-enabled health products. The DSS applies logical rules provided by REFINE experts which generate prioritized lists of assays to be performed (i.e. ITSs) for physicochemical characterisation and for immunotoxicological endpoints. The DSS has been tested against several case studies and was validated by internal project experts as well as external ones. Graphical abstract

REFINE special issue

“…A very practical tool to design NBM-enabled medical products and to estimate their possible toxic potential is the IT-based decision support system (DSS) developed under the responsibility of Green Decision and presented in Zabeo et al [ 14 ]. The purpose of this system is to propose the most time- and cost-effective test strategy to cover the full preclinical characterisation of NMB-containing products.…”