The iNanoBIT project is aimed to apply nanotechnologies for imaging porcine pancreatic islet cellular transplants and induced pluripotent stem cell-derived beta-cells and subsequent regenerative processes in vivo in a porcine model. The project will develop1) novel highly sensitive nanotechnology-based imaging approaches allowing for monitoring of survival, engraftment, proliferation, function and whole body distribution of the cellular transplants in a preclinical porcine model with excellent translational potential to humans; 2) develop and validate the application of state-of-the-art imaging technologies facilitating the provision of new regenerative therapies to preclinical large animal models and patients; 3) directly contribute to the opening of a new market sector for i) imaging equipment (SPECT, PET/MR, optoacoustic imaging in preclinical large animal models and patients), ii) nano-imaging molecule supplies (nanomolecules allowing multimodality imaging of specific cell types with high sensitivity), iii) validated transplantable in vitro differentiated human beta-cells and porcinexenotransplant islets thus will reinforce the European healthcare supply chain for regenerative medicinal products. The iNanoBIT project will provide the currently missing toolbox for preclinical/clinical testing for a safe translation of regenerative medicinal cellular and tissue products, currently under preclinical and clinical trials, which is vital for the competitiveness of the European healthcare sector in this fast-growing area. The consortium of 5 SME and 3 Academic partners is coordinated and driven by the industrial partners from the field of nanotechnology, imaging and stem cell technologies, providing a perfect match and unique combination addressing the scope and expected impact of the call and providing TRL 3/4 starting points for the key technological elements, and expect to arrive to TRL6 levels of validated technologies ready for marketing by the end of the project.

NHPig is an Innovative Health Initiative (IHI) project based on the public-private partnership of the European Union and Europe’s health industries. Its objective is to expand, share and implement biological knowledge of mini-/micropig models with the aim to reduce non-human primates (NHPs) in non-clinical safety studies. The transnational consortium includes experts in porcine medical models, veterinary pathology, computational animal science, non-clinical science, OMICs profiling, new approach methods (NAMs), as well as bioinformatics and artificial intelligence. NHPig will i) characterise humanised minipigs, micropigs and tailored disease models, including systematic biobanking, multi-OMICs profiling, and state-of-the-art imaging modalities; ii) develop, validate and implement biosensors, medical devices, and ‘intelligent’ animal housing for automated data collection and analysis in minipig safety studies; iii) fill significant knowledge gaps in the (patho)physiology of the porcine immune system; iv) validate known toxicity and efficacy biomarkers and discover novel biomarker candidates for non-clinical safety assessment; v) overcome the shortage of laboratory tools and reagents, such as validated antibodies; vi) gain experience in using mini-/micropigs for safety testing of biologicals and new therapeutic modalities; vii) Investigate in vitro to in vivo extrapolation of liver and kidney toxicity in pigs and NHP/humans to provide a comparative link to human new approach methodologies (NAMs); and viii) provide a publicly available database and IT platform for compiling, integrating and analysing existing data in NHPs/humans with data in mini-/micropig models (existing data and data generated within the NHPig programme). The establishment of a regulatory advisory board and an ethics- and animal welfare advisory board will expedite regulatory interactions and ensure compliance with the 3R principles. NHPig will generate the scientific basis for de-selection of NHPs in non-clinical safety assessment, which is an ethical requirement and also imperative according to EU legislation.