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.

<< Background >>Mouse-based studies are essential for deciphering the genetic basis of human diseases. However, there is a proven European and global significant deficiency of formal and specialized courses to acquire the necessary expertise in Mouse Pathobiology, especially in Higher Education. For this reason, universities, research institutions and companies, have come together to establish the PATHBIO consortium and to develop new training opportunities to change this reality.<< Objectives >>The PATHBIO objectives have been: 1. To respond to the increasing need of well-prepared professionals in the area of Mouse Pathobiology 2. To identify the main challenges for professionals working in the area of Mouse Pathobiology 3. To include new areas of knowledge and technologies in the field of Mouse Pathobiology 4. To implement an integrated European educational approach in Mouse Pathobiology<< Implementation >>The PATHBIO consortium has implemented all of the objectives envisaged in the Erasmus+ proposal, obtaining a significant impact on the target audience that has been confirmed by the external evaluation measures. Due to COVID-19 pandemic and the global restrictions, and after consultation with the Agency, PATHBIO adapted the 2020 and 2021 main events to a virtual and dual (face-to-face and on-line) formats.<< Results >>Main outputs of the PATHBIO project have been: a) Organization of three Summer Course editions with the participation of 383 students from 47 countries (28 non-European) and 60 lecturers from 13 different countries (4 non-European) b) Deployment of a Virtual Learning Platform including 270 on-line lectures c) Elaboration of 7 new teaching materials for Mouse Pathobiology d) Design of a Master program on Mouse Pathobiology submitted to the Erasmus Mundus calls in 2021 and 2022