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EU-Förderung (8.499.556 €): Reduzierung nichtmenschlicher Primaten bei der nichtklinischen Sicherheitsbewertung: Die europäische Initiative für Minischwein- und Mikroschweinemodelle Hor 01.10.2024 EU-Rahmenprogramm für Forschung und Innovation "Horizont"
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Reduzierung nichtmenschlicher Primaten bei der nichtklinischen Sicherheitsbewertung: Die europäische Initiative für Minischwein- und Mikroschweinemodelle
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.
Geförderte Unternehmen:
Quelle: https://cordis.europa.eu/project/id/101165643
Diese Bekanntmachung wurde von Englisch nach Deutsch übersetzt. Die Bekanntmachung bezieht sich auf einen vergangenen Zeitpunkt, und spiegelt nicht notwendigerweise den heutigen Stand wider. Der letzte verfügbare Stand wird auf folgender Seite wiedergegeben: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim a. Rhein.