Key activities

1. Compile and publish existing historical safety data in minipig biomedical R&D and discuss data with regulators.
2. Evaluate the translatability of minipigs in human risk assessment following treatment with biologicals and new therapeutic modalities, and discuss future perspectives of the minipigs with regulatory agencies, e.g., by requesting regulatory interactions with European Medicines Agency (EMA) such as scientific advice and/or novel methodology qualification advice to understand possible regulatory hurdles in using minipigs for safety assessment.
3. Minipigs multi-omics and imaging: Generate omics reference data (genomics, transcriptomics, proteomics, metabolomics, and epigenetic information) to enable translational research in minipigs. To further characterise the minipig, imaging technologies such as magnetic resonance imaging (MRI), computed tomography (CT) scans and positron emission tomography (PET) scans are also of interest.
4. Genetically modified pig models including the micro-pig: Characterise and validate humanised and genetically modified minipig models, including the micropig to generate translatable animal models in non-clinical safety assessment.
5. iPig: Digital technologies, clinical data collection and AI: Create, validate, qualify, and benchmark digital solutions that can objectively measure clinically relevant and functional biomarkers in minipigs for use in preclinical toxicity studies in line with the regulatory agencies’ requirements.
6. Minipig immune system: validate reagents, assays, and biomarkers for immunological investigations: Conduct investigative studies in minipigs to support their translational significance in immuno-safety assessments and validate reagents/assays.
7. Project management: Compile, digitalise, and publish existing and newly-produced data.