The Innovative Health Initiative (IHI) is a public-private partnership (PPP) between the European Union and the European life science industries, and these partners sit on our Governing Board. Its main objective is to translate healthcare research and innovation into tangible benefits for patients and society. It is also looking for Europe to become a reference in the fields of interdisciplinary, sustainable and patient-centered health research.

Any organisation established in the EU or a country associated to Horizon Europe is eligible to receive IHI funding. In practice, IHI funding primarily supports the participation in its projects of organisations like universities, research organisations, patient organisations, small and medium-sized enterprises (SMEs), and mid-sized companies. Depending on the type of call for proposals, larger companies may also be eligible to receive IHI funding. Details of who can receive funding is spelt out in the call texts.

Contributing to IHI: industry partners and contributing partners

Large companies that are members of the IHI industry partners contribute to the programme, primarily through 'in-kind' contributions (e.g. their researchers' time, laboratories, data, compounds). They can also make cash contributions. IHI contributing partners provide resources to IHI in the same way.

At least 45% of each project's budget has to come from industry partner / contributing partner contributions (in exceptional cases, a lower percentage may be allowed).

Explanation of this specific topic

The overall objective of this topic is to characterise the minipig for use in R&D of new therapeutics and innovative medical technologies. The knowledge generated in this proposal may facilitate innovative health solutions and improve disease understanding and human predictions. The goal is to advance biomedical R&D by generating background scientific data to evaluate if the minipigs could be a viable and feasible alternative to NHPs in key therapeutic areas, with a special focus on translatability from minipigs to humans.

To fulfil this aim, the proposals should:

Compile and publish existing historical safety data in minipig biomedical R&D and discuss data with regulators.

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.

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.

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.

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.

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.

Project management: Compile, digitalise, and publish existing and newly-produced data.

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