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GSS EU Science Funding Gateway

GSS EU Science Funding Gateway

Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical safety assessment

Summary

IHI JU is based on the idea that interdisciplinary and cross-sector collaboration will enable perspective and breakthrough innovations in healthcare, including the pharmaceutical industry but also new fields such as biopharmaceuticals, medical technologies and biotechnologies.

Programme Name

Innovative Health Initiative

Programme Description

IHI JU is based on the idea that interdisciplinary and cross-sector collaboration will enable perspective and breakthrough innovations in healthcare, including the pharmaceutical industry but also new fields such as biopharmaceuticals, medical technologies and biotechnologies.

Programme Details

Call

Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical safety assessment

Detailed Call Description

Key activities

  • 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.

    • Financing percentage by EU or other bodies / Level of Subsidy or Loan

    The allocation of the €200 000 financial contribution will be decided by the full consortium at the second stage when preparing the full proposal.

    Programme Category
    EU Competitive Programmes
    Total Budget
    € 8 500 000
    Thematic Categories
    • Health
    • Research, Technological Development and Innovation
    Eligibility for Participation
    • Researchers/Research Centers/Institutions
    Call Opening Date
    27/07/2023
    Call Closing Date
    08/11/2023
    EU Contact Point

    All questions regarding JU JU invitations should be directed to infodesk@ihi.europa.eu.

    Website
    Funding&Tenders Call document the IHI JU 4th Call for proposals
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