Pre-clinical therapy studies for rare diseases using small molecules and biologicals – development and validation ERDERA 2025
European Partnership on Rare Diseases (ERDERA) Joint Transnational Call 2025
Amount not specified
Non-profit, Private Business, Research Institution, Public Institution
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What is the Pre-clinical therapy studies for rare diseases using small molecules and biologicals – development and validation ERDERA 2025 Call?
Expected Outcomes
• Predictive and pharmacodynamic biomarkers validated as surrogate endpoints in preclinical models.
• Reproducible preclinical data with independent confirmation, enhancing confidence in exploratory findings.
• Comprehensive PK/PD, toxicology and safety profiles for lead compounds or biologics.
• Dossiers and data packages meeting regulatory expectations to support Investigational New Drug (IND) applications or Clinical Trial Authorisations.
• Strengthened collaborative networks between research groups, model providers and regulatory experts to accelerate translation of therapies into first-in-human trials.
Scope Requirements
• Proposals must cover at least one of the five specified preclinical research areas.
• Translatability into humans must be the central focus; projects should demonstrate relevance to human biology.
• Applicants must demonstrate access to or collaboration with relevant scientific and regulatory expertise (e.g., innovation task forces, competent national authorities).
• Research must adhere to applicable ethical, safety and regulatory standards for preclinical work.
• Projects must be completed within the call timeline (open mid-December 2024; close mid-February 2025).
Special Conditions
• Research must concern rare diseases as defined by the partnership.
• Regulatory compliance: studies supporting clinical trial readiness must conform to EMA/FDA or national competent authority requirements.
• Independent replication studies must be conducted in laboratories separate from the original exploratory work.
• Multi-disciplinary or multi-institutional collaborations are encouraged to ensure access to specialized models and regulatory expertise.
• Applicants must register with the ERDERA call secretariat and adhere to submission guidelines and deadlines.
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