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ERDERA Joint Transnational Call 2025

Canadian Institutes of Health Research

CIHR-IG is pleased to be partnering with approximately 34 international funding organizations in the context of this European Rare Diseases Research Alliance (ERDERA) Joint Transnational Call (JTC) 2025. CIHR-IG is committed to expanding and improving the diagnosis and treatment of rare diseases by creating the conditions needed to bring together creative, dynamic, interdisciplinary teams of researchers from across Canada and the European Community (EC) to collaborate for better health outcome for the rare disease patient community.

The topic of the call is pre-clinical therapy studies for rare diseases using small molecules and biologicals – development and validation.

Projects should focus on a group of rare diseases or on a single rare disease if there is no valid rationale/evidence for the benefit of grouping diseases. If focusing on a single rare disease, applicants must clearly specify why working on a group of rare diseases is not appropriate. The classification of rare diseases follows the European definition, i.e. a disease affecting not more than five in 10,000 persons in the European Community, EC associated states, and Canada.

Only a few rare diseases benefit from treatment options, but possible commonalities exist between groups of rare diseases (i.e., common disease biological pathways, clinical symptoms and/or clinical phenotypes and importantly the combination of those common features). Therefore, with the view of offering more options for more patients suffering from different rare diseases, applicants are strongly encouraged to work on groups of rare diseases with commonalities and assemble criteria of meaningful grouping of the rare diseases under study, based on state-of-the-art scientific discoveries and clinical practice.

Research Areas

Research studies on therapies using small molecules, small non-coding chemically synthesized nucleic acid-based therapies, repurposed drugs or biologicals (e.g., antibodies or proteins such as enzymes, immune modulators or growth factors etc.).

Proposals must cover at least two of the following areas:

Development of novel therapies in a preclinical setting through cell, organoid and animal disease model studies, and/or use of in silico or artificial intelligence models to accelerate the success rate of the pre-clinical stage;
Development of predictive and pharmacodynamics biomarkers correlated to the efficiency of the therapy in a preclinical setting that could serve as surrogate endpoints;
Replication of pre-clinical studies in an independent lab to increase validity of exploratory findings;
Pre-clinical proof of concept studies for evidence of pharmacological activity in vitro and in vivo, pharmaco-kinetics and pharmaco-dynamics of the investigational drug (i.e., small molecule(s) and/or biologic) and first toxicology and safety data as well as studies to support readiness for initiating clinical trial authorization conforming to regulatory requirements.

Translatability into humans should be the key focus of the project, and applicants should demonstrate access to relevant scientific or regulatory expertise (e.g., through innovation task forces or competent national authorities).

Excluded Approaches and Topics

The following approaches and topics are excluded from the scope of the JTC 2025:

ATMP therapies (gene therapy medicinal product (including mRNA-based therapies), somatic cell therapy medicinal product, tissue engineered product, according to EMA definition).
Development of new cell/organoid/animal models, which should already be established.
Set-up or extension of natural history studies / patient registries.
Interventional clinical trials to prove efficacy of drugs/treatments/surgical procedures/medical procedures. This includes studies comparing efficacy, e.g., two surgical techniques or therapies, and projects whose main objective is the implementation of a clinical phase IV pharmacovigilance study.
Projects focusing only on rare neurodegenerative diseases that are within the focus of the Joint Programming Initiative on Neurodegenerative Disease Research (JPND). These are: Alzheimer’s disease and other dementias; Parkinson’s disease (PD) and PD-related disorders; Prion diseases; Motor Neuron Diseases; Huntington’s disease; Spinal Muscular Atrophy and dominant forms of Spinocerebellar Ataxia. Interested researchers should refer to the relevant JPND calls. However, childhood dementias/neurodegenerative diseases are eligible.
Rare infectious diseases, rare cancers and rare adverse drug events in treatments of common diseases. Rare diseases with a predisposition to cancer are eligible.

Specialties

Rare Diseases

Eligibility Requirements

For an application to be eligible, all the requirements stated below must be met:

The Nominated Principal Applicant (NPA) leading the Canadian component must be an independent researcher affiliated with a Canadian postsecondary institution and/or its affiliated institutions (including hospitals, research institutes and other non-profit organizations with a mandate for health research and/or knowledge translation).
The NPA must have their substantive role in Canada for the duration of the requested grant term.
The Institution Paid for the Canadian-led application must be authorized to administer CIHR funds by the application deadline (see List of CIHR Eligible Institutions).
If the Canadian team in the consortium includes more than one Canadian researcher, only one of them must be named the NPA on the Pre-Proposal and Full Proposal submitted to CIHR.
CIHR will follow the Early Career Researcher definition as outlined in the JTC 2025 call for proposals (Section 4).
An individual cannot submit more than one application as an NPA. If the NPA submits more than one application, CIHR will automatically withdraw the last application(s) submitted based on timestamp of submission.

Eligible Countries:

Canada

Sponsor Details

Sponsor Institute/Organizations: Canadian Institutes of Health Research

Sponsor Type: Corporate/Non-Profit

Address: 160 Elgin Street, 9th Floor Address Locator 4809A Ottawa, Ontario K1A 0W9, Canada

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