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ERDERA - cofund partnership

This call addresses research studies in rare diseases

Status

“Pre-clinical therapy studies for rare diseases using small molecules and biologicals – development and validation”

On 10 December 2024 a first joint transnational cofunded call for project funding under the new, large-scale Horizon Europe partnership ‘ERDERA’ was launched, which aims to make Europe a global leader in rare diseases research and innovation, and deliver concrete health benefits to rare disease patients in the next decade by advancing prevention, diagnosis and treatment research.

ERDERA will initiate a range of activities the coming years, with both internal (i.e. ERDERA members) and external activities. The main external activity is about organising open calls for research projects, which is an integral part of this partnership. The FWO, being a research funder, will participate in these calls, with a focus on funding public research institutes from Flanders and their researchers.

This first transnational call addresses 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:

  1. development of novel therapies in a pre-clinical 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.
  2. development of predictive and pharmacodynamics biomarkers correlated to the efficiency of the therapy in a preclinical setting that could serve as surrogate endpoints.
  3. replication of pre-clinical studies in an independent lab to increase validity of exploratory findings.
  4. 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 a 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/regional authorities).

More information

Detailed information on the above-mentioned thematic and topics can be consulted in the call text on the ERDERA call webpage.

Next to the ‘general’ rules for participation, as described in the call text, the ‘national/regional’ FWO eligibility criteria have to be respected alike, as they are of importance for the eligibility of the subproject from Flanders (FWO). These FWO modalities for participation can be consulted in the ‘ANNEX 1: Country and Region-Specific Guidelines’, which is enclosed in the Guidelines for Applicants document (from p. 19 onwards).

Submission

Deadline for pre-proposal submission AND national/regional pre-application via the FWO e-loket

13 February 2025, 13.00 CET (Brussels)

FWO-modalities

FWO participation and -funding addresses both the FWO fundamental (FO) and Strategic Basic Research (SBO) funding channels in this call. The type and scope of the proposed research project will determine the choice of funding channel for the research performed within Flanders (i.e. more fundamental in nature or strongly focused on valorisation potential). Non-compliance with the specific requirements per funding channel might lead to non-eligibility. Note that this is only an FWO requirement: European and/or international partners within the project consortium are free to choose their type of research.

For the fundamental funding channel the respective regulations apply. For the SBO funding channel the SBO regulation should be considered. The latter concern projects with a primarily economic and/or societal finality, of which ‘valorisation’ is an essential - and mandatory - aspect.

Submission

Research proposals are submitted to the ERDERA call secretariat, after registration and by making use of the submission platform which can be found on the submission website, by consortia of European and international researchers, according to the applicable procedures and eligibility criteria included in the call documents mentioned above. Practical information can also be consulted in the Guidelines for Applicants document’, and an example of a pre-proposal template is also available on the ERDERA website.

In case the consortium includes more than one partner requesting funding from FWO, a single online form should be submitted by the PI/(main)promoter, by using its personal e-loket, and containing all relevant information from the different Flemish partners.

The deadline to submit the administrative application to the FWO is the same as the deadline of the joint transnational call (pre-proposal stage). To ensure the eligibility of the proposal, it is recommended to consult the FWO administration at least one week in advance.

New: FWO administrative pre-registration

Applicants for FWO funding must submit an administrative application via the FWO e-loket (only during the pre-proposal phase):

  • For fundamental research projects (FO) select the application type: ‘Research projects – European programme fundamental research’;
  • For strategic basis research projects (SBO) select the application type: ‘Research projects – European programme strategic basic research’.

Call budget

The FWO is able to support two projects for a 36 months duration, with an available maximum budget of 350.000 euro (overhead included) per project/consortium. The FWO budgetary rules, which differ per funding channel, are also clarified in the Guidelines for Applicants document (from p. 19 onwards).

The cofund partnerships under the Horizon Europe framework programme provide for co-financing by the European Commission in addition to national/regional funds. This can result in additional support at the time of the funding decision, based on the final ranking and after international peer review, which can generate additional projects – also for Flanders.

Key points and deviations from the ‘regular’ FWO participatory framework

Some key points and deviations from the ‘regular’ FWO participatory framework to consider:

  • Participation in the framework of the European co-funded partnerships does not interfere with the ‘regular/national’ FWO project submission framework, and is consequently not taken into account with regard to the max. available number of applications that can be applied for and the ones already running. However, researchers can only participate in a maximum of two different international consortia per call, provided they concern different subjects.
  • Diverging overhead arrangements apply for what the fundamental and SBO funding channels are concerned, which is clarified in the Guidelines for Applicants document (from p. 19 onwards).
  • SBO projects aimed at developing a spin-off are not eligible in this context. As such, no mention of this option should be made in the FWO pre-registration document, nor within the ERDERA proposal.
  • Projects have a max. duration of 36 months and should be budgeted accordingly. Automatic extensions/no-cost prolongations are not accepted in this framework. Consequently, article 28 of the FWO research project regulations and article 14 of the SBO project regulations are explicitly excluded.
  • The PI, for each of the participating institutions from Flanders, must hold an admissible appointment that fully covers the duration of the research project. With regard to the ‘FO’ projects, and more specifically regarding the ‘emeritus’ regulation (artikel 10, §7): it does not apply in this context.

Researchers are strongly advised to contact the FWO before submission regarding the eligibility criteria. This to avoid the ineligibility of a researcher individually, and the project consortium as a whole.

Contact

For additional information FWO participation, please contact:

Toon Monbaliu (General and ‘FO’)

europe@fwo.be  

+32 (02)2 550 15 70

Kristien Peeters (‘SBO’)

europe@fwo.be

+32 (0)2 550 15 95