Validation of Fluid-derived Biomarkers for the Prediction and Prevention of Brain Disorders

Last update: Jan 14, 2025 Last update: Jan 14, 2025

Details

Location:

EU 27

Funding agency:

Horizon Europe (2021 - 2027)

Contracting authority type:Development Institution

Status:Awarded

Budget: EUR 25,000,000

Award ceiling: EUR 8,000,000

Award floor: EUR 6,000,000

Sector:Health, Research

Languages:English

Eligible applicants:Unrestricted / Unspecified

Eligible citizenships:

Afghanistan, Albania, Algeria, A ...
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Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Colombia, Comoros, Congo, Costa Rica, Cote d'Ivoire, Croatia, Cuba, Curaçao, Cyprus, Czech Republic, Dem. Rep. Congo, Denmark, Djibouti, Dominica, Commonwealth of, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Eswatini (Swaziland), Ethiopia, Faroe Islands, Fiji, Finland, France, French Polynesia, French Southern Territory, Gabon, Gambia, Georgia, Germany, Ghana, Greece, Greenland, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, Hungary, Iceland, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kiribati, Kosovo, Kyrgyzstan, Laos, Latvia, Lebanon, Lesotho, Liberia, Libya, Lithuania, Luxembourg, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Mauritania, Mauritius, Micronesia, Moldova, Mongolia, Montenegro, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, Nicaragua, Niger, Nigeria, North Korea, North Macedonia, Norway, Pakistan, Palestine / West Bank & Gaza, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Rwanda, Saint Lucia, Saint Martin, Saint Vincent and the Grenadines, Samoa, Sao Tome and Principe, Senegal, Serbia, Sierra Leone, Slovakia, Slovenia, Spain, St. Pierre and Miquelon, Sudan, Suriname, Sweden, Syria, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Tunisia, Turkey, Turkmenistan, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Venezuela, Vietnam, Wallis and Futuna, Yemen, Zambia, Zimbabwe

Date posted: Dec 8, 2022

Attachments • 4

Description

Call Update

Jul 25, 2024 2:51:28 PM

CALL UPDATE: FLASH EVALUATION RESULTS
EVALUATION results

Published: 07.12.2022

Deadline: 11.04.2024

Available budget: EUR 25,000,000

We recently informed the applicants about the evaluation results for their proposals.

The results of the evaluation for the topic HORIZON-HLTH-2024-DISEASE-03-13-two-stage are as follows:

Number of proposals submitted (including proposals transferred from or to other calls): 11

Number of inadmissible proposals: 0

Number of ineligible proposals: 0

Number of above-threshold proposals: 7

Total budget requested for above-threshold proposals: EUR 55,649,250.89

Number of proposals retained for funding: 4

Number of proposals in the reserve list: 1

Funding threshold[1]: 14.5

Ranking

Number of proposals with scores lower or equal to 15 and higher or equal to 14: 4

Number of proposals with scores lower than 14 and higher or equal to 13: 1

Number of proposals with scores lower than 13 and higher or equal to 12: 2

Summary of observers’ report:

Two independent observers were asked to assist the European Health and Digital Executive Agency (HaDEA) in the evaluation of proposals submitted to 9 single and two-stage calls (covering 14 topics) with deadline on 11 April 2024, which were discussed during 2.5 weeks of consensus meetings. They followed the evaluation in order to assess and report on the implementation of the evaluation procedures, on the conduct and fairness of the evaluation process and on the application of the evaluation criteria. Based on the analysis conducted, the observers give independent advice for improvement of the evaluation process.

The evaluation process was fully transparent. The rules and guidelines to be followed were clearly communicated by documents provided to experts, by online and on-site briefings and by instructions given and, where necessary, repeated by the moderators. This ensured a fair and transparent procedure. The evaluation was conducted in an extremely fair and professional way, thanks to a thorough and meticulous preparation and to the helpful and competent HaDEA staff involved, including the quality checkers and the assistant team.

The lump sum method was used in this evaluation. Despite that the budget tables provided detailed information and that guidance was provided, many experts found it challenging assessing the proposed budgets.

The independent observers were impressed by the high quality of the evaluation, and made some further recommendations, for consideration in setting up the rules for the next framework programme. The most important advice is that a higher weight should be assigned to the Excellence criterion. It has at present a weight of 1/3 of the final score. This should be increased, as scientific excellence is the most important factor that determines the quality of a project. Such a change would be in line with international practices.

For questions, please contact the Research Enquiry Service.

[1] Proposals with the same score were ranked according to the priority order procedure set out in the call conditions (for HE, in the General Annexes to the Work Programme or specific arrangements in the specific call/topic conditions).

Apr 19, 2024 5:54:02 PM

Call HORIZON-HLTH-2024-DISEASE-03-two-stage has closed on 11 April 2024.

52 proposals have been submitted. The breakdown per topic is:
HORIZON-HLTH-2024-DISEASE-03-13-two-stage: 11 proposals
Evaluation results are expected to be communicated in July 2024 at the earliest.

Feb 13, 2024 12:06:52 PM

In order to best ensure equal treatment, successful stage 1 applicants do not receive the evaluation summary reports (ESRs) for their proposals, but this generalised feedback with information and tips for preparing the full proposal.

Information & tips

The proposals should address all the individual sub-criteria in each appropriate section of the proposal (Excellence, Impact, Implementation). E.g., the state of the art should be clearly referenced, the methodology and - where relevant – the technical robustness of AI should be clearly described, the pathways to the expected outcomes and impacts, the scale and significance of project’s contributions to the expected outcomes, and all other aspects need to be addressed.
If your proposal contains clinical studies, please read carefully the definition and guidance on the template ‘Information on clinical studies' published on the call page in the Participant Portal (Information on clinical studies (HE)) and remember to upload the template filled in when submitting your proposal.
In stage 2 the eligible costs will take the form of a lump sum contribution as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme. To get started, please read lump sum funding and the guide Lump sum funding - what do I need to know, with details on how to complete the Excel workbook. Recommended: Excel 2013 (Windows) / Excel 2016 (Mac OS) or more recent.
In your stage 2 proposal, you have a chance to address or clarify these issues.

Please bear in mind that your full proposal will now be evaluated more in-depth and possibly by a new group of external experts.

Please make sure that your full proposal is consistent with your short outline proposal. It may NOT differ substantially. The project must stay the same.

Jan 29, 2024 6:35:29 PM

In accordance with General Annex F of the Work Programme, the evaluation of the first-stage proposals was made looking only at the criteria ‘Excellence’ and ‘Impact’. The threshold for both criteria was 4. The overall threshold (applying to the sum of the two individual scores) was set at 9.5 points for topic HORIZON-HLTH-2024-DISEASE-03-13-two-stage that allowed the total requested budget of proposals admitted to stage 2 be as close as possible to 3 times the available budget of EUR 25 000 000 (and not below 2.5 times the budget).

The results of the evaluation are as follows:
- Number of proposals submitted (including proposals transferred from or to other calls): 74
- Number of inadmissible proposals: 0
- Number of ineligible proposals: 0
- Number of above-threshold proposals: 11
- Total budget requested for above-threshold proposals: EUR 86 496 227

We recently informed the applicants about the evaluation results for their proposals.

For questions, please contact the Research Enquiry Service.

https://research-and-innovation.ec.europa.eu/contact-us/research-enquiry-service_en

Sep 20, 2023 6:42:56 PM

First stage of call HORIZON-HLTH-2024-DISEASE-03-two-stage closed on 19 September 2023. 293 proposals were submitted. The breakdown per topic is:

HORIZON-HLTH-2024-DISEASE-03-13-two-stage: 74 proposals
Evaluation results are expected to be communicated on 24 January 2024 at the earliest.

Mar 31, 2023 11:12:09 AM

The submission session is now available for: HORIZON-HLTH-2024-DISEASE-03-13-two-stage(HORIZON-RIA)

Mar 3, 2023 12:37:23 PM

The Director-General responsible for the call HORIZON-HLTH-2024-DISEASE-03-two-stage, has decided to postpone the opening of this topic from 30 March 2023 to 26 April 2023.

Validation of fluid-derived biomarkers for the prediction and prevention of brain disorders

TOPIC ID: HORIZON-HLTH-2024-DISEASE-03-13-two-stage

Programme: Horizon Europe Framework Programme (HORIZON)
Call: Tackling diseases (Two stage - 2024) (HORIZON-HLTH-2024-DISEASE-03-two-stage)
Type of action: HORIZON-RIA HORIZON Research and Innovation Actions
Type of MGA: HORIZON Lump Sum Grant [HORIZON-AG-LS]
Deadline model: two-stage
Planned opening date: 30 March 2023
Deadline dates: 19 September 2023 17:00:00 Brussels time
11 April 2024 17:00:00 Brussels time

Topic description

ExpectedOutcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to most of the following expected outcomes:

The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to underpin the development of the diagnostics, and as such can also facilitate the development of effective therapeutics and/or preventive strategies.
The scientific and clinical communities advance the field through a better understanding of mechanisms underlying brain disorders at the molecular, cellular and systemic level.
The scientific and clinical community make wide use of newly established and where relevant open access databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR^[1] principles, thereby encouraging further use of the data.
Policymakers, funders, scientific and clinical communities, patient organisations, regulators and other relevant bodies are informed of the research advances made, while health professionals envisage use of the biomarker tests for early detection of the disorder and for guiding patients in the selection of personalised treatments/interventions.
Patients and caregivers are sufficiently engaged with the research, which also caters for their needs.

Scope:

Treatments for some high-burden brain disorders are potentially on the horizon^[2]. Consequently, many patients and citizens will want to know if they are eligible for these treatments. For some disorders, a definitive diagnosis is difficult, expensive and time-consuming. Simple blood or other fluid-derived (e.g. saliva, urine, sweat) tests for markers that may indicate early signs of the disorder, and which can be deployed for widespread clinical use are needed.

The brain disorders within the scope of this topic fall under two categories, namely those listed under chapters six and eight of the International Classification of Diseases^[3]. Proposals in the area of mental disorders are encouraged.

Proposals should address all of the following aspects:

Proposals should aim to validate biomarkers that can reliably confirm early stages of the human brain disorder and guide treatment/ intervention selection^[4].
Proposals should aim to provide evidence supporting the regulatory acceptance of the biomarkers^[5].
Exploitation of existing data, biobanks, registries and cohorts is expected, together with the generation of new key data.
Inclusion of patients or patient organisations in the research is strongly encouraged, as to ensure that their views are considered.
Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors should be taken into consideration in the study.
To enable sharing of samples, quality data and advanced analytical and digital tools, consideration should be made for using infrastructures already developed at the European^[6] or national level.
To enable the management of brain disorders, consideration should be made in demonstrating the gained cost efficiency.
SME participation is encouraged.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

[1]See definition of FAIR data in the introduction to this work programme part.

[2]For example, the Nature news feature (March, 2022): Could drugs prevent Alzheimer’s? These trials aim to find out. doi: https://doi.org/10.1038/d41586-022-00651-0

[3]International Classification of Diseases 11^th Revision (ICD-11), developed by the World Health Organization (WHO); Chapter 6: ‘Mental, behavioural or neurodevelopmental disorders’; Chapter 8: ‘Diseases of the nervous system’.

[4]The biomarker should link to a clinical meaningful endpoint.

[5]The European Medicines Agency (EMA) offers scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals.

[6]EU-supported infrastructures include, for example, the BBMRI-ERIC infrastructure for biobanking, the EBRAINS research infrastructure, and various platforms developed by the Innovative Medicines Initiative (IMI) and its successor the Innovative Health Initiative (IHI).