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Grant Analysis

Purpose & Target

Core Objective: To advance the development of antibodies and antibody-derived proteins for preventing and treating infectious diseases with epidemic potential, thereby strengthening global health security and preparedness.
Target Recipient Type and Size: Primarily research and innovation entities, including universities, public bodies, and private companies. Small and Medium-sized Enterprises (SMEs) are specifically encouraged to participate.
SECTOR-SPECIFIC: Health, Biotechnology, Pharmaceutical Development.
Geographic Scope: Open to legal entities established in EU Member States, countries associated with Horizon Europe, and the United States of America. Participation of third countries where target viruses are endemic or have experienced outbreaks is encouraged.
Key Filtering Criteria: Focus on specific viral families (Arenaviridae, Hantaviridae, Poxviridae, Paramyxo, Togaviridae), development stage (preclinical to first-in-human clinical safety studies), and the type of therapeutic (antibodies/antibody-derived proteins).
Grant Frequency and Program Context: This is a single-stage call within the Horizon Europe program's 'Health' cluster for 2025, specifically under the 'Tackling diseases and reducing disease burden' destination. Horizon Europe is a recurring multi-annual funding program.

Financial Structure

Funding Type: Lump sum contributions.
Total Topic Budget: EUR 50,000,000 for the HORIZON-HLTH-2025-01-DISEASE-03 topic.
Grant Amount per Project: EUR 10,000,000 (Expected 5 grants of this size).
Eligible Costs: Costs that would typically be eligible in an actual cost grant, including:
Personnel costs (employees, direct contractors, seconded persons, SME owners).
Subcontracting costs.
Purchase costs (travel, subsistence, equipment, other goods, works, and services).
Other cost categories (financial support to third parties, internally invoiced goods/services, transnational/virtual access to research infrastructure, PCP/PPI procurement, Euratom Cofund staff mobility, ERC additional funding).
Ineligible Costs: Costs that would be ineligible under standard Horizon Europe rules.
Indirect Costs: Calculated by applying a 25% flat rate to eligible direct costs.
Payment Mechanism: Payments do not depend on actual costs incurred. Lump sum contributions per work package are paid upon proper implementation of the work package in accordance with the grant agreement.
Financial Reporting: Beneficiaries have no obligation to document costs incurred for the action, as financial checks/audits will focus on technical implementation and fulfillment of work package conditions.
Co-financing Principle: The total estimated costs of the action must be greater than the estimated Union contributions, ensuring compliance with co-financing.
Financial Guarantees: Between 5% and 8% of the total lump sum is retained as a contribution to the Mutual Insurance Mechanism.
Currency: EUR.

Eligibility Requirements

Organization Type and Structure

Eligible: Any legal entity that can conduct research and innovation activities.
SME (Small and Medium-sized Enterprises) are explicitly encouraged.
UNIVERSITY and PUBLIC research organizations are typically eligible and common participants in Horizon Europe.
ENTERPRISE (large enterprises) are also typically eligible.
OTHER includes research organizations and other legal entities as defined by Horizon Europe rules.
Partnership Requirements: Projects are expected to be collaborative, implying CONSORTIUM is required, involving multiple organizations.

Geographic Location

Eligible Countries for Funding:
EU Member States: AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, GR, HU, IE, IT, LV, LT, LU, MT, NL, PL, PT, RO, SK, SI, ES, SE.
Countries associated with Horizon Europe: Albania (AL), Bosnia and Herzegovina (BA), Georgia (GE), Iceland (IS), Israel (IL), Moldova (MD), Montenegro (ME), North Macedonia (MK), Norway (NO), Serbia (RS), Turkey (TR), Ukraine (UA), United Kingdom (UK).
United States of America (US) legal entities are eligible to receive Union funding.
Encouraged Participation: Third countries where the specified viruses are endemic or where outbreaks have occurred or are ongoing.

Technical and Operational Capacity

Capability to conduct preclinical studies on antibodies and antibody-derived proteins.
Ability to prepare Good Manufacturing Practice (GMP) quality test batches in the EU or European Economic Area.
Capacity to carry out first-in-human clinical safety studies.
Access to and ability to leverage state-of-the-art research infrastructures, such as those contributing to the ISIDORe project.
Track record: Implied need for expertise in relevant scientific and clinical fields.

Exclusion Criteria

Entities assessed as 'high-risk suppliers' of mobile network communication equipment (and any entities they own or control) are not eligible to participate if the topic is identified as 'subject to restrictions for the protection of European communication networks'.

Application Process

Application Timeline and Deadlines

Submission Deadline: 2025-09-16 at 00:00:00.000+0000 (Brussels time, likely).
Planned Opening Date: 2025-05-22.
Evaluation Period: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes (specific dates not provided).

Submission Process

Application Procedure: Single-stage submission.
Submission Platform: Electronic Submission Service via the Funding & Tenders Portal.
Authentication: Requires authentication (e.g., EU Login account) to access the submission system. SMS authentication is no longer possible.
Draft Proposals: Existing draft proposals can be accessed via the 'My Proposals' page of the 'My Area' section on the Funding & Tenders Portal.

Required Documentation and Materials

Standard Application Form (HE RIA, IA): Specific to this call, available in the Submission System.
Detailed Budget Table (HE LS): Required for lump sum proposals.
Clinical Studies Annex: Applicants must provide details of their clinical studies using the template provided in the submission system.

Support and Guidance

Comprehensive Resources: Online Manual, HE Programme Guide, Funding & Tenders Portal FAQ, Research Enquiry Service.
Direct Assistance: National Contact Points (NCPs), Enterprise Europe Network (EEN) for SMEs, IT Helpdesk for technical issues.
Specialized Support: European IPR Helpdesk for intellectual property, CEN-CENELEC and ETSI Research Helpdesk for standardization.
Partner Search: A service is available to help find partner organizations for proposals.

Evaluation Criteria

Standard Horizon Europe Evaluation Criteria

Excellence: Quality of the proposed research and innovation activities.
Scientific and technical quality, methodology, clarity of objectives.
Impact: Potential of the project to contribute to expected outcomes and broader societal, economic, and environmental impacts.
Contribution to EU and global health security, reduction of disease burden, strengthening R&I expertise.
Quality and Efficiency of Implementation: Soundness of the work plan, appropriateness of resources, and management structure.
Management structures, financial plan, risk assessment.

Specific Scoring Factors for this Topic

Relevance to Expected Outcomes:
Demonstrating a clear pathway to contributing to improved scientific and clinical understanding of prophylactic and treatment options.
Providing access to experimental antibodies and antibody-derived proteins for emerging/re-emerging viral infections.
Making candidate antiviral therapies available for clinical deployment during epidemics/pandemics.
Diversification and Acceleration:
Ability to diversify and accelerate the global prophylactic and therapeutic R&D portfolio for specified viral infections.
EU's Leading Role:
Potential to strengthen the leading role of the EU in prophylactic and therapeutic research and development.
Regulatory Pathway:
Clear regulatory pathway for market authorization of developed candidates.
Timely engagement with regulatory bodies.
Quality and Safety Standards:
Adherence to Good Manufacturing Practice (GMP) standards for test batch production.
Societal and Ethical Considerations:
Attention to critical biological and social factors such as sex, age, ethnicity, and disability in clinical studies.
Infrastructure Leverage:
Effective leveraging of already existing and emerging state-of-the-art research infrastructures (e.g., ISIDORe project).
International Cooperation:
Encouraged participation of third countries where the target viruses are endemic or outbreaks have occurred/are ongoing, contributing to the project's reach and impact.

Compliance & Special Requirements

Regulatory Compliance

Good Manufacturing Practice (GMP): Production of test batches must adhere to GMP standards. GMP ensures medicinal products are consistently produced and controlled to quality standards appropriate for their intended use.
Regulatory Engagement: Applicants are expected to engage with regulatory bodies in a timely manner to ensure the adequacy of proposed actions from a regulatory perspective.
Satellite Data Use: If projects utilize satellite-based earth observation, positioning, navigation, or related timing data/services, beneficiaries must use Copernicus and/or Galileo/EGNOS.

Ethical Standards and Considerations

Clinical Studies: Special attention must be paid to critical biological and social factors such as sex, age, ethnicity, and disability.

Technical and Infrastructure Requirements

Research Infrastructures: Proposals should advance research by leveraging already existing and emerging state-of-the-art research infrastructures, such as those that contributed to the ISIDORe project.

Data Protection and Intellectual Property

Data Protection and Privacy: Not explicitly detailed in the provided documents, but standard Horizon Europe rules and EU regulations (e.g., GDPR) will apply.
Intellectual Property: Not explicitly detailed in the provided documents, but standard Horizon Europe rules and grant agreement provisions will apply.

Unique Aspects and Strategic Opportunities

Focus Areas: Projects must exclusively focus on developing antibodies and/or antibody-derived proteins targeting specific priority viruses: Arenaviridae (Junin, Lassa), Hantaviridae (Hantaan, Andes, Sin Nombre), Poxviridae (Variola major), Paramyxo (Hendra, Nipah), and Togaviridae (Venezuelan equine encephalitis virus).
Impact Expectation: Expected to increase therapeutic options for clinical deployment in case of an epidemic or pandemic, and strengthen the EU's leading role in prophylactic/therapeutic R&D.
Affordability and Scale: Proposals should include a critical discussion on the amenability of products to production and distribution at an affordable cost and at a scale sufficient to meet demand in a pandemic context.
Synergies: The European Commission encourages cooperation between EU-funded projects for cross-fertilisation and synergies, including with projects under other Clusters or Pillars of Horizon Europe, or ongoing Horizon 2020 projects. Synergies with the European Health Emergency and Response Authority (HERA) and the EU4Health Programme are also sought.

Grant Details