💰 Funding Details

Funding Description

Call identifier: HORIZON-HLTH-2025-01-DISEASE-03

Action type: HORIZON-RIA — Lump-Sum

Maximum EU contribution per project: €80 million

Opening/Deadline: 22 May 2025 ➜ 16 Sep 2025 (17:00 Brussels time)

What is financed?

1. Pre-clinical optimisation of existing antibody or antibody-derived protein (ADP) candidates against at least one priority virus (Arenaviridae, Hantaviridae, Poxviridae, Paramyxoviridae, Togaviridae).

2. GMP batch production within the EU/EEA.

3. First-in-human Phase I safety trials demonstrating a clear regulatory path.

4. Regulatory & market-access enablers (CMC dossiers, engagement with EMA/FDA, scalability & cost-of-goods studies).

5. Project management, ethics, gender & inclusiveness measures, communication, exploitation and data stewardship aligned with FAIR principles and the Horizon Europe open-science policy.

Budget logic under Lump-Sum MGA

* One consolidated lump sum covers all eligible costs.

* Payments are linked to the accomplishment of work-package-level deliverables and milestones agreed upfront.

* No financial reporting of real costs → focus on technical progress & risk mitigation.

Strategic fit with Destination “Tackling diseases and reducing disease burden”

The topic directly supports:

* EU pandemic preparedness (HERA)

* Diversification of antiviral countermeasures beyond small molecules

* Strengthening EU leadership in biologics R&D and manufacturing

Indicative project profile

* Consortium size: 8–15 beneficiaries (academia, SMEs, large pharma/biotech, clinical sites, research infrastructures, regulators as observers).

* Duration: 48–60 months.

* TRL progression: from ≥ TRL-3/4 (lead candidate identified) ➜ TRL-6 (completion of Phase I).

📊 Evaluation Criteria

Expert Evaluation Criteria Explained

| Criterion | Weight | What evaluators look for |

|-----------|--------|--------------------------|

| Excellence (threshold 4/5) | 1 | • Novelty & validity of antibody/ADP approach

• Robust pre-clinical methodology (humanised mice, NHP if requested)

• Gender, diversity, ethics integration

• Access to BSL-3/4 facilities & ISIDORe services |

| Impact (threshold 4/5) | 1 | • Credible pathway to Destination impacts

• Scalability & affordability in pandemic context

• IP, exploitation, open-science balance

• Contribution to EU strategic autonomy in biologics |

| Quality & Efficiency of Implementation (threshold 4/5) | 1 | • Coherent work plan tied to lump-sum milestones

• Complementarity & capacity of consortium

• Risk management & contingency

• Budget adequacy and justification |

Evaluators use half-point scoring and reach consensus. A cumulative score ≥ 12/15 is required for funding.

📝 Application Strategy

Strategic Application Guide

1. Build a purpose-fit consortium

* Science owners who already possess neutralising antibody/ADP IP.

* GMP manufacturer located in the EU/EEA with viral-BSL capability.

* Translational SMEs to drive CMC and platform innovations.

* Clinical centres in your country and endemic regions to ensure rapid recruitment and equity.

* ISIDORe-linked infrastructure for in-vivo BSL-4 studies.

2. Articulate a sharp scientific narrative

1. Map each work package to an expected outcome listed in the call.

2. Provide head-to-head data versus existing antivirals to justify complementarity.

3. Explain how broad-spectrum or multi-specific formats mitigate viral escape.

3. De-risk implementation under Lump-Sum

* Define clear, binary milestones (e.g., “GMP batch meets EMA release specs”).

* Attach contingency plans (back-up candidates, dual suppliers).

* Apply an 80/20 budget split: 80 % direct R&D WPs, 20 % enabling, management & dissemination.

4. Regulatory foresight

* Present written EMA Innovation Task Force advice or FDA INTERACT notes.

* Include a draft IB/IMPD table of contents.

* Describe compliance with ICH, WHO GMP, and gender/age inclusivity in trial design.

5. Impact & exploitation

* Quantify pandemic demand scenarios and cost-of-goods projections (€/dose).

* Outline access strategy (tiered pricing, voluntary licensing in your country).

* Align with ERA4Health and Global Research Collaboration for Infectious Disease Preparedness (GLoPID-R) for follow-on Phase II/III funding.

6. Cross-cutting excellence

* Data management in line with EOSC & FAIR.

* Integration of AI/ML for epitope mapping.

* Detailed plan for sex- and age-disaggregated endpoints.

💡 Success Factors

Demonstrated Neutralisation Breadth

Provide comparative data showing activity against **multiple strains or related viruses**, positioning the candidate as a high-value pandemic countermeasure.

Early EMA Scientific Advice

Attach minutes or confirmation of EMA ITF or SA meetings to prove **regulatory feasibility** and derisk the clinical plan.

ISIDORe Infrastructure Integration

Leveraging **BSL-3/4 animal and imaging platforms** shortens timelines and showcases optimal use of EU research infrastructures.

Robust Gender & Diversity Plan

Detail how **sex, age, ethnicity, disability** influence immune response and trial recruitment, aligning with Horizon Europe policy priorities.

Clear Access & Commercialisation Model

Present tiered pricing, **equitable licensing in your country**, and partnership with HERA/JPA to facilitate stockpiling.

Contingency-Ready Work Plan

Include **backup antibody clones, dual manufacturing lines, and alternative animal models** mapped to specific risk triggers.

❌ Common Mistakes to Avoid

Ignoring EU/EEA GMP Production Requirement

Many applicants outsource manufacturing to facilities outside the EU/EEA, which **breaches the call mandate** and leads to ineligibility or low implementation scores.

Weak Regulatory Engagement

Proposals that *postpone* EMA or national competent-authority dialogue until after grant signature lack a **clear authorisation pathway**, undermining Impact.

Single-virus Focus without Broad Justification

Targeting only one priority virus **without explaining cross-reactivity or portfolio diversification** is viewed as limited preparedness value.

Vague Lump-Sum Milestones

Deliverables expressed as 'progress reports' instead of **binary, verifiable achievements** hinder payment triggering and raise implementation risks.

Insufficient Inclusion of SMEs and Endemic-Region Partners

The call explicitly encourages SMEs and partners from your country where viruses are endemic; failure to include them weakens capacity, impact and equity angles.

Neglecting Cost-of-Goods Analysis

Evaluators expect evidence that the candidate can be produced **at scale and affordable cost**; omitting a techno-economic assessment erodes credibility.

Development of antibodies and antibody-derived proteins for the prevention and treatment of infectious diseases with epidemic potential

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