💰 Funding Details

Understanding how infections foster and induce non-communicable diseases (HORIZON-JU-IHI-2025-11-02-two-stage)

Programme: Horizon Europe – Innovative Health Initiative Joint Undertaking (IHI JU) 11 ▸ HORIZON-JU-RIA

Type of Grant: Research & Innovation Action (RIA)

Total Indicative Budget per Project: €37,209,000 (no predefined minimum/maximum consortium size)

Call Modality: Two-stage (Short proposal ➜ Full proposal)

Opening Date: 17 June 2025

Deadlines:

• *Stage 1* – 09 Oct 2025, 17:00 (Brussels)

• *Stage 2* – 29 Apr 2026, 17:00 (Brussels)

Purpose of the Call

This topic finances large, multi-stakeholder research that deciphers causal links between infectious agents (IAs) and non-communicable diseases (NCDs) in order to:

* develop early diagnostic, preventative, and therapeutic strategies;

* generate data-driven vaccine concepts that can prevent chronic disease;

* deploy multi-omics biomarkers and AI-assisted cohort mining to stratify risk and personalise interventions; and

* ultimately reduce the long-term burden and cost of Europe’s most prevalent NCDs.

Expected Impacts

1. Accelerated access to cost-effective interventions for burdensome diseases.

2. Defined prevention strategies lowering lifetime risk.

3. Biomarker-guided early interventions that halt disease progression.

4. Improved quality of life & reduced healthcare costs through timely stratification.

5. Strengthened EU leadership by adopting innovative AI, multi-omics and EHDS-compliant data approaches.

Eligibility Snapshot

* Consortium: ≥3 independent legal entities from different eligible countries; at least one must be industry (as IHI JU encourages industry leadership) and one from academia or research.

* Funding Exclusions: Legal entities established in your country if your country = United Kingdom or Canada are *not* eligible for funding (may participate with own funds).

* Admissibility: 20-page limit (Stage 1) / 50-page limit (Stage 2) – follow Part B templates.

* Ethics & Open Science: Compliance with EHDS Regulation, AI Act, and Horizon Europe Open Science requirements (FAIR data, DMP, open access).

Funding Rate & Cost Model

HORIZON Action Grant (Budget-Based).

• Up to 100 % of eligible direct costs for non-profit entities.

• Up to 70 % for for-profit entities (the 25 % flat-rate indirect cost applies).

• IHI JU has no 3A (Availability, Accessibility, Affordability) obligations for this topic.

Ideal Consortium Profile

* Large biobanks & longitudinal cohorts with infection history and NCD endpoints.

* Pharma/biotech & vaccine developers for translational pathways.

* AI/ML SMEs specialised in federated analytics compliant with EHDS.

* Clinical centres for early-phase trials & validation.

* Regulatory science experts ensuring alignment with EMA, HTA and AI Act.

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📊 Evaluation Criteria

Evaluation Criteria & Weighting (two-stage RIA)

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

| Excellence | 50 % | 33 % | 4/5 |

| Impact | 50 % | 33 % | 4/5 |

| Quality & efficiency of implementation | – | 33 % | 3/5 |

What evaluators look for

* Excellence: Clear hypothesis linking specific IAs to defined NCD end-points; robust methodology integrating AI causal inference, statistics, and pre-clinical validation.

* Impact: Credible pathway to EU-level public-health benefit; alignment with EHDS & AI Act; plan for open data repository of IA–NCD causal links.

* Implementation: Balanced, experienced consortium; realistic Gantt chart; risk-mitigation plan for cohort heterogeneity and data privacy hurdles.

> The final ranking uses the IHI ranking rules with special tie-breakers on industry contribution and gender balance in leadership.

📝 Application Strategy

Strategic Application Guide

1. Build a Holistic, Balanced Consortium

1. Map complementary assets (cohorts, -omics platforms, AI pipelines, animal models).

2. Ensure geographical diversity across EU and Associated Countries (remember UK & CA funding exclusion).

3. Create an Industry–Academia–Clinical triangle with defined leadership roles.

4. Integrate patient organisations to strengthen impact and ethics sections.

2. Align Perfectly with Expected Outcomes

| Expected Outcome | Proposal Response |

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

| Causal links & biomarkers | Multi-omics work-package with longitudinal infection/NCD data and mechanistic studies in organoids & in-vivo models |

| Vaccine strategies | Translational WP designing multivalent prophylactic vaccines targeting IA-driven pathways |

| Early intervention | Small-molecule/biologic screening against infection-induced molecular switches |

| QoL improvement | Health-economic modelling showing reduced DALYs & cost savings |

| Innovative approaches | Federated AI pipeline compliant with EHDS + sandbox to align with AI Act |

3. Two-Stage Excellence Tactics

Stage 1 (20 pages)

* Crystal-clear concept diagram of IA→Mechanism→Biomarker→Intervention.

* Provide evidence of access to ≥2 large cohorts/biobanks (LoIs attached).

* Highlight industry commitment (cash or in-kind) early.

* Deliver succinct impact narrative tied to EHDS & European Cancer/AMR/NCD plans.

Stage 2 (50 pages)

* Expand to a fully costed implementation plan with Gantt & PERT.

* Add risk matrix including data privacy, AI bias, regulatory hurdles.

* Provide clinical development roadmap (regulatory milestones, EMA scientific advice).

* Detail IPR & exploitation strategy (incl. JU’s right to object to exclusive licences).

4. Compliance & Regulatory Integration

* Data governance: adopt GA4GH standards, plan for EHDS cross-border data access.

* AI Act readiness: classify ML tools (high-risk vs low-risk) and embed conformity assessment.

* Ethics: address dual-use, re-identification risk, and vulnerable populations.

* Open Science: pre-publish protocols, register assays, commit to Zenodo releases.

5. Budget & Value for Money

* Keep industrial partners’ funding rate at 70 %; document in-kind resources.

* Use unit-cost calculations for patient recruitment and biobanking to show realism.

* Allocate ≥5 % to project management & dissemination – critical in evaluation.

6. Sustainability & Exploitation

* Create a post-project exploitation board with investors, HTA bodies, ECDC.

* Outline licensing pathways for biomarkers/vaccines with affordability clauses.

* Plan spin-offs or public-private platforms that persist beyond funding.

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💡 Success Factors

Early Access to High-Quality Longitudinal Cohorts

Secure signed **MoUs or Data Transfer Agreements** with at least two EU-wide biobanks tracking infection history, vaccination records, and NCD outcomes. Attach LoIs in Stage 1 to prove feasibility.

Integrated Multi-Omics & AI Work-Packages

Design a **seamless pipeline** where genomics, transcriptomics, proteomics, and metabolomics feed into an **EHDS-compliant federated AI platform** for hypothesis generation and patient stratification.

Regulatory Science Embedded from Day 1

Include partners experienced in **EMA scientific advice & HTA early dialogues** to shape biomarker qualification dossiers and pave a clear route for vaccine/therapeutic approvals.

Robust Exploitation & IP Strategy

Outline **freedom-to-operate analyses**, patent landscapes, and JU-compatible licensing models. Show pathways for **commercialisation within 3–5 years** post-project.

Patient-Centric Design

Engage **patient advocacy groups** in governance boards, co-create informed-consent language, and incorporate **quality-of-life endpoints** to elevate societal impact scores.

Transparent Risk & Mitigation Framework

Provide a **living risk registry** covering scientific, regulatory, ethical, and data-privacy domains, with clear **contingency budgets** and decision gates.

❌ Common Mistakes to Avoid

Ignoring UK/Canada Funding Restriction

Applicants sometimes list **funded beneficiaries from the United Kingdom or Canada**, forgetting that these entities are *ineligible for IHI JU funding* under this topic. They can participate **only with own funds**; failure to clarify this leads to ineligibility.

Superficial Link to Expected Outcomes

Many proposals **describe infection & NCD correlation** but do **not demonstrate causal investigation pathways** (e.g., mechanistic validation, biomarker qualification). Reviewers penalise for weak alignment with the five mandatory outcomes.

Underestimating Data Governance Requirements

Overlooking **EHDS compliance, AI Act obligations, and GDPR cross-border data transfer rules** results in low scores under *Quality & Efficiency of Implementation*. Provide a clear data-protection impact assessment (DPIA) and federated analytics plan.

Fragmented Consortium without Industry Leadership

Submissions driven solely by academia often lack **translational and exploitation capacity**. IHI JU evaluates favourably **balanced PPP consortia** where industry co-leads scientific WPs and commits resources.

Budget Inflated with Non-Essential Costs

Including high travel, conference, or overhead costs without linking to **project deliverables** triggers negative *Value for Money* assessments. Keep budgets tied to tangible outputs (cohort access fees, sequencing, regulatory studies).

Late Stakeholder Engagement

Waiting until after proposal submission to contact **biobanks, patient groups, or regulators** often means missing mandatory Letters of Commitment, reducing credibility in impact pathways.

Understanding how infections foster and induce non-communicable diseases

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