💰 Funding Details

Funding Description – HORIZON-HLTH-2025-01-DISEASE-07

1. Grant Snapshot

* Title: Tackling high-burden for patients and under-researched medical conditions

* Call ID: HORIZON-HLTH-2025-01-DISEASE-07

* Programme / Destination: Horizon Europe – Cluster 1 Health / “Tackling diseases and reducing disease burden”

* Type of Action: Research & Innovation Action (RIA) – 100 % funding rate

* Indicative EU contribution per project: €8 – 15 million (no formal cap, but the overall topic budget is €80 million and evaluators will scrutinise cost-efficiency)

* Opening date: 22 May 2025

* Deadline (single stage): 16 Sept 2025, 17:00 CET (Brussels time)

* Project duration (typical): 48–60 months

2. What the Grant Funds

The call finances the full research‐innovation continuum from basic discovery to clinical validation and guideline development for *one* high-prevalence, high-burden yet under-researched condition:

• Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS)

• Autism (neurodevelopmental disorder)

• Gynaecological diseases (e.g. endometriosis, adenomyosis, PCOS)

• Low back pain

• “Other” conditions identified in the 2023 EC scoping study and not covered by previous 2024 call

Fundable activities include (non-exhaustive):

* Multi-omics, imaging, molecular and psychosocial *pathophysiology* studies

* Identification/validation of *biomarkers* for diagnosis, monitoring, stratification

* Development of *clinically relevant models* (in-vitro, in-silico, animal, organ-on-chip, AI)

* *Exploratory or confirmatory clinical studies* (interventional or observational) – template annex mandatory

* Integration of existing *registries, cohorts, biobanks*; generation of FAIR-compliant new data

* *SSH* investigations (stigma, quality-of-life, health-economics, gender, ethics)

* Creation/upgrade of *clinical guidelines*, decision-support tools & policy briefs

* Stakeholder engagement: patients, caregivers, SMEs, regulators, payers

3. Who Is Eligible?

* Minimum consortium: 3 independent legal entities from 3 different EU Member States or Associated Countries

* Typical actors: universities, research institutes, hospitals, ERICs, SMEs/start-ups, patient organisations, public health bodies, social science centres

* US participants, international partners, and UK entities are eligible for funding under HE rules

* Exclusions: projects focusing on rare diseases/rare cancers or on medical conditions already funded under HORIZON-HLTH-2024-DISEASE-03-14 (two-stage)

4. Budget & Cost Rules

* Funding rate: 100 % of eligible direct costs + 25 % flat-rate indirect costs

* Equipment depreciation, clinical trial insurance, data management, open access fees, patient compensation, exploitation/dissemination and ethics costs are eligible

* No co-funding obligation, but in-kind contributions and national co-financing strengthen sustainability

5. Evaluation Particularities

* Standard Horizon Europe criteria (Excellence, Impact, Quality & Efficiency of Implementation) – threshold 4/5 for each; overall 12/15

* EC will ensure a balanced portfolio across medical conditions; the highest-ranked proposal per condition is prioritised if thresholds are met

* Clinical studies ethics, sex-and-gender analysis, data management plan and patient involvement are scrutinised

6. Key Compliance Requirements

* Focus on one eligible medical condition only

* Demonstrate high societal burden + research gap (DALY, QoL, cost-of-illness data)

* Apply FAIR & open-science principles; deposit data in EU infrastructures (BBMRI-ERIC, EGA, etc.)

* Provide Clinical Study Annex (if any human study)

* Address SSH integration, sex/gender, age, ethnicity, socio-economic factors

* Include patient organisations meaningfully (co-creation, governance, dissemination)

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*Failure to comply with any of the above may render the proposal ineligible or non-fundable.*

📊 Evaluation Criteria

Key Evaluation Nuances

* Excellence (≥4/5): Must demonstrate cutting-edge translational methods and SSH integration.

* Impact (≥4/5): Clear route to clinical guidelines, patient benefit within 3-5 years post-project.

* Implementation (≥4/5): Robust clinical governance, risk management and data-sharing protocols.

* Portfolio balance rule: Highest-ranked proposal per medical condition will be prioritised to ensure diversity across funded projects.

📝 Application Strategy

Application Strategy – Winning HORIZON-HLTH-2025-01-DISEASE-07

1. Define Your Focus Early

1. Select one eligible condition and map the unmet needs vs. state of the art.

2. Compile *hard evidence* of prevalence, DALYs, misdiagnosis rates, cost burden.

3. Check CORDIS & EU Funding & Tenders portal to avoid overlap with 2024 projects.

2. Build a Mission-Driven Consortium

* Clinical excellence: leading EU reference centres for the chosen condition.

* Basic & translational researchers: multi-omics, immunology, neurobiology, biomechanics, etc.

* SSH partners: medical anthropologists, economists, ethicists, gender experts.

* Data stewards & e-infrastructure providers: BBMRI-ERIC node, ELIXIR hub, AI experts.

* SMEs/start-ups: diagnostics, digital therapeutics, modelling platforms.

* Patient organisations & caregivers: co-lead WP on engagement & dissemination.

Tips:

• Draft a *consortium agreement* early.

• Cover all key EU regions; non-EU partners add value but cannot replace EU minimum.

3. Craft a Cohesive Narrative

Link every work package (WP) to:

* Expected Outcomes (knowledge, collaboration, FAIR data, guidelines)

* Destination impacts (disease burden ↓, preparedness ↑, patient empowerment)

* KPI-driven objectives (e.g. “identify ≥3 validated biomarkers by year 3”).

4. Robust Work-plan Architecture

WP1 Coordination & Ethics

WP2 Pathophysiology & Risk Factors

WP3 Biomarker / Model Development

WP4 Clinical Validation & Patient Stratification

WP5 SSH: QoL, stigma, health-economics, policy

WP6 Data Management & FAIR compliance

WP7 Guideline Co-creation, Exploitation & Sustainability

WP8 Communication, Dissemination & Patient Engagement

Include *mandatory deliverables*: DMP (M6), periodic open-access publications, gender equality measures, policy briefs, clinical study reports.

5. Integrate Clinical Studies Properly

* Use the Commission’s Clinical Study Annex template.

* Register trials on *EUCTR/ClinicalTrials.gov*, budget insurance & monitoring.

* Obtain ethics approvals before GA signature or list timeline/contingency.

6. Excellence Section Tips (5 pp max)

* Present a clear *conceptual model* linking risk factors → mechanisms → symptoms.

* Reference latest meta-analyses & identify knowledge gaps.

* Highlight novel technologies (e.g. single-cell multi-omics, digital twins).

7. Impact Section Tips (4 pp max)

* Quantify expected reductions in misdiagnosis, time-to-diagnosis, QoL gains.

* Sustainability plan: integration into ERNs, ECDC HERA channels, guideline endorsement by EAU/EAN/EFNS etc.

* Exploitation routes for SMEs (IPR, spin-offs, CE-mark, EMA qualification advice).

8. Implementation Section Tips (6 pp max)

* Gantt + PERT; show critical path & risk matrix (scientific, regulatory, recruitment).

* Allocate budget proportionally; avoid >20 % to coordination.

* Include gender-balanced leadership and a dedicated patient advisory board.

9. Budget & Resources

* Keep total request €8–15 M unless scientifically justified.

* Reserve ≥5 % for data stewardship & open science, ≥3 % for dissemination & exploitation.

* Show *co-funding* or in-kind access to infrastructures to strengthen value-for-money.

10. Submission & Review Checklist

☑ Final consortium gathered & PIC numbers validated

☑ Administrative forms complete (ethics, security, clinical study annex)

☑ DoA complies with page limits (RIA single-stage Part B1: max 45 pp)

☑ Requested EU contribution matches budget table

☑ Proposal uploaded 24 h before deadline; check PDF integrity

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Golden rule: Evaluate your own draft against HE scoring matrix – if any criterion <4, iterate before submission.

Tackling high-burden for patients and under-researched medical conditions

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💰 Funding Details

Funding Description – HORIZON-HLTH-2025-01-DISEASE-07

1. Grant Snapshot

2. What the Grant Funds

3. Who Is Eligible?

4. Budget & Cost Rules

5. Evaluation Particularities

6. Key Compliance Requirements

📊 Evaluation Criteria

Key Evaluation Nuances

📝 Application Strategy

Application Strategy – Winning HORIZON-HLTH-2025-01-DISEASE-07

1. Define Your Focus Early

2. Build a Mission-Driven Consortium

3. Craft a Cohesive Narrative

4. Robust Work-plan Architecture

5. Integrate Clinical Studies Properly

6. Excellence Section Tips (5 pp max)

7. Impact Section Tips (4 pp max)

8. Implementation Section Tips (6 pp max)

9. Budget & Resources

10. Submission & Review Checklist

💡 Success Factors

❌ Common Mistakes to Avoid

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