💰 Funding Details

Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders – Funding Overview

Key Facts

- Call Identifier: HORIZON-HLTH-2025-03-DISEASE-02-two-stage

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

- Type of Action: HORIZON-RIA (Lump-Sum Grant)

- Maximum EU Contribution: €50 million per project (100 % funding rate for eligible costs)

- Submission Modality: Two-stage, blind evaluation at stage 1

- Opening Date: 22 May 2025

- Stage 1 Deadline: 16 Sept 2025, 17:00 (CET)

- Stage 2 Deadline: 16 Apr 2026, 17:00 (CET)

Strategic Rationale

Mental, behavioural and neurodevelopmental disorders (ICD-11 Chapter 06) represent a high-burden, unmet medical need. The topic explicitly calls for:

1. Rigorous clinical validation of innovative pharmacological and non-pharmacological interventions.

2. Mechanistic insight (imaging, omics, physiological & biochemical signatures).

3. Multidisciplinary, transdiagnostic and/or relapse-preventive approaches (e.g. neurostimulation, digital therapeutics, psychotherapy).

4. FAIR data integration with EU infrastructures.

5. Active patient & caregiver engagement and wide stakeholder dissemination (clinicians, regulators, payers, policymakers).

Budgeting & Lump-Sum Logic

- The lump-sum model transfers financial-risk management to the consortium: once work packages (WPs) are accepted, payments are made regardless of actual costs.

- Robust, milestone-based budgeting is therefore essential. Align WP payment triggers with pivotal clinical milestones (e.g. completion of Phase IIb trial, database lock, regulatory scientific advice).

Expected Impact

Projects are expected to deliver state-of-the-art interventions that demonstrably reduce disease burden, enhance quality of life, and inform EU policy. Direct alignment with the Work Programme’s destination text on disease tackling is mandatory.

📊 Evaluation Criteria

Evaluation & Scoring

Stage 1 (blind):

* Excellence — threshold 4/5

* Impact — threshold 4/5

Stage 2:

* Excellence, Impact, Implementation — threshold 4/5 each (cumulative ≥ 12/15)

The Stage 1 budget cut-off will target ≈ 3.5-4× the available budget.

📝 Application Strategy

Winning Strategy for a Two-Stage, Lump-Sum RIA

1. Build a Gold-Standard Consortium

- Clinical breadth: Include leading psychiatric/neurology centres in at least 3 Horizon-eligible your country plus Associated Countries to ensure statistically powered, multi-site trials.

- Technology depth: Combine pharma/biotech SMEs, digital health start-ups, neuro-imaging labs, and device manufacturers for complementary intervention packages.

- Patient voice: Engage umbrella patient organisations as full beneficiaries, not merely advisors.

2. Stage 1 – Blind Excellence & Impact (10 pages max)

1. Problem–Solution fit (≈2 pages): Quantify burden (DALYs, cost) and articulate how your intervention overcomes efficacy/relapse gaps.

2. Scientific breakthrough (≈3 pages): Present mechanistic hypothesis, preliminary data, and transdiagnostic relevance without revealing partners.

3. High-level methodology (≈3 pages): Multicentre, randomised design, inclusive recruitment, adaptive elements.

4. Impact narrative (≈2 pages): Compliance with expected outcomes, alignment with EU mental health strategy, scalability and regulatory pathway.

3. Stage 2 – Full Proposal

- Implementation ≥ 30 pages: Detailed clinical protocol (ICH-GCP), data-management plan (FAIR), risk mitigation, ethics & gender dimension.

- Lump-Sum Breakdown: Map each WP to verifiable deliverables (e.g. “Completion of 400-patient RCT and locked database”).

- Dissemination & Exploitation: Plan for EMA qualification advice, HTA interaction, open-access datasets in EBRAINS or ELIXIR repositories.

4. Evaluation Sweet-Spots

- Excellence 4/5: First-in-class, mechanism-driven, multi-modal data.

- Impact 4/5: Clear public-health savings, patient-reported outcomes, policy uptake.

- Implementation 4/5: Realistic timeline, robust governance, lump-sum maturity assessment.

5. Compliance Checklist

- Blind stage-1 formatting.

- Gender Equality Plan for each public entity.

- Data-management plan (FAIR & GDPR).

- Horizon Europe ethics self-assessment (neuro-imaging, sensitive data).

- Use of Copernicus/Galileo if any remote sensing is planned.

💡 Success Factors

Mechanism-Linked Clinical Endpoints

Select endpoints (e.g. fMRI-derived connectivity changes) that directly test the hypothesised mechanism, thereby strengthening both **scientific excellence** and regulatory credibility.

Integrated Data Lake with FAIR APIs

Deploy a **federated data architecture** compliant with ELIXIR & EOSC standards, enabling secondary analyses and fulfilling open-science obligations.

Regulatory Co-Creation Pathway

Schedule **EMA scientific advice** and national HTA consultations within the project, showing a clear route to market and healthcare uptake.

Multi-Country Living-Lab Recruitment

Utilise digital platforms and community clinics across your country to accelerate enrolment, ensure diversity and facilitate real-world evidence collection.

Robust Governance & Risk Board

Establish an independent **Data Safety Monitoring Board (DSMB)** and a risk-adjusted decision gate process that ties into lump-sum payment triggers.

Patient-Reported Outcome Integration

Embed validated PRO instruments and co-design feedback loops, highlighting long-term quality-of-life gains—the cornerstone of *Impact* scoring.

❌ Common Mistakes to Avoid

Revealing Partner Identities in Stage 1

Under the **blind evaluation pilot**, any mention of organisation names, logos or easily traceable publications in the first-stage proposal leads to automatic rejection.

Insufficient Diversity in Clinical Cohorts

The call stresses representation by **age, sex and ethnicity**. Failure to power subgroup analyses or recruit across multiple your country weakens both *Excellence* and *Impact* scores.

Ignoring Complementary Non-Pharmacological Approaches

Focusing solely on a drug candidate without integrating digital, neurostimulation or psychosocial components misses the topic’s **multidisciplinary requirement**.

Weak Lump-Sum Milestone Definition

Vague deliverables such as “ongoing trial activities” cannot be paid under a lump-sum MGA. **Auditable, binary milestones** are compulsory.

Poor Data-Sharing & FAIR Compliance

Not specifying repositories or metadata standards contradicts the expected outcome on **database integration and re-use**.

Tokenistic Patient Involvement

Advisory-board only roles do not meet the call’s expectation for **constructive engagement** delivering tangible patient benefit.

Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders

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