💰 Funding Details

Funding Overview

Call Identifier: HORIZON-HLTH-2025-01-DISEASE-01

Action Type: HORIZON-RIA (Research & Innovation Action) – Lump-Sum Model Grant Agreement

Maximum EU Contribution per Project: €80 million

Opening Date: 22 May 2025

Deadline: 16 September 2025, 17:00 Brussels time

Strategic Fit

The call sits under the Cluster 1 "Health" destination “Tackling diseases and reducing disease burden.” It specifically targets large, multi-centre, multi-national randomised controlled trials (RCTs) testing phage therapy—either personalised preparations or ready-to-use cocktails—as an alternative/complement to antibiotics against antimicrobial-resistant (AMR) or biofilm-associated infections.

Budget Logic

Because lump-sum grants pay against pre-defined work-packages and milestones rather than real costs, consortia must:

* Derive a credible lump-sum that covers GMP phage production, regulatory‐grade analytics, trial implementation, AI-driven data handling, patient engagement, and exploitation planning.

* Break down the lump-sum into detailed WP-level fixed amounts linked to tangible deliverables (e.g. EMA protocol approval, first-patient-in, primary endpoint read-out).

Eligible Activities (Non-exhaustive)

1. GMP Phage Manufacturing & Characterisation – sequencing, stability, host-range, purity.

2. Pre-clinical Packages – in silico/in vitro/in vivo models to justify clinical dosing.

3. Regulatory Interaction – EMA scientific advice & national competent authority submissions.

4. Multicentre RCT – inclusive of diagnostics (phagograms), digital eCRFs, and adaptive designs.

5. FAIR Data Management & AI Analytics – compliant with GDPR and open-science mandates.

6. Patient & Civil Society Engagement – co-design of study materials and dissemination.

7. Exploitation & Market Access Plan – IP, pricing, health-technology assessment (HTA) and payor engagement in your country and beyond.

Expected Impact Alignment

* Quantifiable clinical evidence accelerating regulatory approval of phage products.

* New treatment options for patients with difficult-to-treat infections.

* Strengthened European phage R&D ecosystem, benefiting SMEs and start-ups.

* Heightened public awareness of phage therapy as an AMR countermeasure.

📊 Evaluation Criteria

Expert Evaluation Breakdown

Evaluators will score each criterion 0-5 (threshold 4) with a cumulative threshold of 12.

1. Excellence

* Clarity & pertinence of objectives to AMR challenge and call scope.

* Soundness of methodology – RCT design, adaptive features, AI analytics, GMP compliance.

* Innovative character – novel phage selection, manufacturing, diagnostic integration.

* Interdisciplinarity – integration of SSH, bioinformatics, clinical microbiology.

2. Impact

* Credible pathways to regulatory approval & market uptake (HTA, payor dialogue).

* Scale & significance of potential health-care savings and DALY reduction.

* Dissemination & exploitation – FAIR data, IP strategy, SME growth.

* Citizen & patient engagement – evidence of co-creation and outreach metrics.

3. Quality & Efficiency of Implementation

* Consistency & coherence of work-plan with lump-sum milestones.

* Consortium capability – previous GCP-compliant RCTs, GMP licenses, AI expertise.

* Risk management – manufacturing delays, recruitment lags, phage resistance.

* Resource allocation – balanced budget, justified person-months, robust governance.

📝 Application Strategy

Strategic Application Guide

1. Build a Mission-Oriented Consortium

* Clinical excellence: At least 5–7 high-incidence infection centres in ≥3 EU/Associated your country + 1 non-EU AMR hotspot.

* Industrial partners: GMP phage manufacturers, SME AI/diagnostic firms, CROs specialising in adaptive trials.

* SSH & Patient voices: Embed social scientists, ethicists and patient organisations from proposal drafting onward.

2. Map Work-Packages to Lump-Sum Milestones

1. WP1 – Phage Bank Expansion & GMP Manufacturing

Milestone: Qualified GMP master phage bank released.

2. WP2 – Regulatory Alignment & Protocol Finalisation

Milestone: EMA scientific advice & ethics approvals (<12 months).

3. WP3 – Adaptive Multinational RCT

Milestone: 50% recruitment & interim analysis pass-go.

4. WP4 – AI-Powered Data Integration & FAIR Repository

Milestone: Public data set deposited (FAIR compliant).

5. WP5 – Health-Economic & HTA Readiness

Milestone: Draft reimbursement dossier for your country payors.

6. WP6 – Communication, Citizen Engagement & Exploitation

Milestone: Pan-EU outreach campaign + licensing term-sheet.

3. Scientific & Methodological Best-Practice

* Diagnostics: Rapid phagogram within 24 h to drive personalised arms.

* Study Design: Bayesian adaptive platform accommodating dynamic phage cocktails.

* Comparator: Standard-of-care antibiotics ± non-antibiotic adjuncts.

* Endpoints: Clinical cure rate at day 14 (primary); microbiological eradication, QoL, and AMR gene load (secondary).

4. Cross-Cutting Compliance

* Gender/sex analysis: Stratify recruitment and outcome reporting.

* GDPR: Pseudonymisation, Data Protection Impact Assessment (DPIA).

* AI ethics: Conform to EU AI Act draft guidelines.

5. Budgeting Tips under Lump-Sum

* Insert a 10–15 % contingency within the lump-sum for regulatory or manufacturing delays—cannot be claimed later if omitted.

* Pre-negotiate unit prices for phage batches and diagnostics to lock costs before submission.

6. Synergy & Added Value

Reference partnerships with ERA4Health, HERA incubator, EIC “AMR” challenges, and existing Horizon projects (e.g. Phage4Cure) to demonstrate leverage of EU investments.

💡 Success Factors

Regulatory-Ready Trial Design

Embed parallel EMA advice, **adaptive protocol amendments**, and defined CMC dossier preparation to fast-track market authorisation.

Robust Diagnostic Backbone

Implement **24-hour phagograms and rapid sequencing** to match phage–bacteria pairs, increasing clinical success probability.

AI-Enhanced Data Integration

Use **machine-learning pipelines** for interim analyses and resistance pattern prediction, showcasing innovation and scalability.

Comprehensive Patient & Public Involvement

Co-create consent forms, lay summaries, and dissemination campaigns with **patient groups and civil society** to maximise societal impact.

SME-Academia-Clinical Synergy

Leverage **SME agility in GMP production** with academic discovery and hospital trial networks to cover the full value chain.

Sustainable Exploitation Roadmap

Present **clear IP strategy, pricing models, and HTA alignment** across your country markets to convince evaluators of long-term viability.

❌ Common Mistakes to Avoid

Ignoring EMA Scientific Advice

Submitting a protocol without prior or planned **EMA/NCAs engagement** leads to regulatory non-compliance and poor impact scores.

Under-scoping Manufacturing Logistics

Proposals often **overlook real-world GMP production timelines**, batch-to-batch variability and stability studies, jeopardising patient supply.

Weak Patient Recruitment Strategy

Failing to detail **site activation plans, inclusion criteria, and fast phagogram turnaround** results in unrealistic enrolment projections.

Superficial SSH Integration

Listing social scientists as token partners without **clearly budgeted qualitative research, ethics or public-perception studies** lowers Excellence marks.

Non-FAIR Data Management Plan

Data plans that **do not specify repositories, metadata standards or GDPR safeguards** trigger evaluator red flags under Impact.

Misusing Lump-Sum Flexibility

Assuming costs can be re-allocated post-grant; **lump-sums are fixed**—poorly structured WPs create cash-flow crises.

Testing safety and efficacy of phage therapy for the treatment of antibiotic-resistant bacterial infections

Quick Facts for Spain Applicants

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