💰 Funding Details

Funding Overview

Call Identifier: HORIZON-JU-IHI-2025-11-04-two-stage

Topic Title: "Leveraging Europe’s Expertise to Accelerate Cell Therapy for Type 1 Diabetes"

Programme / Partnership: Horizon Europe – Innovative Health Initiative JU

Type of Action: HORIZON-JU-RIA (Research & Innovation Action, two-stage)

Indicative EU Contribution per Grant: €37 209 000 (budget-based, reimbursing up to 60 % of total eligible costs; remaining costs expected as industry in-kind contribution)

Total IHI Topic Budget: €74 418 000 (50 % EU, 50 % private)

What the Grant Covers

* Development of standardised impurity thresholds, reference materials and analytical methodologies for stem-cell–derived beta-cell products.

* Pre-clinical and clinical research on immune-modulating strategies, graft survival biomarkers and AI-driven monitoring tools.

* Scale-up of GMP manufacturing, cryopreservation and quality-control processes for beta-cell therapy.

* Validation of real-world, patient-centred clinical endpoints and cost-effectiveness frameworks.

* Establishment of European innovation hubs, clinical networks and specialised training programmes.

Key Financial Rules

1. Two-Stage Application:

* Stage 1 short proposal (max 20 pages) – 09 Oct 2025, 17:00 (Brussels).

* Stage 2 full proposal (max 50 pages, invite-only) – 29 Apr 2026, 17:00.

2. Consortium Composition: Minimum 3 independent entities from 3 different eligible countries; at least 1 beneficiary bringing significant industry in-kind contribution (IKOP).

3. Ineligible for Funding: Legal entities established in the UK or Canada (they may participate at their own cost).

4. Model Grant Agreement: Horizon Europe Action Grant (budget-based) with IHI-specific annexes (IKOP/IKAA, clinical studies, 3A not applicable).

5. Reimbursement Rates: 100 % of direct costs for non-profit participants; 70 % for for-profit, unless non-profit activities (Article 6 HE MGA).

6. Intellectual Property: Results that are direct improvements of a background asset revert to the original owner; plan for ownership transfers must be in the Consortium Agreement.

Complementary Support

* Contact your National Contact Point (NCP) for the Health Cluster in your country.

* Leverage your country's strong industrial base to secure the mandatory 45 % industry contribution at topic level.

* Access to your country research infrastructures for GMP manufacturing, large-animal models and advanced imaging.

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📊 Evaluation Criteria

How Your Proposal Will Be Scored

| Criterion | Weight | What Evaluators Look For |

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

| 1. Excellence | 0–5 | • Clarity of objectives vs. eight topic objectives

• Credibility of methodology (incl. AI model validation, GMP protocols)

• Ambition & innovation beyond SoA in beta-cell therapy |

| 2. Impact | 0–5 (×1.5) | • Contribution to expected outcomes/impacts listed in topic text

• Quality of exploitation, dissemination & communication plan

• Added value of private contribution (IKOP/IKAA) and alignment with EU policies (EHDS, Biotech Act) |

| 3. Quality & Efficiency of Implementation | 0–5 | • Work plan coherence, resources, risk management

• Consortium capability & complementarity

• Appropriateness of budget and 45 % industry contribution rule |

Thresholds:

* 3/5 per criterion

* Overall amassed score ≥10/15, with Impact weighted 1.5.

Tie-breakers: higher Impact → Excellence → industry in-kind %.

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📝 Application Strategy

Strategic Application Guide

1. Build a Mission-Driven Consortium

* Triple Helix: Combine academia (islet biology, immunology), hospitals (transplant centres), and EU-based industry (cell manufacturing, AI health-tech).

* Essential Expertise Matrix:

1. Stem-cell production & GMP scale-up

2. Immunology & tolerance induction

3. Advanced analytics (LC-MS, single-cell -omics)

4. AI / ML developers with MDR-compliant software pipelines

5. Health-economics & HTA

6. Patient organisations representing people living with T1D

* Innovation Hubs: Nominate at least two centres capable of serving as European beta-cell therapy hubs; provide letters of commitment.

2. Map Work Packages to the Eight Objectives

Create an easy-to-read Gantt linking each objective to a dedicated work package (WP), e.g.

* WP1 – Standardisation & Reference Materials (Objective 1)

* WP2 – Immune Modulation & Biomarkers (Objective 2)

* …

* WP8 – Sustainability, Dissemination & Exploitation

3. Regulatory & HTA Early Engagement

* Book *EMA Innovation Task Force* briefing BEFORE Stage 2 submission.

* Align with *EUnetHTA 21* guidelines to co-design cost-effectiveness models early.

4. Data, AI & Ethics Compliance

* Implement FAIR data principles and reference the European Health Data Space Regulation.

* Include a transparent AI model card and traceability pipeline satisfying the EU AI Act.

* Describe how personal data will be pseudonymised and stored in compliance with GDPR and your country national legislation.

5. Sustainability & Exploitation Plan

* Outline a post-project European Beta-Cell Therapy Alliance responsible for maintaining SOPs, digital models and training curricula.

* Provide a tiered access plan for SMEs and hospitals in your country to adopt outcomes after project end.

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💡 Success Factors

Clear Alignment With the Eight Topic Objectives

Mirror each objective in a dedicated work package, include KPIs (e.g., *"≤10% viability loss post-thaw across 3 GMP sites by M30"*).

Early Proof of Sustainability

Provide **signed MoUs** for a post-project Beta-Cell Therapy Alliance maintaining SOPs, registries and AI tools for at least five years.

Integrated AI & Wet-Lab Pipeline

Demonstrate an iterative loop where *in-silico* predictions (Time-in-Range, immune signatures) guide lab experiments and vice-versa, fulfilling Objective 5.

Robust Patient-Centred Endpoints

Define and pilot **Time in Tight Range (70–140 mg/dL)** as a surrogate endpoint, co-created with patient groups, boosting regulatory acceptability.

Pan-European Clinical Network

Commit at least **6 transplant centres in different Member States** to harmonised SOPs and data capture, ensuring statistical power and equity.

Detailed Risk & Mitigation Matrix

Address scientific (graft rejection), regulatory (GMO concerns) and operational (IKOP mobilisation) risks with quantified probabilities and fallback plans.

❌ Common Mistakes to Avoid

Ignoring Industry In-Kind Contribution Rules

Failing to document how the consortium will meet the **45 % private contribution** across the topic leads to ineligibility at GA stage.

Product-Centric Instead of Platform-Centric Approach

Proposing development of a **single proprietary therapeutic candidate** rather than open, broadly applicable standards violates the scope emphasising *translatable tools and methodologies*.

Insufficient Regulatory Engagement Plan

Leaving EMA/HTA interaction to the execution phase scores low on Impact; **briefings must be scheduled** and referenced already in the proposal.

Weak Data Governance & AI Transparency

Submissions often miss details on **model interoperability, data provenance and audit trails** required by the EU AI Act and EHDS, triggering serious ethics flags.

Overlooking UK/Canada Funding Restrictions

Including a cost budget for partners from the UK or Canada without separate self-funding statements will render the budget ineligible.

Generic Patient Involvement

Listing patient organisations without a **defined role in WP design, endpoint selection and dissemination** appears tokenistic and reduces Excellence scoring.

Leveraging Europe's Expertise to accelerate Cell Therapy for Type 1 Diabetes

Quick Facts for Italy Applicants

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