💰 Funding Details

Enhancing Cell Therapies with Genomic Techniques (HORIZON-HLTH-2025-01-TOOL-01)

Key Facts

* Type of Action: HORIZON-RIA (Research & Innovation Action)

* Total Budget per Grant: *up to* €80 million (100 % funding rate for eligible costs)

* Call Opens: 22 May 2025

* Deadline: 16 September 2025 – 17:00 Brussels time (single-stage submission)

* Destination: *Developing and using new tools, technologies and digital solutions for a healthy society*

Expected Outcome

1. Biomedical scientists gain toolkits for engineering therapeutic cells.

2. Improved assays & methods empower biopharma developers.

3. Clinicians access novel cell-based therapies for currently untreatable/poorly treated conditions.

4. Personalised therapy options emerge through next-gen cell engineering.

Scope Highlights

* Engineer allogeneic human stem/somatic cells (“off-the-shelf”).

* Integrate genome & epigenome editing, synthetic biology, CAD tools.

* Build synthetic genetic circuits (on/off, sense-and-respond, theranostic).

* Pre-clinical validation in one *specific* therapeutic area (choose one from the list).

* Include sex-difference analysis, SME participation, regulatory dialogue, and potential JRC collaboration.

> Tip: Proposals that can demonstrate feasibility in first-in-human studies will score extra points for ambition.

Geographic Eligibility

Participants from all EU Member States and Horizon-Europe–associated countries are automatically eligible. Entities in your country outside the EU should confirm association status or national co-funding mechanisms.

📊 Evaluation Criteria

How Your Proposal Will Be Scored

| Criterion | Weight | Threshold |

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

| Excellence | 1 | ≥4/5 |

| Impact | 1 | ≥4/5 |

| Quality & Efficiency of Implementation | 1 | ≥4/5 |

| Cumulative | — | ≥12/15 |

What Evaluators Look For

1. Excellence

* Ground-breaking concept in genome/epigenome engineering.

* Clear, feasible DBT methodology with state-of-the-art tools.

* Quality of interdisciplinary integration (biology, engineering, digital, clinical).

2. Impact

* Credible pathway to clinical translation & market uptake.

* Benefits for patients, healthcare systems, and EU biotechnology leadership.

* Dissemination, exploitation, and IP strategies that leverage your country’s innovation ecosystem.

3. Implementation

* Consortium excellence and complementarity.

* Detailed, realistic work plan, Gantt chart, risk matrix.

* Gender dimension well integrated.

📝 Application Strategy

Strategic Guide to Winning the Grant

1. Pinpoint Your Therapeutic Area

* Select one area (e.g. *Cardiovascular and circulatory system*) and build the entire logic chain around it.

* Map unmet clinical needs and show how engineered cells solve them better than current standards.

2. Assemble a High-Impact Consortium

* Combine:

* Leading gene-editing laboratories

* GMP cell-manufacturing SMEs

* Clinical centres with trial infrastructure

* Regulatory science experts/JRC as interface to EMA and national agencies

* Patient organisations for co-creation & ethics

* Leverage your country’s research infrastructures (e.g., biobanks, imaging platforms).

3. Design a Robust Work Plan

1. Design–Build–Test (DBT) Loops – iterative cycles with CAD, high-throughput screening.

2. Pre-clinical Packages – safety, efficacy, biodistribution, sex-specific analyses.

3. Regulatory Milestones – scientific advice meetings, ATMP classification, GMO dossiers.

4. Clinical Proof-of-Concept – optional Phase I/IIa setup with adaptive design.

4. Integrate Digital & Data Layers

* Use AI-driven modelling for circuit optimisation.

* Include secure data governance aligned with the European Health Data Space.

5. Craft a Persuasive Impact Narrative

* Quantify societal, economic, and environmental benefits.

* Highlight open strategic autonomy (EU leadership in biotech manufacturing).

* Show alignment with your country’s industrial and health priorities.

6. Budget & Risk Management

* Allocate ≥15 % to SMEs to underline innovation pipeline.

* Include contingency plans for regulatory or manufacturing delays.

7. Internal Review & Mock Evaluation

* Score against Excellence, Impact, Implementation (≥4/5 each).

* Conduct a red-team review at least 3 weeks before submission.

💡 Success Factors

Single, Well-Justified Therapeutic Focus

Deeply analysing disease burden, clinical gaps, and market size in one area enables a **laser-sharp value proposition**.

Iterative Design-Build-Test with Digital Twins

Combining **in-silico circuit design, high-throughput screens, and machine-learning optimisation** accelerates discovery and impresses evaluators.

Early and Documented Regulatory Engagement

Scheduling **EMA ‘Innovation Task Force’ meetings** or national competent-authority dialogues shows a mature implementation strategy.

Integrated GMP Manufacturing Work Package

Demonstrating access to **GMP suites and quality-by-design protocols** derisks scale-up and addresses ‘manufacturing workflow’ bottlenecks in the scope.

Stakeholder Co-Creation & Patient Advisory Boards

Actively involving **patient groups and clinicians** from your country and beyond strengthens societal relevance and impact pathways.

Alignment with European Health Data Space

Clear data-governance plans that comply with EHDS showcase foresight on **interoperability and ethical AI use**.

❌ Common Mistakes to Avoid

Targeting Multiple Therapeutic Areas

The topic **explicitly requires focusing on a single therapeutic area**. Submitting a ‘one-size-fits-all’ proposal dilutes impact and is usually scored down under *Excellence*.

Underestimating Regulatory Pathways

Proposals often omit **scientific-advice milestones** or lack ATMP/GMO compliance plans. Evaluators equate this with *implementation risk*.

Ignoring Sex-Based Biological Differences

Failing to include **sex-specific analyses** (cell donors *and* target patient population) breaches Horizon-Europe requirements and costs points in *Excellence*.

Weak SME Participation

Given the topic’s emphasis on translation, proposals without **SME manufacturing or clinical-grade cell expertise** appear less viable.

Superficial Digital Integration

Listing buzzwords like *AI* or *CAD* without concrete workflows, datasets, or performance metrics undermines credibility.

No Plan for JRC Collaboration

The call mentions potential JRC involvement; overlooking this easy synergy is viewed as a missed opportunity.

Enhancing cell therapies with genomic techniques

Quick Facts for Spain Applicants

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