💰 Funding Details

Funding Description

Horizon Europe Innovation Action – Lump Sum

* Call Identifier: HORIZON-HLTH-2025-01-IND-01

* Topic Title: *Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)*

* Maximum EU Contribution per Project: €80 million (lump-sum)

* Opening Date: 22 May 2025

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

What is Financed?

1. Process optimisation for one ATMP class (gene therapy, somatic-cell therapy, tissue-engineered product, or combined ATMP).

2. Integration of enabling technologies – digital twins, AI-driven control, robotics, advanced sensors.

3. Demonstration activities – reduction of cost/time, proof of scalability (centralised *and/or* decentralised).

4. Regulatory validation & strategy – engagement with EMA & national agencies, standardised assays, potency tests.

5. Sustainability measures – green chemistry, waste minimisation, energy-efficient facilities.

6. First deployment in the EU/your country with strong SME participation.

Lump-Sum Specifics

* Budget negotiated ex-ante; no cost reporting – payments linked to *milestones & deliverables*.

* Consortia should build buffers for audit-level evidence of work done (timesheets, procurement files).

Geographic & Entity Eligibility

* Legal entities from Member States, Associated Countries & certain third countries are eligible; note the exclusion of legal entities established in China for Innovation Actions.

* The Joint Research Centre (JRC) can join the consortium post-selection.

* US entities may receive funding under the reciprocity clause.

Indicative EU Priorities Addressed

* Resilient & competitive EU health industry.

* Digital & green transition of biomanufacturing.

* Reduced strategic dependencies for critical therapies in your country/EU.

📊 Evaluation Criteria

Evaluation Criteria & Expert Tips

1. Excellence (Threshold 4/5)

* Credibility of science & technology – show validated preliminary data and *bench-to-pilot* comparability results.

* Innovation beyond state-of-the-art – clearly benchmark against market leaders (e.g., viral-vector yields, CRISPR QC).

* Interdisciplinarity – articulate how AI, robotics, and regulatory science converge.

2. Impact (Threshold 4/5)

* Quantified benefits for patients, industry & regulators; align with Destination KPIs.

* Path to market – include business models for centralised and point-of-care production in your country.

* Sustainability & climate neutrality – life-cycle assessment, ISO 14001 roadmap.

* Dissemination & exploitation – FAIR data, open manufacturing protocols where possible.

3. Quality & Efficiency of Implementation (Threshold 4/5)

* Work-plan granularity consistent with lump-sum reporting; each WP tied to a payment milestone.

* Robust risk matrix (technical, regulatory, supply-chain, IP).

* Governance – steering committee with patient advocate & independent GMP advisor.

➡️ Scoring Hint: Evaluators apply half-point increments—design narratives that make it easy to award a 4.5 or 5 on each sub-category.

📝 Application Strategy

Application Strategy

1. Build a Complementary, Impact-Focused Consortium

* Map the ATMP value chain and recruit partners covering: process engineering, clinical translation, regulatory science, AI/automation vendors, sustainability experts, health-economics, and at least 2 SMEs.

* Involve reference hospitals in your country & other EU hubs for decentralised production pilots.

* Plan a collaboration agreement with JOIN4ATMP CSA to demonstrate synergy and avoid duplication.

2. Choose One ATMP Category & Document Unmet Needs

* Provide a concise problem statement – e.g., CAR-T cost of goods >€300 k/patient.

* Justify why the selected category is ripe for scale-up and how your platform is disease-agnostic.

3. Design a Clear Technology & Regulatory Roadmap

1. Baseline mapping: current TRL, COGS, batch timelines.

2. Innovation packages: digital twin for critical quality attributes, closed automated fill-finish, AI predictive release.

3. Regulatory milestones: EMA scientific advice, GMP comparability packages, qualification of novel assays.

4. Demonstrate Measurable KPIs

* ≥50 % reduction in manufacturing lead-time.

* ≥30 % reduction in COGS.

* ≤5 % batch failure rate.

* CO₂ footprint per dose reduced by ≥20 %.

5. Embed Exploitation & Deployment in your country

* Draft Letters of Intent from regional health authorities for first-in-EU deployment.

* Include a Freedom-to-Operate analysis & IP strategy covering platform and digital components.

💡 Success Factors

Early Involvement of Competent Authorities

Schedule pre-submission meetings with EMA & your country agency **before proposal submission**; reference these commitments to boost regulatory feasibility scores.

Digital Twin Demonstrators

Present a **proof-of-concept digital bioprocess twin** running on historical manufacturing data, illustrating predictive control of critical quality attributes.

Patient-Centric Deployment Model

Include hospital partners that already treat the target indication, showcasing **real-world infusion pathways** and patient-reported outcome metrics.

SME-Driven Innovation Packages

Allocate at least **25 % of the budget to SMEs** supplying robotics modules, AI algorithms or assay kits, reinforcing EU industrial competitiveness.

Robust Environmental KPIs

Integrate a complete **Life Cycle Assessment (ISO 14040)** and set public targets for energy, water, and waste reductions per therapeutic dose.

Consortium-Wide Data Governance Framework

Adopt **GA4GH & FAIR principles** with a shared data lake, clarifying access rights and GDPR compliance from day one.

❌ Common Mistakes to Avoid

Ignoring Lump-Sum Accounting Rules

Applicants recycle traditional cost-reimbursement templates, forgetting that **no periodic cost statements are accepted**. Without clear milestone-deliverable linkage, lump-sum budgets get slashed during grant negotiation.

Selecting Multiple ATMP Categories

The call explicitly says *one* ATMP category per proposal. Covering cell therapy **and** gene-edited iPSCs in a single work-plan dilutes focus and triggers eligibility doubts.

Weak Regulatory Engagement Plan

Missing timelines for **EMA scientific advice** or national competent authority meetings leads evaluators to question translatability. Provide concrete interaction points and responsible partners.

Superficial Sustainability Section

Stating "we will follow green principles" is not enough. Evaluators expect **quantitative CO₂ savings, solvent recycling schemes, and GMP energy metrics**.

Under-estimating Decentralised GMP Complexity

Proposals promising hospital-based manufacturing without detailing **qualification of premises, release testing logistics, and QP oversight** lose credibility.

Overlooking JOIN4ATMP Synergies

Failure to outline collaboration with the existing CSA gives the impression of siloed work and misses easy impact points.

Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)

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