EU-Wide Advantages & Opportunities for “Advancing Cell Secretome-Based Therapies” (HORIZON-HLTH-2025-01-TOOL-02)

1. Single Market Access (450+ M Citizens, 27 MS)

• One authorisation – 27 markets: The project aims to deliver a Phase I/II dossier and ultimately a first-in-class marketing authorisation. Under the EU Centralised Procedure, a single EMA approval opens immediate access to all Member States, dramatically enlarging the addressable patient pool for secretome-based advanced therapies.

• Economies of scale: GMP manufacturing facilities and distribution hubs can be optimised for the whole EU, lowering cost-per-dose versus fragmented national roll-outs.

• Reimbursement leverage: Evidence generated under common Health Technology Assessment (EU-HTA, effective 2025) enables faster, coordinated pricing & reimbursement negotiations, accelerating uptake.

2. Cross-Border Collaboration & Knowledge Exchange

• Mandatory multi-country consortia: Horizon Europe rules require at least three independent entities from three different eligible countries; this naturally embeds pan-European expertise (clinicians, bioprocess engineers, SME biotechs, regulators, patient groups).

• Shared clinical infrastructures: Utilise existing EU platforms (ECRIN, BBMRI-ERIC, EATRIS) for multicentric Phase I/II trials to reach required patient numbers quickly and ensure diversity (sex, ethnicity, co-morbidities).

• Living Labs for biomanufacturing: Connect with European Biomanufacturing Community (EBC) and Vaccine Manufacturing & Innovation Centre (VMIC-EU) for scale-up, process analytics and digital twins.

3. Alignment with Key EU Policies

• Biotechnology & Biomanufacturing Strategy (2024): The topic explicitly addresses “cell-free therapeutic approaches”, a flagship technology area under the new strategy, increasing political visibility and downstream industrial policy support.

• Digital Europe & AI Act: The call encourages organ-on-chip and computational QA/QC. Leveraging EU AI sandboxes and the federated HealthData@EU infrastructure supports compliant in-silico potency modelling.

• Green Deal / Circular Economy: Off-the-shelf secretome products have smaller cold-chain and biowaste footprints than autologous cell therapies, fitting the sustainability goals of the Pharmaceutical Strategy for Europe.

4. EU Regulatory Harmonisation – De-Risking Market Entry

• Early EMA & JRC engagement: The call recommends interacting with competent authorities and JRC for pre-normative science; this de-risks CMC packages and speeds up CTA/MAA.

• Common GMP guidance: EU-wide GMP Annex 1 revisions (2023) standardise aseptic processing; a single set of validated SOPs fulfils multi-national inspection requirements.

• Forthcoming EU SoHO Regulation (blood, tissues, cells & organs): Harmonised provisions will clarify classification of secretome preparations, avoiding divergent national transpositions.

5. Access to Europe’s Innovation Ecosystem

• Research Infrastructures: tap into ESFRI landmarks (INFRAFRONTIER for mouse models, Euro-BioImaging for multimodal imaging, ELIXIR for omics data stewardship).

• Clinical Networks: European Reference Networks (ERNs) for rare pathologies enable rapid identification of trial participants if the target disease is low-prevalence.

• Talent & Training: Marie Skłodowska-Curie DN and EIT Health can fund PhD/MD-PhD pipelines for GMP-compliant bioprocessing and regulatory science.

6. Funding Synergies & Leverage

• Cascading finance: Combine Horizon grant with InvestEU thematic windows (Health & Life Sciences) for pilot GMP suites; venture co-investment is de-risked by EU guarantee.

• Complementary programmes:

• EIC Transition & EIC Accelerator for late-stage IND/phase III.

• EU4Health joint actions for early HTA and real-world-evidence registries.

• Regional ERDF funds for facility build-out (smart specialisation on advanced therapies in ES, DE, NL, FI, etc.).

• STEP Initiative: Secretome bioprocessing qualifies as a critical health technology, increasing probability of additional co-funding and priority access to Fast-Track permitting.

7. Scale, Impact & Societal Value

• Population-level benefit: By prioritising high-DALY indications (e.g. heart failure, osteoarthritis, neurodegeneration), the consortium can demonstrate EU-wide QoL gains and healthcare cost offsets.

• Strategic autonomy: Building EU-based secretome manufacturing reduces dependency on imported ATMPs and strengthens resilience for future health crises.

• SME growth & job creation: Encouraged SME participation fosters new European champions in extracellular vesicle analytics, bioreactor design and GMP CDMOs.

8. Actionable Recommendations for Applicants

1. Form a trisector consortium (academia–clinic–industry) spanning ≥3 MS with at least one SME owning GMP capabilities and one large academic hospital network for trial recruitment.

2. Map regulatory path early via EMA Innovation Task Force & EU-TRACC

• workshops (secretome classification, comparability, potency assays).

3. Embed digital QA/QC: use AI/ML to correlate multi-omics ‘fingerprint’ with batch potency; align with EU AI Act conformity assessments.

4. Write a funding-mix plan (Horizon + EIC + InvestEU) to demonstrate long-term sustainability and scale-up capability to reviewers.

5. Address diversity & inclusiveness KPIs: design trials that balance sex, age and regional representation to meet Horizon Europe’s gender-equality and widening participation criteria.

\*TRACC – Translational Research Advisory Council for Cell & gene therapies (planned under EU Biomanufacturing Strategy)

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By capitalising on unified regulation, pooled expertise and coordinated financing, this Horizon Europe call offers a unique springboard for turning cutting-edge secretome science into the first EU-authorised off-the-shelf regenerative medicine, benefitting patients and industry across the entire Union.