Boosting the translation of biotech research into innovative health therapies

This summary presents the Horizon Europe grant opportunity titled "Boosting the translation of biotech research into innovative health therapies." It is part of the Health Cluster and is designed to accelerate the development of novel biotechnology-derived therapies by funding early-phase clinical research. The grant targets collaborative, multidisciplinary consortia consisting of SMEs, academic institutions, clinicians, and research organizations.

Eligible applicant types include research institutions, universities, SMEs, startups, large enterprises, and public-private partnerships. The funding type for this opportunity is a grant under Horizon Europe, specifically categorized as a Research and Innovation Action (RIA). A consortium is required for submission, typically composed of up to five legal entities from EU member states, associated countries, or eligible third countries.

The main focus is on health-related biotechnology, particularly clinical trials and pharmaceutical innovations, with specific areas of interest such as monoclonal antibodies, therapeutic vaccines, and Advanced Therapy Medicinal Products (ATMPs). The project stage targets the transition from preclinical to early clinical development (Phases I, II, or I/II).

The funding amount ranges from €4 million to €8 million per project, with a total budget of €80 million allocated for this call. The application process is a single-stage open call with a submission deadline of September 16, 2025. Support is monetary and provided directly as a grant for eligible activities.

While the success rates are not explicitly stated, similar Horizon Europe grants indicate a competitive landscape with expected rates between 10-39%. Co-funding is not explicitly required, but contributions to SMEs must comprise at least 50% of the total EU funding attributed to the project.

The proposals need to include a clinical study, demonstrate significant economic potential for the Single Market, and present a detailed exploitation plan that includes a commercialization strategy. Evidence of regulatory approval for the clinical study in the EU is also a key requirement. The maximum project duration is four years.

In summary, this call represents a strategic effort to bridge the gap between biotech research and market-ready therapies, enhancing the competitiveness of the EU's biotechnology sector. It emphasizes the importance of collaborative projects and aims to bring innovative solutions to healthcare providers and patients in the EU.

This is a Horizon Europe call, specifically HORIZON-HLTH-2025-01-TOOL-05, aimed at "Boosting the translation of biotech research into innovative health therapies." It falls under Cluster 1 Health and is a single-stage call. The type of action is HORIZON-RIA Research and Innovation Actions, utilizing a HORIZON Action Grant Budget-Based MGA. The call opened for submission on May 22, 2025, and has a deadline of September 16, 2025, at 17:00 Brussels time.

The expected outcomes of this call are: faster access to innovative therapies for healthcare providers, researchers, and patients; more clinical trials in the EU involving new biotech therapeutic approaches; and strengthened competitiveness for SMEs from the EU and Associated Countries in the health biotech sector.

The scope of the call addresses the challenge of technology transfer to the market in the biotechnology sector, as identified in the Commission Communication 'Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU'. It aims to accelerate the development of innovative biotechnology-based therapies by supporting the initial phases of clinical research. The call targets collaborative, multidisciplinary consortia comprising SMEs, academics, clinicians, and research organizations to launch the clinical development of novel biotechnology-derived therapeutics. Collaboration with European research infrastructures is encouraged. The call focuses on supporting the transition from preclinical to early clinical phases, not the full clinical development needed for market entry. Examples of biotechnology-derived therapies in scope include monoclonal antibodies, therapeutic vaccines, recombinant biomolecules, Advanced Therapy Medicinal Products (ATMPs), nano-based drugs, and RNA therapies. Whole blood, blood components, and other substances of human origin are excluded.

Proposals must include a clinical study (Phase I, II, or I/II), demonstrate significant economic potential for the Single Market, and present a clearly defined exploitation plan with a detailed route to commercialization, intellectual property ownership details, and benefits for SMEs. The exploitation plan should include an anti-shelving strategy, commercial forecasts, follow-up financing strategies, and market authorization plans, with a first deployment envisaged in the EU. Justification of patient populations benefiting from the therapies is required, favoring clinical indications with potentially large patient populations. The maximum project duration is four years. Applicants should provide details of their clinical studies in the dedicated annex using the template in the submission system.

Admissibility conditions are detailed in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form in the Submission System. Eligible countries are listed in Annex B of the Work Programme General Annexes. Specific provisions exist for funding participants from non-EU/non-Associated Countries, as detailed in the Horizon Europe Programme Guide. To demonstrate readiness for clinical testing, proposals must provide evidence of regulatory approval in the EU for a Phase I clinical study. The EU contribution to SMEs must be 50% or more of the total EU contribution. Consortia must consist of at most 5 legal entities as beneficiaries, as described in General Annex B. If projects use satellite-based earth observation, positioning, navigation, and/or related timing data and services, they must use Copernicus and/or Galileo/EGNOS. Other eligible conditions are in Annex B of the Work Programme General Annexes.

Financial and operational capacity and exclusion criteria are in Annex C of the Work Programme General Annexes. Eligible proposals exceeding evaluation thresholds will receive a STEP Seal. Award criteria, scoring, and thresholds are in Annex D of the Work Programme General Annexes. The thresholds for each criterion (Excellence, Impact, Implementation) are 4, with a cumulative threshold of 12. Submission and evaluation processes are in Annex F of the Work Programme General Annexes and the Online Manual. The indicative timeline for evaluation and grant agreement is in Annex F of the Work Programme General Annexes. Legal and financial setup of grants are in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation form templates, guidance documents, model grant agreements, and call-specific instructions are available, including information on clinical studies. Additional documents include the HE Main Work Programme 2025 General Introduction, Health section, and General Annexes, as well as the HE Programme Guide, HE Framework Programme 2021/695, HE Specific Programme Decision 2021/764, EU Financial Regulation 2024/2509, the decision authorizing lump sum contributions, rules for legal entity validation, and the EU Grants AGA. Links to the Funding & Tenders Portal Online Manual, Terms and Conditions, and Privacy Statement are provided. Partner search announcements can be viewed and edited by LEARs, Account Administrators, or self-registrants.

The total budget for this topic is EUR 80,000,000, with individual contributions ranging from EUR 4,000,000 to EUR 8,000,000. The indicative number of grants to be awarded is 10.

This funding opportunity, HORIZON-HLTH-2025-01-TOOL-05, is designed to accelerate the development and market entry of innovative biotechnology-based therapies within the EU. It targets collaborative projects involving SMEs, academic institutions, clinicians, and research organizations, focusing on supporting early-phase clinical trials. The EU aims to strengthen its biotechnology sector, provide faster access to novel treatments for patients, and encourage more clinical research within its borders. By requiring a strong emphasis on SME participation, a clear commercialization strategy, and a commitment to deploying the resulting therapies within the EU Single Market, this call seeks to translate promising research into tangible health and economic benefits for the European Union.

Eligible Applicant Types: The eligible applicant types for this opportunity are SMEs, academics, clinicians, and research organisations. The call targets collaborative multidisciplinary consortia.

Funding Type: The funding type is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA) or a HORIZON Innovation Action (HORIZON-IA) depending on the specific topic. The Model Grant Agreement is a HORIZON Action Grant Budget-Based [HORIZON-AG].

Consortium Requirement: A consortium of multiple applicants is required. The consortium must be composed of at most 5 legal entities as beneficiaries, in addition to the eligibility conditions described in General Annex B.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU Member States and Associated Countries. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects.

Target Sector: The target sector is health, specifically biotechnology and biomanufacturing, with a focus on developing innovative biotechnology-based therapies. The specific areas include monoclonal antibodies, therapeutic vaccines, recombinant biomolecules, Advanced Therapy Medicinal Products (ATMPs), nano-based drugs, and RNA therapies.

Mentioned Countries: The opportunity explicitly mentions the EU and Associated Countries as geographically eligible regions. It also refers to non-EU/non-Associated Countries that have specific provisions for funding participants in Horizon Europe projects.

Project Stage: The project stage targets the transition from preclinical to clinical development, specifically supporting early clinical phases (Phase I, II, or I/II) of novel biotechnology-derived therapeutics.

Funding Amount: The funding amount varies depending on the specific topic within the call, ranging from EUR 2,000,000 to EUR 20,000,000. For example, HORIZON-HLTH-2025-01-TOOL-05 has a budget of EUR 80,000,000 with contributions ranging from EUR 4,000,000 to EUR 8,000,000 and an indicative number of 10 grants.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a grant to support their research and innovation activities.

Application Stages: The application process involves a single stage.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic provides some insight into the potential success rate. For example, HORIZON-HLTH-2025-01-TOOL-05 aims to award 10 grants out of a total budget of EUR 80,000,000.

Co-funding Requirement: Co-funding requirements are not explicitly stated, but the proposed EU contribution going to small and medium-sized enterprises (SMEs) must be 50% or more of the total EU contribution to the project as a whole.

Summary:

This Horizon Europe call, under Cluster 1 Health, aims to boost the translation of biotechnology research into innovative health therapies. The call targets collaborative, multidisciplinary consortia comprising SMEs, academics, clinicians, and research organizations. The goal is to accelerate the development of novel biotechnology-derived therapeutics by supporting early-phase clinical research (Phase I, II, or I/II clinical studies). The funding supports activities that enable faster access to innovative therapies for healthcare providers, researchers, and patients, strengthen the competitiveness of EU and Associated Countries' SMEs in the health biotech sector, and increase the number of clinical trials conducted with new biotech therapeutic approaches in the EU. Eligible projects must include a clinical study, demonstrate significant economic potential for the Single Market, and have a well-defined exploitation plan with a clear route to commercialization, including an anti-shelving strategy, commercial forecasts, follow-up financing strategies, and market authorization plans. The exploitation strategy should prioritize first deployment in the EU. The maximum project duration is four years, and consortia are limited to a maximum of 5 legal entities. A key requirement is that at least 50% of the total EU contribution must go to SMEs. The call encompasses a range of biotechnology-derived therapies, including monoclonal antibodies, therapeutic vaccines, recombinant biomolecules, ATMPs, nano-based drugs, and RNA therapies. The call also requires evidence of regulatory approval in the EU for a Phase I clinical study to demonstrate the investigational product's readiness for clinical testing. The indicative budget and number of grants vary by topic, with opening dates on May 22, 2025, and a deadline of September 16, 2025.