Programme Category
Programme Name
Programme Description
Horizon Europe is the European Union (EU) funding programme for the period 2021 – 2027, which targets the sectors of research and innovation. The programme’s budget is around € 95.5 billion, of which € 5.4 billion is from NextGenerationEU to stimulate recovery and strengthen the EU’s resilience in the future, and € 4.5 billion is additional aid.
Identifier Code
Call
Summary
The Commission Communication ‘Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU’ has recently identified research and technology transfer to the market as a major challenge for the biotechnology sector.
This topic aims to speed up the development of innovative biotechnology-based therapies by supporting the initial phases of clinical research.
SMEs play a key role in the EU’s potential to innovate, with most biotechnology-derived drugs in development being progressed by SMEs and small biotech companies.
Detailed Call Description
However, transitioning from drug discovery and development stages to approved products requires substantial investment and sufficient resources in different areas (e.g., manufacturing, clinical trial management, regulatory affairs, etc.), with the time needed for clinical development often exceeding 10 years. This topic targets collaborative multidisciplinary consortia of SMEs, academics, clinicians and research organisations bringing together the necessary expertise to launch the clinical development of novel biotechnology-derived therapeutics. Collaboration with the relevant European research infrastructures is encouraged. This topic does not address the full clinical development needed to bring products to market but aims to support the critical transition phase from preclinical to clinical development by supporting the early clinical phases. A non-exhaustive list of biotechnology-derived therapies in scope include monoclonal antibodies, (therapeutic) vaccines, recombinant biomolecules, Advanced Therapy Medicinal Products (ATMPs), nano-based drugs, RNA therapies etc. Whole blood, blood components and other substances of human origin are not within the scope of this topic.
Proposals submitted under this topic should include all the following elements:
- A Clinical study either phase I, II or I/II depending on the appropriate stage of development.
- The proposal should convincingly demonstrate a significant economic potential of the final product(s) for the Single Market.
- A clearly defined exploitation plan, with a detailed proposed route to commercialisation, description of the intellectual property ownership and benefit for the SME(s). The plan should include an anti-shelving strategy, commercial forecasts for the product sales & revenue, and strategies for follow-up financing as well as market authorisation. The exploitation strategy should envisage a first deployment in the EU.
- Justification of the patient populations that will benefit directly from the development of the therapies. Clinical indications where potentially large patient populations could benefit will be favoured.
The maximum project duration should not exceed four years.
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
100%
Expected EU contribution per project: between €4.00 & €8.00 million.
Thematic Categories
- Health
- Research, Technological Development and Innovation
- Small-Medium Enterprises and Competitiveness
Eligibility for Participation
- Businesses
- Educational Institutions
- Legal Entities
- Other Beneficiaries
- Private Bodies
- Researchers/Research Centers/Institutions
- Small and Medium Enterprises (SMEs)
Eligibility For Participation Notes
In order to prove that the investigational product is ready for clinical testing, proposals must provide evidence of regulatory approval in the EU already in place for phase I clinical study.
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.
In addition to the eligibility conditions as described in General Annex B, the consortium must be composed of at most 5 legal entities as beneficiaries.
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
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.
Call Opening Date
Call Closing Date
National Contact Point(s)
Research and Innovation Foundation
29a Andrea Michalakopoulou, 1075 Nicosia,
P.B. 23422, 1683 Nicosia
Telephone: +357 22205000
Fax: +357 22205001
Email: support@research.org.cy
Website: https://www.research.org.cy/en/
Contact Person:
George Christou
Scientific Officer
Email: gchristou@research.org.cy