Boosting the translation of biotech research into innovative health therapies

The main goal of this opportunity is to support the development and use of innovative tools, technologies, and digital solutions that improve health outcomes. It focuses on advancing prevention, diagnosis, and therapy through new biotech approaches and clinical trials, while considering ethical and regulatory aspects. Special attention is given to boosting the competitiveness of small and medium-sized enterprises (SMEs) in the health biotech sector and encouraging interdisciplinary research. Projects should involve medical technologies, pharmaceuticals, advanced therapy medicinal products, and digital health technologies. This grant is open to organizations from EU countries, Associated Countries, and, in some cases, select non-EU countries.

• Must include a phase I, phase II, or combined phase I/II clinical study

• Must target development of biotech-derived therapies (e.g. monoclonal antibodies, RNA therapies, ATMPs), excluding blood-based products

• Must involve SMEs and multidisciplinary consortia (e.g. academia, clinicians, CROs)

• Must demonstrate strong market potential and EU commercialisation strategy, including IP, anti-shelving plan, and revenue forecast

• Must justify impact on well-defined patient population, prioritising larger population impact

• Project duration must not exceed 4 years

Example Projects:

• A small biotech company leads a consortium to test a new gene therapy for rare diseases, including a phase I/II clinical trial and a commercialization plan.
• An SME-led group develops a digital diagnostic tool for early cancer detection and conducts a phase I clinical study in collaboration with a university hospital.
• A partnership of up to five organizations, including three SMEs, works on an advanced therapy medicinal product, ensuring SMEs receive at least half of the funding.

• Personnel costs
• Subcontracting
• Travel and subsistence
• Equipment (depreciation or rental)
• Consumables and materials
• Dissemination and communication
• Access to research infrastructure
• IPR and certification
• Audit costs
• Indirect costs (25% flat rate)
• Internally invoiced services

• Budget for this Call: 80,000,000€ 
• Number of Grants attributed: 10
• Maximum value per project: 8,000,000€
• Minimum value per project: 4,000,000€

• Applicants must provide evidence of EU regulatory approval for phase I clinical studies.
• At least 50% of the EU contribution must go to SMEs.
• The consortium must have a maximum of 5 legal entities as beneficiaries.
• Applicants must be from eligible countries as listed in the program guidelines.
• Proposals must follow all admissibility conditions, including page limits and required templates.
• If using satellite-based data, Copernicus and/or Galileo/EGNOS must be used.