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This call supports translational research that bridges the gap between cutting-edge biotechnological discoveries and their application in clinical health therapies. The primary aim is to accelerate the path from proof-of-concept in the lab to clinical development. The call is part of the STEP (Strategic Technologies for Europe Platform) initiative and offers the STEP seal to proposals meeting high-impact criteria, which can unlock additional funding or investment.
Projects should focus on key steps necessary to de-risk biotech innovations and prepare them for clinical testing, including optimization, preclinical validation, scale-up, and regulatory pathway planning.
Opening: 22 May 2025
Deadline(s): 18 Sep 2025
Expected Outcome
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Robust preclinical data packages ready for regulatory submission.
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Validated processes for manufacturing and quality control.
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Strengthened biotech pipelines for health-related applications.
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Increased attractiveness of projects for private and public investors.
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Contributions to EU strategic autonomy in critical health technologies.
Scope
This topic seeks to enhance the maturity and scalability of biotech innovations in healthcare. Projects must:
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Focus on biological or bioengineered innovations with therapeutic potential (e.g., novel molecules, engineered proteins, gene editing tools, advanced drug delivery platforms, synthetic biology applications).
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Include a clear translational strategy with robust preclinical data and feasibility studies.
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Address manufacturing, safety, regulatory, and clinical aspects.
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Involve industry and end-user partners to validate the practical and commercial viability.
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Consider sex, gender, and population diversity in therapy design and validation.
Proposals should demonstrate a clear value chain from discovery to early clinical development, with potential to attract further investment or uptake by healthcare systems.
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