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Förderung der Umsetzung von biotechnologischer Forschung in innovative Gesundheitstherapien

Diese Aufforderung zur Einreichung von Vorschlägen unterstützt die translationale Forschung, die die Lücke zwischen bahnbrechenden biotechnologischen Entdeckungen und ihrer Anwendung in klinischen Therapien schließt. Das Hauptziel ist es, den Weg vom Konzeptnachweis im Labor zur klinischen Entwicklung zu beschleunigen. Die Aufforderung ist Teil der STEP-Initiative (Strategic Technologies for Europe Platform) und bietet das STEP-Siegel für Vorschläge, die hochwirksame Kriterien erfüllen, was zusätzliche Finanzmittel oder Investitionen freisetzen kann.

Die Projekte sollten sich auf die wichtigsten Schritte konzentrieren, die notwendig sind, um das Risiko von Biotech-Innovationen zu verringern und sie für klinische Tests vorzubereiten, einschließlich der Optimierung, der präklinischen Validierung, des Scale-Ups und der Planung des regulatorischen Weges.

Eröffnung: 22. Mai 2025
Einsendeschluss(e): 18. September 2025

Expected Outcome

  • Robuste präklinische Datenpakete für die Einreichung von Zulassungsanträgen.

  • Validierte Prozesse für die Herstellung und Qualitätskontrolle.

  • Gestärkte Biotech-Pipelines für gesundheitsbezogene Anwendungen.

  • Erhöhte Attraktivität der Projekte für private und öffentliche Investoren.

  • Beiträge zur strategischen Autonomie der EU bei kritischen Gesundheitstechnologien.

Scope

Dieses Thema zielt darauf ab, die Reife und Skalierbarkeit von biotechnologischen Innovationen im Gesundheitswesen zu verbessern. Die Projekte müssen:

  • Konzentrieren Sie sich auf biologische oder biotechnologische Innovationen mit therapeutischem Potenzial (z.B. neuartige Moleküle, manipulierte Proteine, Gene Editing Tools, fortschrittliche Plattformen zur Verabreichung von Medikamenten, Anwendungen der synthetischen Biologie).

  • Enthalten Sie eine klare Translationsstrategie mit soliden präklinischen Daten und Machbarkeitsstudien.

  • Behandeln Sie die Aspekte Herstellung, Sicherheit, Regulierung und Klinik.

  • Beziehen Sie Partner aus der Industrie und Endverbraucher ein, um die praktische und kommerzielle Machbarkeit zu prüfen.

  • Berücksichtigen Sie bei der Entwicklung und Validierung von Therapien die Vielfalt der Geschlechter und Bevölkerungsgruppen.

Die Vorschläge sollten eine klare Wertschöpfungskette von der Entdeckung bis zur frühen klinischen Entwicklung aufzeigen, die das Potenzial hat, weitere Investitionen oder die Übernahme durch die Gesundheitssysteme anzuziehen.

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