Use of Biomarkers in Orphan Drug Development

Published by IRDiRC

Biomarker Development Clinical Development Endpoint EndpoInternationalBiomarker Orphan Drug Regulatory Sciences Research and Drug Development

Biomarkers can be utilized as primary surrogate endpoInternationalas a basis for accelerated approval (US), and as secondary or exploratory endpoints for drug mechanism of action or aspects of Safety monitoring.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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Use of Biomarkers in Orphan Drug Development