Biomarker Commercialization Guide

Published by Biomarker Commercialization (BIC) consortium

Biomarker Biomarker Commercialisation Biomarker Discovery Biomarker Validation IVD Assay Regulatory Biomarker Development Research and Drug Development

The Biomarker Commercialization (BIC) Guide supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention to a commercial product. It provides guidance through the technology readiness levels (TRL) and covers the clinical, regulatory, and business aspects of the commercialization process. The tasks are described and partially supported by useful, downloadable documents.

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In vitro diagnostics BIC Regulatory Guide

Published by Biomarker Commercialization (BIC) consortium

Biomarker IVD Biomarker Assay Development Regulatory Research and Drug Development

The BIC In Vitro Diagnostics Regulatory Guide introduces researchers and entrepreneurs to basic understanding of the regulatory process for CE mark of IVD diagnostics, along with the development of the project toward a clinical product

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Tissue Chip for Drug Screening program and Consortium

Published by IRDiRC

Biomarker Drug Discovery Drug Screening Programme High Throughput Screening Library NCATS Research and Drug Development Tissue Chip

NCATS, in collaboration with other NIH Institutes and Centers and the Food and Drug Administration (FDA), is leading the Tissue Chip for Drug Screening program to develop human tissue chips that accurately model the structure and function of human organs — such as the lungs, liver and heart — to help predict drug Safety in humans more rapidly and effectively

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Development and use of Patient-Centered Outcome Measures

Published by IRDiRC

Biomarker Clinical Development Endpoint Patient-Centred Outcome Measure Research and Drug Development

Patient-Centred Outcomes Measures (PCOMs) are questionnaires that ‘directly’ quantify the impact of a disease and treatment on health outcomes that matter to patients (as identified or affirmed by patients themselves, or their caregivers)

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BEST (Biomarkers, Endpoints, and other Tools) Resource

Published by FDA-NIH Biomarker Working Group

Biomarker Clinical Trial Design Endpoint Research and Drug Development

A biomarker discovery and validation guideline for clinical trial design and the drug development.

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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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