Biomarkers

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European Medicines Agency. Qualification of Novel Methodologies for Drug Development: Guidance to Applicants (EMA/CHMP/SAWP/72894/2008). 2014.

Published by European Medicines Agency (EMA)

Drug DevelopmentEMAGuidelinePharmaceuticals 

This guidance is for qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, learned societies and pharmaceutical industry for a specific intended use in pharmaceuticals R&D. 

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Biomarker Validation

Published by Research Advocacy Network

BiomarkerBiomarker ValidationCancer DiseaseDrug Development ToolPreclinicalResearch and Drug Development

This is a review about biomarkers definition and the components of validity. It examines the methods by which biomarkers are validated and consider some examples of cancer biomarkers in use today. It concludes with information about situations where advocates might find this information useful.

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EuroBioBank

Published by Interreg Baltic Sea Region

BiobankEuroBioBankRare diseases

This website offers a set of free biomarker commercialization tools to help researchers, small and medium sized companies (SMEs), and technology transfer offices (TTOs) tackle the highly regulated and interdisciplinary landscape of in-vitro diagnostics applicable biomarkers, i.e., markers intended to provide information on the health status of a person.

The tools guide researchers and product developers through the technology readiness levels (TRL) and remind about the technical, regulatory, and business aspects of the innovation process.

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Biomarkers in Rare Diseases

Published by International Journal of Molecular Sciences

BiomarkersRare diseases

The focus of this article is to provide a broad platform for original research and state-of-the-art reviews on novel or established proteomic, metabolomic, or transcriptomic biomarkers that contribute to the understanding of the underlying molecular mechanisms of rare diseases and/or that can be used for the diagnosis and prognosis of disease and individuals’ responses to therapies. The collection includes eight original research papers, one commentary, and six review articles from groups investigating biomarkers for a diverse range of rare diseases.

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Predictive biomarker-based assay development in the context of drug development and lifecycle

Published by EMA

EMAPredictive Biomarkers

The proposed concept paper is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. The guideline will provide recommendations on the interface between predictive biomarker-based assays including CDx, and the development and lifecycle of a medicine.

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European Medicines Agency. ICH Topic E15. Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (EMEA/CHMP/ICH/437986/2006). 2007.

Published by European Medicines Agency (EMA)

EMAGenomic DataGuidelinePharmacogenomicsSample Coding

This guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics and genomic data and sample coding categories. 

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Gobiom Biomarker Data Base

Published by EXCELRA

BiomarkerDatabase

Gobiom Biomarker Database is a private comprehensive biomarker database that provides information on Proteomic, Genomic, Biochemical, Imaging, Metabolite, Clinical Scoring scales and Cellular biomarkers for 18 different therapeutic areas, covering ~2900 therapeutic indications with its reported utilities like diagnosis, prognosis, monitoring disease progression, treatment response, surrogate, efficacy and toxicity. Information in GOBIOM biomarker database is gathered from diverse sources which include clinical trials, scientific conferences, regulatory-approved documents, literature databases etc.

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FDA Qualification process – Drug Development Tools

Published by IRDiRC

Animal ModelBiomarkerCenter for Drug Evaluation and ResearchClinical DevelopmentDrug Development ToolEndpointQualification ProcessRegulatory AffairsResearch and Drug Development

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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