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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Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases

Published by NIH

BiomarkerClinical OutcomeNatural History

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies alone or in conjunction with the development and validation of clinical outcome assessments (COAs) and/or biomarker studies to address the unmet needs in rare neurodegenerative diseases for children and adults. Through the support of studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development.

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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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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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An overview of the biomarker qualification process that provides information on current evidentiary considerations. It also provides new information on the evolution of the role that preclinical qualification plays in clinical qualification of biomarkers and the novel approaches that are being utilized to improve the process

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The BIC Review Tool is designed to improve communication, it allows an “inventors interview”-type of approach, in addition to being a checklist for Technology Transfer Offices and Researchers. It is designed to improve communication between the stakeholders involved in the commercialization process and to facilitate collaboration. The tool is therefore in a completely different format than the Biomarker Commercialization (BIC) Guide. All introductions and explanations are missing by intention since they can already be found in the BIC Guide, Best & Pitfall Practices handbook or the Regulatory Guide. 

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