Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities

Published by Nature Reviews Neurology

Biomarker DiscoveryResearch and Drug Development Disease or Translational Resource BiomarkerPain Therapeutic BiomarkerChronic PainBiomarker ValidationRegulatory Issue

This article outlined the NIH initiative, Helping to End Addiction Long-term (HEAL). A trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to provide guidance on biomarker discovery and rigorous validation to accelerate high-quality clinical research into neurotherapeutics and pain.

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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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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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Gobiom Biomarker Data Base

Published by EXCELRA

BiomarkerDatabase

Gobiom Biomarker Database is a 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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