it reviews the steps of biomarker development, highlights the key issues in successful validation and implementation, and overviews representative examples in the oncology field. Regulatory issues and future perspectives in the era of big data analysis and precision medicine are discussed.
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Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities
Published by Nature Reviews Neurology
Biomarker DiscoveryBiomarker ValidationChronic PainPain Therapeutic BiomarkerRegulatory IssueResearch and Drug Development Disease or Translational Resource BiomarkerThis 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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Biomarker Commercialization Guide
Published by Biomarker Commercialization (BIC) consortium
BiomarkerBiomarker CommercialisationBiomarker DiscoveryBiomarker ValidationIVD AssayRegulatory Biomarker DevelopmentResearch and Drug DevelopmentThe 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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