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Clinical Biomarkers in Drug Discovery and Development
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- Understanding post-market surveillance requirements for medical devices (US & EU markets)
- Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
- Biomarkers as drug development tools: discovery, validation, qualification and use
- Clinical Biomarkers in Drug Discovery and Development
- Non-Inferiority Clinical Trials to Establish Effectiveness
- FDA Approval Process
- Three tools that help medical device SMBs work remotely
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Clinical Biomarkers in Drug Discovery and Development
[/vc_column_text][vc_column_text]Biomarkers allow for the classification of patient groups and quantifying how well novel medicines reach their intended targets, modify postulated pathophysiological pathways, and achieve therapeutic results. The biomarker challenge in genomics is finding unique molecular signatures in complex biological mixtures linked to natural processes so that novel therapeutic targets may be validated and treatment responses can be predicted. In underserved areas like neurodegeneration and cancer, biomarkers can be used to stratify patient populations or measure therapeutic effectiveness in primary prevention or disease-modification trials. To deliver innovative medications to the appropriate patients faster than they are now, clinically relevant indicators are needed to inform regulatory and therapeutic decision making about candidate pharmaceuticals and their indications.[/vc_column_text][vc_column_text]
Pharmacogenetic/pharmacogenomics biomarkers
Polymorphisms in the genetic code for proteins (exons), promoter regions or cofactors that drive transcription of that protein, or post-translational changes are all clinically significant. These can be used to identify patients at risk of becoming ill and those most likely to benefit from a specific therapy, or those most likely to experience adverse side effects. The creation of novel biomarkers is a must. It will be best accomplished through a partnership between pharmaceutical and diagnostics firms and, in imaging biomarkers, hardware makers. Primary prevention will be provided by identifying individuals at risk and promoting compliance with a regimen that may not offer instant feedback in symptomatic improvement, as with blood cholesterol levels. In contrast, a diagnosis is useless without appropriate treatment (for example, a disease modifier for Alzheimer’s disease).[/vc_column_text][vc_column_text]
References
Frank, Richard, and Richard Hargreaves. “Clinical biomarkers in drug discovery and development.” Nature reviews Drug discovery 2.7 (2003): 566-580.
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