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ASCPT Members-Only Webinar Presented by the Biomarkers & Translational Tools (BTT) Community
: Biomarkers and Experimental Human Models as a Supportive Evidence of Efficacy and Safety in Clinical Development and Their Usage in Clinical Practice
Date and Time
: Tuesday, July 17, 2018, 12:00 PM ET
: Maria Burian, MD, MBA
: Jitendra Kanodia, PhD
: Biomarkers and experimental human models provide supportive evidence of clinical efficacy and safety in drug development process. Use of biomarkers in clinical development helps to shorten time to complete development programs or time to reach a critical decision point as well as to reduce samples size in clinical trials. Biomarkers can be utilized in clinical practice to guide therapy or can be developed as a drug product. This presentation will: a) review biomarker definition and classifications used in clinical development and clinical practice; b) present cases with biomarker and experimental human model applications in clinical development used with the purpose to explain interindividual variability or to clarify mechanism of drug action) c) present cases with biomarkers used as a stratification tool in clinical practice (NT-proBNP-guided therapy in heart failure) or developed as a drug product (BNP as a recombinant drug product to treat heart failure).