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The commercialization of biomarkers touches on a broad range of scientific areas. In the age of personalized
medicine, biomarker analyses are establishing themselves as necessary tools for diagnosis as well as for
determining a path for therapy. Screening tests are employed for determining high risk for cancers of the
breast, prostate, cervix, and colon. In addition, through companion biomarker analyses, determinations can
be made as to the potential effectiveness of treatment (Herceptin, Camptosar, Coumadin). Biomarkers in
the contract research organization (CRO) demonstrate how their commercialization is applied to the drug
development world. In this realm, biomarker results offer insight into mechanism of action and efficacy, as
well as an aid to submission and approval when included in clinical trials. This presentation will touch on
concepts of biomarker development for clinical assessment and relay first-hand experience on biomarker
analysis for drug development from a CRO perspective.
Michael Sullivan completed his MS degree at the University of Florida. He has worked at Worldwide Clinical Trials-
Drug Development Solutions (formerly CEDRA Corporation) for 17 years as a Method Development Scientist, Team
Leader, and most recently, Senior Research Fellow. Over the last two years he has focused on the analysis of small
molecule biomarkers for CNS studies.
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