| Use Of Flow Cytometry For Biomarker Analysis in Pre-clinical and Clinical Phases of New Drug Development |
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Presentation: 1A02 Session: Biomarkers for Predicting Therapeutic ResponsePhilip Marder, Lisa Green, Rita Bowers and Haiyan Long, Lilly Research Laboratories Presenting Author: Philip Marder, Lilly Research Labs - USA According to the Tufts Center for the Study of Drug Development, the cost of developing a new drug has surpassed $900 million. Under intense pressure to control development costs, most companies are evaluating novel approaches. A majority of development costs occur during clinical trials. Compounding the problem is that < 1/4 NCE’s are approved for marketing. For these reasons, finding early evidence of in vivo, target-specific effects would clearly assist in decision-making. Recently, emphasis has grown in the development of drug activity biomarker assays. This presentation will describe how flow cytometry was utilized as an effective tool for biomarker analysis in both pre-clinical and clinical development. Background concepts, assay development, validation and application of several flow cytometric biomarker assays will be described in this presentation. Biomarker assay results on cells taken after in vivo treatment with anti-cancer (zosuquidar trihydrochloride and enzastaurin) and an anti-inflammatory agent (LY293111) will be described. |