High Sensitivity Using Singulex Erenna^® Platform— Experience from Pharma and CRO

Ole Vesterqvist, Senior Director of Clinical Laboratory Science at Covance, Inc.

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Introduction of new technologies over the last two decades has provided scientists with many new technologies. Some of these technologies have improved sensitivity to a degree that biomarkers, that once were impossible to measure, are now routine. The Singulex Erenna platform is one of these technologies that have provided a tool for scientists to push the lower limit of quantitation to the next level. In this presentation, we will look at the use of the Erenna platform to enable measurement of biomarkers in clinical studies at Wyeth Pharmaceuticals at concentration levels that were more than 100-fold lower than previous ELISA assays were capable of. At the end of the presentation, we will focus on the analytical validation of biomarkers using the Erenna patform at Covance Central Laboratory in Indianapolis.

Positioning Quantitative Protein Assays from Discoveries in Whole Genome Sequencing Studies

Reid Townsend, Professor of Medicine at Washington University St. Louis

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Protein biomarkers of human disease hold significant promise for early detection, disease stratification, and, importantly, a quantitative metric to follow the course of therapeutic intervention. However, discovery that has been based on proteomic discovery platforms have not yielded biomarkers that are currently used by oncologists. Yet, peripheral blood-based clinical tests remain a highly attractive patient management tool. To accelerate and focus the discovery phase of biomarker development, we are employing a next generation genomedriven approach whereby genome-wide scanning for gene and chromosomal aberrations inform proteomic biomarker discovery. Our quantitative protein strategy involves multiple platforms for the verification of candidate biomarkers in tissues and plasma: i) next-generation, high sensitivity immunoassays, ii) stable isotope dilution mass spectrometry of surrogate peptides with and without antibody enrichment and iii) reverse-phase protein microarray.

Improved Sensitivity of a PK Assay Using the Erenna^® Immunoassay System

Denise O'Hara, Associate Research Fellow for PK/PD and Metabolism, Pfizer

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The Erenna® immunoassay system offers a technology to improve the sensitivity of protein drug assays. Use of this system to develop and validate a drug assay to support a biotherapeutic clinical pharmacokinetic study will be discussed. Determination of the level of assay sensitivity will be described as well as the various phases of the assay work; reagent selection, storage and resupply, assay development including sample preparation, data analysis, sample through-put and finally the system and assay validation.

The Role of High Sensitivity Immunoassays— from Biomarker Discovery to Clinical Validation

Hanno Langen, Global Head of Protein & Metabolite Technolgies, Roche

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Biomarkers play an important role in the pharmaceutical industry and are assuming an ever greater role in drug discovery and development. The potential benefit of biomarkers is to allow earlier, more robust drug safety and efficacy measurements. Generally, a better understanding of the mechanism of disease progression and therapeutic intervention is needed. Discovery of candidate marker proteins is done by high throughput proteomics methods, but the major bottleneck is the validation of those candidates in the clinical setting. The design of the sample panel is critical. Multiple and high sensitivity protein marker measurements are needed. I will present the current options and gaps in technologies for multiplex and high sensitivity protein measurements.