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Module 1: Design of Effective Translational Research StudiesFACULTY Dr. Kevin RosenblattAssistant Professor in the Department of Pathology and Assistant Director of the Division of Translational Pathology at the University of Texas Southwestern Medical Center in Dallas, TX This module is intended to provide the backdrop for the entire course, namely defining biomarkers and describing their use in diverse settings, including pharmaceutical drug development, diagnostic testing, and basic and translational research. The module will explore different types of clinical trials that may be used in biomarker discovery, and explain strengths and weaknesses of each type. In addition, a description of the various levels of evidence for biomarker acceptance will be provided. Moreover, an underpinning theme emphasizing the requisite bi-directional exchange process between clinical and basic research will be emphasized. We will also explore the two broad classes of biases, namely pre-analytical and analytical. Pre-analytical biases are those that exist prior to any laboratory handling, and include patient demographics, recruitment biases, and absence or presence of co-morbidities or risk factors. Analytical biases are those that exist as a function of laboratory procedures and inherent biases and irreproducibility of a given technology. Proper sample handling will also affect data quality, and time will be devoted to describing research into how common samples (blood, urine, tissue) should be collected and stored to minimize variability. The last part of this module will address in broad terms methodologies that will be utilized in this course and discuss their relative strengths and weaknesses not from a technical standpoint, but from a comparison of directed versus non-directed discovery approaches. Non-directed approaches (commonly called profiling) have a number of limitations with respect to throughput and, for proteomic studies, ability to address low abundance species. In contrast, directed approaches allow the user to determine which species are of particular interest, but comes with its own limitations. Most obvious are hurdles related to: generating antibodies and proteins in functional form; creating an appropriate genomic hybridization library; and requisite specific assumptions prior to the initiation of the experiments. At the end of this module, students should have the ability to: define a biomarker; understand how study design and experimental protocol can have a dramatic impact on conclusions derived; understand the relative strengths and weaknesses to various approaches towards biomarker discovery; and learn effective means of translating from basic research to the clinic and visa versa. GenNext's 2007 In Person Translational Courses have been completed. GenNext would like to thank its Education Partners and excellent instructors for another highly received Translational Research Program.Information regarding GenNext's 2008 program will become available shortly. Sign-up to find out about upcoming GenNext courses. For more information about this course, please contact GenNext Technologies at inform@gennexttech.com or call 650-563-9577.
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