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• W2161330490 abstract "Over the past 10 years, pharmaceutical companies have found compelling reasons to use human tissue in drug discovery and development. In preclinical work, human tissue enables researchers to select and validate drug targets based on humandisease phenotypes, find inherited gene variation that contribute to disease, validate animal disease models, and reclassify disease based on molecular signature. Human tissue allows researchers to overcome some of the inherent disadvantages of animal disease models, which are often poor predictors of similar disease states in man. Also, therapeutic interventions in these animal models often do not have the same pharmacologic results seen in human clinical trials. In clinical research, use of human tissue helps medical teams segment patient populations based on biomarker profiles and thereby better target new medicines for greater patient safety and efficacy. Patients with similar clinical profiles can have different tissue pathology and disease etiology, therefore, combining standard clinical evaluations with assessment of variations in genetic expression or sequence provides clinicians with critical tools to improve patient care. Given the benefits of human tissue, many pharmaceutical companies and academic research centers are motivated to increase its use in target validation and early drug development but encounter a multitude of hurdles in the process. Use of human tissue requires rigorous patient confidentiality and data-security measures, because tissue could be used to reconstruct a patient’s genome, with potential implications for compromising privacy, insurability, and job security. 2,3,18,25 This article discusses the regulatory, pathology, information technology, and administrative issues involved in establishing, managing, and using pathologic samples from surgical specimens in a tissue bank. 22" @default.
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• W2161330490 date "2009-01-01" @default.
• W2161330490 modified "2023-10-16" @default.
• W2161330490 title "Review Paper: Human Tissues for Discovery Biomarker Pharmaceutical Research: The Experience of the Indiana University Simon Cancer Center—Lilly Research Labs Tissue/Fluid BioBank" @default.
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• W2161330490 doi "https://doi.org/10.1354/vp.46-1-2" @default.
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