Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development

__Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development__ gathers diverse experts to present state of the art guidance and application of histopathology in drug development settings ranging from discovery research to human clinical trials. While many current applications of quantitative histology and molecular pathology in the biopharmaceutical industry are focused on oncology, this volume in addition explores non-oncologic disease areas including nonalcoholic steatohepatitis, arthritis, celiac disease, myeloproliferative disorders, neurology, and wound healing. The authors write from years of experience in diagnostic practice and pharmaceutical drug development, aiming to educate pharmaceutical and academic scientists how to best use tissue to diagnose disease and improve the process of drug development. As part of the __Methods in Pharmacology and Toxicology__ series, this volume is designed to provide wisdom and examples that others can follow and apply as part of drug development. Comprehensive and practical, __Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development__ will inform and enlighten both tissue-focused and non-tissue-focused drug development professionals about better use and interpretation of the multidimensional data contained in a tissue biopsy. Histopathology: A Canvas and Landscape of Disease in Drug and Diagnostic Development - Keith A. Wharton Jr. A Field Guide to Homo morphologicus for Biomedical Scientists, Or How to Convey an Understanding of Pathology to Scientists in a Biopharma Enterprise - Humphrey Gardner Outsourcing Tissue Histopathology Investigations in Support of Clinical Trials for Novel Therapeutics: Considerations and Perspectives - Keith A. Wharton Jr., Benjamin H. Lee, Pierre Moulin, Dale Mongeon, Rainer Hillenbrand, Arkady Gusev, Bin Ye, and Xiaoyu Jiang Histopathology in Mouse Models of Rheumatoid Arthritis - Patrick Caplazi and Lauri Diehl Markers Used for Visualization and Quantification of Blood and Lymphatic Vessels - Mohamed E. Salama, David A. Eberhard, and Steven J. Potts Practical Approaches to Microvessel Analysis: Hotspots, Microvessel Density, and Vessel Proximity - Steven J. Potts, David A. Eberhard, and Mohamed E. Salama Quantitative Histopathology and Alternative Approaches to Assessment of Fibrosis for Drug Development in Hepatitis C and Nonalcoholic Steatohepatitis - Steven J. Potts and Johanna K. DiStefano Stereology and Computer-Based Image Analysis Quantifies Heterogeneity and Improves Reproducibility for Grading Reticulin in Myeloproliferative Neoplasms - Mohamed E. Salama, Erik Hagendorn, Sherrie L. Perkins, Jeff L. Kutok, A. Etman, Josef T. Prchal, and Steven J. Potts Image Analysis Tools for Quantification of Spinal Motor Neuron Subtype Identities - Mirza Peljto and Hynek Wichterle Development of a Tissue Image Analysis Algorithm for Celiac Drug Development - Erik Hagendorn, Christa Whitney-Miller, Aaron Huber, and Steven J. Potts Quantitative Histopathology for Evaluation of In Vivo Biocompatibility Associated with Biomedical Implants - Robert B. Diller, Robert G. Audet, and Robert S. Kellar Quantitative Histomorphometry and Quantitative Polymerase Chain Reaction (PCR) as Assessment Tools for Product Development - Robert G. Audet, Robert B. Diller, and Robert S. Kellar Measuring the Messenger: RNA Histology in Formalin-Fixed Tissues - Steven J. Potts, Mirza Peljto, Mahipal Suraneni, and Joseph S. Krueger Algorithm-Driven Image Analysis Solutions for RNA ISH Quantification in Human Clinical Tissues - Mirza Peljto, Joseph S. Krueger, Nicholas D. Landis, G. David Young, Steven J. Potts, and Holger Lange Solid Tissue-Based DNA Analysis by FISH in Research and Molecular Diagnostics - Marcus Otte Preanalytic Considerations for Molecular Genomic Analyses of Tissue - Maureen Cronin Next-Generation Sequencing (NGS) in Anatomic Pathology Discovery and Practice - Matthew J. McGinniss, David A. Eberhard, and Keith A. Wharton Jr. The Impact of Pre-analytic Variables on Tissue Quality from Clinical Samples Collected in a Routine Clinical Setting: Implications for Diagnostic Evaluation, Drug Discovery, and Translational Research - David G. Hicks Adapting HER2 Testing for a Different Organ: New Wine in Old Wineskins - Michael D. Lunt and Christa L. Whitney-Miller Tissue-Based Companion Diagnostics: Development of IHC Assays from an Industry Perspective - Miu Chau and Jon Askaa Development of Tissue-Based Companion Diagnostics: The Relationship Between the Pharmaceutical Company, Diagnostic Partner, and the Biomarker Laboratory - Mark Kockx, Stefanie de Schepper, and Christopher Ung Navigating Regulatory Approval for Tissue-Based Companion Diagnostics - Joseph S. Krueger, Holger Lange, G. David Young, and Steven J. Potts Implementing a Multi-analyte Immunohistochemistry Panel into a Drug Development Program - Carla Heise, Pierre Brousset, Tommy Fu, David A. Eberhard, Graham W. Slack, Camille Laurent and Randy D. Gascoyne Cutpoint Methods in Digital Pathology and Companion Diagnostics - Joshua C. Black, Mahipal V. Suraneni, and Steven J. Potts Annotation Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development gathers diverse experts to present state of the art guidance and application of histopathology in drug development settings ranging from discovery research to human clinical trials. While many current applications of quantitative histology and molecular pathology in the biopharmaceutical industry are focused on oncology, this volume in addition explores non-oncologic disease areas including nonalcoholic steatohepatitis, arthritis, celiac disease, myeloproliferative disorders, neurology, and wound healing. The authors write from years of experience in diagnostic practice and pharmaceutical drug development, aiming to educate pharmaceutical and academic scientists how to best use tissue to diagnose disease and improve the process of drug development. As part of the Methods in Pharmacology and Toxicology series, this volume is designed to provide wisdom and examples that others can follow and apply as part of drug development.Comprehensive and practical, Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development will inform and enlighten both tissue-focused and non-tissue-focused drug development professionals about better use and interpretation of the multidimensional data contained in a tissue biopsy Edited By Steven J. Potts, Flagship Biosciences, Llc, Westminister, Co, Usa, David A. Eberhard, University Of North Carolina, Chapel Hill, Nc, Usa, Keith A. Wharton, Jr., Novartis Institutes For Biomedical Research, Cambridge, Ma, Usa. Includes Bibliographical References And Index. Mode Of Access: World Wide Web.