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.

Explores pathology in oncologic disease and beyond, into other disease areas that have not received as much attention

Histopathology: A Canvas and Landscape of Disease in Drug and Diagnostic Development.- A Field Guide to Homo morphologicus for Biomedical Scientists, Or How to Convey an Understanding of Pathology to Scientists in a Biopharma Enterprise.- Outsourcing Tissue Histopathology Investigations in Support of Clinical Trials for Novel Therapeutics: Considerations and Perspectives.- Histopathology in Mouse Models of Rheumatoid Arthritis.- Markers Used for Visualization and Quantification of Blood Vessels and Lymphatic Vessels.- Practical Approaches to Microvessel Analysis: Hotspots, Microvessel Density, and Vessel Proximity.- Quantitative Histopathology and Alternative Approaches to Assessment of Fibrosis for Drug Development in Hepatitis C and Nonalcoholic Steatohepatitis.- Stereology and Computer-Based Image Analysis Quantifies Heterogeneity and Improves Reproducibility for Grading Reticulin in Myeloproliferative Neoplasms.- Image Analysis Tools for Quantification of Spinal Motor Neuron Subtype Identities.- Development of a Tissue Image Analysis Algorithm for Celiac Drug Development.- Quantitative Histopathology for Evaluation of In Vivo Biocompatibility Associated with Biomedical Implants.- Quantitative Histomorphometry and Quantitative Polymerase Chain Reaction (PCR) as Assessment Tools for Product Development.- Measuring the Messenger: RNA Histology in Formalin Fixed Tissues.- Algorithm-Driven Image Analysis Solutions for RNA ISH Quantification in Human Clinical Tissues.- Solid Tissue-Based DNA Analysis by FISH in Research and Molecular Diagnostics.- Preanalytic Considerations for Molecular Genomic Analyses of Tissue.- Next Generation Sequencing (NGS) in Anatomic Pathology Discovery and Practice.- 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.- Adapting HER2 Testing for a Different Organ: New Wine in Old Wineskins.- Tissue-Based Companion Diagnostics:  Development of IHC Assays from an Industry Perspective.- Development of Tissue-Based Companion Diagnostics:  The Relationship Between the Pharmaceutical Company, Diagnostic Partner, and the Biomarker Laboratory.- Navigating Regulatory Approval for Tissue-Based Companion Diagnostics.- Implementing a Multi-Analyte Immunohistochemistry Panel into a Drug Development Program.- Cutpoint Analysis and Related Statistical Methods in Digital Pathology and Companion Diagnostics.