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.

Part I: Current Perspectives on the Pathology Discipline in the Pharma Industry

1. Histopathology: A Canvas and Landscape of Disease in Drug and Diagnostic Development

            Keith A. Wharton, Jr.

2. 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

3. 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

4. Histopathology in Mouse Models of Rheumatoid Arthritis

            Patrick Caplazi and Lauri Diehl

Part II: Current Directions in Histopathology for Drug Development, Involving Tissue Image Analysis

5. Markers Used for Visualization and Quantification of Blood Vessels and Lymphatic Vessels

            Mohamed E. Salama, David A. Eberhard, and Steven J. Potts

6. Practical Approaches to Microvessel Analysis: Hotspots, Microvessel Density, and Vessel Proximity

            Steven J. Potts, David A. Eberhard, and Mohamed E. Salama

7. 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

8. 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 Kutok, Etman A, Josef T. Prchal, and Steven J. Potts

9. Image Analysis Tools for Quantification of Spinal Motor Neuron Subtype Identities

            Mirza Peljto and Hynek Wichterle

10. Development of a Tissue Image Analysis Algorithm for Celiac Drug Development

            Erik Hagendorn, Christa Whitney-Miller, Aaron Huber, and Steven J. Potts

11. Quantitative Histopathology for Evaluation of In Vivo Biocompatibility Associated with Biomedical Implants

            Robert B. Diller, Robert G. Audet, and Robert S. Kellar

12. Quantitative Histomorphometry and Quantitative Polymerase Chain Reaction (PCR) as Assessment Tools for Product Development

            Robert G. Audet, Robert B. Diller, and Robert S. Kellar

Part III: Current Directions in Histopathology for Drug Development, Involving Molecular Histopathology: In Situ Hybridization

13. Measuring the Messenger: RNA Histology in Formalin Fixed Tissues

            Steven J. Potts, Mirza Peljto, Mahipal Suraneni, and Joseph S. Krueger

14. 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

15. Solid Tissue-Based DNA Analysis by FISH in Research and Molecular Diagnostics

            Marcus Otte

Part III: Current Directions in Histopathology for Drug Development, Involving Molecular Histopathology: Sequencing and Genomics

16. Preanalytic Considerations for Molecular Genomic Analyses of Tissue

            Maureen Cronin

17. Next Generation Sequencing (NGS) in Anatomic Pathology Discovery and Practice

            Matthew J. McGinniss, David A. Eberhard, and Keith A. Wharton, Jr.

Part IV: Current Directions in Histopathology for Drug Development, Involving Companion Diagnostics

18. 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

19. Adapting HER2 Testing for a Different Organ: New Wine in Old Wineskins

            Michael D. Lunt and Christa L. Whitney-Miller

20. Tissue-Based Companion Diagnostics:  Development of IHC Assays from an Industry Perspective

            Miu Chau and Jon Askaa

21. 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

22. Navigating Regulatory Approval for Tissue-Based Companion Diagnostics

            Joseph S. Krueger, Holger Lange, G. David Young, and Steven J. Potts

23. 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

24. Cutpoint Analysis and Related Statistical Methods in Digital Pathology and Companion Diagnostics

            Joshua C. Black, Mahipal V. Suraneni, and Steven J. Potts