Table of Contents

Developing Molecular Diagnostics for Cancer. The Estrogen & Progesterone Receptor — Setting the Scene for Pharmacodiagnostics. The HercepTest® — From Bench to Bedside. Pharmacodiagnostics and Translational Cancer Medicine. Pharmacodiagnostic Testing — Immunohistology. In Situ Hybridisation for Pharmacodiagnostic Testing. Pharmacodiagnostics Test — Microarray. DNA Biomarkers in the Diagnosis and Management of Cancer. Validating the Analytical Power of a Pharmacodiagnostic Test. Drug and Pharmacodiagnostic Co-Development Statistical Considerations. Clinical Validation of Biomarkers in Cancer. Pharmacogenomic Markers for Cancer Therapy. Safety and Efficacy Biomarkers in Oncology Drug Label and Clinical Usage: A Regulatory Perspective. Image Analysis Systems for Cancer Diagnostics. Personalizing Treatment Selection for Breast Cancer. Pharmacodiagnostics and Personalized Medicine in Cancer.

About the Author

Dr Jan Trøst Jørgensen holds an MSc degree in pharmacy and a PhD in clinical pharmacy from the Faculty of Pharmaceutical Sciences, University of Copenhagen. He has worked with drug development in biotech and pharmaceutical companies for more than 25 years, and within the last 10 years his focus has been on drug-diagnostic co-development projects within cancer. Dr Jørgensen is a strong supporter of more individualized pharmacotherapy and has published a number of scientific papers on oncology as well as on stratified and personalized medicine.

Reviews

"The editors have recruited a highly experienced group of both academic medical center and industry-based international authors and produced a concise yet thorough overview of the emerging field of integrated diagnostics and personalized medicine. This book emphasizes slide-based companion pharmacodiagnostics, but also covers in depth post-extraction DNA sequence-based and mRNA profiling-based prognostic and predictive tests for both solid tumors and hematologic malignancies. Chapters on test development, regulatory approval and important consideration of test validation and clinical utility round out this impressive work. Not only will academic departments and cancer centers find this book to be an authoritative reference volume, but also the pharmaceutical and biotechnology industries will be able to gain considerable insight that could play a major role in the shaping of their current and future products." --Prof. Jeffrey S. Ross, Albany Medical College, USA "The topics and information covered in the book are the ones highly demanded in the current clinical biomarker sciences. This volume has successfully made a comprehensive coverage from all the experts in biomarker discovery, development, clinical trial and statistical validation, and practical use. This is definitely one of the references that everyone in this area should have." --Prof. Jae K. Lee, University of Virginia