This unique book provides a thorough overview of developing molecular cancer diagnostic assays, which are the prerequisites for optimal solutions within personalized cancer medicine. The book takes the reader through definitions of the pharmacodiagnostic concept, historical perspectives of the early steps into molecular cancer diagnostics linked to therapy, the basis of different diagnostic molecular techniques, ongoing research, drug-diagnostic co-development, assay validation, clinical trial methodology, regulatory issues around pharmacodiagnostics and future aspects within personalized cancer medicine.
Table of Contents
Developing Molecular Diagnostics for Cancer, H Winther & J T Jørgensen
The Estrogen & Progesterone Receptor — Setting the Scene for Pharmacodiagnostics, K L Cheung
The HercepTest® — From Bench to Bedside, J T Jørgensen & H Winther
Pharmacodiagnostics and Translational Cancer Medicine, F G Rojo Todo
Pharmacodiagnostic Testing — Immunohistology, A S-Y Leong & T Y-M Leong
In Situ Hybridisation for Pharmacodiagnostic Testing, J Bartlett & F M Campbell
Pharmacodiagnostics Test — Microarray, A Glas
DNA Biomarkers in the Diagnosis and Management of Cancer, R R Serizawa & P Guldberg
Validating the Analytical Power of a Pharmacodiagnostic Test, C Taylor
Drug and Pharmacodiagnostic Co-Development Statistical Considerations, R Simon
Clinical Validation of Biomarkers in Cancer, S J Mandrekar & D J Sargent
Pharmacogenomic Markers for Cancer Therapy, S Marsh
Safety and Efficacy Biomarkers in Oncology Drug Label and Clinical Usage: A Regulatory Perspective, A Rahman & F Kalush
Image Analysis Systems for Cancer Diagnostics, K Bloom
Personalizing Treatment Selection for Breast Cancer, L Pusztai
Pharmacodiagnostics and Personalized Medicine in Cancer, J T Jørgensen
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.
"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