Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation

by Jan Trøst Jørgensen (Editor)

Overview

Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. - Covers all aspects, from biomarker discovery, to development and regulatory approval - Explains the "how to" aspects of companion diagnostics - Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

Product Details

ISBN-13:	9780128135402
Publisher:	Elsevier Science & Technology Books
Publication date:	05/08/2019
Sold by:	Barnes & Noble
Format:	eBook
Pages:	508
File size:	20 MB
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About the Author

Jan Trøst Jørgensen holds a master’s degree in pharmaceutical science and a Ph.D. in clinical pharmacy from the University of Copenhagen, Denmark. He has more than 30 years of experience in research and development in pharmaceutical, biotech and diagnostic companies, such as Novartis, Novo Nordisk and Dako/Agilent. Within the past 15-20 years, his focus has been on drug-diagnostic co-development projects in oncology. Dr. Jørgensen is a strong supporter of a more individualized pharmacotherapy, and he has published a number of scientific papers on companion diagnostics, drug-diagnostic co-development as well as on stratified and personalized medicine. Furthermore, he has been quoted as inventor or co-inventor on several patents and patent applications. He also serves as referee for scientific journals and research foundations and he has given lectures at various universities as well as at national and international conferences. In the recent years, Dr. Jørgensen has also worked as editor and co-author on books and special focus editions for scientific journals and are member of several editorial boards. Dr. Jørgensen was featured in 2015 interview for Elsevier R&D Solutions, Pharm & Life Sciences about his work on precision medicine and his development of a drug-diagnostic co-development model.

Table of Contents

1. Foreword2. An Introduction to Companion and Complementary Diagnostics3. The Drug-Diagnostic Co-Development Model4. Systems Biology and Biomarker Development in Cancer Signaling Therapy5. Immunohistochemistry6. In Situ Hybridization7. Polymerase Chain Reaction8. Next Gen Sequencing Based Companion Diagnostics: From Biomarker Discovery to Clinical Implementation9. Current Next Generation Sequencing Based Companion Diagnostics and their Analytical Validation10. Companion and Complementary Diagnostics by Mass Spectrometry11. Molecular Imaging Companion Diagnostics12. Circulating Tumor DNA Analysis and Opportunities for Personalized Cancer Medicine13. Companion Diagnostics Assay Development – Prototype, Verification and Analytical Validation14. Tissue is the Issue: Challenges in Oncology Clinical Trial Tissue Sample Collection for Biomarker Analyses and Companion Diagnostics15. Adaptive Trial Designs for Biomarker Driven Clinical Trials with Quantitative and Multiple Candidate Biomarkers16. Companion Diagnostics Based on Time to Event Data17. Regulatory Requirements for Companion Diagnostics and Drug-Diagnostic Co-Development in the United States of America18. Companion Diagnostics and Biomarker Tests in the European Medicines Agency's Assessment of Medicinal Products19. Understanding the Current Regulatory Landscape for Companion Diagnostic Products in China20. Regulatory requirements for companion diagnostics – Japan21. Economic Evaluation of Companion and Complementary Diagnostics22. A Risk Based Paradigm of Biomarkers in Clinical Trials23. Implementing Companion Diagnostic Testing in the Clinic24. Osimertinib (TAGRISSO) and the cobas EGFR Mutation Test v225. QMS Omecamtiv Mecarbil Immunoassay and Omecamtiv Mecarbil Co-Development26. Current Status and Future Direction of Companion Diagnostics

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From the Publisher

The first comprehensive book on companion and complementary diagnostics