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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.
List of contents
1. Foreword
2. An Introduction to Companion and Complementary Diagnostics
3. The Drug-Diagnostic Co-Development Model
4. Systems Biology and Biomarker Development in Cancer Signaling Therapy
5. Immunohistochemistry
6. In Situ Hybridization
7. Polymerase Chain Reaction
8. Next Gen Sequencing Based Companion Diagnostics: From Biomarker Discovery to Clinical Implementation
9. Current Next Generation Sequencing Based Companion Diagnostics and their Analytical Validation
10. Companion and Complementary Diagnostics by Mass Spectrometry
11. Molecular Imaging Companion Diagnostics
12. Circulating Tumor DNA Analysis and Opportunities for Personalized Cancer Medicine
13. Companion Diagnostics Assay Development - Prototype, Verification and Analytical Validation
14. Tissue is the Issue: Challenges in Oncology Clinical Trial Tissue Sample Collection for Biomarker Analyses and Companion Diagnostics
15. Adaptive Trial Designs for Biomarker Driven Clinical Trials with Quantitative and Multiple Candidate Biomarkers
16. Companion Diagnostics Based on Time to Event Data
17. Regulatory Requirements for Companion Diagnostics and Drug-Diagnostic Co-Development in the United States of America
18. Companion Diagnostics and Biomarker Tests in the European Medicines Agency's Assessment of Medicinal Products
19. Understanding the Current Regulatory Landscape for Companion Diagnostic Products in China
20. Regulatory requirements for companion diagnostics - Japan
21. Economic Evaluation of Companion and Complementary Diagnostics
22. A Risk Based Paradigm of Biomarkers in Clinical Trials
23. Implementing Companion Diagnostic Testing in the Clinic
24. Osimertinib (TAGRISSO) and the cobas EGFR Mutation Test v2
25. QMS Omecamtiv Mecarbil Immunoassay and Omecamtiv Mecarbil Co-Development
26. Current Status and Future Direction of Companion Diagnostics
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.
