Companion and Complementary Diagnostics. From Biomarker Discovery to Clinical Implementation

Table 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

Authors

Jan Trøst Jørgensen Director, Dx-Rx Institute, Denmark. 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.