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
prototype, verification and analytical validation 12. Tissue sample collection for biomarker analyses and companion diagnostics in oncology clinical trial 13. Drug-diagnostic codevelopment
early phase clinical studies 14. Clinical development
clinical validation and clinical utility 15. Diagnostic Metrics and Statistical Considerations 16. Regulatory requirements
United States of America 17. Regulatory requirements
Europe 18. Regulatory requirements
China 19. Regulatory requirements
Japan 20. Health economic evaluation of the use of companion diagnostics 21. Impact of the drug-diagnostic codevelopment model on drug development 22. Implementing companion diagnostic testing in clinic 23. Quality control and proficiency testing for CDx assays 24. Osimertinib (Tagrisso) and the Cobas EGFR Mutation Test v2 25. Omecamtiv mecarbil and the QMS Omecamtiv Mecarbil Immunoassay 26. Molecular imaging companion diagnostics 27. Bringing Drug and Companion Diagnostic to the Market 28. Future direction of companion diagnostics
Jan Trøst Jørgensen has 25 years of experience from research and development in pharmaceutical, biotechnology and clinical device companies. He has held a series of managing positions at Director and Vice President level in Novartis, Novo Nordisk, Nycomed, Pronosco, Pharmexa and T-cellic. He has a PhD in Clincial Pharmacy, Faculty of Pharmaceutical Science, University of Copenhagen, Denmark and has over 50 scientific publications, including acting as topic editor for the Frontiers Research Topics issue on drug-diagnostics co-development in oncology. He is a member of the American Society of Clinical Oncology, the Danish Society of Clinical Pharmacy and the European Society of Pharmacogenomics and Personalized Therapy, amongst others. 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.