The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book?it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science.

For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/ClassicBiomarkers

1. Biomarker Applications in the Pharmaceutical Industry 2. The Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development 3. Regulatory Experience at the EMA 4. Regulatory Experience at the PMDA

Section 1: Biomarker Development and Qualification in the Pharmaceutical Industry 5. Pfizer 6. Astra Zeneca 7. Novartis 8. BMS 9. CTCs

Section 2: Toxicogenomic Biomarkers 10. Gene Logic 11. Johnson and Johnson 12. ILSI-HESI

Section 3: Biomarkers of Drug Safety 13. “Classic” Markers of Liver Injury 14. Urinary Biomarkers of Kidney Injury

Section 4: Consortia 15. ILSI-HESI 16. C-Path Institute 17. Beyond QT

Section 5: Path to Regulatory Qualification Process Development 18. FDA 19. PMDA 20. The tortuous path from development to qualification of biomarkers

The primary audience includes pharmaceutical scientists and pharmacologists, clinicians and drug development managers and executives involved in pharmaceutical development.

• Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science
• Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use
• Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities