The Path From Biomarker Discovery To Regulatory Qualification

Paperback | August 7, 2013

byFederico GoodsaidEditorWilliam B. Mattes

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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 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.

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From the Publisher

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, chal...

PhD, Vice President, Strategic Regulatory Intelligence, Vertex Pharmaceuticals, Cambridge, MAWilliam B. Mattes, PhD, DABT, Senior Director of COPD Biomarkers Qualification Consortium, COPD Foundation and Founder and Principal, PharmPoint Consulting
Format:PaperbackDimensions:206 pages, 9 × 6 × 0.68 inPublished:August 7, 2013Publisher:Academic PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0123914965

ISBN - 13:9780123914965

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Table of Contents

Preface

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

Editorial Reviews

"This book focuses on the use of biomarkers in drug development, for efficacy and targeted drug therapy as well as for predicting drug harm. It is a collection of papers that present the authors' examples of their work using biomarkers, not only for drug development but also for regulatory review."--Doody.com, January 3, 2014*** "Scientists from academia, drug companies, and regulatory agencies explore ways to develop biomarkers and integrate them in both developing and regulating drugs. They cover the impact of biomarker qualification regulatory processes on the critical path for drug development, biomarker development and qualification in the pharmaceutical industry, toxicogenomic biomarkers, biomarkers of drug safety, consortia, and the path to regulatory qualification process development."--Reference & Research Book News, December 2013