The Path from Biomarker Discovery to Regulatory Qualification

by Federico Goodsaid, William B. Mattes

Overview

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

Product Details

ISBN-13:	9780123914965
Publisher:	Elsevier Science
Publication date:	08/07/2013
Pages:	206
Product dimensions:	7.40(w) x 9.20(h) x 0.50(d)

About the Author

PhD, Vice President, Strategic Regulatory Intelligence, Vertex Pharmaceuticals, Cambridge, MA

William B. Mattes, PhD, DABT, Senior Director of COPD Biomarkers Qualification Consortium, COPD Foundation and Founder and Principal, PharmPoint Consulting

Table of Contents

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

What People are Saying About This

From the Publisher

A valuable collection of experiences and perspectives on biomarker qualification, its history and current practice in regulatory settings for those working in the biomarker development, pharmaceutical and regulatory communities

Editorial Reviews

Reviewer: Patrick J. McDonnell, PharmD (Temple University School of Pharmacy)
Description: 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.
Purpose: The purpose is to present an overview that provides a perspective on the use of biomarkers in a variety of situations in the development and regulation of drugs. There is also a focus on pharmacoeconomics, of course, with issues of therapeutic efficacy and drug safety with the biomarker use.
Audience: It is not clear for whom the book is intended. From the title, it would appear to be an introduction for those entering this field, but the authors' accounts of their own experiences seem to be directed at readers well-versed in the industry, and I am not sure this should be the goal of such a book. I have no doubt of the authors' credibility, but I think the book should be more explanatory.
Features: It covers topics in biomarker development based on the individual authors' experiences (for the most part) in their roles as scientists and regulatory affairs personnel, primarily for the pharmaceutical industry. Some chapters are more complete and explanatory where others tackle more ethereal concepts. This "collection of experiences" is a shortcoming if the editors expect to introduce this topic to those outside the field.
Assessment: I expected a more general and explanatory introduction to the use of biomarkers in the field of drug development, but I could not even find a definition of a biomarker. A collection of experiences by those working in the field in a book attempting to introduce general concepts of this topic works better in some chapters than others. However, as written, the book would be useful only to those already somewhat well versed in this area.

Doody's Review Service

"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 and Research Book News, December 2013

From the Publisher