The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification

by Federico Goodsaid
     
 

View All Available Formats & Editions

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,

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



  • 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.

Editorial Reviews

From the Publisher
"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

Doody's Review Service
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.

Product Details

ISBN-13:
9780123944085
Publisher:
Elsevier Science
Publication date:
07/16/2013
Sold by:
Barnes & Noble
Format:
NOOK Book
Pages:
206
File size:
3 MB

Meet 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

Customer Reviews

Average Review:

Write a Review

and post it to your social network

     

Most Helpful Customer Reviews

See all customer reviews >