The Path from Biomarker Discovery to Regulatory Qualification

1st Edition

Print ISBN: 9780123914965
eBook ISBN: 9780123944085
Imprint: Academic Press
Published Date: 7th August 2013
Page Count: 206
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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:

Key Features

  • 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.


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

Table of Contents



Section 1: Introduction

1. Biomarker Applications in the Pharmaceutical Industry

Diagnostic Applications

Prognostic Applications

Intervention Management/Monitoring

Concluding Remarks


2. Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development


Has the Process at the FDA (CDER) Achieved the Goals Originally Proposed by the Pharmacogenomics Guidance in 2005 and the Critical Path Opportunities List and Report in 2006?

What are the Strengths and Weaknesses of the Different Versions of a Biomarker Qualification Process Developed in Each ICH Region?

How Well Have the Different Versions of This Process Been Harmonized across These Regions?

What are the Opportunities and Challenges for a Single, Universal, Biomarker Qualification Process?

How Can We Develop Metrics with Which to Measure the Impact of These Processes on Drug Development and Their Acceptance by the Pharmaceutical Industry?



3. Regulatory Experience of Biomarker Qualification in the EMA

Other Informal Interactions with the EMA

Examples of Qualification Opinions

4. Regulatory Experience at the FDA, EMA, and PMDA: Regulatory Experience at the PMDA



Section 2: Biomarker Development and Qualification in the Pharmaceutical Industry

5. The Impact of Changing Context of Use on Weight of Evidence for Qualification of Biomarkers: A Case Study in Ischemic Stroke

6. Safety Biomarker Development and Qualification in the Pharmaceutical Industry

7. First-Ever Regulatory Biomarker Qualification – Review and Insights by a Participant


8. Metabolomics-Derived Biomarkers of Drug-Induced Skeletal Muscle Injury and Urinary Bladder Transitional Cell Carcinom


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© Academic Press 2013
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"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.", 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