The Path from Biomarker Discovery to Regulatory Qualification book cover

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:


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

Paperback, 206 Pages

Published: August 2013

Imprint: Academic Press

ISBN: 978-0-12-391496-5


  • "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


  • Table of Contents

    Section 1: Background

    1. Biomarker Applications in the Pharmaceutical Industry - William Mattes, PharmaPoint

    2. Fundamental Principles of Biomarker Qualification - Issam Zineh, CDER/FDA

    3. The Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development - Federico Goodsaid, Vertex

    4. Regulatory Experience at the FDA, EMA, and PMDA - Shashi Amur, CDER/FDA, Spiros Vamvakas, EMA, and Yoshiaki Uyama, PMDA.

    5. Biomarkers in the Co-Development of Drugs and Tests - Elizabeth Mansfield, CDRH/FDA

    Section 2: Vignettes of Biomarker Development and Qualification

    6. Biomarker Development and Qualification in the Pharmaceutical Industry -

    Merck. John Wagner and Frank Sistare, Merck

    Pfizer. Stephen Williams, Pfizer

    Roche. Jackie Vonderscher, Roche

    Novartis. Frank Dieterle, Novartis

    Astra-Zeneca. Stephen Furlong, Astra-Zeneca

    BMS. Bruce Car, BMS

    Vertex. Martyn Botfield, Vertex

    7. Toxicogenomic Biomarkers

    Phase-1 Molecular Toxicology. Lawrence Kier

    Incyte. Mary Jane Cunningham, Southern Institute

    Gene Logic. Donna Mendrick, FDA

    Johnson and Johnson. Peter Lord

    ILSI-HESI. Cindy Afshari, Amgen

    8. Pharmacogenomic Biomarkers

    Warfarin. Lawrence Lesko, University of Florida

    Clopidogrel. Michael Pacanowski, CDER/FDA

    D-Met Chip. Richard Hockett, Affymetrix

    9. Oncology Biomarkers

    Herceptin. Eric Walk, Ventana

    OncoDx. Kimberly Popovitz, Genomic Health

    K-Ras. Scott Patterson, Amgen

    CTCs. Howard Scher, Sloan-Kettering

    10. Biomarkers of Drug Safety

    Cardiac Safety: Troponins. Peter O’Brien, Dublin

    Urinary Biomarkers of Kidney Injury. Joseph Bonventre, Harvard

    Genetic Markers for Drug-Induced Liver Injury. Sally John, Pfizer/iSAEC

    11. Consortia

    ILSI-HESI. Michael Holsapple, ILSI-HESI

    C-Path Institute. Ray Woosley, C-Path

    FNIH. David Wholley, Biomarkers Consortium

    iSAEC. Arthur Holden, iSAEC

    Beyond QT. Jean-Phillipe Couderc, University of Rochester

    Digestive System Motility. Michael Camilleri, Mayo Clinic

    12: Tortuous Path to Regulatory Qualification Process Development

    ECVAM. Thomas Hartung, Johns Hopkins

    ICCVAM. Len Schechtman

    FDA. Janet Woodcock, CDER/FDA

    EMA. Eric Abadie and Marisa Papaluca-Amati, AFSSAPS/EMA

    PMDA. Yoshiaki Uyama, PMDA

    Section 3. Past, Present and Future of Biomarker Qualification - Federico Goodsaid, Vertex Pharmaceuticals.


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