Skip to main content
SpringerLink
Log in

Translating Molecular Biomarkers into Clinical Assays

Techniques and Applications

  • Book
  • © 2016

Overview

Editors:
  1. Russell Weiner

    1. Translational Biomarkers and Personalized Medicine, Edison, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  2. Marian Kelley

    1. MKelley Consulting LLC, West Chester, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  • Introduces new associations to established topics such as, quantitative proteomics in the context of immunhistochemistry (IHC) assays and tissue biobanking for personalized medicine
  • Comprehensive review of traditional validation methods i.e. cell-based assays and mass spectrometry
  • Defines the business and market of biomarkers through commercial biomarker assay kits and biomarker CRO services
  • Includes supplementary material: sn.pub/extras

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 21)

This is a preview of subscription content, log in via an institution to check access.

Access this book

Log in via an institution
eBook USD 129.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access

Licence this eBook for your library

Institutional subscriptions

Table of contents (19 chapters)

  1. Front Matter

    Pages i-xiii
    Download chapter PDF

  2. Fit-for-Purpose Validation

    • Chad Ray
    Pages 1-15

  3. Biomarkers in Drug Discovery and Development: Pre-analytical and Analytical Considerations

    • R. Aleks Davis, Andrew P. Mayer, Ronald R. Bowsher
    Pages 17-25

  4. Biomarker Discovery

    • Omar F. Laterza, Xuemei Zhao
    Pages 27-35

  5. Application of Quantitative Biomeasures in Early Drug Discovery

    • Scott T. Fountain, Paolo Vicini
    Pages 37-46

  6. Biomarkers in Discovery and Preclinical Phase During Drug Development

    • Jean W. Lee
    Pages 47-56

  7. Incorporating Clinical Biomarkers into Clinical Trials

    • Paul W. Rhyne
    Pages 57-67

  8. Perspectives on Tissue Biobanking for Personalized Medicine

    • Uma Prabhakar
    Pages 69-76

  9. The Role of Commercial Biomarker Assay Kits in Preclinical and Clinical Trials

    • William Nowatzke, Ronald R. Bowsher
    Pages 77-86

  10. Quantification of Protein Biomarkers Using Liquid Chromatography Tandem Mass Spectrometry

    • Hendrik Neubert
    Pages 87-98

  11. LC/MS Methods for Small Molecule Biomarkers

    • Michael P. Sullivan
    Pages 99-113

  12. Application of Cell-Based Assays in Clinical Trials

    • Manjula P. Reddy, Amy Kate Sasser
    Pages 115-126

  13. New Technologies for Cellular Analysis

    • Peter J. O’Brien, Tim Wyant, Virginia Litwin
    Pages 127-140

  14. Current Flow Cytometry Methods for the Clinical Development of Immunomodulatory Biologics

    • Richard Wnek, Michelle Tseng, Dianna Wu
    Pages 141-151

  15. Key Mass Spectrometry Techniques Used in Clinical Biomarker Research

    • Mingxiang Lin
    Pages 153-161

  16. Clinical Genomic Biomarker Assay Development: Technologies and Issues

    • Ken C N Chang, Matthew J. Marton
    Pages 163-176

  17. Implementation of Immunohistochemistry Assays for Clinical Trial Sample Analyses

    • Marisa Dolled-Filhart, Usha Singh, Dianna Wu, K. Emancipator
    Pages 177-187

  18. Managing Biomarker Outsourcing: CRO Evaluation, Streamline Outsource Process, and Quality Management

    • Jeffrey A. Tsou
    Pages 189-199

  19. In Situ Hybridization in Clinical Biomarker Development

    • Usha Singh, Marisa Dolled-Filhart, Dianna Wu
    Pages 201-210

  20. Erratum to: Translating Molecular Biomarkers into Clinical Assays

    • Russell Weiner, Marian Kelley
    Pages E1-E1
Back to top

Keywords

About this book

This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation of new cytometry methods. Expertly curated by two practicing professionals in drug development and biotherapeutics, individual chapters are selected for novel and sound research; information is chosen based on its relevance to lab applications and clinical trials, such as the topic of selecting animal models for their relevancy to humans. The book is multifaceted, discussing the ethics and issues with biospecimens and providing an in-depth analysis to the differences between pre-clinical and clinical assay development. The book is an essential read for general readers who need an introduction to the history and background of biomarkers,  and it also provides critical analyses of various new validation methods for practitioners and researchers. 

Editors and Affiliations

  • Translational Biomarkers and Personalized Medicine, Edison, USA

    Russell Weiner

  • MKelley Consulting LLC, West Chester, USA

    Marian Kelley

About the editors

Russell Weiner is a senior level biopharmaceutical professional with expertise in pharmaceutical and biologic drug development, clinical trial conduct, regulated bioanalysis, use of biomarkers in early clinical decision making and developing companion diagnostic strategies. He is the Executive Director and head of Clinical Bioanalytical, Biomarkers and Companion Diagnostics team at Daiichi Sankyo Inc. He acquired his Ph.D. at the Albany Medical College. Dr. Weiner led clinical development teams responsible for transitioning therapeutics from discovery through phase two ‘proof-of-concept’ studies. With over 40 publications, he is also part of the Foundation of the NIH Cancer Steering Committee for The Biomarkers Consortium. 



Marian Kelley is a leading expert in biotherapeutic drug development from biomarker application to assay analysis. She is the president and founder of MKelley Consulting, LLC, a company that provides bioanalytical support in drug development including validation of biomarker methods, immunogenicity and pharmacokinetic studies, and cell-based assays. Marian was  the founding secretary of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG); she co-chaired the Workshop on Assay Reproducibility for Incurred Samples held in Crystal City; and most recently, she leads the L1 global harmonization team on Run Acceptance for LBA resulting in a published white paper. Kelley is coauthor or coeditor of over 30 publications. She is also an extensively experienced trainer in validation of methods and quality control. 

Bibliographic Information

  • Book Title: Translating Molecular Biomarkers into Clinical Assays

  • Book Subtitle: Techniques and Applications

  • Editors: Russell Weiner, Marian Kelley

  • Series Title: AAPS Advances in the Pharmaceutical Sciences Series

  • DOI: https://doi.org/10.1007/978-3-319-40793-7

  • Publisher: Springer Cham

  • eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)

  • Copyright Information: American Association of Pharmaceutical Scientists 2016

  • Hardcover ISBN: 978-3-319-40792-0Published: 30 August 2016

  • Softcover ISBN: 978-3-319-82185-6Published: 14 June 2018

  • eBook ISBN: 978-3-319-40793-7Published: 22 August 2016

  • Series ISSN: 2210-7371

  • Series E-ISSN: 2210-738X

  • Edition Number: 1

  • Number of Pages: XIII, 212

  • Number of Illustrations: 8 b/w illustrations, 16 illustrations in colour

  • Topics: Pharmaceutical Sciences/Technology, Pharmacy

Publish with us

Policies and ethics

Back to top

Search

Navigation