Translating Molecular Biomarkers into Clinical Assays

1. Front Matter

   Pages i-xiii

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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

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. 

• Biomarker
• pharmacokinetics
• FDA
• bioanalysis
• target engagement

• Translational Biomarkers and Personalized Medicine, Edison, USA

  Russell Weiner

• MKelley Consulting LLC, West Chester, USA

  Marian Kelley

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. 

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