Translating Molecular Biomarkers into Clinical Assays

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.

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

Autorentext
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.

Inhalt
Foreword.- Fit-For-Purpose Validation.- Biomarkers in Drug Discovery and Development: Pre-Analytical and Analytical Considerations.- Biomarker Discovery.- Application of Quantitative Biomeasures in Early Drug Discovery.- Biomarkers in discovery and preclinical phase during drug development.- Incorporating clinical biomarkers into clinical trials.- Perspectives on Tissue Biobanking for Personalized Medicine.- The role of commercial biomarker assay kits in preclinical and clinical trials kits.- Quantification of protein biomarkers using liquid chromatography tandem mass spectrometry.- LC/MS methods for small Molecule biomarkers.- Cell-based Assays.- New Technologies for Cellular Analysis.- Flow cytometry methods for the Clinical Development of Immunomodulatory Biologics.- Key mass spectrometry techniques used in clinical biomarker research.- Clinical Genomic Biomarker Assay Development: Technologies and Issues.- Implementation of Immunohistochemistry assays for clinical trial sample analyses.- Strategic Approach to Outsourcing Clinical Biomarker Assays through CRO Relationships.- In situ hybridization (ISH) in Clinical Biomarker Development.