Translating Molecular Biomarkers into Clinical Assays (eBook)

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. 

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.