Biomarkers in Drug Development

Discover how biomarkers can boost the success rate of drugdevelopment effortsAs pharmaceutical companies struggle to improve the success rateand cost-effectiveness of the drug development process, biomarkershave emerged as a valuable tool. This book synthesizes and reviewsthe latest efforts to identify, develop, and integrate biomarkersas a key strategy in translational medicine and the drugdevelopment process. Filled with case studies, the bookdemonstrates how biomarkers can improve drug development timelines,lower costs, facilitate better compound selection, reducelate-stage attrition, and open the door to personalizedmedicine.Biomarkers in Drug Development is divided into eightparts:* Part One offers an overview of biomarkers and their role in drugdevelopment.* Part Two highlights important technologies to help researchersidentify new biomarkers.* Part Three examines the characterization and validation processfor both drugs and diagnostics, and provides practical advice onappropriate statistical methods to ensure that biomarkers fulfilltheir intended purpose.* Parts Four through Six examine the application of biomarkers indiscovery, preclinical safety assessment, clinical trials, andtranslational medicine.* Part Seven focuses on lessons learned and the practical aspectsof implementing biomarkers in drug development programs.* Part Eight explores future trends and issues, including dataintegration, personalized medicine, and ethical concerns.Each of the thirty-eight chapters was contributed by one or moreleading experts, including scientists from biotechnology andpharmaceutical firms, academia, and the U.S. Food and DrugAdministration. Their contributions offer pharmaceutical andclinical researchers the most up-to-date understanding of thestrategies used for and applications of biomarkers in drugdevelopment.