Michael R. Bleavins – författare

Discover how biomarkers can boost the success rate of drug development efforts

As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine.

Biomarkers in Drug Development is divided into eight parts:

Part One offers an overview of biomarkers and their role in drug development.

Part Two highlights important technologies to help researchers identify new biomarkers.

Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose.

Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine.

Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs.

Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns.

Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

Discover how biomarkers can boost the success rate of drug development efforts

As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine.

Biomarkers in Drug Development is divided into eight parts:

Part One offers an overview of biomarkers and their role in drug development.

Part Two highlights important technologies to help researchers identify new biomarkers.

Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose.

Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine.

Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs.

Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns.

Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicineHelps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratoryUpdates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoringIncludes case studies of biomarkers that have helped and hindered decision makingReviews of the first edition:"If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and "...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation." (ChemMedChem)

This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development.

Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring Includes case studies of biomarkers that have helped and hindered decision making Reviews of the first edition:"If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn''t be, then this book is for you." (ISSX) and "...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation." (ChemMedChem)