Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy

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9780470169278: Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

About the Author :

MICHAEL R. BLEAVINS, PhD, is cofounder of Michigan Technology and Research Institute. He retired from Pfizer/Warner-Lambert/Parke-Davis in 2006 and has twenty-three years of experience in pharmaceutical research, development, and biomarkers with more than sixty-five peer-reviewed publications.

CLAUDIO CARINI, MD, PhD, FRCPath, is Chief Medical Officer and Vice President for Clinical Research at Fresenius. Previously, Claudio served as Global Head of Translational Medicine at MDS and Global Head of Biomarkers at Hoffmann-La Roche. Claudio has more than twenty years of experience in the field of immunology and biomarkers and has authored more than 200 publications in international and domestic peer-reviewed journals.

MALLÉ JURIMA-ROMET, PhD, is Senior Director for Development and Regulatory Services at MDS Pharma Services, where she provides strategic and scientific consulting to pharmaceutical and biotech sponsors, and leads drug development program teams. Mallé has authored over forty peer-reviewed publications and is an adjunct professor at the University of Montreal.

RAMIN RAHBARI, MS, is cofounder and Senior Consultant at Innovative Scientific Management. Previously, Ramin has held positions at Pfizer, Synaptic, and Parke-Davis pharmaceutical companies, leading cross-functional biomarker teams.

Review :

"[This book] is unquestionably the best available and most updated source of information on the use of biomarkers in Translational Medicine available today. The Editors superbly crafted an excellent resource and straightforward read. ... Aptly described by the editors, biomarkers have emerged as a useful and valuable tool for anyone working in the research and development of novel pharmaceuticals. Replete 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. ... This book is absolutely crucial for drug-development scientists and researchers. Each of the winning chapters has been penned by an official in the relevant field. This is a book that should not be missed by anyone working with biomarkers in the challenging and changing market of today."
Raffaele Baffa, MD, Translational Sciences, MedImmune, LLC

"The book by Bleavins, et al. is a real tour de force on the topic of biomarkers, and attacks the subject in a well balanced and very holistic way. This is by far the most comprehensive treatise on the topic of biomarkers that has been published to date. The chapters are extremely well written, and it was great fun to read the historical aspects that reminds every reader that biomarkers are not a new invention. Chapters that dwell on the qualification, analytical, and regulatory considerations are very sobering as they show that the use of biomarkers sound easy in theory but considerably more difficult in practice.... The ability of this book to address issues from the scientific to the investment attests to the holistic nature that the editors chose to address in a topic deceptively named with one word...biomarkers. Overall the chapters are evenly informative and consistently well written and organized, which is tribute to the editors.... [A] remarkable aspect of this book is the breadth of experience and diversity of the authors. Rather than maintaining an uniform view from one fraction of the biomarker user world , the editors were broadly inclusive of a wide set of disciplines from academia, pharma industry, and regulatory but also from commercial and laboratory organizations. This diversity brings a richness of experience and knowledge that propels the book to a level of insight that is atypical for a topic of this nature. Another area for which the editors should receive great credit is in the breath of biomarker considerations. The landscape is large and ranges from the more traditional serum analytical assay to the complexities of imaging and genetic biomarkers and the unique issues associated with these fields. Another strength of the book is highlighting examples of the applications of biomarkers in a couple of diseases.... Overall this is an excellent book and will serve as a superb reference for anyone in the field of drug development and translational medicine. It is highly informative, rich in detail and extensive in breath. It deserves to be on the shelf of anyone involved in the discipline of biomarker application. The editors should be commended for having delivered an exceptional piece of work on a very topical issue."
--Diane K. Jorkasky, M.D., Aileron Therapeutics, Inc.

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