--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.