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

With the awareness that drug development has had diminishing success over the last 10 to 15 years, there has been an increasing consideration of ways to triage successful from nonsuccessful agents early in the drug development process. Biomarkers have come to forefront in this context both at the level of the FDA, in their articulation of the critical path, and many pharmaceutical companies that now require the codevelopment of a biomarker together with the new chemical entity. While many have looked to biomarkers as a panacea for the ills of drug development, many have realized that having a biomarker enhances the clarity of decisions in drug development but there remain many issues associated with their use. At times the hype about biomarkers has far outstripped their realistic contribution. 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 remind 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 sounds easy in theory but is considerably more difficult in practice. Furthermore the chapter on the valuation of biomarkers in drug development starts to bring to the forefront the stark reality of how much resource is required when investing in a biomarker strategy. 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 a tribute to the editors. The one observation I would make is that it is very clear that the definitions of biomarkers as they are put into practice remain fractionated and without consistency, as evidenced by the different terms used in the various chapters. While the authors may have tried to forge consistency, I think this would have been an uphill battle since the opinions on biomarker terminology seem to remain a topic of religious fervour. The field, however, would benefit by greater consistency in terminology. One of the most enjoyable chapters was on the application of statistics to biomarker evaluation because it was written in a style that was highly approachable and amusing, an unusual combination when discussing statistics. This chapter will be well received by those without a penchant for heavy statistical and mathematical considerations of the topic. Another remarkable aspect of this book is the breadth of experience and diversity of the authors. Rather than maintaining a uniform view from one fraction of the biomarker user world, the editors were broadly inclusive of a wide set of disciplines not only 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 application of biomarkers in a couple of diseases. Unfortunately these diseases are exemplars of those for which biomarkers exist in plenty. It would have been helpful to have some discussion on diseases where the ability to use biomarkers is far more difficult and limited due to the site of the pathology or the nature of disease. It would have been helpful to highlight alternative strategies in these areas, but this is a small criticism. 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.