Bert Spilker, PhD, MD-the author of a variety of books on topics pertaining to clinical trials, including 

Guide to Clinical Studies and Developing Protocols

Quality of Life and Pharmacoeconomics in Clinical Trials (2nd Ed.), 

(1996), to name just a few-is releasing his 16th reference textbook on clinical trials and drug development, 

Guide to Drug Development: A Comprehensive Review and Assessment

Dr. Spilker is the sole author of the 1250 pages that is compiled into 118 chapers, and according to him, the unique aspects of the book are as follows:

Provides      the most comprehensive description, discussion, and evaluation of      methodologies used to discover, develop, manage the processes, and expand      the indications of marketed drugs as well as achieving regulatory approval      and conducting postmarketing activities. 

Ideally      suited for courses and staff training, with dozens of case studies in      three separate chapters and many others throughout the book, as listed in      the index; plus specific questions to discuss that are listed at the end      of all 118 chapters.

Most      importantly, many discussions and even complete chapters review tips and      lessons on avoiding failures to ensure success in product development.

The      entire book applies to medical devices, drugs, biotech products, vaccines,      diagnostics and other medical products. 

Useful      as a desk reference to answer frequently asked questions and to address      many issues that arise and are not discussed in other published sources.

Over      300 diagrams and hundreds of tables illustrate ways of conceptualizing      many ideas and approaches to the topics discussed. 

Bert Spilker, PhD, MD, FCP, FFPM, is an independent consultant who works with a large number of pharmaceutical, biotech and medical device companies, primarily in the areas of regulatory affairs, clinical trials and development. His work focuses on creating strategies, preparing and reviewing documents, arranging FDA meetings and solving problems. 

He was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA (Pharmaceutical Research and Manufacturers of America) based in Washington, D.C.  He was President and cofounder (in 1993) of Orphan Medical, Inc., a public pharmaceutical company that develops and markets important medical products for patients with uncommon diseases. He brought 7 drugs to the market in the first five years of its existence.  He is well known as the author of 16 textbooks on clinical trial methods and the processes of drug discovery and development.  These books are widely considered to be the standard references on clinical trials and drug development.  He has worked at four major pharmaceutical companies for over 20 years (Pfizer, Philips-Duphar, Sterling-Winthrop, and Burroughs Wellcome) in medicine discovery, development, and management.  He served on the Steering Committee for the International Conference on Harmonization, or ICH, and has received numerous honors including the FDA Commissioner’s Special Citation for work in the orphan medicine area.  

He is Clinical Professor of Pharmacy Practice at the University of Minnesota and Adjunct Professor of Medicine and Clinical Professor of Pharmacy at the University of North Carolina in Chapel Hill. He is visiting professor of clinical pharmacology at the University of Illinois Medical School.  His medical training in pharmacology and internal medicine was at Cornell Medical College, State University of New York (Downstate Medical Center), University of California Medical School in San Francisco, University of Miami Medical School (Ph.D. to M.D. Program) and Brown University Medical School.

His website is www.bertspilker.com; and he can be contacted at 