Bert Spilker, PhD, MD, FCP, FFPM, is one of the foremost authorities on clinical trials, regulatory affairs and drug developments.  He is an author of “the standard” pharmaceutical industry reference books, with extensive experience in drug management, drug discovery research, regulatory affairs and clinical practice. Dr. Spilker is an independent consultant who 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. In addition he serves on the Boards of Directors of six companies and the Board of Advisors of seven organizations. He is well known as the author of 15 books on clinical trial methods and the processes of drug discovery and development. These books are considered by many as the standard references on clinical trials and drug development. In addition, he authored over 140 articles and 14 book chapters. He 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 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 and Duke University. He trained in pharmacology and internal medicine at Cornell Medical College, State University of New York (Downstate Medical Center), University of California at San Francisco, University of Miami Medical School (Ph.D. to M.D. Program) and Brown University Medical School.
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