BERT SPILKER, PhD, MD, FCP, FFPM

Overview
Dr. Spilker 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.

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Noteworthy

• Consulted with over 250 pharmaceutical and health related companies and organizations

• Co-founded Orphan Medical and built it from one person (himself) to a staff of 35 and brought 7 drugs to the market in five years

• 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

• Represented US Industry on the ICH Steering Committee

• Received numerous honors including the FDA Commissioner’s
  Special Citation
   

Positions Held

• President, Bert Spilker & Associates

• CEO & President, Relox Medical

• Senior Vice President, Scientific and Regulatory at PhRMA

• President, Orphan Medical

• Vice President, Chronimed

• Director of Project Coordination, Burroughs Wellcome

• Senior Clinical Research Scientist, Burroughs Wellcome

• Senior Medical Consultant, JRB Associates

• Senior Research Scientist, Sterling-Winthrop

• Senior Research Scientist, Philips-Duphar

• Senior Research Scientist, Pfizer

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Education

• AB in chemistry at the University of Pennsylvania

• PhD in Pharmacology at SUNY Downstate Medical Center

• Post-Doctoral research at U of California Medical School (SF)

• MD at University of Miami PhD to MD program

• Residency in Internal Medicine at Brown Medical School