Company Profile

Bert Spilker

Contact Us:

8004 Overhill Road
Bethesda, Maryland

Phone: 301-718-5150
Fax: 301-657-1403
E-mail: bas@bertspilker.com
Alt E-mail: bertspilker0@gmail.com

Brochures: (Acrobat)

  • Bert Spilker & Associates
  • "Enhancing Your Meetings with FDA"
  • . Biography of Dr. Bert A. Spilker

    Bert Spilker, PhD, MD, FCP, FFPM, 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. 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.

    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.

    His medical training in pharmacology and internal medicine was 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.

    Copyright © 2002-2013 Bert Spilker & Associates, LLC. All rights reserved.