Bert Spilker, Ph.D., M.D., FCP, FFPM
Dr. Spilker’s 15 textbooks on drug development are required reading in the pharmaceutical industry. Bert has a remarkable range of knowledge and 40-year experience advising FDA, NIH and multiple drug development programs world-wide. Founding CEO of Orphan Medical pharmaceutical company was a remarkable achievement with significant Fast Track drug approvals leading to life-saving medications. Dr. Spilker worked in multiple major pharmaceutical companies and served as S.V.P./Scientific and Regulatory Affairs for PhRMA. His service on the Steering Committee for the International Conference on Harmonization received numerous honors including the FDA Commissioner's Special Citation for work in the orphan medicine area. Bert’s medical training in pharmacology and internal medicine was at Cornell Medical College, SUNY; UCSF, U. Miami Medical School (Ph.D. to M.D.) and Brown University Medical School.