Robert E. Silverman

A 21-year (1992-2013) veteran of Merck & Co., Dr. Silverman reached the level of Executive Director in the Department of Global Regulatory Strategy, Policy and Safety at Merck Research Laboratories. During this time, he oversaw the submission and regulatory authority interactions for 9 New Drug Applications (NDAs)/World-wide Marketing Applications (WMAs), more than 50 major supplemental NDAs/WMAs, more than 30 U.S. INDs, and more than 50 U.S. FDA conferences/meetings. Dr. Silverman was eight years (1984-1992) at the NIH as an extramural Branch Chief (Diabetes, NIDDK). His medical and scientific training included an MD and PhD (Biological Chemistry) from Washington University in St. Louis School of Medicine (1972-1978), medical residency at Yale University (1978-1981), and subspecialty fellowship (Endocrinology and Metabolism) at the NIH (1981-1984).

Currently, Dr. Silverman is an independent, individual consultant providing assessment, advice, and assistance to therapeutics developers on the strategic regulatory aspects of the development of novel therapeutics encompassing early development, initial registration/approval and post-approval life-cycle management of their projects including their interaction with governmental regulatory authorities.