Stephen Miller, PhD

Steve Miller received a B.S. in chemistry in 1978 from SUNY at Stony Brook, and his Ph.D. in organic chemistry from the University of Wisconsin at Madison (1983). After a postdoctoral appointment at the Pharmaceutical Chemistry Department in Madison (1984), he joined the National Institutes of Health. His work at NIH (1985-1993) focused on the synthesis and study of enzyme inhibitors and fluorescent substrates. Dr. Miller joined the FDA in 1994, as a chemistry reviewer in the Center for Drug Evaluation and Research. In his current position with the FDA’s Office of Pharmaceutical Quality, he focuses on the chemistry, manufacturing and controls (CMC) data for antiviral drugs that are entering clinical trials in the US (IND applications), or that have reached the marketing application (NDA) stage. His current professional interests include the scientific and regulatory aspects of drug substance manufacture and quality control, with particular emphasis on issues related to mutagenic impurities, polymorphism, and stereochemistry. He participated in the ICH M7 Expert Working Group, as FDA’s Deputy Topic Leader, and is currently the FDA Topic Leader on the ICH Q11 Starting Material Q&A Implementation Working Group.