Michael Klein

Michael Klein specializes in controlled substance review for new drugs, focusing on regulatory submissions and guidance for drug development. Currently, they serve as the Director of Controlled Substances at Cote Orphan and hold positions as Senior Director at IQVIA and Director at QuintilesIMS. Previously, Michael was the Director of the Controlled Substance Staff at the US Department of Health and Human Services from 2007 to 2017. They are pursuing a Bachelor of Science in Pharmacy and a PhD in Medicinal and Pharmaceutical Chemistry from the University of Illinois, and have completed postdoctoral work in Organic Synthesis at Argonne National Laboratory.