Jonathan S. Helfgott is program coordinator in the MS in Regulatory Science program at Johns Hopkins University where he teaches and advices students. Additionally, he is the Director of Global Regulatory Affairs at Stage 2 Innovations. Prior to joining Stage 2 Innovations in early 2015, Mr. Helfgott was formerly the Associate Director for Risk Science, within the Office of Scientific Investigations at FDA’s Center for Drug Evaluation & Research (CDER). Prior to joining CDER in 2010, Mr. Helfgott worked at the FDA’s Center for Devices and Radiological Health (CDRH) within the Division of Bioresearch Monitoring (BIMO).