I am currently Vice President, Regulatory Affairs, at Regeneron Pharmaceuticals in Tarrytown, NY. I am trained in internal medicine and infectious diseases. I have over 20 years of experience at the US FDA, including 12 years as the Director of the Office of Antimicrobial Products, an Office of approximately 150 people. While at FDA I have worked on a wide range of issues in the area of infectious diseases (e.g., antimicrobial drug development, emerging infectious diseases, antimicrobial resistance initiatives, initiatives for limited population antimicrobial drugs, emergency use authorization, and tropical diseases) and drug shortages. My work has involved overseeing the development of a wide range of antimicrobial products, working with international regulators, and working more broadly within the international infectious diseases community. I also have experiences working on a number of different drug safety issues. As an Office Director in the Office of New Drugs, I have also been involved with advising on scientific, policy, and regulatory issues across a wide range of products and therapeutic areas.