Inovio Pharmaceuticals, Inc. announced the appointment of Dr. Ami Shah Brown as vice president regulatory affairs. Dr. Brown, who joined Inovio in 2011 as senior director of regulatory affairs, will be responsible for developing and implementing Inovio’s regulatory strategies, including leadership over regulatory submissions, regulatory compliance, advertising and promotion review, and registrations to support Inovio’s product pipeline.
Dr. J. Joseph Kim, Inovio’s president & CEO, said, “Ami has shown technical excellence and leadership in successfully moving our DNA-based therapy for women’s health, VGX-3100, through its phase II regulatory process. This is now leading to the initiation of phase III for this program before the end of this year. We expect her strategic guidance and counsel to be invaluable as we advance multiple cancer and infectious disease products through the clinical and regulatory process.”
Prior to Inovio, Dr. Brown was director, vaccine operations, at the Sabin Vaccine Institute in Washington, D.C., where she contributed to the early work of the Sabin Vaccine Institute Product Development Partnership (Sabin PDP), an internationally recognized PDP for the creation of safe, effective, low-cost vaccines for tropical infections in developing countries. She had previous experience at the Johns Hopkins Bloomberg School of Public Health’s Center for Immunization Research, the Emory University Department of Medicine, and the Centers for Disease Control and Prevention (CDC) at the National Center for HIV, STD and TB prevention. She began her career at the University of Pennsylvania Department of Pathology and Laboratory Medicine.
She holds a PhD from Johns Hopkins University’s Bloomberg School of Public Health, a Master of Public Health (MPH) degree from Emory University’s Rollins School of Public Health, and a BA in Biology from the University of Pennsylvania.