Upstate Medical University

Lisa Ware

Director, Regulatory Affairs

Lisa Ware, MS is the Director of Regulatory Affairs and the Sponsor Representative for SUNY Upstate Medical University. She has over 40 years of experience in product development, with 20 of those in early phase regulatory submissions. She joined the Global Health Institute in 2013 and, as part of the team, she prepares Investigational New Drug (IND) Applications for submission to the FDA and works closely with internal or external clients to ensure that the clinical, laboratory, data and statistical teams are aligned to meet requirements of a regulated clinical trial.

Prior to joining Global Health, she worked at the Walter Reed Army Institute of Research in the Malaria Vaccine Development Branch. Here she was a bench scientist developing malaria vaccines, testing them in in vitro and in vivo experiments. As products showed promise, she helped develop protocols for cGMP production, GLP toxicology testing and GCP clinical trials and moved into the regulatory world of FDA IND Applications. While in the Translational Medicine Branch at Walter Reed, she supported both the Department of Clinical Trials and the Pilot Bioproduction Facility, taking products from an idea to manufacturing to people. She finds her work very rewarding with the knowledge that any little bit she can do to help get a new drug or vaccine to the market might make a difference to those help save lives.

She received her bachelor's in biology from St. Anselm College, her Master's in Genetics from George Washington University, and her Certificate in Regulatory Compliance from Hood College. Outside of work, she enjoys camping and traveling with her husband and pets, getting together with her three grown children, her extended family, and friends.