Deputy Director
US Food and Drug Administration
Dr. Ke Ren is the Associate Director in the Division of Bioequivalence III/Office of Bioequivalence/Office of Generic Drug (OGD)/FDA. She joined the OGD in March 2008. Ke received her Ph.D. in Pharmaceutical Science from the University of Florida in 2005. Her Ph.D. work involved developing mechanism-based PK/PD studies targeting alpha-7 nicotinic receptors for Alzheimer’s disease.
Her work in the FDA focuses on bioequivalence evaluation. She has developed extensive expertise in generic drug development in various therapeutic areas. She also a key member in several Nasal/inhalation Working groups, which include 1) evaluation different approaches for the analysis of In-Vitro bioequivalence studies of nasal/inhalation Drug Product; 2) a systemic investigation on the total variability of in-vitro bioequivalence tests of nasal drug products submitted in ANDAs; and 3) development of a step-wise procedure for PBE analysis of orally inhaled and nasal drug product bioequivalence studies. All these works have been received regulatory science section outstanding contributed paper award at the AAPS Annual meeting.