Back to Speakers

Speaker's Biography

Theresa Mullin

Director, Office of Strategic Programs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Dr. Theresa Mullin serves as Director of OSP, whose mission is to transform and modernize drug regulatory operations, leading the CDER international program, data standards, business informatics, lean management, program analysis, and major drug user fee negotiations. Having led successful negotiations for the previous 3 cycles of reauthorization, Mullin recently served as FDA's lead negotiator for the 2017 reauthorization of the Prescription Drug User Fee Act (PDUFA), a program that currently provides more than $800 million per year in fee funding for new drug review. She has also served as FDA's lead negotiator for the 2017 reauthorization of the Biosimilar User Fee Act (BsUFA). Mullin leads the FDA Patient Focused Drug Development Initiative, an effort begun in 2012. She also heads the FDA delegation to the International Council on Harmonization (ICH), the primary venue for international harmonization of drug regulatory standards. Before joining CDER in September 2007, Mullin was Assistant Commissioner for Planning in the FDA Office of Commissioner, where she served as Director of the Office of Planning. Since joining FDA, Mullin has received numerous awards including the Senior Executive Service Presidential Rank Award for Distinguished Service in 2011, and the Presidential Rank Award for Meritorious Service in 2006. Most recently, she has been named a recipient of the 2016/2017 FDLI Distinguished Service and Leadership Award. Before coming to FDA, Mullin was a Senior Manager with The Lewin Group, specializing in health care consulting, and prior to that, Principal Scientist at Decision Science Consortium, specializing in decision research and analysis. Mullin received her B.A., magna cum laude, in Economics from Boston College, and Ph.D. in Public Policy Analysis from Carnegie-Mellon University.