New Associate Director Appointed to CDER

Pharmaceutical Manufacturing
09/07/2007

Dr. Theresa Mullin will be joining CDER on September 24, as the Associate Director for Analysis and Strategic Initiatives.  Dr. Mullin will be on detail until the permanent appointment process has been completed.  In this position, Dr. Mullin will lead CDER’s long-range planning and strategic modernization initiatives.

Dr. Mullin brings a combination of expertise in methods of risk benefit and decision analysis, use of quantified expert judgments, regulatory business process analysis, and performance planning.   Her knowledge of econometric and other mathematical analysis of scientific data will allow the Center to leverage quantitative forecasting to further strategic policy initiatives.  She also has experience in leading special initiatives in performance management and modernization at FDA.

Dr. Mullin was formerly the Assistant Commissioner for Planning and Director of the Office of Planning, in the Office of Commissioner.  As the chief planner, Dr. Mullin has led the development of FDA’s Strategic Action Plans and performance plans incorporated into agency budget requests.  She has led FDA-industry negotiations for both the 2002 reauthorization of PDUFA and the currently proposed 2007 reauthorization.

Dr. Mullin played a critical role in establishing the new FDA Bioinformatics Board (BiB) and provided early support for the FDA Critical Path initiative through planning and project management to enable development of the 2004 report Innovation Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.  As head of the Office of Planning, she has also provided oversight of agency cost-benefit analyses to gauge the public impact of agency rulemaking on a wide range of issues, including analysis of proposed or final rules addressing issues such as BSE, condom labeling, bacterial vaccines, MUMS, electronic drug registration and listing, physician labeling, reprocessed single use medical devices, and phenylpropanolamine OTC drugs.

Prior to her work at FDA, Dr. Mullin spent over ten years’ working as a Principal Scientist with Decision Science Consortium, and as Senior Manager with the Lewin Group, in the design and development of analytic tools and methods for decision support.