Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA

Serves as principal advisor on strategy, leads FDA Patient Focused Drug Development, leads the New Inspection Protocol Project, and heads FDA delegation to the International Council on Harmonization. She directed development of CDER’s benefit-risk framework for new drug evaluation and is leading development of guidance to industry.  Theresa led FDA negotiations in 2017 and the previous 3 cycles of reauthorization of the Prescription Drug User Fee Act, now providing $1B in annual funding for new drug review.  Since joining FDA she has received awards including Senior Executive Service Presidential Rank Award for Distinguished Service in 2011, Presidential Rank Award for Meritorious Service in 2006, and 2017 FDLI Distinguished Service and Leadership Award.  Theresa studied Economics at Boston College, and received her PhD in Public Policy Analysis from Carnegie-Mellon University.

My Sessions

Life Sciences Panel: Decision Analysis and Medical Benefit-Risk Decision Making with the FDA

Grays Peak

Pharmaceutical industry and regulators use decision analysis within their organizations to support complex benefit risk decision-making.  Systematic use of quantitative benefit risk assessment is possible in future interactions between these stakeholders.  Regulators are exploring ways in which quantitative decision analysis approaches, methods and tools can be used to inform benefit risk assessment and decision making […]

Life Sciences