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Featuring: Theresa Mullin, PhD, Director, Office of Strategic Programs, Center for Drug Evaluation and Research, US Food and Drug Administration

Moderator: Marc Boutin, Chief Executive Officer, National Health Council

Theresa M. Mullin directs strategic programs including business informatics for CDER. The Office of Strategic Programs plays a lead role in a number of CDER’s strategic initiatives and modernization efforts including development of benefit-risk and other decision support tools, the international program, data standardization, lean management, program analysis, informatics, and major user fee negotiations.

Dr. Mullin currently leads the CDER Patient Focused Drug Development Initiative and the FDA delegation to the International Conference on Harmonization. She is serving as FDA lead negotiator for the upcoming Prescription Drug User Fee Act (PDUFA) reauthorization, having similarly led negotiations for 2012 PDUFA V and BSUFA authorizations. PDUFA currently generates nearly $800 million in fee revenues to support the process of human drug review.

Before joining CDER in September 2007, Dr. Mullin was Assistant Commissioner for Planning in the FDA Office of Commissioner. In that role she led previous FDA user fee negotiations with the pharmaceutical industry for the 2007 and the 2002 reauthorizations of PDUFA. Since joining FDA Dr. Mullin has received the Senior Executive Service Presidential Rank Award for Meritorious Service in 2006 and for Distinguished Service in 2011.

Before coming to FDA, Dr. 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. Dr. Mullin received her B.A., magna cum laude, in Economics from Boston College, and Ph.D. in Public Policy Analysis from Carnegie-Mellon University.

Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum, starting with the development of new drugs, to regulatory oversight of health care delivery, to shared decision-making at the point of care. Under his leadership, the National Health Council has convened a broad range of stakeholders to create and effectively implement pragmatic strategies and public policy that address diverse issues, such as enhancing patient engagement, advancing the development of new treatments, and developing a better health delivery system to meet the needs of people with chronic conditions.

Boutin has a long history of board and committee service. Currently he serves as a member of the Patient-Centered Outcomes Research Institute (PCORI) Patient Engagement Advisory Panel, FasterCures Benefit-Risk Advisory Council, and the Medical Device Innovation Consortium (MDIC) Patient-Centered Benefit-Risk Steering Committee.

Boutin has been actively involved in patient advocacy organization management, health advocacy, and both federal and state policy throughout his career. He is a founding member of the international Patient-Focused Medicine Development consortium and has served on the Governing Board of the International Alliance of Patients’ Organizations as a member and treasurer. He is also a former member of the Partnership to Fight Chronic Disease Board of Directors, the Humana Cares Clinical Advisory Board, the eHealth Initiative Leadership Council, Community Health Charities Board of Directors, Healthcare Systems Research Collaboratory, and the North America Advisory Board to the Drug Information Association.