Pharmaceutical Compliance and Enforcement to Achieve Drug Quality: Establishing a Strategic Framework of Outcomes with Performance Indicators Mayflower Hotel • Washington, DC November 14-15, 2016

Participant List

Barbara Allen Charles Cooney Senior Director for Global Quality Systems, Eli Robert T. Haslam Professor of Chemical Lilly Engineering, Massachusetts Institute of Technology Deborah Autor Head of Strategic Global Quality and Regulatory Thomas Cosgrove Policy, Mylan Acting Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food Ilisa Bernstein and Drug Administration Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food Alonza Cruse and Drug Administration Director, Pharmaceutical Quality Program, Office of Regulatory Affairs, Office of Global Malcolm Bertoni Regulatory Operations and Policy, U.S. Food and Associate Commissioner for Planning, Office of Drug Administration Planning, Office of Planning, Policy, Legislation, and Analysis, Office of the Commissioner, U.S. Gregory Daniel Food and Drug Administration Clinical Professor, Duke Fuqua School of Business and Deputy Director, Duke-Margolis Ashley Boam Center for Health Policy, Duke University Director, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality, Kristen DeMaio Center for Drug Evaluation and Research, Special Assistant, Pharmaceutical Quality U.S. Food and Drug Administration Program, Office of Regulatory Affairs, Office of Global Regulatory Operations and Policy, U.S. Katherine Bond Food and Drug Administration Vice President, International Regulatory Affairs, Global External Affairs, U.S. Pharmacopeial Jennifer Devine Convention Vice President, Global Legal Affairs - Standards, U.S. Pharmacopeial Convention Sarina Coates Research Assistant, Duke-Margolis Center for Joseph Famulare Health Policy, Duke University Vice President, Global Compliance and External Collaboration, Genentech Heather Colvin Project Director, Duke-Margolis Center for Maxine Fritz Health Policy, Duke University Executive Vice President, Pharma Biotech Consulting, NSF Health Sciences, NSF International

Ted Fuhr Tim Mackey Partner, McKinsey & Company Assistant Professor, University of California, San Diego - School of Medicine; Associate Director, Andrew Gonce Masters Program in Health Policy and Law and Chief of Staff to the Senior Vice President, Director, Global Health Policy Institute, Technical Operations, Purdue Pharma University of California School of Medicine, San Diego Henry Grabowski Professor Emeritus of Economics and Director Mark McClellan of the Program in Pharmaceutic and Health Robert J. Margolis Professor of Business, Economics, Duke University Medicine, and Policy and Director, Duke- Margolis Center for Health Policy, Duke Katie Greene University Research Associate, Duke-Margolis Center for Health Policy, Duke University Marie R. McDonald Vice President, Consulting Services, Michie Hunt QuintilesIMS Acting Deputy Director and Senior Project Manager, Office of Executive Programs, Center Caleb Michaud for Drug Evaluation and Research, U.S. Food Special Assistant to the Associate Commissioner and Drug Administration for Planning, Office of Planning, Office of Planning, Policy, Legislation, and Analysis, Office Valerie Jensen of the Commissioner, U.S. Food and Drug Associate Director, Drug Shortage Staff, Office Administration of the Center Director, Center for Drug Evaluation and Research, U.S. Food and Drug Karla Miller Administration Vice President of Pharmacy Services and Clinical Therapeutics, Hospital Corporation of America Amber Jessup Senior Economist, Data Policy Division, Office of Kara Morgan the Assistant Secretary for Planning and Research Leader, Health and Analytics, Battelle Evaluation, U.S. Department of Health and Human Services Ellen Morrison Assistant Commissioner for Operations, Office Trina Kaylor of Operations, Office of Regulatory Affairs, Assistant Vice President, Pharmacy Operations Office of Global Regulatory Operations and and Expense Management, HealthTrust Policy, U.S. Food and Drug Administration Purchasing Group Richard Moscicki Susan Laska Deputy Center Director for Science Operations, Senior Advisor Medical Products, Office of Center for Drug Evaluation and Research, U.S. Operations, Office of Regulatory Affairs, Office Food and Drug Administration of Global Regulatory Operations and Policy, U.S. Food and Drug Administration

2

Eric Nelson John Troiani Director, Division of Compliance, Office of Senior Medical Advisor, Office of Compliance, Surveillance and Compliance, Center for Center for Drug Evaluation and Research, U.S. Veterinary Medicine, U.S. Food and Drug Food and Drug Administration Administration Martin Van Trieste Sarah Pope Miksinsk Chairman, Parenteral Drug Association Board of Director of the Office of New Drug Products and Directors and Recently Retired Chief Quality Acting Director of the Office of Surveillance, Officer and Senior Vice President, Amgen Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Keith Webber Drug Administration Senior Director, Regulatory Affairs, Perrigo Company, PLC François Sallans Vice President, Quality & Compliance and Chief Fran Zipp Quality Officer, Johnson & Johnson President and Chief Executive Officer, Lachman Consultant Services, Inc. Neil Stiber Acting Deputy Director, Office of Surveillance, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

3