Regulatory Science Core Competencies and Curricular Guidelines A Workshop by PhRMA Foundation, University of Rochester and Georgetown University September 23, 2014 WORKSHOP PARTICIPANTS Joan Adamo, Ph.D. Associate Director for Regulatory Support Services University of Rochester Thomas E. Colonna, Ph.D., J.D. Associate Director of Regulatory Science Johns Hopkins University Jay Gandy, Ph.D. Salvo Alesci, M.D., Ph.D. Professor & Chair Vice President, Scientific and Regulatory Affairs Dept. of Environmental & Occupational Health PhRMA University of Arkansas for Medical Sciences (UAMS) Chris Austin, M.D. Director NCATS, NIH Kathy Giacomini, Ph.D. Chair, Bioengineering and Therapeutic Sciences University of California, San Francisco Nancy Beck, Ph.D. Jesse Goodman, M.D., M.P.H. Program Development Manager Director , Center on Medical Product Access, Safety Reagan‐Udall Foundation for the FDA and Stewardship (COMPASS) Khaled Bouri, Ph.D., M.P.H. Georgetown University Senior Science Advisor Rashmi Gopal‐Srivastava, M.S., Ph.D.. FDA, OC, Office of Regulatory Science and Innovation Director, Extramural Research Program Office of Rare Diseases Research (ORDR) Martha A. Brumfield, Ph.D. NCATS, NIH President & CEO The Critcal Path Institute Chekesha Clingman, Ph.D., M.B.A. Peter Honig, M.D., M.P.H. Senior Vice President, Worldwide Regulatory Affairs Pfizer Special Assistant, CDR USPHS Francis Kalush, Ph.D. FDA, Office of Translational Sciences Health Programs Coordinator Professional Affairs and Stakeholder Engagement Nadine Cohen, Ph.D. FDA, Office of the Center Director Senior Vice President of Regulatory Affairs and R&D Compliance Vincent Lau, Ph.D. Biogen Idec Vice President of Research and Graduate Education American Assn of Colleges of Pharmacy Regulatory Science Core Competencies and Curricular Guidelines A Workshop by PhRMA Foundation, University of Rochester and Georgetown University September 23, 2014 WORKSHOP PARTICIPANTS Emma Meagher, M.D. Jane Reese‐Coulbourne, M.S., ChE Director, Translational Research Training Programs Executive Director Associate Dean, Clinical Research Reagan‐Udall Foundation for the FDA University of Pennsylvania Director at Large, ACTS Michael A. Rogawski, M.D., Ph.D. Professor of Neurology Carol Merchant, M.D., M.P.H. University of California, Davis Program Director Common Fund Career Development Programs Michael Rosenblatt, M.D. NCATS, NIH Exec. VP & Chief Medical Officer Merck & Co Robert Meyer, M.D. Director, Virginia Center for Regulatory and Translational Science University of Virginia Garry Neil, M.D. Global Head, Research & Development Medgenics Stephen Ostroff, M.D. Acting Chief Scientist FDA, Office of the Chief Scientist Heather Pierce, J.D., M.P.H. Sr. Director, Science Policy & Regulatory Counsel American Assn of Medical Colleges Jim Polli, Ph.D. Professor of Pharmaceutical Sciences Co‐Director, University of Maryland ‐ CERSI Director, Online MS in Regulatory Science Degree Program Wendy Sanhai, Ph.D., M.B.A. Senior Managing Scientist, Health Sciences Exponent, Inc. Chris Sasiela, Ph.D., RAC Regulatory Specialist National Heart Lung and Blood Institute NHLBI, NIH Ira Shoulson, M.D. Director, Program for Regulatory Science & Medicine Principle Investigator, CERSI Georgetown University Steven Snapinn, Ph.D. Vice President, Global Biostatistics & Epidemiology Amgen Regulatory Science Core Competencies and Curricular Guidelines A Workshop by PhRMA Foundation, University of Rochester and Georgetown University September 23, 2014 WORKSHOP PARTICIPANTS Scott Steele, Ph.D. Meeting Observers Director, Government & Academic Research Alliances Samantha Crowe, Ph.D. Director (Operations), NYS Data Science Center Director, Regulatory and Scientific Affairs of Excellence PhRMA University of Rochester Natalia Khuri Howard Uderman, M.D. PhD Student Senior Medical Director University of California, San Francisco Novo Nordisk Clinical Associate Professor of Medicine Temple University York Tomita, Ph.D. Office of Regulatory Science and Innovation Office of the Chief Scientist FDA Leslie D. Wheelock, M.S., R.N. Director, Office of Scientific Professional Development Office of the Chief Scientist Office of the Commissioner, FDA Erin Wilhelm, MPH Project Director, CERSI Program for Regulatory Science & Medicine Georgetown University Meeting Coordinator Eileen Cannon Executive Director PhRMA Foundation