Board on Health Sciences Policy Roundtable on Translating Genomic-Based Research for Health Conflict of Interest and Medical Innovation: Ensuring Integrity while Facilitating Innovation in Medical Research A Workshop June 5, 2013 National Academy of Sciences Building 2101 Constitution Ave., N.W. Washington, DC 20037 Workshop Objectives: To articulate and clarify current conflict of interest policies To examine and discuss the scope and goals of conflict of interest policies To examine the effect of current conflict of interest policies on medical innovation To identify best practices and potential solutions for facilitating innovation under current conflict of interest policy implementation while still ensuring scientific integrity and public trust 8:30 8:45 A.M. Welcoming Remarks and Charge to Workshop Speakers and Participants Sharon F. Terry, Roundtable Co-Chair and Workshop Chair President and CEO Genetic Alliance SESSION I: CURRENT LANDSCAPE FOR MEDICAL INNOVATION Moderator: Allen Lichter, American Society of Clinical Oncology 8:45 9:15 A.M. Conflict of Interest and Medical Innovation Bernard Lo President Greenwall Foundation 500 Fifth Street, NW Phone: 202 334 3756 Washington, DC 20001-2721 Fax: 202 334 1329 www.iom.edu/genomicroundtable E-mail: aberger2@nas.edu
9:15 9:45 A.M. Enhancing the Development of Novel Medical Products and Clinical Applications Neal Cohen Vice Dean, School of Medicine Professor of Anesthesia and Perioperative Care and Medicine Director, International Medical Services University of California, San Francisco 9:45 10:15 A.M. Developing Policies for Conflict of Interest Sally Rockey Deputy Director for Extramural Research National Institutes of Health 10:15 10:45 A.M. Discussion with Speaker and Attendees 10:45 11:00 A.M. BREAK SESSION II: IMPACT OF CONFLICT OF INTEREST POLICIES ON INNOVATION 11:00 11:15 A.M. Industry Perspectives Moderator: Bernard Lo, Greenwall Foundation Gabriela Lavezzari Assistant Vice President, Scientific Affairs PhRMA 11:15 11:30 A.M. Academic Perspective 11:30 11:45 A.M. Government Perspective Heather Pierce Senior Director, Science Policy and Regulatory Counsel AAMC Krishna Balakrishnan Senior Technology Manager, Office of Strategic Alliances National Center for Advancing Translational Sciences 11:45 12:25P.M. Discussion with Speakers and Attendees
12:25 P.M. 1:10 P.M. WORKING LUNCH SESSION III: PUBLIC PERCEPTIONS OF CONFLICT OF INTEREST Moderator: Jill Hartzler Warner, Food and Drug Administration 1:10 1:30 P.M. Serving Public Interest and Facilitating Innovation: Portrayals of Conflict of Interest Charles Ornstein Senior Reporter ProPublica 1:30 1:50 P.M. Innovation in the Interest of Society Mary Grealy President Healthcare Leadership Council 1:50 2:10 P.M. Discussion with Speakers and Attendees SESSION IV: BEST PRACTICES TO FACILITATE INNOVATION 2:10 2:15 P.M. FDA 2:15 2:20 P.M. Tech Transfer Moderator: Dorit Zuk, National Institutes of Health Michelle T. McMurry-Heath Associate Director for Science Center for Devices and Radiological Health Food and Drug Administration Todd Sherer Associate Vice President for Research Executive Director, Office of Technology Transfer Emory University
2:20 2:25 P.M. Industry 2:25 2:30 P.M. Academia Paul Billings Chief Medical Officer Life Technologies Corporation 2:30 2:35 P.M. Public/Consumer/Advocate Guy Chisolm Director, Innovation Management and Conflict of Interest Program Cleveland Clinic Margaret Anderson Executive Director FasterCures 2:35 2:40 P.M. Providers Henry Brem Harvey Cushing Professor Chairman, Department of Neurosurgery Professor of Neurosurgery, Ophthalmology, Oncology and Biomedical Engineering Johns Hopkins University School of Medicine 2:40 2:45 P.M. Medical Professional Society Allen Lichter Chief Executive Officer American Society of Clinical Oncology 2:45 3:50 P.M. Roundtable Discussion with Speakers and Attendees 3:50 4:05 P.M. BREAK SESSION V: CONVERGENCE ON CONFLICT OF INTEREST Moderator: Sharon Terry, Genetic Alliance
4:05 4:50 P.M. Panel Discussion Panelists: Margaret Anderson, FasterCures Gabriela Lavezzari, PhRMA Allen Lichter, American Society of Clinical Oncology Bernard Lo, Greenwall Foundation Michelle T. McMurry-Heath, Food and Drug Administration Heather Pierce, AAMC SESSION VI: CONCLUSION 4:50 5:00 P.M. CONCLUDING REMARKS 5:00 P.M. ADJOURN Sharon F. Terry, Roundtable Co-Chair and Workshop Chair President and CEO Genetic Alliance