Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary (2014)

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A Workshop Agenda 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 Avenue, NW Washington, DC 20418 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. 53 

54 COI AND MEDICAL INNOVATION 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 Chief Executive Officer Genetic Alliance 8:45–10:45 SESSION I: CURRENT LANDSCAPE FOR MEDICAL INNOVATION Moderator: Allen S. Lichter Chief Executive Officer American Society of Clinical Oncology 8:45–9:15 Conflict of Interest and Medical Innovation Bernard Lo President Greenwall Foundation 9:15–9:45 Enhancing the Development of Novel Medical Products and Clinical Applications Neal H. 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 Developing Policies for Conflict of Interest Sally J. Rockey Deputy Director for Extramural Research National Institutes of Health 10:15–10:45 Discussion with Speaker and Attendees 

APPENDIX A 55 10:45–11:00 BREAK 11:00 A.M.– SESSION II: IMPACT OF CONFLICT OF 12:25 P.M. INTEREST POLICIES ON INNOVATION Moderator: Bernard Lo President, Greenwall Foundation 11:00–11:15 Industry Perspectives Gabriela Lavezzari Assistant Vice President, Scientific Affairs PhRMA 11:15–11:30 Academic Perspective Heather H. Pierce Senior Director, Science Policy and Regulatory Counsel AAMC 11:30–11:45 Government Perspective Krishna Balakrishnan Senior Technology Manager, Office of Strategic Alliances National Center for Advancing Translational Sciences 11:45 A.M.– Discussion with Speakers and Attendees 12:25 P.M. 12:25–1:10 WORKING LUNCH 1:10–2:10 SESSION III: PUBLIC PERCEPTIONS OF CONFLICT OF INTEREST Moderator: Jill Hartzler Warner Acting Associate Commissioner for Special Medical Programs Food and Drug Administration 

56 COI AND MEDICAL INNOVATION 1:10–1:30 Serving Public Interest and Facilitating Innovation: Portrayals of Conflict of Interest Charles Ornstein Senior Reporter ProPublica 1:30–1:50 Innovation in the Interest of Society Mary R. Grealy President Healthcare Leadership Council 1:50–2:10 Discussion with Speakers and Attendees 2:10–3:50 SESSION IV: BEST PRACTICES TO FACILITATE INNOVATION Moderator: Dorit Zuk Science Policy Advisor to the Deputy Director for Extramural Research National Institutes of Health 2:10–2:15 FDA Michelle T. McMurry-Heath Associate Director for Science Center for Devices and Radiological Health Food and Drug Administration 2:15–2:20 Tech Transfer Todd Sherer Associate Vice President for Research Executive Director, Office of Technology Transfer Emory University 2:20–2:25 Industry Paul Billings Chief Medical Officer Life Technologies Corporation 

APPENDIX A 57 2:25–2:30 Academia Guy M. Chisolm III Director, Innovation Management and Conflict of Interest Program Cleveland Clinic 2:30–2:35 Public/Consumer/Advocate Margaret Anderson Executive Director FasterCures 2:35–2:40 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 Medical Professional Society Allen S. Lichter Chief Executive Officer American Society of Clinical Oncology 2:45–3:50 Roundtable Discussion with Speakers and Attendees 3:50–4:05 BREAK 4:05–5:00 SESSION V: CONVERGENCE ON CONFLICT OF INTEREST Moderator: Sharon Terry President and Chief Executive Officer Genetic Alliance 

58 COI AND MEDICAL INNOVATION 4:05–4:50 Panel Discussion Panelists: Margaret Anderson Executive Director FasterCures Gabriela Lavezzari Assistant Vice President, Scientific Affairs PhRMA Allen S. Lichter Chief Executive Officer American Society of Clinical Oncology Bernard Lo President Greenwall Foundation Michelle T. McMurry-Heath Associate Director for Science Center for Devices and Radiological Health Food and Drug Administration Heather Pierce Senior Director, Science Policy and Regulatory Counsel Association of American Medical Colleges 4:50–5:00 SESSION VI: CONCLUSION 4:50–5:00 CONCLUDING REMARKS Sharon F. Terry, Roundtable Co-Chair and Workshop Chair President and Chief Executive Officer Genetic Alliance 5:00 ADJOURN