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:
| 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 |
| 10:45–11:00 | BREAK |
| 11:00 A.M.–12:25 P.M. | SESSION II: IMPACT OF CONFLICT OF 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.–12:25 P.M. | Discussion with Speakers and Attendees |
| 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 |
|
| 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 |
|
| 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 |
| 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 |