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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×

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.
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×

 

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
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
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
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
Page 53
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
Page 54
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
Page 55
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
Page 56
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
Page 57
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
Page 58
Next: Appendix B: Speaker Biographical Sketches »
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Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together.

Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.

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