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Risk and Rewards in Medical Technology Innovation:
Conflict of Interest at the Academic/Industry Interface
July 22 - 23, 2001
Stanford Park Hotel, Menlo Park, California (July 22nd)
Stanford University Littlefield Center, Stanford, California (July 23rd)
Agenda
| Sunday, July 22 |
| 5:00 - 6:00 p.m. |
Reception
Location: Stanford Park Hotel, Woodside Foyer
Hosted by Stanford University School of Medicine |
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| 6:00 - 7:45 p.m. |
Dinner Meeting
Location: Stanford Park Hotel, Woodside Room
Welcome
Hon. David Durenberger
President, Medical Technology Leadership Forum
Philip A. Pizzo, M.D.
Dean, Stanford University School of Medicine
Keynote Address:
Greg Koski, Ph.D., M.D.
Director, Office for Human Research Protections
Department of Health and Human Services |
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| 7:45 - 8:00 p.m. |
Case Study Introduction
Mildred Cho, Ph.D.
Senior Research Scholar, Stanford Center for Biomedical Ethics
Kendra Dimond, J.D.
Partner, Arent Fox Kintner Plotkin & Kahn, Washington, DC
Paul Yock, M.D.
Martha Meier Weiland Professor of Medicine, Stanford University
Director, Medical Device Network & Center for Research in
Cardiovascular Interventions |
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| Monday, July 23 All sessions will be held in the Stanford University Littlefield Center, Wattis Room
A shuttle to the Littlefield Center will depart from the Stanford Park Hotel promptly at 7:00 a.m. |
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| 7:15 - 7:30 a.m. |
Continental Breakfast |
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| 7:30 - 7:45 a.m. |
Welcome, Introductions and Meeting Purpose
Kenneth Keller, Ph.D.
Chairman, Medical Technology Leadership Forum
Charles M. Denny, Jr., Professor of Science and Technology
Hubert H. Humphrey Institute of Public Affairs,
University of Minnesota
Donald Kennedy, Ph.D.
Bing Professor of Environmental Science and President Emeritus,
Stanford University
Editor, Science
Former Commissioner, U.S. Food and Drug Administration
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| 7:45 - 8:00 a.m. |
Recap: Conflict of Interest Case Study
Donald Kennedy, Ph.D.
Program Overview:
Key stakeholders from
- Federal and state government
- Universities
- Patient advocacy groups
- Physicians/professional medical organizations
- Medical technology industry
- Technology innovators
Goals:
- Identify and analyze key
policy issues related to the management of conflict of interest created
by the relationship between industry and clinical researchers inherent
in medical technology development, testing and transfer.
- Develop a profile of the risks and rewards associated
with the collaboration between industry and clinical researchers in
medical technology development, testing and transfer.
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| 8:00 - 9:00 a.m. |
Panel: Innovator/Physician Perspective
This panel discussion features prominent
physician inventors who have successfully developed and commercialized
medical technologies with widely recognized benefit to patient care.
Thomas Fogarty, M.D.
Professor of Vascular Surgery, Stanford University
Senior Partner, Three Arch Partners
Rodney Perkins, M.D.
Founder and Director, California Ear Institute
John Simpson, M.D., Ph.D.
Founder and Chairman, Fox Hollow Technologies, Inc.
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| 9:00 - 10:00 a.m. |
Panel: Government Perspective
This panel discussion features policy makers
from government agencies that have responsibility for the oversight of
conflicts of interest in medical research.
Greg Koski, Ph.D., M.D.
Director, Office for Human Research Protections
U.S. Department of Health and Human Services
Belinda Seto, Ph.D.
Deputy Director, Office of Extramural Research
National Institutes of Health
Grant Bagley, M.D., J.D.
Partner, Arnold & Porter
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| 10:00 - 10:15 a.m. |
Break |
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| 10:15 - 11:15 a.m. |
Patient and Research Advocate Perspective
This panel discussion features leaders in
advocacy for the interests of patients associated with clinical
research, including both their interest in promoting research aimed at
developing safe and effective treatments and their interest in ensuring
the protection of human subjects involved in research.
Phyllis Greenberger, M.S.W.
President and CEO
Society for Women's Health Research
Alan Milstein, J.D.
Sherman, Silverstein, Kohl, Rose & Podolsky
Adjunct Faculty, Temple University School of Law
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| 11:15 - 12:15 p.m. |
Industry Perspective
This panel discussion features representatives
from the medical device manufacturing industry who are specifically
involved with the interaction between corporate innovators and clinical
research institutions.
Patricia Garvey, Ph.D.
Senior Vice President, Clinical & Regulatory Affairs
Edwards Life Sciences LLC
Neal E. Fearnot, Ph.D.
President, MED Institute, Inc.
Frank M. Fischer
President and CEO, NeuroPace, Inc.
Philip M. Young
General Partner, US Venture Partners
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| 12:15 - 1:30 p.m. |
Lunch |
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| 1:30 - 2:45 p.m. |
University and Research Institute Perspective
The following experts will discuss the views
of universities and other research institutions relating to the
management and regulation of their relationships with industry arising
from medical technology research.
Eugene A. Bauer, M.D.
Vice President, Medical Center
Stanford University
William Danforth, M.D.
Chancellor Emeritus & Board of Trustees Vice Chairman Washington University, St. Louis
Edward Holmes, M.D.
Vice Chancellor-Health Sciences and Dean, School of Medicine
University of California, San Diego
Joseph Martin, M.D., Ph.D.
Dean, Harvard Medical School
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| 2:45 - 3:00 p.m. |
Wrap-Up and Next Steps
Kenneth Keller, Ph.D.
Donald Kennedy, Ph.D.
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| 3:00 p.m. |
Adjournment |
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