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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
   
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

   
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

   
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.

   
7:15 - 7:30 a.m. Continental Breakfast
   
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

   
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:

  1. 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.

  2. Develop a profile of the risks and rewards associated with the collaboration between industry and clinical researchers in medical technology development, testing and transfer.
   
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.

   
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

   
10:00 - 10:15 a.m. Break
   
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

   
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

   
12:15 - 1:30 p.m. Lunch
   
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

   
2:45 - 3:00 p.m. Wrap-Up and Next Steps

Kenneth Keller, Ph.D.

Donald Kennedy, Ph.D.

   
3:00 p.m. Adjournment

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