Author Disclosures

From the editor: The rapidly changing landscape of biomedical conflicts of interest
Guy M. Chisolm III, PhD, Vice Chairman, Lerner Research Institute, and
Professor, Department of Cell Biology, Cleveland Clinic

Opening comments: The mandate of innovation management
Delos M. Cosgrove, MD, CEO and President, Cleveland Clinic

Research, Innovation, and Safety: Doing the Right Thing

Prologue: A case study in biomedical conflicts
Nina Totenberg, Legal Affairs Correspondent, National Public Radio

Fostering innovation without compromising integrity
Philip A. Pizzo, MD, Dean and Professor of Pediatrics and of Microbiology and Immunology,
Stanford University School of Medicine

Innovation and industry-academia interactions:
Where conflicts arise and measures to avoid them
P. Roy Vagelos, MD, Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.;
Former CEO, Merck & Co., Inc.

Overregulation of conflicts hinders medical progress
Thomas P. Stossel, MD, Professor of Medicine, Harvard Medical School

Panel discussion: Research, innovation, and safety: Doing the right thing
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Philip A. Pizzo, MD; Thomas P. Stossel, MD; and P. Roy Vagelos, MD

Guiding Principles: Where Are We Headed?

Conflict-of-interest management: Efforts and insights from the
Association of American Medical Colleges
Darrell G. Kirch, MD, President and CEO, Association of American Medical Colleges

Medical devices and conflict of interest: Unique issues and an industry code to address them
Paul A. LaViolette, MBA, Chief Operating Officer, Boston Scientific Corporation; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

The challenge for NIH ethics policies: Preserving public trust and biomedical progress
Norka Ruiz Bravo, PhD, Deputy Director for Extramural Research, National Institutes of Health

Panel discussion: Guiding principles: Where are we headed?
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Darrell G. Kirch, MD; Paul A. LaViolette, MBA; and Norka Ruiz Bravo, PhD

Keynote Address

Building and retaining trust in the biomedical community
Dick Thornburgh, Counsel, K & L Gates; Former Governor of Pennsylvania;
Former Attorney General of the United States

Applications in the Real World:
Defining Boundaries and Managing Innovation

Interactions of the public and private sectors in drug development:
Boundaries to protect scientific values while preserving innovation
Gail H. Cassell, PhD, DSc (hon), Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar
for Infectious Diseases, Eli Lilly and Company

Beyond disclosure: The necessity of trust in biomedical research
Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics,
University of Minnesota

Panel discussion: Applications in the real world:
Case studies in defining boundaries and managing innovation
Moderated by Claudia R. Adkison, JD, PhD, Executive Associate Dean, Administration and Faculty Affairs,
Emory University School of Medicine
Case studies submitted by Michael J. Meehan, Esq., Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, and Claudia R. Adkison, JD, PhD
Panelists: Gail H. Cassell, PhD, DSc (hon); Jeffrey P. Kahn, PhD, MPH; Philip A. Pizzo, MD;
and Thomas P. Stossel, MD

Conflicts, Compliance, and Enforcement:
Government Priorities and Initiatives

Protecting subjects without hampering research progress:
Guidance from the Office for Human Research Protections
Bernard A. Schwetz, DVM, PhD, Director, Office for Human Research Protections,
US Department of Health and Human Services

Fraud, conflict of interest, and other enforcement issues in clinical research
James G. Sheehan, Associate US Attorney, US Attorney’s Office, US Department of Justice

Panel discussion: Conflicts, compliance, and enforcement: Government priorities and initiatives
Moderated by Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panelists: Bernard A. Schwetz, DVM, PhD, and James G. Sheehan

Guidelines and Performance: Creating a Culture of Ethics

Creating an institutional conflict-of-interest policy at Johns Hopkins:
Progress and lessons learned
Edward D. Miller, MD, Dean of the Medical Faculty, Johns Hopkins School of Medicine;
CEO, Johns Hopkins Medicine

Managing ethical performance in organizations: Insights from the corporate world
Edward Soule, CPA, PhD, Associate Professor, McDonough School of Business, Georgetown University

Panel discussion: Guidelines and performance: Creating a culture of ethics
Moderated by Susan H. Ehringhaus, JD, Associate General Counsel for Regulatory Affairs,
Association of American Medical Colleges
Panelists: Edward D. Miller, MD, and Edward Soule, CPA, PhD

Articles in these proceedings were developed by the Cleveland Clinic Journal of Medicine staff from transcripts of audiotaped presentations at the “National Dialogue on Biomedical Conflicts of Interest
and Innovation Management” and then reviewed and revised by the respective speakers.

Copyright © 2007 The Cleveland Clinic Foundation. All rights reserved.

The statements and opinions expressed in this supplement to the Cleveland Clinic Journal of Medicine are those of the authors and not necessarily of the Cleveland Clinic Foundation or its Board of Trustees. They do not necessarily represent formal practice guidelines in effect at Cleveland Clinic.

The Cleveland Clinic Journal of Medicine (ISSN 0891-1150) is published 12 times yearly by The Cleveland Clinic Foundation.

Subscription rates: U.S. and possessions: personal $108; institutional $134; single copy/back issue $20. Foreign: $134; single copy/back issue $20. Institutional (multiple-reader rate) applies to libraries, schools, hospitals, and federal, commercial, and private institutions and organizations. Individual subscriptions must be in the names of, billed to, and paid by individuals.

Postmaster address changes: Cleveland Clinic Journal of Medicine, NA32, 9500 Euclid Avenue, Cleveland, OH 44195. Subscription orders, editorial, reprint, and production offices (same address): (216) 444-2661 (phone); (216) 444-9385 (fax); ccjm@ccf.org (e-mail); www.ccjm.org (Web).

Printed in USA.