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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
This workshop summary was prepared by the Institute of Medicine's Roundtable for the Development of Drugs and Vaccines Against AIDS, chaired by Barton F. Haynes and Paul A. Volberding and directed by Leslie M. Hardy. The document reports major themes of the workshop discussions; these themes, however, do not represent policy statements by the Institute of Medicine.
The report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.
The Roundtable is supported by the American Foundation for AIDS Research, the Pharmaceutical Research and Manufacturers of America, the U.S. Army, the U.S. Public Health Service, and the U.S. Department of Veterans Affairs.
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ROUNDTABLE FOR THE DEVELOPMENT OF DRUGS AND VACCINES AGAINST AIDS
BARTON F. HAYNES (Cochair), F.M. Hanes Professor of Medicine,and Director,
Duke University Arthritis Center, Duke University School of Medicine, Durham, North Carolina
PAUL A. VOLBERDING (Cochair), Chief,
AIDS Program and Clinical Oncology, San Francisco General Hospital, San Francisco, California
JAMES ALLEN, Vice President,
Group on Science Technology and Public Health, American Medical Association, Chicago, Illinois
ARTHUR J. AMMANN, Director,
The Ariel Project for the Prevention of HIV Transmission from Mother to Infant, Novato, California
DAVID BARR, Director,
Treatment Education and Advocacy, Gay Men's Health Crisis, New York, New York
DAVID W. BARRY, Group Director,
Research, Development and Medical Affairs, The Wellcome Research Laboratories, Research Triangle Park, North Carolina
LAWRENCE S. BROWN, Assistant Clinical Professor of Medicine,
College of Physicians and Surgeons, Columbia University, and Senior Vice President, Addiction Research and Treatment Corporation, Brooklyn, New York
DONALD S. BURKE, Colonel,
Medical Corps, U.S. Army, and Director, Division of Retrovirology, Walter Reed Army Institute of Research, Rockville, Maryland
BRUCE A. CHABNER, Director,
Division of Cancer Treatment, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
MAX D. COOPER, Investigator,
Howard Hughes Medical Institute, Professor of Medicine, Pediatrics, and Microbiology, University of Alabama, Birmingham
MARTIN DELANEY, Founding Director,
Project Inform, San Francisco, California
R. GORDON DOUGLAS, Vice President,
Merck & Co., Inc., and President, Merck Vaccine Division, Merck & Co., Inc., Whitehouse Station, New Jersey
ANTHONY S. FAUCI, Director,
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
DAVID FEIGAL, Director,
Division of Antiviral Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland
GERALD FRIEDLAND, Director,
AIDS Program, Yale University School of Medicine, Yale-New Haven Hospital, New Haven, Connecticut
L. PATRICK GAGE, Chief Operating Officer,
Genetics Institute, Inc., Cambridge, Massachusetts
KRISTINE M. GEBBIE, First National AIDS Policy Coordinator,
Executive Office of the President, Washington, D.C.
PETER BARTON HUTT, Partner,
Covington & Burling, Washington, D.C.
STEPHEN W. LAGAKOS, Professor of Biostatistics,
Harvard School of Public Health, Boston, Massachusetts
HELEN RODRIGUEZ-TRIAS, Pediatric Consultant in Health Programming,
Brookdale, California
CATHERINE M. WILFERT, Professor of Pediatrics and Microbiology,
Department of Pediatrics, Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina
Institute of Medicine Staff
LESLIE M. HARDY, Project Director
JENNIFER K. HOLLIDAY, Project Assistant
MICHAEL A. STOTO, Director,
Division of Health Promotion and Disease Prevention
WORKSHOP SPEAKERS
DAVID W. BARRY, Group Director,
Research, Development and Medical Affairs, The Wellcome Research Laboratories, Research Triangle Park, North Carolina
STEPHEN K. CARTER, Senior Vice President,
World Wide Clinical Research & Development, Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, New Jersey
BRUCE A. CHABNER, Director,
Division of Cancer Treatment, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
MARTIN DELANEY, Founding Director,
Project Inform, San Francisco, California
HAROLD EDGAR, Professor of Law,
Columbia University School of Law, New York, New York
ANTHONY S. FAUCI, Director,
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
L. PATRICK GAGE, Chief Operating Officer,
Genetics Institute, Inc., Cambridge, Massachusetts
BARTON F. HAYNES, F.M. Hanes Professor of Medicine, and Director,
Duke University Arthritis Center, Durham, North Carolina
DANIEL HOTH, Senior Vice President and Chief Medical Officer,
Cell Genesys, Foster City, California
PETER BARTON HUTT, Partner,
Covington & Burling, Washington, D.C.
THOMAS MAYS, Director,
Office of Technology Development, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
DAVID SCHULKE, Chief Health Policy Advisor,
The Honorable Ron Wyden, U.S. House of Representatives, Member, Energy and Commerce Committee, Health and Environment Subcommittee, Washington, D.C.
PAUL A. VOLBERDING, Chief,
AIDS Program and Clinical Oncology, San Francisco General Hospital, San Francisco, California
TIMOTHY WESTMORELAND, Counsel,
Subcommittee on Health and the Environment, U.S. House of Representatives, Washington, D.C.
PARTICIPANTS
MOISES AGOSTO, Research and Treatment Advocacy Manager,
Department of Public Policy, National Minority AIDS Council, Washington, D.C.
PAUL BLAKE, Vice Presidentand Medical Director,
Clinical Research, Development & Medical Affairs of North America, SmithKline Beecham, King of Prussia, Pennsylvania
QUETA BOND, President,
The Burroughs Wellcome Fund, Morrisville, North Carolina
BEN CHENG,
Information Advocacy Associate, Project Inform, San Francisco, California
CHARLES CHESSON, Clinical Trials Director,
SEARCH Alliance, Los Angeles, California
DEBORAH COTTON, Assistant Professor of Medicine,
Harvard Medical School, Boston, Massachusetts
RICHARD CROUT, Former Vice President,
Boehringer Mannheim Pharmaceuticals Corporation, and Institute of Medicine Scholar-in-Residence, Bethesda, Maryland
JOSEPH DIMASI, Senior Research Fellow,
Center for the Study of Drug Development, Tufts University, Boston, Massachusetts
DINO DINA, President,
Biocine Company, Chiron Corporation, Emeryville, California
CAROLYN FULCO, Study Director,
Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine, Washington, D.C.
ROBERT GOLDBERG, Senior Research Fellow,
Gordon Public Policy Center, Brandeis University, Springfield, New Jersey
LEWIS GROSSMAN, Associate,
Covington & Burling, Washington, D.C.
MARGARET JOHNSTON, Deputy Director,
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
JACK KILLEN, Director,
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
BARBARA MCGAREY, Deputy Director,
Office of Technology Transfer, National Institutes of Health, Bethesda, Maryland
TERESA MCGOVERN, Legal Director,
HIV Law Project, AIDS Service Center, Lower Manhattan, New York
JEAN MCKAY, Public Health Specialist,
Office of AIDS and Special Health Issues, Food and Drug Administration, Rockville, Maryland
HARRY MEYER, Former President,
Medical Research Division, American Cyanamid Company, Waterford, Virginia
CHARLES NELSON, Treatment and Research Advocate,
Department of Public Policy, National Minority AIDS Council, Washington, D.C.
JOHN PALENICEK, Legislative Health Policy Fellow,
Committee on Labor and Human Resources, U.S. Senate, Washington, D.C.
WILLIAM PAUL, Director,
Office of AIDS Research, National Institutes of Health, Bethesda, Maryland
RICHARD RETTIG, Study Director,
Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine, Washington, D.C.
ZEDA ROSENBERG, Assistant Director for Prevention Research,
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
MICHAEL SAAG, Associate Professor of Medicine,
University of Alabama at Birmingham
WHAIJEN SOO, Assistant Vice President and Senior Director,
Clinical Virology and AIDS Research, Hoffmann-La Roche, Inc., Nutley, New Jersey
PETER STALEY, Founding Director,
Treatment Action Group, New York, New York
PAUL TRAN, Research Cluster Head,
Office of the National AIDS Policy Coordinator, U.S. Department of Health and Human Services, Washington, D.C.
Acronyms and Abbreviations
ACTG
AIDS Clinical Trials Group
AIDS
Acquired immune deficiency syndrome
AZT
Zidovudine
CRADA
Cooperative Research and Development Agreement
CTA
Clinical Trial Agreement
ddI
Didanosine
DHHS
U.S. Department of Health and Human Services
GAO
U.S. General Accounting Office
HEW
U.S. Department of Health, Education, and Welfare
HIV
Human immunodeficiency virus
ICC
Inter-Company Collaboration for AIDS Drug Development
IP
Intellectual property
IPA
Institutional Patent Agreement
NCI
National Cancer Institute
NIH
National Institutes of Health
PHS
U.S. Public Health Service
Preface
The Roundtable for the Development of Drugs and Vaccines Against AIDS was established in 1988 by the Institute of Medicine. Composed of leaders from government, the pharmaceutical industry, academia, and patient advocacy groups, its mission is to identify and help resolve impediments to the rapid availability of safe, effective drugs and vaccines for human immunodeficiency virus (HIV) infection and acquired immune deficiency syndrome (AIDS). The Roundtable accomplishes its mission through regular meetings of its membership, during which urgent issues are identified and discussed, as well as through public conferences and workshops that explore scientific and policy matters central to the development of AIDS therapeutics. This report is a summary of a workshop held on May 6, 1994, in Washington, D.C.
The purpose of the workshop was to examine the challenges and opportunities inherent in government and industry collaborations on HIV/AIDS research and therapeutic development. Many of the concerns and suggestions that surfaced during the workshop deliberations, however, have broad applications beyond the field of HIV/AIDS drug development. Workshop participants explored some of the current impediments to collaboration; the implications for progress toward the discovery of novel therapeutic candidates and their development into marketed products, particularly when barriers that discourage or prevent collaborative research may exist; and ways to overcome existing obstacles. A variety of perspectives on these issues was presented, including those of government researchers and administrators, the pharmaceutical industry, the biomedical and clinical research communities, congressional staff, and consumer advocates.
This report is not a consensus document but rather a synthesis of selected scientific or public policy aspects of the workshop presentations and discussions. It contains no recommendations or conclusions, and the Roundtable has neither altered nor commented on the views and opinions expressed by the speakers except for purposes of clarity. The Roundtable and staff wish to thank our consultant, Tom Burroughs, for his able assistance in preparing this summary. We also thank, once again, the workshop speakers for their thoughtful presentations and all participants for the lively, provocative discussions throughout the workshop.