Government and Industry Collaboration in AIDS Drug Development

Summary of a Workshop Held on May 6, 1994

Leslie M. Hardy, Editor

Roundtable for the Development of Drugs and Vaccines Against AIDS

Division of Health Promotion and Disease Prevention

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.
1994



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 Government and Industry Collaboration in AIDS Drug Development Summary of a Workshop Held on May 6, 1994 Leslie M. Hardy, Editor Roundtable for the Development of Drugs and Vaccines Against AIDS Division of Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1994

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 National Academy Press 2101 Constitution Avenue, NWWashington, DC20418 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. Additional copies of this report are available in limited quantities from: Division of Health Promotion and Disease Prevention Institute of Medicine 2101 Constitution Avenue, NW Washington, DC 20418 (202) 334-2453 Copyright1994by theNational Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 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

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 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

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 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.

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 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.

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 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.

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 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

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 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.

OCR for page R1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 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.