Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents

Interim Report

Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents

Medical Follow-up Agency and

Board on Life Sciences

INSTITUTE OF MEDICINE

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES



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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents Interim Report Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents Medical Follow-up Agency and Board on Life Sciences INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 study was supported by Contract No. DAMD17-02-C-0099 between the National Academy of Sciences and the U.S. Army. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. Additional copies of this report are available in limited quantities from the Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents through the Medical Follow-up Agency, 500 Fifth Street, N.W., Washington, DC 20001. This report is also available online at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M.Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm.A.Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V.Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M.Alberts and Dr. Wm.A.Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report COMMITTEE ON ACCELERATING THE RESEARCH, DEVELOPMENT, AND ACQUISITION OF MEDICAL COUNTERMEASURES AGAINST BIOLOGICAL WARFARE AGENTS LESLIE Z.BENET (Chair), Professor, Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco WALTER E.BRANDT, Senior Program Officer, Malaria Vaccine Initiative BARRY S.COLLER, Vice President for Medical Affairs, David Rockefeller Professor of Medicine, and Head of the Laboratory of Blood and Vascular Biology, The Rockefeller University GLENNA M.CROOKS, President, Strategic Health Policy International, Inc. R.GORDON DOUGLAS, JR., Scientific Consultant JACQUES S.GANSLER, Professor and Roger C.Lipitz Chair, Center for Public Policy and Private Enterprise, School of Public Affairs, University of Maryland ANTHONY L.ITTEILAG, Independent Consultant DENNIS L.KASPER, Executive Dean for Academic Programs, William Ellery Channing Professor of Medicine, and Professor of Microbiology and Molecular Genetics, Harvard Medical School STEVEN J.KELMAN, Albert J.Weatherhead III and Richard W.Weatherhead Professor of Public Management, John F.Kennedy School of Government, Harvard University RICHARD F.KINGHAM, Partner, Covington and Burling PETER PALESE, Professor and Chair, Department of Microbiology, Mount Sinai School of Medicine PAUL D.PARKMAN, President, Parkman Associates RONALD J.SALDARINI, Scientific Consultant JANE E.SISK, Professor, Department of Health Policy, Mount Sinai School of Medicine ELAINE TUOMANEN, Professor and Chair, Department of Infectious Diseases, St. Jude Children’s Research Hospital BENJAMIN J.WEIGLER, Director, Animal Health Resources, Division of Shared Resources, Fred Hutchinson Cancer Research Center JANET WESTPHELING, Associate Professor, Department of Genetics, University of Georgia Medical Follow-up Agency Board Liaison TIMOTHY R.GERRITY, Director, WPI Bioengineering Institute Consultant JAMES D.MARKS, Professor, Anesthesia and Pharmaceutical Chemistry, University of California, San Francisco Project Staff LOIS JOELLENBECK, Senior Program Officer, Medical Follow-up Agency JANE DURCH, Senior Program Officer, Medical Follow-up Agency KAREN KAZMERZAK, Research Associate, Medical Follow-up Agency PHILLIP BAILEY, Senior Project Assistant, Medical Follow-up Agency

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report Auxiliary Staff RICHARD N.MILLER, Director, Medical Follow-up Agency JENNIFER KUZMA, Senior Program Officer, Board on Life Sciences, Division on Earth and Life Studies (until January 2003) FRANCES SHARPLES, Director, Board on Life Sciences, Division on Earth and Life Studies PAMELA RAMEY-MCCRAY, Administrative Assistant, Medical Follow-up Agency ANDREA COHEN, Financial Associate, Institute of Medicine

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report Reviewers This report has been reviewed in draft form in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The review of this report was overseen by Morton Swartz, Massachusetts General Hospital, and Gilbert Omenn, University of Michigan. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report Contents     INTRODUCTION   1     STUDY COMMITTEE AND STUDY CHARGE   1     STUDY PROCESS   2     STATUS OF THE COMMITTEE’S INVESTIGATIONS   3     REFERENCES   4     APPENDIX: AGENDAS FOR INFORMATION-GATHERING MEETINGS   5

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