BIOLOGICAL THREATS AND TERRORISM

Assessing the Science and Response Capabilities

Workshop Summary

Stacey L. Knobler, Adel A.F. Mahmoud, and Leslie A. Pray, Editors

Based on a Workshop of the Forum on Emerging Infections

Board on Global Health

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, DC



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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary BIOLOGICAL THREATS AND TERRORISM Assessing the Science and Response Capabilities Workshop Summary Stacey L. Knobler, Adel A.F. Mahmoud, and Leslie A. Pray, Editors Based on a Workshop of the Forum on Emerging Infections Board on Global Health INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, DC

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this workshop summary 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. Support for this project was provided by the U.S. Department of Health and Human Services’ National Institutes of Health, Centers for Disease Control and Prevention, the U.S. Agency for International Development, and the U.S. Food and Drug Administration; U.S. Department of Defense; U.S. Department of State; U.S. Department of Veterans Affairs; U.S. Department of Agriculture; American Society for Microbiology; Bristol-Myers Squibb Company; Burroughs Wellcome Fund; Eli Lilly & Company; Pfizer; GlaxoSmithKline; and Wyeth-Ayerst Laboratories. This report is based on the proceedings of a workshop that was sponsored by the Forum on Emerging Infections. It is prepared in the form of a workshop summary by and in the name of the editors, with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editors and not those of the Forum on Emerging Infections. The content of those sections is based on the presentations and the discussions that took place during the workshop. International Standard Book Number: 0-309-08253-6 Library of Congress Control Number: 2002101411 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, D.C. 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP’s home page at www.nap.edu. The full text of this report is available at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2002 by the National 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 serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. COVER: The background for the cover of this workshop summary is a photograph of a batik designed and printed specifically for the Malaysian Society of Parasitology and Tropical Medicine. The print contains drawings of various parasites and insects; it is used with the kind permission of the Society.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE Shaping the Future for Health

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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. Kenneth I. Shine 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 chairman and vice chairman, respectively, of the National Research Council.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary FORUM ON EMERGING INFECTIONS ADEL MAHMOUD (Chair), President, Merck Vaccines, Whitehouse Station, New Jersey STANLEY LEMON (Vice-Chair), Dean, School of Medicine, The University of Texas Medical Branch, Galveston, Texas STEVEN BRICKNER, Research Advisor, Pfizer Global Research and Development, Pfizer Inc., Groton, Connecticut GAIL CASSELL, Vice President, Infectious Diseases, Eli Lilly & Company, Indianapolis, Indiana GORDON DEFRIESE, Professor of Social Medicine, University of North Carolina, Chapel Hill, North Carolina CEDRIC DUMONT, Medical Director, Department of State and the Foreign Service, Washington, DC JESSE GOODMAN, Deputy Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland RENU GUPTA, Vice President and Head, U.S. Clinical Research and Development, and Head, Global Cardiovascular, Metabolic, Endocrine, and G.I. Disorders, Novartis Corporation, East Hanover, New Jersey MARGARET HAMBURG, Vice President for Biological Programs, Nuclear Threat Initiative, Washington, DC CAROLE HEILMAN, Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland DAVID HEYMANN, Executive Director, Communicable Diseases, World Health Organization, Geneva, Switzerland JAMES HUGHES, Assistant Surgeon General and Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia SAMUEL KATZ, Wilburt C. Davison Professor and Chairman Emeritus, Duke University Medical Center, Durham, North Carolina PATRICK KELLEY, Colonel, Director, Department of Defense Global Emerging Infections System, Walter Reed Army Institute of Research, Silver Spring, Maryland MARCELLE LAYTON, Assistant Commissioner, Bureau of Communicable Diseases, New York City Department of Health, New York, New York JOSHUA LEDERBERG, Raymond and Beverly Sackler Foundation Scholar, The Rockefeller University, New York, New York CARLOS LOPEZ, Research Fellow, Research Acquisitions, Eli Lilly Research Laboratories, Indianapolis, Indiana LYNN MARKS, Global Head of Infectious Diseases, GlaxoSmithKline, Collegeville, Pennsylvania STEPHEN MORSE, Director, Center for Public Health Preparedness, Columbia University, New York, New York MICHAEL OSTERHOLM, Director, Center for Infectious Disease Research and Policy and Professor, School of Public Health, University of Minnesota, Minneapolis, Minnesota

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary GARY ROSELLE, Program Director for Infectious Diseases, VA Central Office, Veterans Health Administration, Department of Veterans Affairs, Washington, DC DAVID SHLAES, Vice President, Infectious Disease Research, Wyeth, Pearl River, New York JANET SHOEMAKER, Director, Office of Public Affairs, American Society for Microbiology, Washington, DC P. FREDRICK SPARLING, J. Herbert Bate Professor Emeritus of Medicine, Microbiology, and Immunology, University of North Carolina, Chapel Hill, North Carolina I. KAYE WACHSMUTH, Deputy Administrator, Office of Public Health and Science, United States Department of Agriculture, Washington, DC C. DOUGLAS WEBB, Senior Medical Director, Bristol-Myers Squibb Company, Princeton, New Jersey MICHAEL ZEILINGER, Infectious Disease Team Leader, Office of Health and Nutrition, U.S. Agency for International Development, Washington, DC Liaisons ENRIQUETA BOND, President, Burroughs Wellcome Fund, Research Triangle Park, North Carolina NANCY CARTER-FOSTER, Director, Program for Emerging Infections and HIV/AIDS, U.S. Department of State, Washington, DC EDWARD McSWEEGAN, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland STEPHEN OSTROFF, Associate Director for Epidemiologic Science, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia Staff STACEY KNOBLER, Director, Forum on Emerging Infections MARJAN NAJAFI, Research Associate LAURIE SPINELLI, Project Assistant

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary BOARD ON GLOBAL HEALTH DEAN JAMISON, (Chair), Director, Program on International Health, Education, and Environment, University of California at Los Angeles YVES BERGEVIN, Chief, Health Section, UNICEF, New York, New York PATRICIA DANZON, Professor, Health Care Systems Development, University of Pennsylvania, Philadelphia RICHARD FEACHEM, Institute for Global Health, UC San Francisco/UC Berkeley, San Francisco, California NOREEN GOLDMAN, Professor, Woodrow Wilson School of Public and International Affairs, Princeton University, Princeton, New Jersey ARTHUR KLEINMAN, Maude and Lillian Presley Professor of Medical Anthropology/Professor of Psychiatry and Social Medicine, Harvard Medical School, Boston, Massachusetts ADEL MAHMOUD, President, Merck Vaccines, Whitehouse Station, New Jersey ALLAN ROSENFIELD, Dean, Mailman School of Public Health, Columbia University, New York, New York SUSAN SCRIMSHAW, Dean, School of Public Health, University of Illinois at Chicago JOHN WYN OWEN, Secretary, Nuffield Trust, London, United Kingdom GERALD KEUSCH, (Liaison), Director, Fogarty International Center, National Institutes of Health, Bethesda, Maryland DAVID CHALLONER, (IOM Foreign Secretary), Vice President for Health Affairs, University of Florida, Gainesville Staff JUDITH BALE, Director PATRICIA CUFF, Research Associate STACEY KNOBLER, Study Director MARJAN NAJAFI, Research Associate KATHERINE OBERHOLTZER, Project Assistant JASON PELLMAR, Project Assistant MARK SMOLINSKI, Study Director LAURIE SPINELLI, Project Assistant

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary REVIEWERS All presenters at the workshop have reviewed and approved their respective sections of this report for accuracy. In addition, this workshop summary has been reviewed in draft form by independent reviewers chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine (IOM) in making the published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The Forum and IOM thank the following individuals for their participation in the review process: Roger Breeze, Agricultural Research Service, Washington, DC Richard Johnson, The Johns Hopkins University, Baltimore, Maryland Stuart Nightingale, U.S. Department of Health and Human Services, Washington, DC Gerald Parker, U.S. Army Medical Research and Material Command M. Patricia Quinlisk, Iowa State Department of Health, Des Moines, Iowa Robert Ryder, University of North Carolina at Chapel Hill, North Carolina The review of this report was overseen by Melvin Worth, Scholar-in-Residence, National Academy of Sciences, who was 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 editors and individual authors.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Preface The Forum on Emerging Infections was created in 1996 in response to a request from the Centers for Disease Control and Prevention and the National Institutes of Health. The goal of the Forum is to provide structured opportunities for representatives from academia, industry, professional and interest groups, and government* to examine and discuss scientific and policy issues that are of shared interest and that are specifically related to research and prevention, detection, and management of emerging infectious diseases. In accomplishing this task, the Forum provides the opportunity to foster the exchange of information and ideas, identify areas in need of greater attention, clarify policy issues by enhancing knowledge and identifying points of agreement, and inform decision makers about science and policy issues. The Forum seeks to illuminate issues rather than resolve them directly; hence, it does not provide advice or recommendations on any specific policy initiative pending before any agency or organization. Its strengths are the diversity of its membership and the contributions of individual members expressed throughout the activities of the Forum. ABOUT THE WORKSHOP In the wake of the events of September 11, already mounting concerns about bioterrorism became imminent priorities for policymakers, researchers, *   Representatives of federal agencies serve in an ex officio capacity. An ex officio member of a group is one who is a member automatically by virtue of holding a particular office or membership in another body.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary public health officials, and private industry. These communities continue to grapple with ways to better understand the potential threats and ensure the country’s ability to preempt an attack or respond to the consequences. The Forum on Emerging Infections was uniquely positioned through its representation of multi-sector science and policy expertise to convene a working group discussion on the next steps for responding to bioterrorism. Much has been written and discussed over the last decade about the potential use of biological agents in warfare or in terrorist attacks. Initiatives to prevent and respond to such events have been developed and implemented within areas of federal, state, and local government. The scientific, healthcare, policy, and law enforcement communities have also created specific agendas to address these threats. The November 27–29, 2001, workshop of the Forum explored the current scientific understanding of threatening pathogens and what measures have been put in place to better monitor, prevent, and respond to their emergence. To determine where progress has been made and where gaps remain, Forum presentations and discussions reviewed existing policies, infrastructure, and research and scientific tools. Additionally, Forum presentations and discussions sought to identify the obstacles to preparing an optimal response, particularly as it relates to the complexities of interaction among private industry, research and public health agencies, regulatory agencies, policymakers, academic researchers, and the public. During this three-day workshop, Forum members and invited guests explored the issues surrounding emerging opportunities for more effective collaboration as well as the scientific and programmatic needs for responding to bioterrorism. ORGANIZATION OF WORKSHOP SUMMARY This workshop summary report is prepared for the Forum membership in the name of the editors, with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editors and not those of the Forum on Emerging Infections sponsors or the Institute of Medicine (IOM). The contents of the unattributed sections are based on the presentations and discussions that took place during the workshop. The workshop summary is organized within chapters as a topic-by-topic description of the presentations and discussions. Its purpose is to present lessons from relevant experience, delineate a range of pivotal issues and their respective problems, and put forth some potential responses as described by the workshop participants. The Summary and Assessment chapter discusses the core messages that emerged from the speakers’ presentations and the ensuing discussions. Although this workshop summary provides an account of the individual presentations, it also reflects an important aspect of the Forum philosophy. The

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary workshop functions as a dialogue among representatives from different sectors and presents their beliefs on which areas may merit further attention. However, the reader should be aware that the material presented here expresses the views and opinions of those participating in the workshop and not the deliberations of a formally constituted IOM study committee. These proceedings summarize only what participants stated in the workshop and are not intended to be an exhaustive exploration of the subject matter. ACKNOWLEDGMENTS The Forum on Emerging Infections and the IOM wish to express their warmest appreciation to the individuals and organizations who gave valuable time to provide information and advice to the Forum through participation in the workshop. The Forum is indebted to the IOM staff who contributed during the course of the workshop and the production of this workshop summary. On behalf of the Forum, we gratefully acknowledge the efforts led by Stacey Knobler, director of the Forum and coeditor of this report, who dedicated much effort and time to developing this workshop’s agenda, and for her thoughtful and insightful approach and skill in translating the workshop proceedings and discussion into this workshop summary. We would also like to thank the following IOM staff and consultants for their valuable contributions to this activity: Leslie Pray, Rob Coppock, Marjan Najafi, Laurie Spinelli, Judith Bale, Mark Smolinski, Katherine Oberholtzer, Patricia Cuff, Paige Baldwin, Jennifer Otten, Clyde Behney, Bronwyn Schrecker, Sally Stanfield, Sally Groom, Michele de la Menardiere, Francesca Moghari, and Beth Gyorgy. Finally, the Forum also thanks sponsors that supported this activity. Financial support for this project was provided by the U.S. Department of Health and Human Services’ National Institutes of Health, Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration; U.S. Department of Defense; U.S. Department of State; U.S. Department of Veterans Affairs; U.S. Department of Agriculture; American Society for Microbiology; Bristol-Myers Squibb Company; Burroughs Wellcome Fund; Eli Lilly & Company; Pfizer; GlaxoSmithKline; and Wyeth-Ayerst Laboratories. The views presented in this workshop summary are those of the editors and workshop participants and are not necessarily those of the funding organizations. Adel Mahmoud, Chair Stanley Lemon, Vice-Chair Forum on Emerging Infections

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Contents     SUMMARY AND ASSESSMENT Adel Mahmoud   1 1   INTRODUCTION   20     The Role of Research in Countering Bioterrorism, Anthony S. Fauci   22     The Political Perspective of the Bioterrorism Threat, William Frist   28     Update on the Implications of Anthrax Bioterrorism, James M. Hughes   30     Framing the Issues, Edward M. Eitzen, Jr.   32     Framing the Debate: Applying the Lessons Learned, Michael T. Osterholm   34     Building Capacity to Prevent and Respond to Bioterrorism, Margaret A. Hamburg   37     Bioterrorism: Communicating an Effective Response, Scott R. Lillibridge   39 2   ASSESSING OUR UNDERSTANDING OF THE THREATS   43     Overview,   43

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary     Anthrax, Arthur M. Friedlander   47     Medical Countermeasures Against the Re-emergence of Smallpox Virus, Peter B. Jahrling   51     Tularemia and Plague: Assessing Our Understanding of the Threat, David T. Dennis   55     Botulinum Toxin as a Bioweapon, Stephen S. Arnon   57     Research Considerations for Better Understanding of Biological Threats, Kenneth Alibek   64     Aerosol Technology and Biological Weapons, C.J. Peters, Richard Spertzel, William Patrick   66     Reducing the Risk: Foodborne Pathogen and Toxin Diagnostics, Susan E. Maslanka, Jeremy Sobel, Bala Swaminathan   77 3   VACCINES: RESEARCH, DEVELOPMENT, PRODUCTION, AND PROCUREMENT ISSUES   85     Overview,   85     Vaccines for Threatening Agents: Ensuring the Availability of Countermeasures for Bioterrorism, Philip K. Russell   87     The Department of Defense and the Development and Procurement of Vaccines Against Dangerous Pathogens: A Role in the Military and Civilian Sector?, Anna Johnson-Winegar   91     Applications of Modern Technology to Emerging Infections and Disease Development: A Case Study of Ebola Virus, Gary J. Nabel   101     Meeting the Regulatory and Product Development Challenges for Vaccines and Other Biologics to Address Terrorism, Jesse L. Goodman   105     Moving the Vaccine Agenda Forward: Obstacles and Opportunities, Stanley Plotkin   110 4   THE RESEARCH AGENDA: IMPLICATIONS FOR THERAPEUTIC COUNTERMEASURES TO BIOLOGICAL THREATS   113     Overview,   113     Countermeasures to Biological Threats: The Challenges of Drug Development, Gail H. Cassell   115     The FDA and the End of Antibiotics, David M. Shlaes and Robert C. Moellering, Jr.   116     The Role of Antivirals in Responding to Biological Threats, C.J. Peters   119

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary     New Research in Antitoxins, R. John Collier   131     Recombinant Human Antibody: Immediate Immunity from Botulinum Neurotoxin and Other Class A Biothreat Agents, James D. Marks   134     Meeting the Regulatory and Product Development Challenges to Address Terrorism, Andrea Meyeroff   139     Regulation and Production of Recombinant Human Antibodies, Kathryn E. Stein   142 5   ASSESSING THE CAPACITY OF THE PUBLIC HEALTH INFRASTRUCTURE   148     Overview,   148     Lessons Being Learned: The Challenges and Opportunities, Julie L. Gerberding   149     The Response Infrastructure: Investigating the Anthrax Attacks, Bradley Perkins   152     The Centers for Disease Control Bioterrorism Investigation, Kevin Yeskey   154     VA Capability to Enhance the Medical Response to a Domestic Biological Threat, Kristi L. Koenig   155     The Progress, Priorities, and Concerns of Public Health Laboratories, Mary J.R. Gilchrist   160     The Role of the Centers for Public Health Preparedness, Stephen S. Morse   165     The Role of Coordinated Information Dissemination: The Cascade System in the United Kingdom, John Simpson   167     State and Local Needs for Responding to Bioterrorism, Michael S. Ascher   170     U.S. Public Health Service Office of Emergency Preparedness, Donald C. Wetter   172     Assessing State and Territorial Health Departments, James J. Gibson   173     Countering Bioterrorism Threats: Local Public Health Perspectives, Thomas L. Milne   176     Public Health Priorities for Responding to Bioterrorism, Ruth L. Berkelman   178 6   SCIENTIFIC AND POLICY TOOLS FOR COUNTERING BIOTERRORISM   182     Overview,   182

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary     Innovative Surveillance Methods for Monitoring Dangerous Pathogens, Julie A. Pavlin, Patrick Kelley, Farzad Mostashari, et al.   185     The Use of Computational Modeling in Responding to Biological Threats, Donald S. Burke   197     Diagnostics and Detection Methods: Improving Rapid Response Capabilities, David A. Relman   199     National Security and Openness of Scientific Research, Ronald M. Atlas   203     Coordinating the Intelligence, Public Health, and Research Communities, Craig Watz   210     Virtually Assured Detection and Response: Utilizing Science, Technology, and Policy Against Bioterrorism, Scott P. Layne   211     Research and the Public Health Response, Eric Eisenstadt   217     APPENDIXES     A   Agenda: Biological Threats and Terrorism: How Prepared Are We? Assessing the Science and Our Response Capabilities,   220 B   Information Resources,   225 C   Testimony of Joshua Lederberg, Ph.D.,   235 D   Summary of the Frist-Kennedy “Bioterrorism Preparedness Act of 2001”,   239 E   Department of Health and Human Services: Food and Drug Administration [Docket No. 01N–0494],   244 F   Veterans Affairs/Department of Defense Contingency,   252 G   The Model State Emergency Health Powers Act,   254 H   NACCHO Research Brief: Assessment of Local Bioterrorism and Emergency Preparedness,   257 I   Statement on Vaccine Development,   262 J   Testimony of Kenneth I. Shine, M.D.,   269 K   Glossary and Acronyms,   275 L   Forum Member, Speaker, and Staff Biographies,   287

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary BIOLOGICAL THREATS AND TERRORISM

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary