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Biological Science and Biotechnology in Russia

CONTROLLING DISEASES AND ENHANCING SECURITY

Committee on Future Contributions of the Biosciences to Public Health, Agriculture, Basic Research, Counterterrorism, and Nonproliferation Activities in Russia

Office for Central Europe and Eurasia

Development, Security, and Cooperation Policy and Global Affairs

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

In cooperation with the Russian Academy of Sciences

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu



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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Biological Science and Biotechnology in Russia CONTROLLING DISEASES AND ENHANCING SECURITY Committee on Future Contributions of the Biosciences to Public Health, Agriculture, Basic Research, Counterterrorism, and Nonproliferation Activities in Russia Office for Central Europe and Eurasia Development, Security, and Cooperation Policy and Global Affairs NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES In cooperation with the Russian Academy of Sciences THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security 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/Grant No. 6035 between the National Academy of Sciences and the Nuclear Threat Initiative. 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. International Standard Book Number 0-309-09704-5 A limited number of copies are available from the Office for Central Europe and Eurasia, National Research Council, 500 Fifth Street, NW, Washington, DC 20001; (202) 334-2644. Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu Copyright 2006 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security 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. Ralph J. Cicerone 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. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Dedicated to Dr. Maurice Hilleman Humanitarian, Colleague, Mentor, and Friend 1920-2005

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security COMMITTEE ON FUTURE CONTRIBUTIONS OF THE BIOSCIENCES TO PUBLIC HEALTH, AGRICULTURE, BASIC RESEARCH, COUNTERTERRORISM, AND NONPROLIFERATION ACTIVITIES IN RUSSIA DAVID FRANZ, Midwest Research Institute, Chair DAVID ASHFORD, Centers for Disease Control and Prevention CAROL BLAIR, Colorado State University GAIL H. CASSELL, Eli Lilly and Company MAURICE HILLEMAN, Merck Institute for Vaccinology1 CHRISTOPHER P. HOWSON, March of Dimes Birth Defects Foundation PETER B. JAHRLING, U.S. Army Medical Research Institute of Infectious Diseases PAUL KEIM, Northern Arizona University JAMES LEDUC, Centers for Disease Control and Prevention MATTHEW MESELSON, Harvard University REBECCA MORTON, Oklahoma State University FREDERICK MURPHY, University of California at Davis JOSEPH SILVA, University of California at Davis RICHARD WITTER, USDA-ARS Avian Disease & Oncology Laboratory, Michigan RUSS ZAJTCHUK, Chicago Hospitals International, LLC Staff GLENN E. SCHWEITZER, Program Director RITA S. GUENTHER, Senior Program Associate AMY E. MOORE, Program Assistant KELLY ROBBINS, Senior Program Officer SARA GRAY, Senior Program Associate 1   Deceased April 11, 2005.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Acknowledgments The committee expresses its appreciation to the many Russian and U.S. officials and specialists who contributed their ideas during the preparation of this report. The Nuclear Threat Initiative, a private foundation, and the National Research Council (NRC) provided the financial support for this study. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, 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. We wish to thank the following individuals for their review of this report: Donald Burke, Johns Hopkins University; Douglas Causey, Harvard University; Charles Fogelgren, Southern Research Institute; Tatiana Gremyakova, International Science and Technology Center; Alexander Klibanov, Massachusetts Institute of Technology; Victor Maleyev, Central Research Institute of Epidemiology; Michael Moodie, Chemical and Biological Arms Control Institute; Harley Moon, Iowa State University; Dmitry Morozov, Biokad, Inc.; Sergey Netesov, VECTOR; Melanie Peterson, United States Department of Agriculture; Evgenii Sventitsky, Institute of Highly Pure Biopreparations; Nikolai Vlasov, Ministry of Agriculture; Mary Wilson, Harvard University; and Vitaly Zverev, Institute of Viral Preparations.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Mary Jane Osborne, University of Connecticut, and Patricia Danzon, University of Pennsylvania. Appointed by the NRC, 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. In addition to the formal reviewers of the report, there were many who offered their time and expertise over the course of the study’s development. The committee wishes to express its appreciation to all those who contributed. In particular, Michael Balady, James Bartholomew, Randy Beatty, Anne Harrington, Lev Sandakhchiev, Vladimir Skulachev, Mark Smolinski, Rob Tosatto, and Vitaly Zverev participated in a series of meetings and discussions which transformed initial thoughts into the first draft of this manuscript during a productive July 2003 week in Woods Hole, MA. Sergey Furgal, Yevgeny Grishin, Ramil Khabriev, Sergey Netesov, Mikhail Paltsev, Evgenii Severin, and Nikolai Vlasov, along with their colleagues, shared many valuable insights with members of the committee during their several research trips to Russia undertaken as part of this study. They frequently provided hard-to-find data, regulations, and information upon which the committee’s analysis was based; their openness and frankness were offered in the best spirit of international science. The final trip was to St. Petersburg in July 2004, when the committee had the opportunity to meet again with many of these Russian colleagues. Undoubtedly there are those who are inadvertently absent from these acknowledgements. The committee recognizes that without the efforts and professionalism of those named and unnamed, this and other cooperative work between Russia and America could not be accomplished.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Contents     Summary   1     Introduction   10 1   A Vision for Russia’s Future   21 2   Pillar One: Improving Surveillance and Response   27 3   Pillar Two: Meeting Pathogen Research Challenges   36 4   Pillar Three: The Promise of Biotechnology   47 5   Pillar Four: The Human Resource Base   59 6   Reshaping U.S.-Russian Cooperation in the Biological Sciences and Biotechnology   65     Epilogue   76     Appendixes         A   Committee Biographies   81     B   Organizations Consulted During the Study   86     C   Decision of the Board of the Ministry of Health of the Russian Federation: Tasks for the Periods 2001–2005 and 2006–2010 (Excerpt from Protocol No. 6)   89

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security     D   Main Goals and Objectives in Combating Infectious Diseases in the Russian Federation   93     E   Regulations Regarding the Federal Service for Supervision in the Sphere of Health and Social Development   96     F   Recent Reports by the National Academies on Global Health Concerns   104     G   Bioterrorism: A National and Global Threat Gennady G. Onishchenko   106     H   Highest Priority Measures for Creating a System to Counter Biological Terrorism K. K. Raevsky   108     I   National Immunization Calendar of the Russian Federation   113     J   Selected Russian Research and Related Institutions with Activities Relevant to Infectious Diseases, Diagnostics, Treatment, Prevention, and Control   115     K   Scientific and Methodological Research Results Highlighted by the Russian Ministry of Health and Social Development Gennady G. Onishchenko   120     L   List of Research Projects Proposed in Open Competitions Organized in 2003   125     M   Test Systems and Other Products Being Developed in Russian Laboratories   127     N   RosAgroBioProm Organizational Structure   131     O   Activities of Russian Research Institutes in Developing Vaccines for Human Use   132     P   Regulation of the Russian Government on Licensing Activities Connected with the Use of Infectious Disease Antidotes, No. 731   133     Q   Bioengagement Programs Financed by the United States Government   137     R   International Programs and Projects of Special Significance to the Ministry of Health and Social Development   143     References   145