Appendix F

About the Authors

Committee Members

George W. Korch, Jr., PhD, (Co-Chair), is Senior Science Advisor to the Assistant Secretary for Preparedness and Response, Health and Human Services, and Visiting Professor, Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health. Dr. Korch retired from the U.S. Army Medical Department in 2008, where he had served in a number of leadership roles, including the Commander of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Director of the Department of Defense Medical Chemical and Biological Defense Research Program. He also served as one of the first Directors of the National Biodefense Analysis and Countermeasure Center (NBACC), Department of Homeland Security. His area of expertise is in viral and rickettsial zoonotic diseases and in medical countermeasure development (vaccines, therapeutics and diagnostics) for biodefense needs. He is the co-chair of the Federal Experts Security Advisory Panel for the National Security Staff and participates on a variety of working groups within the federal government concerning national and international biosecurity and health. He serves or has served on such committees as the Institute of Medicine’s Forum on Microbial Threats, was appointed by the Maryland Governor to the State’s Life Sciences Advisory Board and serves on the Standards Development Committee for the American Type Cell Culture. He has co-authored one book on medical defense against biological threats as well as published articles regarding arboviral diseases and biodefense issues.

Steven M. Niemi, DVM, (Co-Chair), is Director of the Center for Comparative Medicine at Massachusetts General Hospital and an Instructor in Pathology at Harvard Medical School. Dr. Niemi is a Diplomate and President-elect of the American College of Laboratory Animal Medicine. He is an Ad hoc Consultant with AAALAC, International, a past President of the Scientists Center for Animal Welfare, and a member of the American Association for Laboratory Animal Science, American



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Appendix F About the Authors Committee Members George W. Korch, Jr., PhD, (Co-Chair), is Senior Science Advisor to the Assistant Secretary for Preparedness and Response, Health and Human Services, and Visiting Professor, Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health. Dr. Korch retired from the U.S. Army Medical Department in 2008, where he had served in a number of leadership roles, including the Commander of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Director of the Department of Defense Medical Chemical and Biological Defense Research Program. He also served as one of the first Directors of the National Biodefense Analysis and Countermeasure Center (NBACC), Department of Homeland Security. His area of expertise is in viral and rickettsial zoonotic diseases and in medical countermeasure development (vaccines, therapeutics and diagnostics) for biodefense needs. He is the co-chair of the Federal Experts Security Advisory Panel for the National Security Staff and participates on a variety of working groups within the federal government concerning national and international biosecurity and health. He serves or has served on such committees as the Institute of Medicine’s Forum on Microbial Threats, was appointed by the Maryland Governor to the State’s Life Sciences Advisory Board and serves on the Standards Development Committee for the American Type Cell Culture. He has co-authored one book on medical defense against biological threats as well as published articles regarding arboviral diseases and biodefense issues. Steven M. Niemi, DVM, (Co-Chair), is Director of the Center for Comparative Medicine at Massachusetts General Hospital and an Instructor in Pathology at Harvard Medical School. Dr. Niemi is a Diplomate and President-elect of the American College of Laboratory Animal Medicine. He is an Ad hoc Consultant with AAALAC, International, a past President of the Scientists Center for Animal Welfare, and a member of the American Association for Laboratory Animal Science, American 131

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132 ANIMAL MODELS FOR ASSESSING COUNTERMEASURES Veterinary Medical Association, Veterinary Cancer Society, and ILAR Council. He has published on alternatives to animal experimentation and his current research interests include alleviating distress in laboratory animals. Nicholas H. Bergman, PhD, is Senior Principal Investigator, National Biodefense Analysis and Countermeasures Center. His research in the past has focused on the identification of targets for therapeutic intervention using genomics and proteomics, and more recently on the ways these approaches can be best used for microbial forensics. His lab includes both experimental and computational biologists, and their work has involved the use of a range of systems-level approaches in understanding the biology and pathogenesis of a variety of bacterial pathogens, including B. anthracis, F. tularensis, S. aureus, S. pyogenes, and A. baumannii. Dr. Bergman is a member of the Interoperability Working Group, NIH/NIAID Biodefense Proteomics Research Centers, the NIAID Systems Biology of Infectious Disease Scientific Working Group, and is the chairperson of the NBACC Institutional Biosafety Committee. He was formerly Co-Director, NIAID/University of Michigan Biodefense Proteomics Research Center. He also served as an external reviewer for the U.S. Department of State, Russian Nonproliferation Office and International Science and Technology Center; the US Department of Homeland Security/National Biodefense Analysis and Countermeasures Center (NBACC); Defence Research and Development Canada—Centre for Security Science; and U.S. Army Medical Research and Materiel Command Grants Office. Daniel J. Carucci, MD, MSc, PhD, is the President of Global Health Consulting, Inc., providing profit and non-profit organizations, international NGOs, multilateral and service organizations who are working toward improving the impact of global health investments. The organization provides strategic and technical assistance in global health to major international private sector corporations focused on increasing demand for quality health products and services, improving integration of health services across sectors, leveraging corporate capabilities applied to global health, and supporting large-scale global health programs. As Vice President for Global Health at the United Nations Foundation, Dr Carucci supported programs and fostered diverse partnerships to address the United Nations Millennium Development Goals. He spearheaded programs to amplify the voices of African leaders for improved health in Africa, worked to increase the awareness and impact of global health investments and supported innovations in global health technology, communications and finance. As Director of the Grand Challenges in Global Health Initiative at the Foundation for the National Institutes of Health, he oversaw a $200 million investment portfolio of research programs supported by the Bill & Melinda Gates Foundation in cutting edge technologies directed at solving technical barriers to improved global health. He completed 20 years active service as a U.S. Navy physician and research scientist. As Director of the U.S. Navy Malaria Vaccine Program he led a team of scientists and physicians in cutting edge genomic approaches to the development and testing of malaria vaccines, establishing partnerships with the biotechnology industry and building clinical trial capabilities in the developing world. Dr Carucci received a Medical Degree from the University of Virginia, School of Medicine; a Masters of Science in Clinical Tropical Medicine and a Doctor of Philosophy from the London School of Hygiene & Tropical Medicine. He is an Honorary Professor of the London School of Tropical Medicine & Hygiene and the recipient of the prestigious 2002 American Medical Association Nathan Davis Award for Outstanding Government Service, the 2000 Chairman of the Joint Chiefs of Staff Award for Excellence in Military Medicine, and the1989 Operational Flight Surgeon of the Year. He has published over 70 peer-reviewed articles and book chapters. His personal awards while with the U.S. Navy include the Legion of Merit with gold star (in lieu of a second award), Meritorious Service Medal with gold star (in lieu of a second award), Navy Commendation Medal and Navy Achievement Medal.

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133 APPENDIX F Susan A. Ehrlich, JD, LLM retired after serving eighteen years as a judge on the Arizona Court of Appeals. She received her BA degree from Wellesley College and her JD and LLM (biotechnology and genomics) degrees from Arizona State University. Prior to joining the Arizona Court of Appeals, she was an Assistant U.S. Attorney for the District of Arizona, a Department of Justice Civil Division Appellate Section attorney, and the law clerk for the Chief Justice of the Arizona Supreme Court. She has received numerous awards throughout her career. Judge Ehrlich currently serves on the National Science Advisory Board for Biosecurity and as an adjunct professor, Department of Microbiology and Immunology, University of Texas Medical Branch – Galveston/Galveston National Laboratory. Gigi Kwik Gronvall, PhD, is a Senior Associate at the Center for Biosecurity of UPMC and an Assistant Professor of Medicine at the University of Pittsburgh. She is an immunologist by training. She serves on the American Association for the Advancement of Science (AAAS) Committee on Scientific Freedom and Responsibility, and she participated in the European Union Visitors Programme for 2011. Dr. Gronvall served as the Science Advisor of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism from April 2009 until the Commission ended in February 2010. She has testified before Congress about the safety and security of high-containment biological laboratories in the United States and served on several task forces related to laboratory security, including a 2008 Defense Science Board task force and a 2008 National Academy of Sciences (NAS) panel charged with providing technical input on the risk of operating Boston University’s National Emerging Infectious Diseases Laboratory (NEIDL). Dr. Gronvall has investigated and presented policy recommendations on the governance of science to the Biological Weapons Convention (BWC) in Geneva, Switzerland (2003, 2005, and 2006). Dr. Gronvall is an Associate Editor of the quarterly journal Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. Thomas Hartung, MD, PhD, is Director of the Center for Alternatives to Animal Testing (CAAT) and the inaugural Chair for Evidence-Based Toxicology in the Department of Environmental Health Sciences at the Johns Hopkins Bloomberg School of Public Health. He holds a joint appointment for Molecular Microbiology and Immunology. Dr. Hartung headed the European Centre for Alternative Methods (ECVAM) at the European Commission Joint Research Centre in Italy. Dr. Hartung joined the faculty at University of Konstanz in 1994, where served as an Assistant Professor of Biochemical Pharmacology, then as an Associate Professor in the Department of Pharmacology and Toxicology until 2002, with a focus on immunomodulatory treatments of infectious diseases and immune recognition of bacterial toxins. He has been a full professor of Pharmacology and Toxicology at Konstanz since 2003. Dr. Hartung also served as the CEO of the Steinbeis Technology Transfer Center for In Vitro Pharmacology and Toxicology (InPuT). He has authored more than 350 papers. Elizabeth Heitman, PhD, is Associate Professor and Director of Clinical and Research Ethics in the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center. Her primary research addresses the evaluation of education in the responsible conduct of research, and the cultural awareness and professional socialization of students and researchers. Dr. Heitman is the Director of a five-year, research ethics education program for Costa Rican biomedical researchers and research ethics review committees, sponsored by the NIH’s Fogarty International Center, and Chair-Elect of the Clinical Research Ethics Key Function Committee of the Clinical and Translational Science Award (CTSA) Consortium. She is the coauthor of The Ethical Dimensions of the Biological and Health Sciences (with Drs. Ruth Ellen Bulger and Stanley Joel Reiser).

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134 ANIMAL MODELS FOR ASSESSING COUNTERMEASURES Malak Kotb, PhD is a Senior Research Career Scientists at the VA System, Director of the Midsouth Center for Emerging Infectious Diseases (MI-CEID), and Chairperson for the University of Cincinnati College of Medicine, Department of Molecular Genetics, Biochemistry and Microbiology. Dr. Kotb has been involved in studies of the mechanism and complex genetics of human diseases and has developed small animal models for systems genetics and systems biology of infectious diseases. Kotb established and directed the Immunology and Immunogenetics program at UTHSC and was later appointed as Director of Translational Research Programs and of the Biodefense Research Program. She was also named A.C. Mullins Endowed Professor of Translational Research and Director of the MidSouth Center for Biodefense and Security. She served on a seven member external panel for the CDC on Anthrax Vaccine, was appointed to the Advisory Board of the National Council for Preparedness and Security and was appointed to the Task Force for Preparation for Avian Flu Pandemic by the Governor of Tennessee. Dr. Kotb chaired the NIH Immunological Sciences (Host Defense and Innate Immunity) and the Immunity and Host Defense (IHD) study sections. She served on advisory boards and NIH delegations to European countries. Kotb also chaired several Ad hoc NIAID Infectious Diseases review panels. Her research has been supported by funds mainly from the VA, NIH and DOD. She has published over 175 original articles, edited two books, contributed 20 book chapters and 13 invited reviews. She continues her research activities in the fields of translation medicine, focusing on systems approaches to infectious diseases and cancer therapeutics. Jens H. Kuhn, MD, PhD, PhD, MS, is a Managing Consultant at Tunnell Consulting, Inc., King of Prussia, PA, and Lead Virologist (Contractor) at NIH/NIAID's new maximum-containment facility, the Integrated Research Facility at Fort Detrick (IRF-Frederick) in Frederick, MD. Kuhn specializes in highly virulent viral pathogens and recently published Filoviruses - A Compendium of 40 Years of Epidemiological, Clinical, and Laboratory Studies (Vienna: Springer, 2008). He has studied and worked, among other countries, in Germany, Russia, South Africa, and South Korea. In the US, he rotated through the Arthropod-borne Infectious Disease Laboratory (AIDL), Ft. Collins, CO, the Centers for Disease Control and Prevention (CDC), Atlanta, GA, and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), Ft. Detrick. Frederick, MD. In 2001, Kuhn was the first Western scientist with permission to work in the former Soviet biological warfare facility "Vektor" in Siberia, Russia, within the US DoD’s Cooperative Threat Reduction Program. Kuhn was a contributor to the Center for International and Security Studies at Maryland’s Controlling Dangerous Pathogens Project and a member of the Center for Arms Control and Nonproliferation’s CBW Scientist Working Group in Washington, DC, is a member of the editorial board of Applied Biosafety – Journal of the American Biological Safety Association and Archives of Virology, and a member of the ICTV Filoviridae Study Group. C. Rick Lyons, MD, PhD, was named Director of the Infectious Disease Research Center at Colorado State University in 2010. Dr. Lyons is a physician-scientist trained as a Hematologist/Oncologist. He received his MD and doctorate from University of Texas Southwestern Medical School in Dallas, Texas. He received his doctorate in Immunology and his training in Hematology/Oncology at the Brigham and Women's Hospital in Boston, Massachusetts. He comes to Colorado State University from the University of New Mexico Health Science Center in Albuquerque where he was professor of Medicine and Director of the Center for Infectious Diseases and Immunology. His scientific expertise is in developing animal models of human diseases that can be used to translate products into humans. Dr. Lyons has over twenty five years experience in developing and performing research in animal models of infectious disease. There are three main emphases in his research: 1) Develop the most accurate animal models of infection that mimic human disease; 2) Apply cutting edge technology to analyze the endpoints during in vivo infection; and 3) Develop strong collaborations with internal and external

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135 APPENDIX F investigators to bring the most expertise to bear on these issues. In the last ten years he has focused his research on a variety of emerging infections particularly in the field of bioweapons including Bacillus anthracis and Francisella tularensis using a variety of species to examine their pathogenesis including mice, rats, rabbits and primates. Stephen S. Morse, PhD, is Professor of Clinical Epidemiology at Columbia University’s Mailman School of Public Health, co-Director of the PREDICT project of the USAID Emerging Pandemic Threats (EPT) program, and Visiting Professor at the University of California, Davis. He was also founding director of the Columbia University Center for Public Health Preparedness, at the Mailman School of Public Health. He also holds an Adjunct Faculty appointment in The Rockefeller University. He was Program Manager for Biodefense at the federal Defense Advanced Research Projects Agency (DARPA), where he directed the Advanced Diagnostics program, co-directed the “Pathogen Countermeasures” program, and managed DARPA’s research collaborations with Russian scientists. Before that, he was Assistant Professor (Virology), The Rockefeller University. He chaired the 1989 National Institutes of Health (NIH) Conference on Emerging Viruses, for which he originated the concept of “emerging viruses”. Dr. Morse was founding Chair of ProMED (international Program to Monitor Emerging Diseases) and founding Section Editor of the CDC journal Emerging Infectious Diseases. He was also Secretary of the American Committee on Laboratory Animal Diseases (ACLAD). He is the editor of two books, Emerging Viruses (Oxford University Press, 1993; paperback, 1996), which was selected by American Scientist for its list of “The Top 100 Science Books of the [20th] Century”, and The Evolutionary Biology of Viruses (Raven Press, 1994). He was a member of the IOM Committee on Emerging Microbial Threats to Health, IOM Committee on Xenograft Transplantation, and the NRC Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents. He served on the Steering Committee of the IOM Forum on Microbial Threats, in addition to serving on several other committees, government advisory panels, and journal editorial boards. He is a Fellow of the AAAS, the American Academy of Microbiology, the American College of Epidemiology, the New York Academy of Sciences (past Chair, Microbiology Section), the New York Academy of Medicine, and an elected life member of the Council on Foreign Relations. Fred Murphy (IOM), DVM, PhD, is Professor, Department of Pathology, University of Texas Medical Branch (UTMB), Galveston. He is dean emeritus and distinguished professor emeritus of the School of Veterinary Medicine at the University of California, Davis. He is also distinguished professor emeritus of the School of Medicine, UC Davis. Earlier, he served as the director, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC) and before that as the director of the Division of Viral and Rickettsial Diseases at CDC. At UTMB, Dr. Murphy is a member of the Institute for Human Infections and Immunity (and its Executive Board), The Center for Biodefense and Emerging Infectious Diseases, the Galveston National Laboratory, the Center for Tropical Diseases and the McLaughlin Endowment for Infection and Immunity (and member of its Executive Board). Dr. Murphy’s professional interests include the virology, pathology and epidemiology of highly pathogenic viruses/viral diseases: (1) Rabies: long running studies leading to the identification of more than 25 viruses as members of the virus family Rhabdoviridae, identification and characterization of the first rabies-like viruses, and major studies of rabies pathogenesis in experimental animals, including the initial descriptions of infection events in salivary glands and in muscle; (2) Arboviruses: long running studies of togaviruses and bunyaviruses with the initial proposal for the establishment and naming of the virus family Bunyaviridae, and characterization of "reo-like" viruses culminating in the establishment and naming of the virus genus Orbivirus; (3) Viral hemorrhagic fevers: long running studies leading to the initial discovery of Marburg and Ebola viruses, and characterization of several other hemorrhagic fever viruses, culminating in the establishment and naming of the virus families Arenaviridae (e.g., Lassa

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136 ANIMAL MODELS FOR ASSESSING COUNTERMEASURES virus) and Filoviridae (Marburg and Ebola viruses), and elucidation of the pathology and pathogenesis of the diseases in man, monkeys, hamsters and guinea pigs caused by these exceptionally virulent agents; (4) Viral encephalitides: long running studies of the pathogenesis of neurotropic viruses in experimental animals, including alphaviruses, flaviviruses, bunyaviruses, enteroviruses, paramyxoviruses, herpesviruses, and others. He has been a leader in advancing the concept of “new and emerging infectious diseases” and “new and emerging zoonoses.” Most recently his interests have included the threat posed by bioterrorism. Dr. Murphy has a B.S. in Bacteriology, a D.V.M. from Cornell University, and a Ph.D. in Comparative Pathology from UC Davis. Vikram S Patel, PhD, is a Deputy Director in the Division of Drug Safety Research in CDER at FDA. He is responsible for guiding safety related preclinical research, including research in the area of toxicology, pharmacokinetics, drug metabolism and transporters. He is recognized for his expertise in pharmacokinetic/pharmacodynamic modeling and simulations, physiological modeling (including biomarker modeling and simulations), drug metabolism, in-vitro/-in vivo correlations, and in drug formulation and delivery. Prior to joining the FDA, Dr. Patel was Senior Director of Discovery Pharmacokinetics at Wyeth where he was responsible for overseeing and providing pharmacokinetic, Toxicokinetic, and pharmacokinetic/ pharmacodynamic support for all discovery projects (small and large molecules). Prior to 2002, he worked for Procter and Gamble Pharmaceuticals where he developed and established a GLP pre-clinical PK section. He also developed a sustained release product called Macrobid®, currently marketed worldwide. Dr. Patel has extensive experience in drug formulation, clinical and preclinical pharmacokinetic areas. His research interests include development of pharmacokinetic/pharmacodynamic models, modeling and characterization of absorptive processes, development of in vivo - in vitro relationships and use of pharmacokinetics in dosage form development and optimization. James R. Swearengen, DVM, is the Comparative Medicine Veterinarian for the National Biodefense Analysis and Countermeasures Center and a former Senior Director of the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC International). Dr. Swearengen received his veterinary medical degree from the University of Missouri-Columbia in 1982. He is a former Deputy Commander of the U.S. Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland, and served as the laboratory animal medicine consultant to the U.S. Army Surgeon General. He retired from the U.S. Army in 2005. Dr. Swearengen is a member of the AAALAC International Council on Accreditation and is board certified in both veterinary preventive medicine and laboratory animal medicine. He is a Past-President of the American College of Laboratory Animal Medicine (ACLAM) and serves on the United States Animal Health Association Board of Directors. National Academies Staff Lida Anestidou, DVM, PhD, is Senior Program Officer at the Institute for Laboratory Animal Research of the U.S. National Academy of Sciences, where she directs a diverse portfolio of studies on the use of laboratory animals; biodefense and biosecurity; and research integrity/responsible conduct of research. Among other projects, she directed the Update of the Guide for the Care and Use of Laboratory Animals (2011). Prior to this position she was Research Instructor at the Center for Biomedical Ethics and Society, Vanderbilt University Medical Center. She earned her doctorate in biomedical sciences from the University of Texas at Houston. Dr. Anestidou also holds a Doctor of Veterinary Medicine degree from Greece (her home country) and an M.S. in Veterinary Sciences from the University of Florida. She is an editorial board member of Science and Engineering Ethics, Lab Animal, and SciTech Lawyer and an ad

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137 APPENDIX F hoc reviewer for the American Journal of Bioethics. She is a member of the American Bar Association/American Association for the Advancement of Science National Conference of Lawyers and Scientists. Dr. Anestidou serves as an expert reviewer in the Ethics Evaluation of grant applications to the 7th Framework Program of the European Research Council and the European Commission Directorate General Research. India Hook-Barnard, PhD, is Program Officer with the Board on Life Sciences of the National Research Council. She came to the National Academies from the National Institutes of Health where she was a Postdoctoral Research Fellow from 2003 to 2008. Her research investigating the molecular mechanism of gene expression focused on the interactions between RNA polymerase and promoter DNA. Dr. Hook-Barnard earned her PhD from the Dept. of Molecular Microbiology and Immunology at the University of Missouri. Her graduate research examined translational regulation and ribosome binding in Escherichia coli. At the National Academies, she contributes to projects in a variety of topic areas. Much of her current work is related to issues of molecular biology, microbiology, biosecurity, synthetic biology, and genomics. Dr. Hook-Barnard has directed the U.S. Canada Regional Committee for the International Brain Research Organization since 2008, and she was the study director for the consensus reports, Sequence-Based Classification of Select Agents: A Brighter Line (2010); and Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease (2011).

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