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Protecting the Frontline in Biodefense Research: The Special Immunizations Program Appendix A Committee Member Biographies Donald S. Burke, M.D. (Chair), is the dean of the University of Pittsburgh Graduate School of Public Health, the UPMC-Jonas Salk Professor of Global Health, associate vice chancellor for global health, and director of the Center for Vaccine Research. Before coming to the University of Pittsburgh, Dr. Burke was a professor at the John Hopkins Bloomberg School of Public Health, where he served as associate chair of the Department of International Health and director of the Center for Immunization Research. He also served as principal investigator of National Institutes of Health-supported research projects on HIV vaccines, biodefense, and emerging infectious diseases. Prior to his tenure at Johns Hopkins, Dr. Burke served 23 years on active duty in the U.S. Army, leading military infectious disease research at the Walter Reed Army Institute of Research in Washington, DC, and at the Armed Forces Research Institute of Medical Sciences in Bangkok, Thailand. He retired with the rank of colonel. In addition to many decorations received while in military service, Dr. Burke has been honored by the scientific community. He is an elected fellow of the American Association for the Advancement of Science, the American Academy of Microbiology, the Royal Society of Tropical Medicine and Hygiene, the American College of Physicians, the Infectious Disease Society of America, and the Institute of Medicine. He served as president of the American Society of Tropical Medicine and Hygiene in 1995–1996. Dr. Burke has authored or co-authored more than 200 research reports. Recent selections in his bibliography include reports on the evaluation of the likely effectiveness of strategies for containing an emerging pandemic influenza in Southeast Asia, on simulation of the dynamic effects of antibody-dependent enhancement on the fitness of viruses, on detection of traveling waves in the
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program epidemiology of dengue hemorrhagic fever, and on emergence of unique primate T-lymphotropic viruses among central African bushmeat hunters. Dr. Burke’s career-long mission has been prevention and mitigation of the impact of epidemic infectious diseases of global importance. His research activities have spanned a wide range of science “from the bench to the bush,” including development of new diagnostics, population-based field studies, clinical vaccine trials, computational modeling of epidemic control strategies, and policy development and evaluation. W. Emmett Barkley, Ph.D., is the president of Proven Practices, LLC where he supports environmental health and safety programs at major academic research universities and government agencies. He is the former director of laboratory safety at the Howard Hughes Medical Institute and has recently served on the Committee on Prudent Practices in the Laboratory: An Update. His experience includes 24 years at the National Institutes of Health (NIH), where he served as the founding director of the NIH Division of Safety. Dr. Barkley was a principal contributor to several authoritative guidelines in the fields of biological and chemical safety, including the NIH Guidelines for the Laboratory Use of Chemical Carcinogens, the NIH Guidelines for Research Involving Recombinant DNA Molecules, and the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories. He received a bachelor of civil engineering from the University of Virginia and the master of science and doctorate degrees in environmental health from the University of Minnesota. Gerardo Chowell, Ph.D., is an assistant professor in the School of Human Evolution and Social Change at Arizona State University (ASU). Prior to joining ASU, Dr. Chowell was a director’s postdoctoral fellow with the Mathematical Modeling and Analysis Group (Theoretical Division) at the Los Alamos National Laboratory. He performs mathematical modeling of emergent and re-emergent infectious diseases (including SARS, influenza, Ebola, and foot-and-mouth disease) with an emphasis in quantifying the effects of public health interventions. His research interests include agent-based modeling, model validation, and social network analysis. Dr. Chowell received his Ph.D. in biometry from Cornell University and his engineering degree in telematics from the Universidad de Colima, Mexico. Alan S. Cross, M.D., is professor of medicine at the University of Maryland School of Medicine and researcher at its Center for Vaccine Development. Dr. Cross has three major areas of interest: the development of a vaccine for the prevention and treatment of sepsis, the early interactions of Bacillus anthracis with the host immune system, and the role of sialic acid in innate and adaptive immunity. A previous phase I study with a detoxified endotoxin vaccine complexed to group B meningococcal outer membrane protein revealed that while
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program the vaccine was well-tolerated, it was only weakly immunogenic. Currently, preclinical studies in murine models as well as clinical studies in human subjects are continuing with this vaccine given in conjunction with novel adjuvants. The relative roles of Toll-like receptors and Fc receptors in mediating macrophage killing of B. anthracis is another focus of the laboratory. The ability of the various B. anthracis structures (spore and vegetative forms and exosporium) to initiate macrophage signaling pathways leading to the killing of the organism is being characterized, and the effects of anthrax toxins on myeloid function are being defined. Finally, Dr. Cross found that the sialidase (neuraminidase) activity of various cells in the immune system is an essential element of innate and adaptive immunity. Currently, the laboratory is focusing on the mechanisms by which human neutrophil sialidase regulates cellular trafficking in both in vivo and in vitro model systems. These studies rely on endothelial cell culture systems as well as murine models of inflammation. Dr. Cross is past president of the International Endotoxin and Innate Immunity Society. Dr. Cross earned his B.A. from Harvard College and his M.D. from the University of Pennsylvania. Stephen W. Drew, Ph.D., is a former Distinguished Senior Scientist at Merck & Co., Inc., where his responsibilities encompassed the development of new process technologies for biologics and pharmaceutical manufacturing and technology transfer. Since retirement from Merck, he has founded two new companies—Drew Solutions LLC, a direct consulting firm, and Science Partners LLC, an advocacy company for medicines and technologies—that support the biotechnology and pharmaceutical industries. Prior to his retirement, he held vice presidential positions of responsibility at Merck & Co., Inc. as the vice president of Vaccine Science and Technology, the vice president of Vaccine Operations, and the vice president of Technical Operations & Engineering. He joined Merck in 1981 to create the Department of Biochemical Engineering. At Merck, he contributed to the process development and manufacture of several conventional and recombinant microbial products ranging from antibiotics to vaccines. Dr. Drew works in manufacturing processes for human and animal vaccines; recombinant biologics; chemical, biological, and engineering technology for bulk manufacture of pharmaceuticals and biologics; capital project engineering; process engineering; and fermentation, cell culture, isolation, and purification processes for sterile products. Dr. Drew received his B.S. and an M.S. in food science from the University of Illinois, and a Ph.D. in biochemical engineering from the Massachusetts Institute of Technology. He was elected to the National Academy of Engineering in 1993 and is a member of several professional organizations serving interests in chemical engineering, chemistry, and biology. He has held offices in the American Institute of Chemical Engineers, the American Chemical Society, the American Society for Microbiology, and the Society for Industrial Microbiology, and is a Founding Fellow of the American Institute for Medical and Biological Engineering. He has served as chairman of
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program the advisory committee to the Engineering Directorate of the National Science Foundation. He is a member of two standing committees of the National Research Council and has participated in many National Research Council studies. Kathryn Edwards, M.D., is the Sarah Sell Professor of Pediatrics, director of the division of Pediatric Clinical Research at the Kennedy Center, Vanderbilt University, and director of the Vanderbilt Vaccine Research Program. Dr. Edwards’s work focuses on the evaluation of vaccines for the prevention of infectious diseases in adults and children. She has conducted large efficacy trials of influenza vaccine and has coordinated multicenter trials of vaccines against Hemophilus influenza type b, Bordetella pertussis, Streptococcus pneumoniae, and vaccinia vaccines. She is currently studying dose-sparing strategies for influenza vaccine and avian influenza vaccines. She also conducts active population-based surveillance to monitor the impact of new vaccines on disease burden. Through National Institutes of Health and Centers for Disease Control and Prevention funding Dr. Edwards has performed many of the pivotal studies on vaccine effectiveness, vaccine safety, and vaccine impact in the past three decades. She is actively engaged in mentoring young clinical investigators and in teaching residents, medical students, and fellows. Her clinical work is focused on preventing and managing infectious diseases in children. Robert J. Hawley, Ph.D., RBP, CBSP, is an independent consultant on biological safety, biosecurity and biosurety issues. Before retiring in April 2011, he served as Senior Advisor, Science, for Midwest Research Institute’s Mid-Atlantic Operations and was responsible for the technical oversight of all group biosafety, biosecurity, and biosurety projects, and support staff. He performed incident investigations, biosafety threat and risk assessments, and threat and vulnerability and emergency requirements analyses at designated facilities to mitigate security and safety risks regarding the storage and handling of biological threat agents. Dr. Hawley also provided training in biological safety operations, maximum containment, recombinant DNA technology, and the science and safety of microbial agents and toxins for BSL-2, BSL-3, and BSL-4 operations. Before joining MRI in 2003, he worked at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) for 15 years, where he was responsible for formulating, implementing, and interpreting USAMRIID’s microbiological and industrial safety policies and procedures. Positions filled during his tenure at USAMRIID include safety and occupational health specialist, safety and occupational health manager, chief of the Safety and Radiation Protection Office, and Command Biological Safety Officer. Dr. Hawley received his master’s degree in virology from the Catholic University of America and Ph.D. degree in microbiology from the College of Medicine and Dentistry of New Jersey. He conducted research on mycobacteria and streptococci at the Georgetown University Schools of Medicine and Dentistry, Holy Cross
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program Hospital, and the University of Maryland before joining USAMRIID. He is a former president of the American Biological Safety Association (ABSA) and its Chesapeake Branch. He received the Council of Principal Scientists Science Award, Midwest Research Institute, in 2006 and the Everett Hanel, Jr. Presidential Award from the American Biological Safety Association in 2005. He was a member of the United Nations Special Commission (UNSCOM) Inspection Team in Iraq (1995); member of the team to sample for Bacillus anthracis at Stepnogorsk, Kazakhstan (1997); member of the World Health Organization team tasked to inspect the smallpox facility at the State Research Centre of Virology and Biotechnology in Novosibirsk, Central Siberia (1999, 2002, and 2009), and at the Centers for Disease Control and Prevention (2009). He consulted for the Environmental Protection Agency in Boca Raton, Florida (October 2001) and Washington D.C. (October 2001), for sampling and decontamination of facilities exposed to Bacillus anthracis spores. He was a member of the Defense Science Board Task Force on Defense Against Terrorist Use of Biological Weapons, Office of the Secretary of Defense (2002). He is a member of the Editorial Review Board of Applied Biosafety: Journal of the American Biological Safety Association; non-affiliated member of the Institutional Biosafety Committee at the University of Maryland, Baltimore, and a member of the Biological Sciences Experts Group, Office of the Director of National Intelligence. He served as a member of the Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins, National Academy of Sciences and a member of the Great Lakes Regional Center of Excellence Evaluation Committee (November 2010). He is the author or co-author of more than 250 abstracts, presentations, and publications in the areas of microbial taxonomy, chemistry, and genetics, plasmid-mediated antibiotic resistance, rapid diagnostic technology, medical aspects of AIDS, biological safety, biocontainment and decontamination, protection against biological warfare agents, bioterrorism and biological safety, decontamination, sterilization, disinfection, and antisepsis, biosafety and biosecurity regulatory impact, safety considerations in the BSL-4 (maximum) containment laboratory, and the science and safety of biological toxins. Thomas G. Ksiazek, D.V.M., Ph.D., is a professor in the departments of Pathology and of Microbiology and Immunology at the University of Texas Medical Branch (UTMB) at Galveston, Texas, senior staff scientist and director of the High Containment Operations Core at Galveston National Laboratory, and director of the University of Texas Medical Branch National Biodefense Training Center. He has previously served as chief of the Special Pathogens Branch, Division of Viral and Rickettsial Diseases (DVRD), National Center for Zoonotic, Vector-borne, and Enteric Diseases, Centers for Disease Control and Prevention (CDC); chief of the Disease Assessment Section, Special Pathogens Branch, DVRD, National Center for Infectious Diseases, CDC (1991–2005);
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program and chief of the Rapid Diagnosis Department, Disease Assessment Division, U.S. Army Medical Research Institute of Infectious Diseases, Ft. Detrick (1988–1991). Dr. Ksiazek’s scientific interests include the epidemiology/ecology and laboratory diagnosis of hemorrhagic fevers and arthropod-borne viral diseases. He has served as a consultant on operational biosafety and facility design to the U.S. Department of Agriculture, UTMB, U.S. Department of Defense, and U.S. Department of Homeland Security, and several international laboratories. Dr. Ksiazek received his D.V.M. from Kansas State University (1970); M.S. from the University of Wisconsin Madison (1976) and Ph.D. from the University of California (1984). He received the Army Surgeon General’s Award of an “A” skill identifier (1990); the Department of the Army Research and Development Achievement Award for Technical Achievement (1990), the Pekka Halonen Award for Diagnostic Virology (1993), and four Department of Health and Human Services Secretary’s Awards for Distinguished Service. He was the Founders Lector, American College of Veterinary Preventive Medicine (1995); delivered the Stilt Lecture, Association of Military Surgeons of the United States (1995); and is a Snowden Lecture Awardee, Australian Animal Health Laboratory (2009). He is the author or co-author of more than 330 research papers and his international experience includes long-term professional assignments in England, Taiwan, Indonesia, and Egypt as well as extensive outbreak experience in Asia, Africa, and South America. Thomas P. Monath, M.D., is a partner in the Pandemic and Biodefense Fund of Kleiner Perkins Caufield & Byers. He is also adjunct professor, Harvard School of Public Health. From 1992 to 2006, Dr. Monath was chief scientific officer and an executive director at Acambis (a publicly traded biopharmaceutical company), where he directed R&D on dengue, West Nile, Japanese encephalitis, yellow fever, Clostridium difficile, as well as smallpox vaccines for defense against bioterrorism. Dr. Monath received his undergraduate degree from Harvard College and M.D. from Harvard Medical School and trained in internal medicine at the Peter Bent Brigham Hospital, Boston. COL Monath retired from the U.S. Army in 1992 after 24 years in the uniformed services. From 1973–1988, he was director of the Division of Vector-Borne Viral Diseases, Centers for Disease Control, Fort Collins, CO, and from 1989 to 1992 he was chief of the Virology Division, U.S. Army Medical Research Institute of Infectious Diseases. He is on the editorial board of five scientific journals. He received the Nathanial A. Young Award (1984), the Richard M. Taylor Award (1996), and the Walter Reed Medal (2002) from the American Society of Tropical Medicine & Hygiene and was president of that society (2004–2005). He has served on numerous government and international committees on infectious diseases and biosecurity, World Health Organization expert committees, and the National Vaccines Advisory Committee (U.S.). Dr. Monath has published
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program over 385 papers and edited 6 books on the epidemiology, immunology, and pathogenesis of viruses and on vaccine development. Peter A. Patriarca, M.D., is senior clinical consultant for the Biologics Consulting Group, Inc. in Bethesda, MD, where he provides a wide range of regulatory advice to various clients in the drug industry, focusing primarily on vaccines and other biological products. Dr. Patriarca’s specialties include regulatory strategy, product development strategy, clinical protocol design, submission preparation and review, and Food and Drug Administration (FDA) and Advisory Committee meeting preparation. Prior to working for Biologics Consulting Group, Inc., Dr. Patriarca was the corporate head and vice president of world-wide Regulatory Affairs and Pharmacovigilance for MedImmune, Inc., from 2001 to 2005. He earned his B.S. at the University of Notre Dame, his M.D. at Tulane University School of Medicine, and is a board-certified pediatrician. Dr. Patriarca served as a Commissioned Officer in the U.S. Public Health Service from 1980 to 2000. During some of that time, he worked at the FDA, where he served as director of the Division of Viral Products in the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research. In that capacity, he worked on quality and consistency of chemistry manufacturing controls and clinical reviews, actively participated in sponsor meetings, and was intimately involved with regulatory decisions and policy affecting the development and approval of numerous investigational products. In his work at the Centers for Disease Control and Prevention, he was a field and clinical investigator, with about 100 peer-reviewed journal publications, and was a major contributor to immunization programs and policy promulgated through the Advisory Committee on Immunization Practices. Dr. Patriarca’s product experience includes vaccines, plasma derivatives, monoclonal antibodies, and small molecules. He is an expert on influenza, poliomyelitis, measles, and pertussis and has extensive international experience (including interactions with high-level World Health Organization personnel), vaccine policy experience, and experience as an investigator in epidemiologic research and large-scale vaccine efficacy studies. Holly A. Taylor, Ph.D., M.P.H., is an assistant professor in the Department of Health Policy and Management, Bloomberg School of Public Health and a core faculty member of the Berman Institute of Bioethics at the Johns Hopkins University. She received her B.A. from Stanford University, her M.P.H. from the School of Public Health at the University of Michigan, and her Ph.D. in health policy with a concentration in bioethics from the Bloomberg School of Public Health, Johns Hopkins University. Before pursuing her doctoral degree, Dr. Taylor was a presidential management intern with the Department of Health and Human Services and spent two years rotating through AIDS-related policy positions at the National AIDS Program Office, National Commission on
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program AIDS, the San Mateo County Health Department, and the Senate Committee on Labor and Human Resources. After completing her internship, Dr. Taylor spent two years as special assistant to the director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. In 1999, Dr. Taylor received a Mentored Scientist Development Award to pursue theoretical and practice aspects of justice in human subject research. She currently serves as associate director for empirical research at the Berman Institute of Bioethics. Dr. Taylor has served on the Institutional Review Boards of the Bloomberg School of Public Health and the Johns Hopkins School of Medicine. Her primary interests are research ethics, local implementation of federal policy relevant to human subject research, HIV/AIDS policy, and qualitative research methods. Thomas E. Walton earned his D.V.M degree from Purdue University in 1964, a Ph.D. degree from Cornell University in virology in 1968, and a D.Sc. (honoris causae) from Purdue University in 1999. He is a diplomate of the American College of Veterinary Microbiologists and a Fellow of the Society for Tropical Veterinary Medicine. He has 31 years of experience in infectious diseases research, research leadership, and research management at the Middle America Research Unit of the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Canal Zone (1968–1972, research veterinarian; equine encephalomyelitides and vesicular stomatitis); the Arthropod-borne Animal Diseases Research Laboratory of the Agricultural Research Service (ARS), U.S. Department of Agriculture (USDA), Denver, CO, and Laramie, WY (1972–1992, research leader, bluetongue, epizootic hemorrhagic disease, equine encephalomyelitides, and vesicular stomatitis); the national program staff, ARS, USDA, Beltsville, MD (1992–1995, national program leader for animal health responsible for animal health program quality and relevance for 13 ARS animal health laboratories); and the National Animal Disease Center, ARS, USDA, Ames, IA (1995–1997, director, research leadership and management for indigenous livestock diseases). In addition, he has 11 years’ experience in regulatory veterinary medicine as associate deputy administrator and acting deputy administrator for veterinary services (VS), Animal and Plant Health Inspection Service (APHIS), USDA, Washington, DC, and director of the Centers for Epidemiology and Animal Health, VS, APHIS, USDA, Fort Collins, CO. He is author or co-author of more than 150 scientific publications on infectious disease research with exotic and zoonotic pathogens and regulatory veterinary medicine. Since retirement in 2006, he has served as a consultant to several companies on the design and environmental assessment of veterinary and human infectious diseases biocontainment laboratories and as a consultant to the Millennium Challenge Corporation and USDA, Foreign Agriculture Service for veterinary medical projects in the Republic of Namibia and in the Republic of Mongolia.