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BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version (2015)

Chapter: Appendix D: Biographies of Committee Members

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Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
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Appendix D

Biographies of Committee Members

Georges C. Benjamin, M.D., became executive director of the American Public Health Association, the nation’s oldest and largest organization of public health professionals, in 2002. Prior to that he was secretary of the Maryland Department of Health and Mental Hygiene, where he played a key role in developing Maryland’s bioterrorism plan, following 4 years as the department’s deputy secretary for public health services. Dr. Benjamin started his medical career in 1981 in Tacoma, Washington, where he managed a 72,000-patient-visit ambulatory care service as chief of the Acute Illness Clinic at the Madigan Army Medical Center. A few years later, he served as chief of emergency medicine at the Walter Reed Army Medical Center. After leaving the Army, he chaired the Department of Community Health and Ambulatory Care at the District of Columbia General Hospital. He was promoted to acting commissioner for Public Health for the District of Columbia and later directed one of the busiest ambulance services in the nation as interim director of the Emergency Ambulance Bureau of the District of Columbia Fire Department. Dr. Benjamin has served as a member of the Institute of Medicine’s (IOM’s) Board on Population Health and Public Health Practice and on several other IOM and IOM/National Research Council (NRC) committees in areas such as training physicians for public health careers, measures to enhance the effectiveness of the Centers for Disease Control and Prevention quarantine station expansion plan for U.S. ports of entry, evaluation of the metropolitan medical response systems program, and research and development needs for improved civilian medical response to chemical or biological terrorism

Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

incidents. He is currently a member of the NRC’s Report Review Committee. Dr. Benjamin is a graduate of the Illinois Institute of Technology and the University of Illinois College of Medicine. He is board certified in internal medicine and is a fellow of the American College of Physicians and a fellow emeritus of the American College of Emergency Physicians.

Kenneth I. Berns, M.D., Ph.D., is distinguished professor emeritus in the Department of Molecular Genetics and Microbiology at the University of Florida. He also serves as a member of the National Science Advisory Board for Biosecurity, a federal advisory committee that addresses issues related to biosecurity. He has served as a member of the Composite Committee of the United States Medical Licensing Examination, chairman of the Association of American Medical Colleges, president of the Association of Medical School Microbiology and Immunology Chairs, president of the American Society for Virology, president of the American Society for Microbiology and vice president of the International Union of Microbiological Societies. Dr. Berns’ research examines the molecular basis of replication of the human parvovirus and the adeno-associated virus and its ability to establish latent infections and be reactivated. His work has helped provide the basis for use of this virus as a vector for gene therapy. Dr. Berns received his M.D. and Ph.D. in biochemistry from the Johns Hopkins University. He is a member of the National Academy of Sciences and the Institute of Medicine.

Bruce Budowle, Ph.D., is director of the University of North Texas Health Science Center ’s Institute of Applied Genetics and a professor in the Department of Molecular and Medical Genetics. He received a Ph.D. in genetics in 1979 from Virginia Polytechnic Institute and State University. From 1979 to 1982, Dr. Budowle was a postdoctoral fellow at the University of Alabama at Birmingham. Working under a National Cancer Institute fellowship, he carried out research predominately on genetic risk factors for such diseases as insulin-dependent diabetes mellitus, melanoma, and acute lymphocytic leukemia. In 1983, Dr. Budowle joined the research unit at the Federal Bureau of Investigation (FBI) to carry out research, development, and validation of methods for forensic biological analyses. Some of Dr. Budowle’s efforts over the last decade are in counterterrorism, primarily in efforts involving microbial forensics and bioterrorism. Dr. Budowle is heavily involved in the forensic applications of bioterrorism and has been involved in developing the field known as microbial forensics. In this field, Dr. Budowle has been the chair of the FBI’s Scientific Working Group on Microbial Genetics and Forensics, whose mission was to set quality assurance guidelines, develop criteria for biologic and user databases, set criteria for a national repository, and develop forensic

Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

genomic applications. He also has served on the Steering Committee for the Colloquium on Microbial Forensics sponsored by American Society of Microbiology and was the organizer of three Microbial Forensics Meetings held at the Banbury Center in the Cold Spring Harbor Laboratory.

Charles Chiu, M.D., Ph.D., is an associate professor in Laboratory Medicine and Medicine, Infectious Diseases at the University of California, San Francisco (UCSF). He is also the director of UCSF-Abbott Viral Diagnostics and Discovery Center at China Basin and associate director of the UCSF Clinical Microbiology Laboratory. Dr. Chiu is an expert in the emerging field of viral metagenomics, and his research is focused on the development of microarray and deep sequencing technologies for viral pathogen discovery and clinical diagnostics. He is also the principal investigator on an R01 grant from the National Institutes of Health on blood bank pathogen screening, California Discovery, UC-MEXUS, and recipient of National Research Fund for Tickborne Diseases grants on the microbial epidemiology of encephalitis, diarrhea, and Lyme disease, a QB3 Rogers Family Foundation Award in translational diagnostics, and a UCSF-Abbott Viral Discovery Award. Dr. Chiu has more than 30 patents and peer-reviewed publications in scientific journals and ongoing collaborations with research groups and public health agencies worldwide, including Abbott Diagnostics, Inc., Global Viral Forecasting, the U.S. Centers for Disease Control and Prevention, the American Red Cross, and the Texas Biomedical Research Institute.

John M. Hardham, Ph.D., is an associate research fellow and technical director for the Emerging Infectious Disease Program at Zoetis, Inc. (formerly Pfizer Animal Health). Dr. Hardham is also a commander in the U.S. Navy Reserve where he serves as the executive officer for the 4th Marine Medical Battalion. After completion of his postdoctoral fellowship at the University of Texas Medical School in Houston, he became a research scientist for Pfizer, Inc. in 1999. Dr. Hardham has served in a variety of roles in the research and development of vaccines and bio-pharmaceutical products. He accepted a direct commission into the U.S. Naval Reserves as a Lieutenant Junior Grade in 1994. Over the next decade, he served at several naval and fleet hospitals around the country, as environmental health officer and administrative officer, before being mobilized into active duty for the Iraq War in 2003. Dr. Hardham served as the Microbiology Lab director and Preventive Medicine Mobile Medical Augmentation Response Team microbiologist for Navy Environmental Preventative Medicine Unit 6, Pearl Harbor, HI. From 2006 to 2011, Dr. Hardham was assigned to the Office of the Assistant Secretary of Defense for Nuclear and Chemical and Biological Defense Programs,

Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

where he served as the deputy medical director and then medical director. In this role, he directed the Department of Defense Medical Countermeasure Development Program and the Advanced Development and Manufacturing Initiative. He served on numerous committees and advisory roles to the Department of Defense and the Department of Health and Human Services and has made briefings to various House and Senate committees, intelligence community programs, executive office committees, and the National Security Council. Dr. Hardham’s personal military decorations include the Joint Service Commendation Medal (awarded by Secretary of Defense Robert Gates), the Navy Commendation Award, the Navy Achievement Medal (six awards), the National Defense Service Medal, the Armed Forces Reserve Medal (Bronze M), and the Outstanding Volunteer Service Medal. He received a B.S. in microbiology from The Pennsylvania State University, and M.S. and Ph.D. degrees in microbiology from the University of North Carolina, Chapel Hill.

Grace Kubin, Ph.D., is director of the Laboratory Services Section of the Department of State Health Services in Austin, Texas. In this role, she oversees activities of the Lab Operations and Quality Control Units of the South Texas Health branch, and also serves as the Clinical Laboratory Improvement Act director for both the Austin and South Texas laboratories. She previously served as the laboratory operations unit director (2010-2011) and emergency preparedness branch manager (2007-2010) for the Department of State Health Services. She is a member of the Association of Public Health Laboratories’ Public Health Preparedness and Response Committee and has served as a member of the Centers for Disease Control and Prevention/Association of Public Health Laboratories’ Laboratory Efficiencies Initiatives Workgroups on Harmonization of Platforms, 2012; Sharing of Test Services Policy Guide, 2012; and Public Health Laboratory Data Management Tool, 2012, as well as Chair of the Laboratory Response Network National Conference Planning Committee, 2012. Dr. Kubin has received honors including the Emerging Leader award from the Association of Public Health Laboratories (2009) and the Charles E. Sweet award for Excellence in Leadership from the Department of State Health Services (2009). She received her M.A. in microbiology and Ph.D. in biological sciences from the University of Texas at Austin.

M. Allen Northrup, Ph.D., is a principal at the Northrup Consulting Group, and is the founder of Microfluidic Systems and a co-founder of Cepheid. He received his Ph.D. in biomedical engineering from the University of California, Davis. He then spent over 8 years as a researcher at the Lawrence Livermore National Laboratory and the University of California at Berkeley, where he was the first to demonstrate the poly-

Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

merase chain reaction process in a micro-machined silicon chip. He also co-developed microactuators and microactuator materials. Dr. Northrup has 50 issued U.S. and foreign patents, 40 peer-reviewed publications, and is a member of the National Academy of Engineering.

Tom Slezak has been involved with bioinformatics at Lawrence Livermore National Laboratory (LLNL) for 30 years after receiving B.S. and M.S. degrees in computer science from the University of California, Davis. Mr. Slezak is currently the associate program leader for informatics for the Global Security Program efforts at LLNL. He was involved with the Human Genome Program from 1987 to 2000, leading the informatics efforts at LLNL and then the Department of Energy’s Joint Genome Institute from 1997 to 2000. In 2000, he began to build a pathogen bioinformatics team at LLNL, pioneering a novel whole-genome analysis approach to DNA signature design. His team developed signature targets for multiple human pathogens that were used at the 2002 Winter Olympic Games under the BASIS program and later adapted for use nationwide in the Department of Homeland Security (DHS) BioWatch program. Under a close collaboration with the Centers for Disease Control and Prevention, the LLNL team has been called on for computational help on smallpox, SARS, monkeypox, avian influenza, and numerous other pathogens. In addition to continuing work on human and agricultural pathogens, Mr. Slezak’s team is currently focusing on signatures of mechanisms of virulence, antibiotic resistance, and evidence of genetic engineering. They have been focusing on detecting novel, engineered, and advanced biothreats for several years, leveraging high-risk Intelligence Technology Innovation Center and DHS funding. Mr. Slezak has chaired or served on multiple advisory boards, including the rice genome project, mouse and maize genetics databases, spruce tree genome project (Canada), plant pathogens, and a National Institute of Allergy and Infectious Diseases sequencing center contract renewal.

Peter M. Vallone received his Ph.D. in chemistry from the University of Illinois at Chicago in 1999. In 1999 he was awarded a NRC postdoctoral fellowship that brought him to the Biotechnology Division at the National Institute of Standards and Technology (NIST). After completing his postdoctoral work in 2001, Dr. Vallone became a permanent staff scientist at NIST and he is currently the leader of the Applied Genetics group. During the last 14 years, Dr. Vallone has worked on developing multiplex assays for the detection of genetic variation, has developed methods for the rapid amplification of STR loci, and has been involved in the characterization of nucleic acid–based reference materials. Dr. Vallone has also developed various bioinformatic software tools for the design of nucleic acid-based assays (e.g., AutoDimer). Dr. Vallone has published over 40 peer-reviewed articles in the area of DNA thermodynamics and forensic DNA testing.

Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

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Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
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Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
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Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
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Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
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Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 175
Suggested Citation:"Appendix D: Biographies of Committee Members." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
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 BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version
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BioWatch is an air monitoring system deployed in jurisdictions around the country with the goal of detecting the presence of certain high risk pathogenic microorganisms. It relies on a network of federal and nonfederal collaborative relationships to be successful, and is one part of a larger array of disease surveillance, intelligence-gathering, and biomonitoring activities in support of public safety and health. The assays used in the BioWatch system to detect the presence of pathogens in collected samples rely on the technique of polymerase chain reaction (PCR) to sensitively and specifically amplify target nucleic acid sequences.

BioWatch PCR Assays evaluates and provides guidance on appropriate standards for the validation and verification of PCR tests and assays in order to ensure that adequate performance data are available to public health and other key decision makers with a sufficient confidence level to facilitate the public health response to a BioWatch Actionable Response. This report discusses principles of performance standards, reviews information from several existing guidance documents and standards that might be applicable to BioWatch, and discusses assay testing efforts that have occurred or are ongoing. BioWatch PCR Assays provides recommendations on general principles and approaches for a performance standard and validation framework to meet BioWatch's mission. The report also considers how developments in technology, particularly in multiplex PCR and next-generation sequencing, can contribute to the ability of the BioWatch program to meet current and future challenges.

This report has been determined to contain information exempt from disclosure under 5 U.S.C. 552(b). Section 15 of the Federal Advisory Committee Act provides that the National Academies shall make its final report available to the public unless the National Academies determines that the report would disclose matters described in one or more of the exemption provisions under the Freedom of Information Act (FOIA). In such case, the National Academies "shall make public an abbreviated version of the report that does not disclose those matters." This unrestricted, abbreviated version of the report represents, in so far as possible, the committee's findings, recommendations, and other substantive material without disclosing materials described in 5 U.S.C. 552(b).

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