Appendix A

PUBLIC WORKSHOP AGENDA

July 6-7, 2005

National Academy of Sciences Building

2101 C St., NW Washington D.C.

Wednesday, July 6, 2005

8:30 – 9:00 am

Chuck Hobbs, Lovelace Respiratory Research Institute

Charge to the Committee

Goals of the Workshop

9:00 – 9:40 am

Michael Moodie, Chemical and Biological Arms Control Institute

Issues Related to the Biological Weapons Convention

9:40 – 10:20 am

Lew Schrager, FDA

Issues Related to Animal Rule

10:40 – 11:20 am

Charles Plopper, UC Davis

Comparative Anatomy for Various Animal Models

11:20 – 12:00 pm

Joe Mauderly, Lovelace Respiratory Research Institute

Comparative Lung Physiology for Various Animal Models



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Appendix A PUBLIC WORKSHOP AGENDA July 6-7, 2005 National Academy of Sciences Building 2101 C St., NW Washington D.C. Wednesday, July 6, 2005 8:30 – 9:00 am Chuck Hobbs, Lovelace Respiratory Research Institute Charge to the Committee Goals of the Workshop 9:00 – 9:40 am Michael Moodie, Chemical and Biological Arms Control Institute Issues Related to the Biological Weapons Convention 9:40 – 10:20 am Lew Schrager, FDA Issues Related to Animal Rule 10:40 – 11:20 am Charles Plopper, UC Davis Comparative Anatomy for Various Animal Models 11:20 – 12:00 pm Joe Mauderly, Lovelace Respiratory Research Institute Comparative Lung Physiology for Various Animal Models 63

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64 DEVELOPING COUNTERMEASURES AGAINST AEROSOLIZED AGENTS 1:00 – 1:40 pm Leah Scott, DSTL, Porton Down, UK Making Biodefense Products Happen: Emerging models 1:40 – 2:20 pm Gareth Griffiths, DSTL, Porton Down, UK Making Biodefense Products Happen: Correlates of protection 2:20 – 3:00 pm Victor DeGruttola, Harvard University Statistical Issues in Validating Surrogate Endpoints in Clinical Trials 3:10 – 3:50 pm Eric Harvill, Pennsylvania State University Pathogenesis of Bordetella 3:50 – 4:30 pm Maryna Eichelberger, Virion Systems, Inc. Pathogenesis of Respiratory Viruses 4:30 – 5:30 pm Panel Discussion Thursday, July 7, 2005 8:30 – 8:35 am Jack Harkema (committee member), Michigan State University Review of Day 1 and Overview of Day 2 8:35 – 9:15 am Mark Hernandez, University of Colorado Characterizing Microorganisms in Aerosols 9:15 – 9:55 am Brian Wong, CIIT Considerations in the Generation and Characterization of Bioaerosols 9:55 – 10:35 am Beth Hutchins, Schering Plough Biopharma Standardizing Agent Characteristics between Labs: The adenovirus reference material model 10:45 – 11:25 am Chad Roy, USAMRIID Inhalation Exposure Systems 11:25 – 12:05 pm Mike Foster, Duke University Routes of Exposure for Bioaerosols 12:40 – 1:20 pm Louise Pitt, USAMRIID Biology of Appropriate Dose in Animals vs. Humans

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65 APPENDIX A 1:20 – 2:00 pm Chris Gennings, Virginia Commonwealth University Experimental Design and Statistical Approaches to Dose- response 2:00 – 2:40 pm Richard Corley, Pacific Northwest National Laboratory Modeling/imaging of Airways 2:40 – 3:20 pm Robert Phalen, University of California, Irvine Particle-deposition Patterns 3:20 – 4:00 pm Panel Discussion Adjourn

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66 DEVELOPING COUNTERMEASURES AGAINST AEROSOLIZED AGENTS BIOGRAPHICAL INFORMATION ABOUT THE SPEAKERS Richard A. Corley, a Staff Scientist for Biological Monitoring and Modeling in the Environmental Technology Directorate of the Pacific Northwest National Laboratory, received his Ph.D. in environmental toxicology from the University of Illinois in 1985. Prior to joining PNNL in 1996, he spent 11 years at the Dow Chemical Company’s Toxicology Research Laboratory. While at Dow, he functioned as the Technical Group Leader of the chronic toxicology laboratory and inhalation toxicology laboratory and served as a toxicology advisor for several industrial research organizations. Dr. Corley’s general research interests are the development of physiologically based pharmacokinetic and pharmacodynamic models of environmental/industrial chemicals and these models’ applications in human health risk assessment. Current research activities include: the development of three-dimensional computational fluid- dynamics models of the respiratory system for gas, vapor, and particulate dose- response realtionships; kinetics and mechanisms of action of industrial chemicals; dermal and respiratory bioavailability of volatile organics; and development of models for embryo/fetal dosimetry. Dr. Corley has served on numerous workshops or advisory panels for the National Academy of Sciences, National Institutes of Health, Environmental Protection Agency, American Chemistry Council, Agency for Toxic Substances and Disease Registry, and International Life Sciences Institute, and he has written over 160 peer-reviewed publications, book chapters, technical reports, and published abstracts in pharmacokinetic modeling and toxicology. Victor DeGruttola is Professor of Biostatistics at the Harvard School of Public Health. His research activities focus on the development of statistical methods required for appropriate public health response to the AIDS epidemic, and he has worked in particular on transmission of the human immunodeficiency virus (HIV), natural history of infection with HIV, and clinical research on AIDS therapies. These efforts involve not only statistical methodology but also public health surveillance systems, medical issues surrounding HIV infection, and concerns of communities most affected by the epidemic; and their goals include forecasting future AIDS incidence, developing strategies for clinical research on HIV infection, and evaluating the public health impact of antiviral treatment. The statistical issues in which Dr. DeGruttola has been engaged include evaluating the degree to which the treatment response of markers of HIV infection constitute adequate evidence for clinical efficacy; and he has also worked on projections of AIDS incidence using data from the New York City Department of Health. A special focus of this activity was estimation, using data combined from a variety of sources, of the risk that children of HIV-infected mothers would develop AIDS in the first 10 years of life.

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67 APPENDIX A Maryna Eichelberger of Virion Systems, Inc. (Rockville, Md.) uses the cotton rat as animal model to study respiratory viral pathogenesis and immunity. She is also an adjunct assistant professor in the Department of Microbiology and Immunology at the Uniformed Services University in Bethesda, Md. Dr. Eichelberger received her B.Sc. and M.Sc. degrees from the University of Natal, Republic of South Africa, and her Ph.D. from the University of Alabama at Birmingham. There she studied the structure and function of influenza virus neuraminidase in the laboratory of Gillian Air, and she continued her interest in viral immunity as a postdoctoral fellow with Peter Doherty at St. Jude Children’s Research Hospital in Memphis, Tenn. Dr. Eichelberger was an assistant professor in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health before taking a position in the biotech industry. Her primary interests are in the development of vaccines to prevent—and therapeutic agents to treat—diseases caused by respiratory viral pathogens. W. Michael Foster, a Research Professor of Medicine in the Division of Pulmonary and Critical Care Medicine at Duke University Medical Center, received his Ph.D. in physiology from New York University. Dr. Foster’s laboratory performs research on humans and animal models and investigates the biological effects of inhalational hazards (particulate and gases) on airway and parenchymal lung tissues. These efforts focus on barrier function of the respiratory epithelial membrane—the primary location at which inhaled gases and particulate initially impinge upon lung tissue. Imaging and exposure techniques developed for human study have also been integrated with initiatives that utilize lab models. Dr. Foster’s specific areas of interest and expertise include: (1) in vivo tissue response of the lung (human and animal model) using inhalation of inert, sterile, radiolabeled test particles and noninvasive radioimaging techniques—an approach essential to characterizing the epithelial barrier system of the airway surface; and (2) effects of oxidant-type air pollution (e.g., ozone at ambient urban concentrations) on lung epithelial membrane physiology. Chris Gennings is a Professor in the Department of Biostatistics at Virginia Commonwealth University (Richmond, Va.) and a founding Principal in Solveritas, LLC, a company focusing on analysis/assessment of chemical mixtures. She has been working on statistical issues associated with chemical mixtures for almost 20 years, with funding sources that include the U.S. Army Medical Research Institute of Chemical Defense, Health Effects Institute, Environmental Protection Agency, National Institutes of Health, and World Health Organization. Dr. Gennings is the Principal Investigator on a training grant from the National Institute of Environmental Health Sciences, titled “The Integration of Chemical Mixtures Toxicology and Statistics,” that fully supports five doctoral students in her department who are developing statistical methods

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68 DEVELOPING COUNTERMEASURES AGAINST AEROSOLIZED AGENTS associated with mixtures issues. Her research goals include bridging the gap between statistical methods development and their applications and use in real world problems. Eric Harvill is an Assistant Professor of Microbiology and Infectious Disease at Pennsylvania State University. His primary research interest is in the interactions between bacterial pathogens and the host immune system, and his group investigates the molecular bases for bacterial virulence factors and host immune functions using the tools both of bacterial genetics and mouse molecular immunology. They focus on bordetella bacteria, which are highly infectious, cause a range of respiratory diseases, and persist for the life of the animal despite an active immune response. These characteristics are indicative of a highly evolved bacterium-host interaction. Dr. Harvill has studied basic immunology since earning his Ph.D. at the University of California, Los Angeles. Mark Hernandez is Associate Professor of Environmental Engineering at the University of Colorado, Boulder. His research interfaces classical industrial hygiene and sanitary engineering with recent advances in molecular biology to study airborne primary biological materials and the microbial ecology of aerosols under in situ conditions. Dr. Hernandez teaches courses on introductory environmental engineering, wastewater engineering, and applied environmental microbiology. Beth Hutchins is Director of Process Sciences at Schering Plough Biopharma (formerly Canji, Inc., and DNAX Research Institute). SP Biopharma is Schering Plough’s center of excellence for discovery research and early development of biologics, including gene therapy, monoclonal antibodies, and recombinant proteins. Dr. Hutchins received her Ph.D. in molecular biology from Washington University in St. Louis in 1982 and was a postdoctoral fellow at Stanford University, where she studied xenotransplantation of islets for diabetes. Dr. Hutchins then worked for Syva Company (the diagnostic arm of Syntex Corp.) for five years prior to moving to Genentech in 1988. There she was responsible for immunochemistry-based analytical methods for recombinant protein development; her primary contributions were the methods supporting development of Herceptin®. Dr. Hutchins joined Canji, Inc., in San Diego in 1993 as Director of Quality and Analytical Sciences, responsible for setting up the Quality Assurance Unit and developing analytical-methods support for product candidates. Today, as part of SP Biopharma, her department is responsible for production and characterization of preclinical materials, preclinical sample analyses, and development of process and analytical methods to support new-product candidates and characterize research reagents. Joe L. Mauderly is Vice President of the Lovelace Respiratory Research Institute (LRRI) in Albuquerque, N.M.; President of one of its subsidiaries, the

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69 APPENDIX A Lovelace Biomedical and Environmental Research Institute; and Director of one of its research programs, the National Environmental Respiratory Center. He was Director of the Inhalation Toxicology Research Institute before its merger with LRRI. After receiving his Doctor of Veterinary Medicine degree from Kansas State University and brief periods in clinical practice and the U.S. Air Force, Dr. Mauderly specialized in research on comparative respiratory physiology, comparative pulmonary responses to inhaled toxicants, and the human health hazards of materials inhaled in the workplace and environment. During the past decade his research has focused on disentangling the physical- chemical interactions of complex mixtures of air contaminants, including engine emissions, that cause health effects. He has authored or co-authored over 250 articles, chapters, and books, and published technical reports. Dr. Mauderly is on the editorial boards of Inhalation Toxicology, Experimental Lung Research, and Environmental Health Perspectives. He is a member of the Particulate Matter Panel of the Clean Air Scientific Advisory Committee and the National Research Council’s (NRC) Committee on Changes in New Source Review Programs for Stationary Sources of Air Pollutants. He also serves on the advisory committees of several research centers and programs. Dr. Mauderly is an Adjunct Professor of Medicine at the University of New Mexico and a member of the joint LRRI/UNM NIEHS Environmental Health Center’s Environmental Lung Disease Research Core and Internal Advisory Committee. Among his past appointments, he was Chairman of the Clean Air Scientific Advisory Committee of the EPA Science Advisory Board, Chairman of the NRC Committee to review the NARSTO review of particulate matter science, member of the NRC Committee on Research Priorities for Airborne Particulate Matter, Chairman of the Environmental and Occupational Health Assembly of the American Thoracic Society, President of the Inhalation Specialty Section of the Society of Toxicology, member of the Research Committee of the Health Effects Institute, Chairman of the Air Pollution Health Advisory Committee of the Electric Power Research Institute, and Associate Editor of Fundamental and Applied Toxicology. Michael Moodie is co-founder and President of the Chemical and Biological Arms Control Institute. In this capacity, he is responsible for all aspects of the Institute’s activities, including oversight of programs, design and implementation of projects, outreach, administration, and publications. In government, Mr. Moodie served from 1990 to 1993 as Assistant Director for Multilateral Affairs at the U.S. Arms Control and Disarmament Agency (ACDA), where he was responsible for, among other issues, chemical and biological arms control. He has also served as Special Assistant to the Ambassador and Assistant for Special Projects at the U.S. Mission to NATO. In the policy research community, Mr. Moodie has held senior research positions at the Foreign Policy Research Institute, the Institute for Foreign Policy Analysis, and the Center for Strategic and International Studies, where he was also Senior Advisor to the President. He has been a Visiting Lecturer at Georgetown

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70 DEVELOPING COUNTERMEASURES AGAINST AEROSOLIZED AGENTS University’s School of Foreign Service and a consultant to the President’s Foreign Advisory Board, the U.S. Navy, and ACDA. Robert Franklynn Phalen directs the Air Pollution Health Effects Laboratory at the University of California, Irvine (UCI). He also holds two academic appointments in the School of Medicine at UCI: Professor in the Department of Community and Environmental Medicine; and Professor in the Center for Occupational and Environmental Health. His research is in several areas, including: lung modeling for predicting doses from inhaled particles; lung morphometry for growing mammals; health effects of inhaled air pollutants; and applied aerosol physics. In 1971, he obtained a Ph.D. in biophysics, with specialization in inhalation toxicology, from the University of Rochester. His postdoctoral research in aerosol physics and inhaled-particle deposition modeling was conducted at the Inhalation Toxicology Research Institute (now the Lovelace Respiratory Research Institute) in Albuquerque, N.M. In 1972, Dr. Phalen joined the College of Medicine at UCI to establish the Air Pollution Health Effects Laboratory, which conducts studies relating to the toxicology of air pollutants. He has served on the editorial boards of three scientific journals and as an editor of one. He has published over 100 scientific papers, authored a book titled Inhalation Studies: Foundations and Techniques (CRC Press, 1984), edited another book on a similar topic (CRC Press, 1996), and authored The Particulate Air Pollution Controversy (Kluwer Academic Publishers, 2002). Dr. Phalen has organized four major international scientific conferences on the health effects of particulate air pollution. He recently received the Public Education Award from the California Biomedical Research Association and the Career Achievement Award from the Inhalation Specialty Section of the Society of Toxicology. He is a Fellow of the Academy of Toxicological Sciences. Louise Pitt is Director of the Center for Aerobiological Sciences at the U.S. Army Medical Research Institute of Infectious Diseases. She earned her Ph.D. from the University of Witwatersrand, South Africa. Charles Plopper is Professor of Anatomy, Physiology, and Cell Biology at the University of California, Davis. The goal of his research is to identify and characterize the cellular mechanisms that define the response of the respiratory system to environmental toxicants. Research efforts have defined the subpopulations of pulmonary cell phenotypes that are susceptible to specific model compounds, and the laboratory work has been carried out on a microenvironment-specific basis that clearly defines the heterogeneity in the response of different subpopulations of each cellular phenotype to short-term exposure. Two related research projects investigate postnatal development of the respiratory system (specifically the Clara cells) and the development of an investigative strategy that will allow characterization of cellular and metabolic processes involved in cell-specific lung toxicity in situ in local environments.

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71 APPENDIX A Chad Roy is in the Center for Aerobiological Sciences at the U.S. Army Medical Research Institute of Infectious Diseases. He earned his Ph.D. in inhalation toxicology from the University of Iowa in 1999. Lewis K. Schrager is a Lead Medical Officer in the Division of Counterterrorism, within the Office of Counterterrorism and Pediatric Drug Development of the FDA’s Center for Drug Evaluation and Research. He oversees a research portfolio that includes support for: studies of antibiotic efficacy against pneumonic plague in an African green monkey model, in collaboration with the U.S. Army Research Institute of Infectious Diseases and the National Institute of Allergy and Infectious Diseases (NIAID); and studies of gentamicin efficacy against naturally occurring human plague, in collaboration with the Centers for Disease Control and Prevention. Dr. Schrager is a board- certified internist and infectious-disease specialist. Prior to joining the FDA he served for nearly 10 years with NIAID’s Division of AIDS. He received his B.A. from Johns Hopkins University and his M.D. degree from Vanderbilt University Medical School. Dr. Schrager served as a resident in internal medicine at the University Hospital/Bellevue Medical Center in New York City; and he was an infectious-disease fellow at the Harvard University Joint Fellowship in Infectious Diseases and at the Albert Einstein College of Medicine/Montefiore Medical Center. Leah Scott is in the Biomedical Sciences Department at the Defence Science and Technology Laboratory at Porton Down, United Kingdom. She was awarded the GlaxoSmithKline laboratory animal welfare prize for developing and championing remote monitoring of laboratory animals, particularly primates. Brian Wong is Senior Research Investigator in the Division of Biological Sciences and a Supervisor of Inhalation Services at the CIIT Centers for Health Research (CHR). His research in inhalation toxicology has included: development of specialized equipment for conducting inhalation studies; and programming for the automation of exposure control and data collection. He has a special interest in the application of aerosol-science technology to study the deposition and retention of aerosols in the respiratory tract, especially to validate mathematical models under development at the CIIT CHR. He earned his Ph.D. in environmental engineering science from the California Institute of Technology.