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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary Appendix D Biographic Information on the Speakers and Panelists for a Symposium on Toxicity-Pathway-Based Risk Assessment SPEAKER BIOGRAPHIES Tina Bahadori is the managing director for the Long-Range Research Initiative (LRI) program of the American Chemistry Council. She is responsible for the direction of the LRI, which sponsors a multimillion-dollar independent research program that advances the science of risk assessment of the health and ecologic effects of chemicals to support decision-making by government, industry, and the public. Dr. Bahadori was instrumental in developing the LRI’s strategic plan and shaping its global initiatives through the International Council of Chemical Associations. Dr. Bahadori is the president (2009-2010) of the International Society of Exposure Science. She is an associate editor of the Journal of Exposure Science and Environmental Epidemiology. She has served as a member of several committees of the National Academies; as a peer reviewer for the U.S. Environmental Protection Agency’s STAR grants; as a member of the Advisory Panel for the Aerosol Research Inhalation Epidemiology Study; and as a member of the internal steering committee and one of the principal investigators for the St. Louis-Midwest Particulate Matter Supersite. She was also a member of the Chemical Exposure Working Group on the National Children’s Study. She received her doctorate in environmental science and engineering from the Harvard School of Public Health. Kim Boekelheide is professor of medical sciences in the Department of Pathology and Laboratory Medicine of Brown University and director of the university’s Superfund Basic Research Program. His research examines fundamental molecular mechanisms by which environmental and occupational toxicants induce tes-
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary ticular injury. Current projects include the study of co-exposure synergy using model testicular toxicants and of the effects of in utero endocrine-disruptor exposure on steroidogenesis and a predisposition to cancer. Dr. Boekelheide serves on the National Research Council Standing Committee on Use of Emerging Science for Environmental Health Decisions and previously served on the Committee on Toxicity Testing and Assessment of Environmental Agents (which produced Toxicity Testing in the 21st Century), the Subcommittee on Fluoride in Drinking Water, and the Committee on Gender Differences in Susceptibility to Environmental Factors: A Priority Assessment. He is a councilor of the Society of Toxicology and a past member of the Board of Scientific Counselors of the National Toxicology Program (NTP) and has been a member of various expert panels (such as those on bisphenol A, phthalates, and bromopropanes) of the NTP Center for the Evaluation of Risks to Human Reproduction. Dr. Boekelheide received his MD and his PhD in pathology from Duke University and is board-certified in anatomic and clinical pathology. John Bucher is associate director of the National Toxicology Program (NTP) of the National Institutes of Health’s National Institute of Environmental Health Sciences. His research interests include characterization of the toxic and carcinogenic potential of a variety of chemicals, mixtures, and physical agents of interest to the NTP, and issues related to the improvement of research tools and assays. As associate director of the NTP, Dr. Bucher is responsible for oversight of the NTP toxicology and carcinogenesis studies, of the NTP Report on Carcinogens, and of the NTP Center for the Evaluation of Risks to Human Reproduction and for administrative support for the Alternative Animal Assay Validation Program of the Interagency Coordinating Committee on the Validation of Alternative Methods. Newer efforts include the development of initiatives that examine the genetic basis of variations in response to environmental agents and implementation of new tools for toxicity testing as outlined in the NTP vision and roadmap for the future. Dr. Bucher earned a PhD in pharmacology from the University of Iowa and is a diplomate of the American Board of Toxicology. George Daston is a Victor Mills Society Research Fellow at Procter & Gamble Company. He is also an adjunct professor in the Department of Pediatrics and the Developmental Biology Program of the University of Cincinnati. Dr. Daston’s current research efforts are in toxicogenomics and mechanistic toxicology, particularly in addressing how findings in these fields can improve risk assessment of chemicals. He has published over 100 peer-reviewed articles, reviews, and book chapters and has edited three books. His professional activities include serving as president of the Teratology Society, as a councilor of the Society of Toxicology, as a member of the U.S. Environmental Protection Agency (EPA) Board of Scientific Counselors, and as a member of the National Toxicology Program Board of Scientific Councilors. He is a member of the National Research Council (NRC) Standing Committee on Use of Emerging Science for Environmental Health Decisions and has served as a member of the Committee on Developmental Toxicology, the
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary Subcommittee on Arsenic in Drinking Water, the Committee on Research Opportunities and Priorities for EPA, and the Board on Environmental Studies and Toxicology. Dr. Daston is editor of Birth Defects Research: Developmental and Reproductive Toxicology. He has been awarded the Josef Warkany Lectureship by the Teratology Society and the George H. Scott Award by the Toxicology Forum and was elected a fellow of the American Association for the Advancement of Science. Dr. Daston received his PhD from the University of Miami and postdoctoral training at EPA’s laboratories in Research Triangle Park, NC. E. Donald Elliott is an adjunct professor of law at Yale Law School and Georgetown Law Center, where he teaches a course comparing chemical regulation in the United States and the European Union. He has taught environmental law, administrative law, and law and science, and he is the author of over 60 articles. As a practicing lawyer, Mr. Elliott heads the Environment, Health and Safety Department of Willkie Farr & Gallagher LLP and is a partner in its Washington, DC, office. Formerly, Mr. Elliott was assistant administrator and general counsel for the U.S. Environmental Protection Agency (EPA), and he has served as a consultant in improving the relationship of law and science for the Federal Courts Study Committee and the Carnegie Commission for Law, Science, and Government. He has cochaired the National Environmental Policy Institute’s Committee on Improving Science at EPA, he is a member of the National Research Council’s Board on Environmental Studies and Toxicology, and he serves on the boards of the Environmental Law Institute and the Center for Clean Air Policy. Mr. Elliott earned his JD from Yale University. Elaine M. Faustman is a professor of environmental and occupational health sciences at the University of Washington School of Public Health and Community Medicine and directs the Institute for Risk Analysis and Risk Communication. Her research interests include understanding mechanisms of developmental and reproductive toxicants, characterizing in vitro techniques for developmental-toxicology assessment, and developing biologically based dose-response models for noncancer risk assessment. Her research expertise includes the development of tools for incorporating new scientific findings into risk-assessment decisions. Dr. Faustman is an elected fellow of the American Association for the Advancement of Science and of the Society for Risk Analysis. She has also been involved in several National Research Council committees, including the Committee on Spacecraft Exposure Guidelines, the Committee on Developmental Toxicology, and the Committee on Toxicology. Dr. Faustman received a PhD in toxicology from Michigan State University. Albert J. Fornace, Jr, is a professor in the Department of Biochemistry and Molecular and Cellular Biology, a professor in the Department of Oncology, and chair of molecular cancer research at the Lombardi Comprehensive Cancer Center of Georgetown University. He is also an adjunct professor at the Harvard School of Public Health. His research investigates the complex pathways in-
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary volved in cellular responses to environmental stressors and the detection of markers in gene expression and metabolites that could be used to detect exposure easily. Previously, he held positions in laboratories at the National Cancer Institute, including stints as an expert consultant, a senior investigator, and an acting chief. Dr. Fornace earned his MD from Jefferson Medical College. Lynn R. Goldman, a pediatrician and an epidemiologist, is a professor at the Johns Hopkins University Bloomberg School of Public Health, where her areas of focus are environmental health policy, public-health practice, and children’s environmental health. Dr. Goldman previously served as the assistant administrator for the U.S. Environmental Protection Agency (EPA) Office of Prevention, Pesticides and Toxic Substances. During her tenure at EPA, Dr. Goldman was responsible for the nation’s pesticide, toxic substances, and pollution prevention laws, and she was successful in promoting children’s health issues and furthering the international agenda for global chemical safety. Prior to joining EPA, Dr. Goldman served in several positions in the California Department of Health Services, most recently as head of the Division of Environmental and Occupational Disease Control. She has served on numerous boards and expert committees, including the Committee on Environmental Health of the American Academy of Pediatrics and the Centers for Disease Control and Prevention Advisory Committee on Childhood Lead Poisoning Prevention. She has served as a member of numerous National Research Council (NRC) committees, including the Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, the Committee on Clinical Trial Registries, and the Committee to Evaluate the Hazardous Materials Management Program of the Bureau of Land Management. She currently is vice chair of the Institute of Medicine (IOM) Roundtable on Environmental Health Sciences, chair of the IOM Committee on Secondhand Smoke Exposure and Acute Coronary Events, and a member of the NRC Standing Committee on Risk Analysis Issues and Reviews. Dr. Goldman received her MD from the University of California, San Francisco. Bernard D. Goldstein is dean of the University of Pittsburgh Graduate School of Public Health. Previously, he served as the director of the Environmental and Occupational Health Sciences Institute, a joint program of Rutgers, the State University of New Jersey, and the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School. He was also principal investigator for the Consortium of Risk Evaluation with Stakeholder Participation. Dr. Goldstein was assistant administrator for research and development in the U.S. Environmental Protection Agency (EPA) in 1983-1985. His past activities include serving as a member and chair of the National Institutes of Health Toxicology Study Section and EPA’s Clear Air Scientific Advisory Committee. He has also served on numerous National Research Council and Institute of Medicine (IOM) committees, including being chair of the Committee on the Role of the Physician in Occupational and Environmental Medicine, the Committee on Biomarkers in Environ-
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary mental Health Research, and the Committee on Risk Assessment Methodology. He chairs the Committee to Review the NIOSH Hearing Loss Research Program. Dr. Goldstein is a member of IOM and chaired its Section on Public Health, Biostatistics, and Epidemiology. He is a member and past president of the Society for Risk Analysis. He is a member and fellow of the American College of Environmental and Occupational Medicine (whose Robert A. Kehoe Award of Merit he has received) and a member of the Collegium Ramazzini, the Society for Occupational and Environmental Health, the Society of Toxicology, and the American Public Health Association. Dr. Goldstein earned an MD from New York University. Federico Goodsaid is associate director for operations in genomics at the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA). In this role, he works on the regulatory application and development of genomics and biomarkers. Previously, he was a senior staff scientist of applied biosystems and lead for the Molecular Toxicology Group at Schering-Plough Research Institute, where his collaboration with FDA led to one of the first genomic-data submissions to FDA. He was also director of assay and development at the Fluidigm Corporation, a microfluidics company based in San Francisco, CA. Dr. Goodsaid earned a PhD in molecular biophysics and biochemistry from Yale University and was a postdoctoral fellow at Cornell University and Washington University in St. Louis. John Groopman is a professor of oncology, Anna M. Baetjer Professor of Environmental Health, and director of the National Institute of Environmental Health Sciences Center in Urban Environmental Health at Johns Hopkins University. His research involves the development and application of molecular biomarkers of exposure to, dose of, and effect of environmental carcinogens and focuses on the translation of mechanistic research to public health on the basis of prevention strategies. Dr. Groopman has earned several honors, including the National Cancer Institute Research Career Development Award and membership in the Delta Omega Honor Society in Public Health and Phi Beta Kappa. He has served as a member of the National Research Council Committee on How Toxicogenomics Could Inform Critical Issues in Carcinogenic Risk Assessment of Environmental Chemicals, the Standing Committee on Emerging Issues and Data on Environmental Contaminants, and the Panel on Life Sciences. Dr. Groopman received a PhD in toxicology from the Massachusetts Institute of Technology. John Groten is vice president of the Drug Safety Organization in Europe for Schering Plough, where he is responsible for providing toxicology support for pharmaceuticals during the discovery, preclinical, and full-development stages. He is also a part-time professor and chair of combination toxicology at Wageningen University, the Netherlands. Earlier, Dr. Groten was executive director of the Business Unit of BioSciences at TNO Quality of Life, an independent contract research and technology organization founded in the Netherlands. Throughout his
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary career, Dr. Groten has headed several toxicology and life-science departments and has completed business training to handle financial and general managerial work related to research and development efficiently. He has participated in many international scientific and regulatory committees on the safety assessment of chemical mixtures, and he has published over 100 papers in scientific journals and books on combination toxicology. Dr. Groten earned a PhD in toxicology from Wageningen University and is a certified toxicologist (the Netherlands and Eurotox). Thomas Hartung is director of the Center for Alternatives to Animal Testing (CAAT) and the Doerenkamp-Zbinden Chair for Evidence-Based Toxicology in the Department of Environmental Health Sciences of the Johns Hopkins School of Public Health. His career began on the faculty of the University of Konstanz, Germany, where he was an assistant professor of biochemical pharmacology and an associate and later full professor of pharmacology and toxicology. He also served as the CEO of the Steinbeis Technology Transfer Center for In Vitro Pharmacology and Toxicology. Before his position at CAAT, Dr. Hartung was the head of the European Centre for the Validation of Alternative Methods (ECVAM) at the European Commission Joint Research Centre in Italy. As head of ECVAM, he was integral in accelerating the alternative-methods validation process and in enabling a network of more than 400 experts in all stakeholder groups to facilitate global regulatory harmonization in toxicity testing. Dr. Hartung received a PhD in biochemical pharmacology from the University of Konstanz and an MD in toxicology from the University of Tubingen, Germany. Robert Kavlock is director of the National Center for Computational Toxicology in the Office of Research and Development (ORD) of the U.S. Environmental Protection Agency (EPA). During his 24 years at EPA, he has served as special assistant (computational toxicology) to the director of the National Health and Environmental Effects Research Laboratory (NHEERL); as acting associate director for health, NHEERL; as director of the Reproductive Toxicology Division, NHEERL; as chief of the Perinatal Toxicology Branch; and as research biologist of the Perinatal Toxicology Branch. Dr. Kavlock is a member of the Society of Toxicology and the Teratology Society. He has served on the editorial boards of Toxicological Sciences and Teratogenesis, Carcinogenesis and Mutagenesis, and he now serves on the editorial boards of the Journal of Toxicology and Environmental Health, Part B; the Journal of Children’s Health; Birth Defects Research, Part B; and Neurotoxicity and Teratology. Dr. Kavlock has been the recipient of numerous honors and awards, most recently being named the EPA/ORD Statesman of the Year and receiving the EPA Bronze Medal. He is an active participant in expert committees, advisory panels, and organizing committees, such as the National Institute of Environmental Health Sciences Superfund Basic Research Program Peer Review Panel, the EPA Science Forum on Computational Toxicology, and the OECD Molecular Screening Initiative Working Group. Dr. Kavlock earned a PhD in embryology from the University of Miami.
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary Gregory Kedderis is an independent researcher and consultant in biochemistry, pharmacology, and toxicology in Chapel Hill, NC. He is also an adjunct associate professor in the Nicholas School of the Environment and Earth Sciences and in the Integrated Toxicology and Environmental Health Program of Duke University. His research interests include the relationship between chemical dosimetry and biologic effects, mechanisms of toxicity of drugs and xenobiotics, and mechanisms of genotoxicity and chemical carcinogenesis. Before his independent consultancy, he held positions as director of the Chemical Carcinogenesis Research Program and director of the Division of Biochemistry and Molecular Genetics at the Chemical Industry Institute of Toxicology (now Hamner Institutes for Health Sciences). Dr. Kedderis is author or coauthor of over 70 publications. He has served on a number of national and international committees and workshops sponsored by the International Life Sciences Institute, the European Centre for Validation of Alternative Methods, and other organizations. He has served on the editorial boards of Drug Metabolism and Disposition and the Journal of Pharmacology and Experimental Therapeutics, and he was reviews editor for Chemico-Biological Interactions. He is a member of the Society of Toxicology and of the Chemical Substances Threshold Limit Values Committee of the American Conference of Governmental Industrial Hygienists. Dr. Kedderis earned a PhD in biochemistry from Northwestern University Medical and Dental School. George D. Leikauf is a professor in the Department of Environmental and Occupational Health of the University of Pittsburgh. His research investigates the functional genomics of acute lung injury, asthma, and chronic obstructive pulmonary disease. He is interested in uncovering the genetic basis of increased susceptibility to pulmonary epithelial injury and repair and in examining the transcriptional regulation of molecular targets. Dr. Leikauf has served on numerous national and international committees, including the National Institutes of Health’s National Advisory Environmental Health Sciences Council and Center for Scientific Review Advisory Committee, the American Physiological Society’s Perkins Memorial Fund Committee, the American Thoracic Society’s Program Committee, and the International Advisory Committee for the 8th and 9th Inhalation Symposiums. He has also served as a member of the National Research Council Committee on Applications of Toxicogenomics Technologies to Predictive Toxicology. Dr. Leikauf received a PhD in environmental health sciences from the New York University Medical Center. Warren Muir is executive director of the Division on Earth and Life Studies of the National Academies. He was founder and president of the Hampshire Research Institute, director of the Office of Toxic Substances of the U.S. Environmental Protection Agency, and senior staff member of the Council on Environmental Quality in the Executive Office of the President. Dr. Muir holds master’s and doctoral degrees in chemistry from Northwestern University and did post-doctoral study in epidemiology at the Johns Hopkins University.
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary William Pennie is the executive director of compound safety prediction at Pfizer Global Research and Development, Groton, CN. After fellowships at the National Institutes of Health, Dr. Pennie started his industrial career at the Central Toxicology Laboratories of Zeneca in Macclesfield, England, working primarily on estrogen-receptor selectivity, receptor-mediated transcription, microarray technologies, mechanistic toxicology, and novel predictive toxicology approaches to help in compound selection. Since joining Pfizer in 2002, Dr. Pennie has led the Molecular and Investigative Toxicology Group and was the research site lead for drug safety research and development in Groton. Most recently, he has built, and leads, a new group in Pfizer Global Research that aims to develop mechanistic understanding of toxicity further, to build predictive models for toxicity mechanisms, and to integrate them into early design cycles of medicinal chemistry. Dr. Pennie received his PhD from the Beatson Institute for Cancer Research (Glasgow University). Peter Preuss is director of the National Center for Environmental Assessment (NCEA) at the U.S. Environmental Protection Agency (EPA), where his role is to oversee all major activities in NCEA and to pursue innovative approaches to risk assessment. His expertise is in risk assessment and its applications, science policy and law, and the use of comparative risk assessment as a tool in setting environmental priorities domestically and internationally. Dr. Preuss has been a director at EPA since 1988; before then, he was the associate executive director for health sciences at the U.S. Consumer Product Safety Commission and director of the New Jersey Department of Environmental Protection. Dr. Preuss earned a PhD in biology from Columbia University. Alvaro Puga is a professor of molecular biology and environmental health at the University of Cincinnati, deputy director of the National Institute of Environmental Health Sciences Center for Environmental Genetics, and associate director of the Superfund Basic Research Program at the University of Cincinnati Medical Center. His laboratory investigates the response of individuals and populations to toxic or carcinogenic environmental agents. The long-term objective of that work is to elucidate the molecular mechanisms that underlie the response. Before his work at the University of Cincinnati, Dr. Puga served for 15 years in several capacities at the National Institutes of Health in the Institute of Dental Research and the Institute of Child Health and Human Development. Dr. Puga is the recipient of the Society of Toxicology Lectureship Award and the University of Cincinnati College of Medicine Richard Akeson Award for Excellence in Teaching. He has participated in numerous national and international committees, including serving as a member of the National Research Council Committee on EPA’s Exposure and Human Health Reassessment of TCDD and Related Compounds and the Institute of Medicine Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. Dr. Puga earned a PhD in molecular biology and biophysics from Purdue University.
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary Kenneth Ramos is a professor of biochemistry and molecular biology in the University of Louisville Health Sciences Center, director of the Center for Genetics and Molecular Medicine, and director of the National Institute of Environmental Health Sciences Center for Environmental Genomics and Integrative Biology. His research on molecular mechanisms of environmental pathogenesis focuses on the molecular biology of L1 retroelements, inference of genetic regulatory networks, and developmental basis of environmental disease. Dr. Ramos has served on numerous National Research Council committees, including being a member of the Committee for a Review of Evidence Regarding the Link Between Exposure to Agent Orange and Diabetes, a member of the Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides for the first and second biennial updates, and chair of the Standing Committee on Emerging Issues and Data on Environmental Contaminants. Dr. Ramos earned a PhD in biochemical pharmacology at the University of Texas at Austin. Lorenz Rhomberg is a principal with Gradient Corporation, an environmental-sciences consulting firm. He is an expert in quantitative risk assessment, including dose-response analysis, pharmacokinetic modeling, and probabilistic methods, with special expertise in chlorinated solvents. His focus includes science policy and methodology for human health risk assessment, including approaches to weight of toxicologic evidence for human hazard and cross-species extrapolation. Before joining Gradient, Dr. Rhomberg was on the faculty of the Harvard School of Public Health and worked at the U.S. Environmental Protection Agency. Dr. Rhomberg is active in professional groups and environmental policy development, focusing on current issues in the interpretation of toxicologic data in human health risk assessment through service on panels sponsored by government, industry, and such organizations as the International Life Sciences Institute. He has served on several National Research Council committees, including the Committee on Assuring the Safety of the Defense Department’s Mail, the Committee on Testing and Evaluation of Standoff Chemical Agent Detectors, and the Subcommittee on Manufactured Vitreous Fibers, and he is currently a member of the Standing Committee on Risk Analysis Issues and Reviews. Dr. Rhomberg earned his PhD in population biology from the State University of New York at Stony Brook. Ivan Rusyn is an associate professor with tenure in the Department of Environmental Sciences and Engineering of the School of Public Health of the University of North Carolina (UNC) at Chapel Hill. He directs the Laboratory of Environmental Genomics and the Carolina Center for Computational Toxicology in the Gillings School of Global Public Health of UNC. He also serves as associate director of the Curriculum in Toxicology and is a member of the Lineberger Comprehensive Cancer Center, the Center for Environmental Health and Susceptibility, the Bowles Center for Alcohol Studies, and the Carolina Center for Genome Sciences. Dr. Rusyn served on several working groups convened by the National Research Council and the World Health Organization-International Agency for Research on Cancer. Dr. Rusyn’s laboratory has an active research portfolio funded
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary by the National Institutes of Health and the U.S. Environmental Protection Agency with a focus on the mechanisms of action of environmental toxicants and the genetic determinants of susceptibility to toxicant-induced injury. His laboratory applies molecular, biochemical, genetic, and genomics approaches to understanding the mechanisms of environmental-agent-related disease, and his studies on health effects of environmental agents have resulted in 80 peer-reviewed publications. Dr. Rusyn received his MD from the Ukrainian State Medical University in Kiev and his PhD in Toxicology from UNC-Chapel Hill. He also trained at the University of Düsseldorf in Germany and at the Massachusetts Institute of Technology. Gina Solomon is a senior scientist at the Natural Resources Defense Council. She is also an associate clinical professor of medicine, director of the Occupational and Environmental Medicine Residency Program, and associate director of the Pediatric Environmental Health Specialty Unit of the University of California, San Francisco. Her work has included over 40 scientific papers, book chapters, and reports on air pollution, pesticides, global warming, and other environmental and occupational threats to health. Dr. Solomon serves on the U.S. Environmental Protection Agency’s Science Advisory Board Drinking Water Committee, the National Toxicology Program Board of Scientific Counselors, and the California Scientific Guidance Panel for biomonitoring. Dr. Solomon earned her MD from Yale University and did her postgraduate training in internal medicine, public health, and occupational and environmental medicine at Harvard University. Rusty Thomas is a senior investigator at the Hamner Institutes for Health Sciences and the director of the Center for Genomic Biology and Bioinformatics. His current research focuses on the development and application of genomic and high-throughput screening technologies and bioinformatics tools to address problems in environmental toxicology, drug safety, and chemical risk assessment. Dr. Thomas received his MS in radiation ecology and his PhD in toxicology from Colorado State University and performed his postdoctoral research in molecular biology and genomics at the McArdle Cancer Research Laboratory of the University of Wisconsin. Brian Thrall is the technical group leader of cell biology and biochemistry in the Biological Sciences Division of the Pacific Northwest National Laboratory. He holds adjunct positions in the graduate research program of Washington State University and regularly serves on special-emphasis review panels for the National Institutes of Health in proteomic and genomic analysis of cancer and as a proposal reviewer for the Department of Energy, the Air Force Office of Scientific Research, and the Department of State. Dr. Thrall’s research focuses on the mechanisms by which environmental agents modulate cell-signaling pathways to influence the balance between cell proliferation and cell death. His research uses genomic and proteomic strategies to investigate the molecular mechanisms of cross-regulation between growth-factor, inflammatory, and stress-signaling pathways with macrophages and various epithelial cells as model systems. Dr. Thrall is
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary the author or coauthor of over 50 peer-reviewed publications. He is a member of the American Society for Cell Biology, the Society of Toxicology Molecular Biology Specialty Section, and the Pacific Northwest Association of Toxicologists. He earned his PhD in pharmacology from Washington State University. Roger Ulrich is founder and chief development officer of Calistoga Pharmaceuticals, Inc., a company focused on the development of PI3 kinase inhibitors for cancer and inflammatory diseases. He is responsible for all aspects of drug development, and he continues to pursue his interests in the phenotypic and genotypic traits that contribute to adverse drug reactions. Dr. Ulrich’s industrial career began at the Upjohn Company, and he has held various scientific and leadership positions in the pharmaceutical industry, including those of senior scientist with the Upjohn Company and Pharmacia & Upjohn Inc., director of regulatory toxicology and safety pharmacology with Abbott Laboratories, and senior scientific director with Merck Research Laboratories Rosetta Inpharmatics. He is a member of the Academy of Toxicological Sciences and the author of more than 125 publications. He is an internationally recognized lecturer on toxicology, genomics, and drug discovery; he continues to maintain adjunct academic appointments; and he serves on various editorial boards, government and academic advisory boards, and working committees. Dr. Ulrich earned a PhD in cellular and molecular biology from West Virginia University. Katrina Waters is a senior research scientist and bioinformatics team leader in the Computational Biology and Informatics Group of the Pacific Northwest National Laboratory (PNNL). Her research interests are focused on the reconstruction of cell-response networks from integrated gene and protein expression data to enable predictive mechanistic modeling of disease and toxicity pathways. Her current projects include pathway-based biomarker discovery for environmental exposure to lung toxicants, including disease-susceptibility factors, and network modeling of lung inflammation by examining macrophage and epithelial cell paracrine communication. She also has two collaborative projects with the University of Washington and Oregon Health Sciences University to perform data modeling of host-pathogen interactions. Before her position at PNNL, Dr. Waters was a senior research biochemist in molecular and investigative toxicology for drug safety risk assessment at Merck Research Laboratories. At Merck, she used microarray technologies to determine mechanisms of toxicity of drugs about which there were safety concerns and to identify biomarkers of tissue-specific toxicity. Dr. Waters earned a PhD in biochemistry from the University of Wisconsin, Madison. Helmut Zarbl is a professor of environmental and occupational medicine at the Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey (UMDNJ). He is a member of the Environmental and Occupational Health Sciences Institute (EOHSI), a joint institute of UMDNJ and Rutgers University. He is also director of the National Institute of Environmental Health
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary Sciences Center for Environmental Exposures and Disease at EOHSI and the associate director for public-health science at the Cancer Institute of New Jersey. Dr. Zarbl’s research has focused largely on toxicogenomics and functional genomics, carcinogenesis, molecular and cellular biology, and toxicology. Specifically, his work seeks to understand molecular mechanisms of chemical carcinogenesis and chemoprevention and the genetic basis of differential susceptibility to mammary carcinogenesis in animal and in vitro model systems. He is also involved in technology development, including his patented work on RNAi and its application to the development of novel platforms for function genomics. Dr. Zarble is a fellow of the Academy of Toxicological Sciences and is a member of the National Research Council (NRC) Standing Committee on Use of Emerging Science for Environmental Health Decisions. He previously served as a member of the NRC Committee on Applications of Toxicogenomic Technologies to Predictive Toxicology. Dr. Zarbl earned a PhD in biochemistry from McGill University. PANELIST BIOGRAPHIES Charles Auer was the director of the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) and retired from EPA in January 2008 after a 32-year career there. As the director of OPPT, he was responsible for oversight of the Toxic Substances Control Act and had a lead role in promoting pollution prevention, both in the agency and with external stakeholders. During his time at EPA, OPPT was responsible for numerous collaborative efforts, such as the High Production Volume Challenge Program, the Presidential Green Chemistry Challenge, Design for the Environment, the Nanoscale Materials Stewardship Program, the Chemical Assessment and Management Program, the PFOA 2010/2015 Stewardship Program, and other voluntary regulatory efforts. A chemist by training, Mr. Auer has broad experience in assessment and management of new and existing chemicals, genetically engineered microorganisms, and nanoscale materials. He has also worked with the Organisation for Economic Co-operation and Development and has had extensive bilateral and multilateral interactions with the European Union, Canada, Japan, China, and other major U.S. trading partners. David Jacobson-Kram is associate director for pharmacology and toxicology in the U.S. Food and Drug Administration’s Office of New Drugs. Over the last 25 years, he has served as principal and co-principal investigator on several National Institutes of Health (NIH) grants and government contracts. Dr. Jacobson-Kram has published over 80 abstracts, 57 original articles in peer-reviewed journals, and 30 review articles and book chapters. He has served as a council member, treasurer, and chairman of the Genetic Toxicology Association; an executive council member of the Environmental Mutagen Society; the editor of Cell Biology and Toxicology; the president of the National Capital
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Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change - A Symposium Summary Area Chapter of the Society of Toxicology; and member of NIH special study sections. He has also been elected as a diplomate of the American Board of Toxicology. Dr. Jacobson-Kram received a PhD in embryology from the University of Connecticut. William Kaufmann is a professor of pathology and laboratory medicine, director of the genetic susceptibility research core at the Center for Environmental Health and Susceptibility, and director of the Program in Toxicogenomics of the University of North Carolina (UNC) at Chapel Hill. His laboratory is concerned with the mechanisms of human carcinogenesis with special interest in cell-cycle check-points that act to preserve chromosomal stability. Dr. Kaufmann is a member of the Environmental Mutagen Society and of the American Association for Cancer Research. He has served as associate editor of Mutagenesis and has served on the editorial board of Carcinogenesis. He has also served on numerous program, grant, and contract review groups; UNC committees; and national committees, including service as the chair of the Toxicogenomics Research Consortium Steering Committee, a member of the Environmental Mutagen Society Awards Committee, and a member of the American Society of Investigative Pathology Program Committee. Dr. Kaufmann earned a PhD in experimental pathology from UNC at Chapel Hill. Jonathan Wiener is the William R. and Thomas L. Perkins Professor of Law at Duke Law School, professor of environmental policy at the Nicholas School of the Environment, and professor of public-policy studies at the Sanford Institute of Public Policy of Duke University. In 2008, he served as president of the Society for Risk Analysis (SRA) and was inducted as a fellow of SRA. In 2003, he received the Chauncey Starr Young Risk Analyst Award from SRA for exceptional contributions to the field of risk analysis by a scholar 40 years old or younger. Since 2002, he has been a university fellow of Resources for the Future. From 2000 to 2005, he was the founding faculty director of the Duke Center for Environmental Solutions. Prof. Wiener has been a visiting professor at Harvard Law School, the University of Chicago Law School, Sciences Po, and l’Ecole des Hautes Etudes en Sciences Sociales in Paris. He has written widely on U.S., European, and international environmental law and risk regulation, including several books and numerous articles in diverse journals in law, policy, risk, toxicology, and other fields. Before coming to Duke in 1994, Prof. Wiener served in the G.H.W. Bush and Clinton administrations in the Department of Justice, the Office of Science and Technology Policy, and the Council of Economic Advisers. He was a law clerk to federal judges Stephen Breyer and Jack Weinstein after earning his AB in economics and JD at Harvard University.