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Advanced Comprehensive Toxicology Speakers
Simon Authier, DVM, MSc, MBA, PhD, DSP
Deputy Chief Scientific Officer, Senior Director of Scientific Operations and Veterinary Science, CiToxLAB Dr. Authier obtained a doctor in veterinary medicine degree from the University of Montreal and specialized in nonclinical studies after completing a PhD in preclinical pharmacology. He then completed a MBA in corporate finances and management. Over the past years, Dr. Authier investigated methodologies in nonclinical regulatory safety pharmacology studies with the objective of improving study designs for optimal sensitivity and decision making in this field. Dr. Authier overviews the work of a team of scientists and veterinarians specialized preclinical research for IND, BLA and NDA filing with a focus on safety pharmacology. He participated in face-to-face US FDA pre-IND meetings and overviewed conduct of preclinical studies for a number of small and large molecules over the last 14 years working at CIToxLAB North America. He was an invited speaker at various scientific conferences including the US Food and Drug Administration (FDA), Canadian Society of Quality Assurance, the Safety Pharmacology Society, American College of Toxicologists (ACT), Japanese Society of Safety Pharmacology and the American Association of Laboratory Animal Science to name a few. For the last seven years, Dr. Authier was an invited professor in immunolgy and pharmacology at University of Montreal, Canada. To date, Dr. Authier has provided scientific overview for more than 800 studies assessing cardiovascular, respiratory, neurological, gastrointestinal, and renal safety pharmacology.
William Brock, PhD, DABT, ATS
Dr. Bill Brock received his PhD in toxicology from the University of Kentucky (1983), and did a postdoctoral fellowship at UK. From his postdoctoral fellowship, he joined DuPont’s Haskell Laboratory and spent 17 years in various research, testing and management roles. Subsequently, Bill joined Unilever, a worldwide consumer product company, and then the international consulting firm Environ. In 2004, he became an independent toxicology consultant. He is the Director of Toxicology for Otsuka Pharmaceuticals.
Dr. Brock provides pharmacology and toxicology research and testing advice for early- through late-stage pharmaceutical development for worldwide regulatory submissions. Furthermore, he provides scientific and regulatory consulting advice and safety and risk assessments to clients in the chemical, medical device, food and consumer product industries. His primary research interests include human health risk and exposure assessments with an interest in the mechanisms of toxicity associated with human exposures to xenobiotics. Dr. Brock has authored or co-authored more than 50 publications, and has authored or coauthored several book chapters and is a co-editor on two toxicology and regulatory books. He has served as a member and in a leadership capacity for several national and international toxicology organizations. Dr. Brock is currently an expert reviewer for IPEC’s Excipients Panel.
Dr. Brock is a Diplomate of ABT, a Fellow of ATS, and has served as a Board member and President for both ABT and ATS. Dr. Brock has served in various leadership capacities or as a member of various professional organizations and committees for the ACT, SOT and others. Dr. Brock is an Associate Editor for the International Journal of Toxicology, and a reviewer for Food and Chemical Toxicology, Toxicological Sciences, Toxicology and Industrial Health, Current Eye Research and other leading toxicology journals.
Matthew Campen, PhD, MSPH
Dr. Campen is a Regents’ Professor of Pharmaceutical Sciences at the University of New Mexico College of Pharmacy and an expert in the cardiopulmonary health effects of air pollution. He is also broadly interested in the cross-talk of the cardiovascular and respiratory system in health and disease, conducting basic, and clinical research into the nature of comorbidities that promote cardiovascular illness. His primary research focus involves the impact of inhaled toxicants, especially common air pollutants, on vascular function and injury. After graduating from the University of North Carolina School of Public Health, Dr. Campen trained in a pulmonary medicine postdoctoral fellowship at the Johns Hopkins University School of Medicine. Prior to his current appointment, he worked as an independent scientist at the Lovelace Respiratory Research Institute in Albuquerque, conducting both grant- and contract-funded research. Dr. Campen has published over 90 peer-reviewed articles and recently authored the “Toxic Responses of the Heart and Vascular System” chapter in Casarett and Doull’s Toxicology: The Basic Science of Poisons 9th ed. Dr. Campen currently serves as an Associate Editor for Toxicological Sciences and, in 2013, he shared the Toxicological Sciences Editor-in-Chief position with Dr. John Lipscomb and he was recently awarded the SOT Achievement Award in 2014. He has been a regular contributor and advisor to the Environmental Protection Agency for aspects of air pollution toxicology, including a term as an ad hoc member of the Clean Air Scientific Advisory Committee.
Mary Ellen Cosenza, PhD, DABT, ATS, RAC
Mary Ellen Cosenza is a regulatory consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the US, Europe, and emerging markets. Most recently, she served as the Executive Director, US Regulatory Affairs, at Amgen, Inc. During her 20-year tenure at Amgen, she led the International Emerging Markets Regulatory Department and served as an Executive Director of Global Regulatory Affairs and Safety. In addition to her leadership roles in Regulatory Affairs, she also served as the Senior Director of Toxicology at Amgen. Prior to joining Amgen, she served as a Principal Scientist for the Medical Research Division of American Cyanimid Company (now Pfizer).
She is also an instructor at the University of Southern California where she teaches a graduate level course on Food and Drug Toxicology. Mary Ellen received her PhD from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.
Mary Ellen is a Diplomat of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, member of the Society of Toxicology (SOT), Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS), and holds Regulatory Affairs Certification for both the US and EU. Mary Ellen has been a member of ACT since 1988, serving as an active speaker and session chair. Most notably, she developed the first Study Director Training Course in 2001 and has served as a member of the ACT Education Committee, as Councilor, and as Treasurer. Mary Ellen is a recent Past-President of ACT.
Lydia Cox, PhD, DABT
Lydia is the Director of Regulatory Affairs at Nichino America, Inc., a wholly owned subsidiary of Nihon Nohyaku Co. Ltd., Japan’s first and oldest agrochemical manufacturing company. In her current role, she leads the regulatory affairs team based in Wilmington, DE and is focused on the development, registration, and stewardship of products for the crop protection sector in the US and Canada. She has a BS in animal science from Cornell University and a PhD in toxicology from University of the Sciences in Philadelphia, Pennsylvania. After completing her postdoctoral training at New York University’s Institute of Environmental Medicine in Tuxedo, New York, Lydia joined DuPont’s Haskell Global Centers for Health and Environmental Sciences. While at DuPont, she worked in various roles as a toxicologist including study director and monitor for mammalian studies, group leader in genetic toxicology, and toxicology liaison to provide strategic guidance for registration and stewardship initiatives. She has also worked as a toxicology consultant for Critical Path Services in Garnet Valley, Pennsylvania for projects in the industrial chemical, medical device, and cosmetic sectors. She is a Diplomate of the American Board of Toxicology.
David Dorman, DVM, PhD, DABVT, DABT, ATS
Dr. David Dorman is a professor of toxicology in the Department of Molecular Biomedical Sciences at North Carolina State University (NCSU). Dr. Dorman’s research interests include neurotoxicology, nasal toxicology, pharmacokinetics, and cognition and olfaction in animals. He completed his undergraduate training in chemistry at the University of San Diego and he pursued additional graduate training in organic chemistry at the University of Colorado-Boulder. Afterward she received a DVM from Colorado State University and then completed a combined PhD and veterinary toxicology residency program at the University of Illinois at Urbana-Champaign followed by completion of a postdoctoral fellowship at the Chemical Industry Institute of Toxicology (CIIT). He is a diplomate of the American Board of Veterinary Toxicology and the American Board of Toxicology. He is a former Hamner Institutes for Health Sciences Division Director and Associate Dean of Research and Graduate Studies at the NCSU College of Veterinary Medicine. He has chaired or served on numerous National Research Council (NRC) committees and is a National Associate of the NRC. He has served on other advisory boards for the US Navy, the National Aeronautics and Space Administration, the US Department of Agriculture, and is a former member of the National Toxicology Program Board of Scientific Counselors. His research accomplishments have been recognized through his receipt of the Society of Toxicology’s Achievement Award, the Zoetis Award for Research Excellence, and being elected as a Fellow of the American Association for the Advancement of Science. Dr. Dorman is also a fellow of the Academy of Toxicological Sciences. He was the recent recipient of a Fulbright Specialist Program Award where he will lecture at the host institution, the University of Adelaide, on chemical risk assessment during mid-2018.
Mary Beth Genter, PhD, DABT, ATS
Dr. Mary Beth Genter has been an academic toxicologist since completing graduate studies in the Integrated Toxicology Program at Duke University and postdoctoral studies at the Chemical Industry Institute of Toxicology in 1990. Dr. Genter’s background is in neurotoxicology, and she has a special interest in the olfactory system, both as a target for toxicant-induced damage and as a route of drug delivery. Prior to joining the University of Cincinnati Department of Environmental Health, Dr. Genter was employed by the North Carolina State University Department of Toxicology, where, among other responsibilities, she served as the toxicologist for the North Carolina Cooperative Extension Service. She also served as a member of the North Carolina Secretary’s Scientific Advisory Board on Toxic Air Pollutants. Dr. Genter has published over 70 peer-reviewed manuscripts, and served as an advisor for the USEPA during the reevaluation of the IRIS naphthalene document. Dr. Genter is a diplomate of the American Board of Toxicology (ABT; 1992-present) and served on the ABT Board of Directors (2004-2008). She was named a Fellow of the Academy of Toxicological Scientists in 2012. She is currently (2008-present) Editor-in-Chief of International Journal of Toxicology, the official journal of the American College of Toxicology, where she also serves as a Councilor. Dr. Genter is also a member of the Toxicology in Vitro Editorial Board, and a reviewer for approximately 2 dozen papers for other journals per year. Dr. Genter serves on the Council of the Society of Toxicology (2016–2019) and recently completed a term on the National Toxicology Program Board of Scientific Counselors (2013–2017). She is a member of the American College of Toxicology, the Society of Toxicology, the Association for Chemoreception Sciences, and Sigma Xi.
Alan Hoberman, PhD, DABT, ATS
Dr. Hoberman has been employed by Charles River Laboratories, Preclinical Services, Pennsylvania (formerly Argus Research Laboratories, Inc.) since 1981. Currently he is Executive Director, Global Developmental, Reproductive, and Juvenile Toxicology. He is a Diplomat of the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, with over 85 publications and book chapters. He is the co-editor of Pediatric Non-Clinical Drug Testing, Principles, Requirements, and Practices published in January 2012.
Dr. Hoberman has been a member of the American College of Toxicology since 1979 and is currently the Treasurer. He has been a member of the Teratology Society since 1978 and is currently the Vice-President. He is past president of the Reproductive and Developmental Toxicity Specialty Section of the Society of Toxicology and past president of the Middle Atlantic Reproductive and Teratology Association, as well as past president of the Arkansas Biotechnology Organization.
Debie Hoivik, PhD, DABT
Dr. Hoivik received her PhD in toxicology from the University of Connecticut and conducted her postdoctoral research at Texas A&M. She spent eight years at GlaxoSmithKline in a variety of roles in Medicine Safety where she was responsible for the nonclinical product development strategy and execution as well as regulatory interactions and submissions for new therapeutic entities. Dr. Hoivik joined Boehringer-Ingelheim Pharmaceuticals in 2005 and she was the Director of Toxicology Operations. She is currently at Akebia Therapeutics. Dr. Hoivik has authored five invited book chapters, 24 peer reviewed manuscripts, and 25 abstracts. She has served ACT in a variety of roles (e.g., Councilor, Secretary, Continuing Education Committee, Nominating Committee, Program Committee); she is currently Co-Chair of the SOT Education Committee; served on the SOT Communication Committee; and she is currently the President of the Northeast Society of Toxicology. Dr. Hoivik has also served on multiple pharmaceutical consortiums and workgroups. She has been a member of the Editorial Review Board for the International Journal of Toxicology since 2004 and serves as a reviewer for Toxicological Sciences. Dr. Hoivik was certified by the American Board of Toxicology in 1999.
Michael Kierski, PhD
Dr. Michael Kierski is an environmental biologist and toxicologist with Exponent, Inc. who for 33 years has helped clients evaluate and solve complex environmental problems. He received his BA in environmental biology from Saint Mary’s University in 1984 and his PhD in environmental toxicology from the University of Minnesota in 1992. Over his consulting career he has planned and managed environmental investigations and remediation projects, many of them for Superfund sites, some with a natural resource damage assessment (NRDA) component. He has also provided ligation support on a number of legal cases related to environmental contamination. Dr. Kierski has over his career evaluated human and ecological risks associated with chemicals in all components of the environment including soil, soil gas, sediment, groundwater, drinking water, air, food, and biota. Much of his work includes evaluating chemical risks at legacy contaminated sites located across the United States and associated with clients’ industrial processes and products. He has specialized expertise on the toxicology and fate and transport of metals, particularly lead, and organic chemicals such as PAHs, PBDEs, PCBs, PFAS, pesticides, chlorinated solvents, and explosives.
Over the past 10 years, Dr. Kierski’s work has increasingly emphasized relative risk approaches to help clients make more informed decisions about the risks associated with aging infrastructure and products or processes they use. In addition, he has used a causal analysis approach on complex legal cases where multiple stressors could have similar affects if not evaluated for cause by using different spatial or temporal perspectives. Dr. Kierski is a member of the Society of Environmental Toxicology and Chemistry (SETAC) and the Society of Risk Analysis (SRA). He is currently on the Board of Directors of Midwest SETAC, and he regularly presents at SETAC conferences on a variety of topics related to chemical risk assessment and has taught short courses on human health and ecological chemical risk assessment.
Thomas A. Lewandowski, PhD, DABT, ERT
Dr. Tom Lewandowski is a toxicologist and chemist working in Gradient’s Seattle, Washington office. He received his PhD in toxicology from the University of Washington School of Public Health. He also holds an MPH in environmental health from the University of Michigan. Dr. Lewandowski has over 30 years of experience in the areas of risk assessment, product safety evaluation, pharmacokinetics, and metals toxicology. Current areas of particular interest include skin sensitization, cannabinoids, and chemical alternatives assessment. He is board certified as a toxicologist in both the US (DABT) and Europe (ERT). He is also a fellow of the Academy of Toxicological Sciences (ATS). He was previously an Associate Professor of environmental health at Brooklyn College/The City University of New York where he taught courses in environmental health, human physiology, and sustainability. He is currently an affiliate faculty member at the University of Washington School of Public Health where he lectures on metals toxicology and risk assessment. He is the author of numerous publications related to risk assessment methods (in particular the use of computational models). He is a member of the OARS WEEL committee, which reviews toxicology data to develop workplace exposure guidelines for new chemical agents. He is also currently an officer of the SOT Dermal Toxicology Specialty Section.
David McMillan, PhD, DABT
Dr. McMillan graduated from the Department of Biomedical Engineering at Vanderbilt University, and received his PhD in Toxicology from the University of Rochester School of Medicine and Dentistry. He then completed a postdoctoral fellowship at the University of Vermont Medical Center in the Department of Pathology and Laboratory Medicine. Dr. McMillan joined the US Food & Drug Administration in 2016 and is now a Senior Toxicologist in the Division of Pharmacology/Toxicology for Infectious Disease, assigned to the Division of Antivirals. He became a Diplomate of the American Board of Toxicology in 2018.
Leslie Recio, PhD, DABT
Dr. Leslie Recio is the ILS Chief Scientist, leader of the ILS Genetic and Molecular Toxicology group. The ILS Genetic and Molecular Toxicology group offers GLP/OECD-compliant genetic toxicology test battery and investigative toxicology-based research. Current research studies are focused on integrating gene expression profiling with apical endpoints assessed in rodents, hepatocytes and human cell lines toxicology models. Dr. Recio received his MS and PhD from the University of Kentucky conducting his doctoral research in mammalian cell mutagenesis at the Biology Division of Oak Ridge National Laboratory and in 1986, Dr. Recio was a postdoctoral fellow at CIIT. Dr. Recio has authored or co-authored 80 peer reviewed publications in the areas of mutagenesis, toxicogenomics and regulatory based genotoxicity assessment. In 2010, Dr. Recio was appointed to the SOT Council on Diversity Initiatives. In 2011, he was elected as the 2012 president of the Hispanic Organization of Toxicologist. Dr. Recio was on the 5th International Working Group for Genotoxicity Testing in focused on integration of genotoxicity with standard rodent toxicology testing. In 2012, Dr. Recio was appointed to the OECD Genetic Toxicology Expert Group charged with revising OECD test guidelines for regulatory genetic toxicology testing in mammalian cells. In 2012, Dr. Recio was named Director of Genomics for ILS Genomics. He is part of an ILSI/HESI Genomics Committee collaboration developing methods for gene expression profiling from FFPE tissues using microarrays and next generation sequencing technologies. Dr. Recio currently serves on the Editorial Boards for Toxicological Sciences and Mutation Research—Reviews in Mutation Research.
Robert Roy, PhD, DABT, ATS
Dr. Robert Roy has been a toxicologist at 3M for over 22 years. Rob is currently a Lead Toxicology Specialist in the 3M Corporate Toxicology and Environmental Sciences group. At 3M he has been actively involved in the support of the global toxicology (and regulatory toxicology) efforts of many of 3M divisions and business units. Some of these toxicologically-related activities include the placing, monitoring and evaluation of both short-term and longer-term toxicity studies, the health hazard assessment of raw materials, intermediates, and finished industrial and consumer products, and the preparation of human health risk/safety assessments for industrial and consumer products (including for Prop65). He also derives all DNELs and DMELs used in 3M REACH registrations, has been the Chair of the 3M OEL committee for over 20 years, and serves on many internal 3M committees and work groups.
Rob has been a Diplomate of the ABT since 1994 and served on the ABT Board of Directors from 2013 – 2017. He is actively involved in teaching and advising students at the graduate level at University of Minnesota where he is an Adjunct Associate Professor in the School of Public Health (Toxicology Graduate Program). He also serves on the editorial boards of toxicology journals, is actively involved in development and teaching of CE courses in toxicology for the Society of Chemical Hazard Communication (SCHC) and is a faculty member in the Graduate Program in Product Stewardship at Indiana University. Rob is a Fellow of the Academy of Toxicological Sciences (ATS), has served on the SOT CE Committee, is a 25-year member of the national OEL-developing Workplace Environmental Exposure Levels (WEEL) Committee, is a member of the NIOSH Board of Scientific Counselors (BSC) and serves/has served on several other ACC, University of Minnesota, AIHA, ECETOC-sponsored committees and work groups
Elizabeth M. Vancza, PhD, DABT
Dr. Elizabeth M. Vancza is a Managing Toxicologist for SafeBridge Consultants, Inc., with over 10 years’ experience providing support to clients in the pharmaceutical and biotechnology industries. Typical areas of support include: occupational toxicology, potent compound safety evaluation and risk assessment, product safety, and evaluation of environmental health and safety issues. She is a Diplomate of the American Board of Toxicology and is a Registered Specialist in Safety Data Sheet & Label Authoring, as defined by the AIHA Registry Programs. She has a BS in Biology from Fairfield University in Fairfield, CT, and received both her MS and PhD degrees in Toxicology from New York University, where she is currently a Guest Lecturer. She is actively involved in the SOT, having served on various committees for different specialty sections, particularly in the areas of regulatory toxicology and risk assessment. She currently serves as the Vice President for the SOT’s Northeast Regional Chapter. She has also served on the Program Committee for the Society of Chemical Hazard Communication for over 8 years.