= Members Only
Advanced Comprehensive Toxicology Speakers
Dr. William J. Brock received his PhD in toxicology from the University of Kentucky (UK) (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 world-wide consumer product company, and then the international consulting firm Environ. In 2004, he became an independent toxicology consultant and then joined Otsuka Pharmaceuticals in late 2010.
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 co-authored 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 the American Board of Toxicology, 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, and other leading toxicology journals.
Susan Emeigh Hart, VMD, PhD, DACVP, DABT, ERT
Dr. Susan Emeigh Hart is a board certified veterinary anatomic and clinical pathologist (Diplomate, ACVP), a Diplomate, American Board of Toxicology (DABT), and a Eurotox Registered Toxicologist (ERT), certified by the UK Register of Toxicologists. She received her VMD from the University of Pennsylvania School of Veterinary Medicine. After a brief tenure in mixed veterinary practice, she enrolled in a combined veterinary pathology residency and PhD program in the Department of Pathobiology at the University of Connecticut, where she also concurrently held an NIEHS-sponsored postdoctoral fellowship through the School of Pharmacy, Section of Toxicology. Her twenty-plus year career in industry has provided her with broad-based experience in all aspects of preclinical drug development for small molecule pharmaceutical agents and biotechnology products (antibody-based products as well as novel agents such as naturally derived peptides, aminosterols, therapeutic enzymes and gene therapy products). Her areas of expertise include renal, hematologic and ocular pathology and physiology, biomarker identification and development, pathology of commonly used laboratory animals, mechanistic toxicology, mitochondrial pathology, interstitial matrix biology, and cell-matrix interactions. She has an extensive bibliography, which includes book chapters, peer-reviewed publications (primary research and review articles) and published abstracts. She is an active member of a number of professional organizations (AACC, ABT, ACVP, BioSafe, STP, SOT), for which she has held elected offices, served on committees, and has been invited to present on a variety of topics at local, national and international meetings.
Gregory L. Finch, PhD, DABT
Dr. Gregory L. Finch is a Research Fellow/toxicologist in Drug Safety Research and Development at Pfizer in Groton, Connecticut. He earned a PhD in Chemical Ecology from the University of California Davis, then served as a postdoctoral researcher then scientist at Lovelace Respiratory Research Institute in Albuquerque, New Mexico. He was an inhalation toxicologist at Lovelace, and focused on aerosol generation and characterization, the adverse effects of inhaled toxicants either alone or in combination, and lung dosimetry and clearance of materials from the respiratory tract. At Pfizer, his work focused initially on inhaled drug development and in characterizing the safety and fate of inhaled macromolecules in the lung. Dr. Finch was part of a multidisciplinary team that gained regulatory approval for the first inhaled insulin drug product. His efforts then expanded more broadly to the use of nonclinical data in human health risk assessment. He has participated in moving several drugs through late-stage development and/or registration and is currently the Drug Safety team leader for several projects in clinical development. He belongs to a team evaluating novel drug delivery technologies, and has developed strategies to assess potential safety issues around these technologies. He also provides internal strategic support to advance the application of toxicity data and risk assessment in biotherapeutics and biosimilar drug development. Dr. Finch is a member of the Society of Toxicology, and is a Diplomate of the American Board of Toxicology, with previous service on the ABT Board of Directors. Currently, he is one of Pfizer’s members of the Board of Directors of the Nanomedicines Alliance.
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 US Environmental Protection Agency 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, a member of the Toxicology In Vitro Editorial Board, and a reviewer for approximately two dozen papers for other journals per year. Recently, Dr. Genter was appointed to the Society of Toxicology Scientific Program Committee (2012–2016) and the National Toxicology Program Board of Scientific Counselors (2013–2017). She is a member of the American College of Toxicology, the Association for Chemoreception Sciences, Sigma Xi, and the Society of Toxicology.
Kenneth L. Hastings, DrPH, DABT, ATS
Dr. Hastings joined the US Food and Drug Administration in 1991 as a pharmacology/toxicology reviewer in the Division of Antiviral Drug Products, where he was involved in review and approval of several drugs for the treatment of HIV/AIDS. In 1997, Dr. Hastings was appointed Pharmacology/Toxicology Supervisor in the Division of Special Pathogen and Immunologic Drug Products, where he was involved in review of several marketing applications for drugs to treat tuberculosis, malaria, serious bacterial and fungal diseases, and for use in transplant medicine. In 2003, Dr. Hastings was appointed Associate Director for Pharmacology and Toxicology in the Office of New Drugs. In this position, he served as tertiary reviewer for various review divisions. Dr. Hastings served on many committees and working groups while in government service, including several guidance committees (immunotoxicology, safe start dose, nonclinical studies for pediatric clinical trials, phototoxicity, metabolites in safety testing, biologic counterterrorism, and phospholipidosis). Dr. Hastings was lead CDER representative for the ICCVAM validation of the murine local lymph node assay, acting director of the International Regulatory Issues Staff in the Office of Regulatory Affairs, acting FDA safety coordinator for ICH, and lead FDA negotiator for ICH S8.
He has served in several professional societies, including the American Board of Toxicology (Past President), the American College of Toxicology (Past President), the Society of Toxicology (Past President of the Immunotoxicology Specialty Section), board member of the Biotechnology Industry Organization BioSafe Leadership Team, and past Co-Chair of the Nonclinical Special Interest Community of the Drug Information Association. Dr. Hastings is a Fellow in the Academy of Toxicological Sciences. Dr. Hastings received his Doctor of Public Health degree from the University of North Carolina, School of Public Health in 1987, where he completed his doctoral research at the Chemical Industry Institute of Toxicology.
Dr. Hastings served as a Peace Corps volunteer in Fiji, where he was a special assistant to the Permanent Secretary for Health. Following this, he completed a post-doctoral fellowship and was then appointed Research Associate in the Pharmacology/Toxicology Research Laboratory, Department of Anesthesiology, University of Arizona prior to his position at FDA/CDER.
From 2007 to 2014, Dr. Hastings was Associate Vice President for Regulatory Policy, Sanofi. His responsibilities included serving as in-house advisor to corporate management on drug development regulatory policy, primarily concerning USFDA and ICH. He served as corporate liaison with numerous scientific and industrial groups, including PhRMA and BioSafe. Dr. Hastings is currently an independent consultant.
Anthony L. Kiorpes, PhD, DVM, DABT
Dr. Anthony L. Kiorpes is a graduate of Columbia University (BA Biology, 1970), the University of Wisconsin-Madison (MS Veterinary Science, 1974; PhD Physiology, 1977), Kansas State University (DVM, 1982), and the University of Arkansas (MBA, 1999). He has over 22 years of experience as a toxicologist working in food, pharmaceutical, and medical device development and safety. A former university professor and large animal veterinarian, Dr. Kiorpes has authored/co-authored over 50 scientific articles, abstracts, and book chapters in physiology, toxicology, and veterinary medicine. He has been an invited speaker on topics ranging from the Good Laboratory Practice Act to Carcinogenicity Testing to Toxicokinetics. He has been an active member ofthe American College of Toxicology since 1998, serving on the Finance Committee from 2006 through 2008 and beginning a three-year term on Council in 2012. A full member of The Society of Toxicology (SOT), The American Physiological Society, and the American Veterinary Medical Association including the Minnesota chapter, he was past president and councilor of the Northland Chapter of SOT and an adjunct professor in the Graduate Toxicology Program at the University of Minnesota. Dr. Kiorpes is currently an independent consultant working with pharmaceutical and medical device clients (River Bluff Associates) and serves on the business advisory board of the University of Minnesota’s office of technology transfer. Dr. Kiorpes is a 1994 Diplomate of the American Board of Toxicology.
Fred Kirchner, PhD, DABT
Dr. Fred Kirchner has 33 years experience in toxicology field in the pharma, consumer product, and environmental assessment industries. He has expertise in drug development and management of programs. He was a member of the Board of Directors of the American Board of Toxicology from 2006 to 2010. Employers include: Argonne National Laboratory, Colgate Palmolive, Ciba-Geigy, SmithKline-Beecham, Wyeth, and Covance.
Richard W. Lane, PhD, DABT
Dr. Richard W. Lane is Director of Corporate Scientific Affairs at PepsiCo where he serves as a scientific advisor to PepsiCo’s businesses in the areas of toxicology, safety assessment, exposure evaluation, product safety, and regulatory affairs. His responsibilities include providing strategic technical input to senior management and interacting with PepsiCo’s legal, toxicology, and food safety experts globally. He serves as the PepsiCo liaison for food chemical safety to major trade associations and scientific organizations.
Prior to joining PepsiCo he was employed by Unilever’s foods business for 17 years. He also has experience in toxicology and safety evaluation in the flavor and fragrance, pharmaceutical, and petrochemical industries.
Dr. Lane is certified in general toxicology by the American Board of Toxicology and is an active member of the Society of Toxicology where he has been the President of the Food Safety Specialty Section. He was a member of the editorial board of Food and Chemical Toxicology for ten years. He has authored and co-authored papers and book chapters on toxicology and its application to the safety of food additives and contaminants.
Dr. Lane received a bachelor’s degree in chemistry from Dartmouth College and a doctorate in pharmacology from the Medical College of Virginia of Virginia Commonwealth University.
Ranulfo Lemus, ScD, DABT
Dr. Ranulfo Lemus is a Diplomat of the American Board of Toxicologists, and member of the Society of Toxicology and the American College of Toxicology; with expertise on metals, inhalation, combustion, and genetic toxicology. He obtained his Doctor of Science degree from Tulane University, and conducted postdoctoral studies at the University of Pittsburgh.
During his tenure from 2001 until 2007 as an Associate Principal Scientist for Philip Morris USA he managed a testing program that conducted in vivo micronucleus, smoke chemistry, bacterial and mammalian mutagenicity, mammalian cytotoxicity, and 90-day rat-inhalation studies. In addition, he managed the evaluation of direct and indirect materials used in the production of tobacco products.
From 2007 to 2013 as Principal Toxicologist at ARCADIS US Inc., Dr. Lemus provided Global Product Stewardship Services by assessing the human health risks from exposure to metals and consumer products. He registered nine tungsten substances under the European Union regulatory framework for the Registration, Evaluation and Authorization of Chemicals (REACH). In February 2013, Dr. Lemus was appointed the HSE Director of the International Tungsten Industry Association and in September 2013 he joined Advanced Testing Laboratories Inc. as Principal Toxicologist.
Dr. Lemus is the author of twenty-seven published peer review research papers (seven as first author) and a recipient of the 2003 NIOSH’s Alice Hamilton Award for Occupational Safety and Health in the Biological Science Category.
John C. Lipscomb, PhD, DABT, ATS
Dr. John C. Lipscomb completed his PhD in Interdisciplinary Toxicology 1991 at the University of Arkansas for Medical Sciences, where he conducted his dissertation research in the area of pharmacokinetics and metabolism at the US Food and Drug Administration’s National Center for Toxicological Research. John served in the US Air Force at Wright-Patterson AFB Ohio as Chief of the Metabolism Section, conducting and publishing original research to define human interindividual metabolic variability in the support of physiologically based pharmacokinetic modeling. In 1998, Dr. Lipscomb transferred to the US Environmental Protection Agency’s (EPA) National Center for Environmental Assessment in Cincinnati, Ohio, where he serves as a risk assessor for environmental contaminants. His responsibilities include conducting and reviewing technical risk assessments for cancer and noncancer effects via the oral and inhalation routes. His works supports the US EPA’s Integrated Risk Information System (IRIS) assessments as well as assessments conducted under the Provisional Peer Reviewed Toxicity Value Program—a customer-oriented program to assist decision making for National Priority List (Superfund) sites. He has also led the development of US EPA guidance on the inclusion of quantitative toxicokinetic and toxicodynamic data to avoid the application of default uncertainty factor values for inter and intraspecies extrapolation (Data Derived Extrapolation Factors). Dr. Lipscomb co-edited a text, Toxicokinetics and Risk Assessment (Informa, 2007). He is an Adjunct Assistant Professor of Toxicology at the University of Louisville, risk assessment lecturer at the University of Kentucky and provided risk assessment training to Health Canada (2009–2013). Dr. Lipscomb is an Associate Editor for Toxicological Sciences, Toxicology Mechanisms and Methods, and Toxicology Reports, a Past President of the American Board of Toxicology, the Society of Toxicology’s Ohio Valley Chapter and Risk Assessment Specialty Section, and has served as a Councilor for the Society of Toxicology.
Susan A. MacKenzie, VMD, PhD, DABT
Dr. Susan A. MacKenzie is a senior research toxicologist at DuPont Haskell Global Centers for Health and Environmental Sciences. She received her VMD from the University of Pennsylvania in 1977, and spent five years in small animal veterinary practice. She worked as a research technician in an experimental pathology/chemical carcinogenicity laboratory at the University of North Carolina, and then completed a PhD in toxicology in 1991, from the Rutgers/University of Medicine and Dentistry of New Jersey, Joint Graduate Program of Toxicology. She then joined DuPont, where she has held positions as a senior research toxicologist and global regulatory toxicologist. She certified as a Diplomate of the American Board of Toxicology in 1991, and was a member of the board from 2007–2011, serving as Examination Chair, President, and Vice-President of the Board. She has been a member of the AVMA, Mid-Atlantic Society of Toxicology, Society of Toxicology, and served as a Councilor for the SOT Comparative and Veterinary Specialty Section.
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.
Amy L. Roe, PhD, DABT
Dr. Amy L. Roe received her PhD in Toxicology from the University of Kentucky in 1997. She completed a two year Postdoctoral Fellowship at the University of Cincinnati under the guidance of Dr. Daniel Nebert. In 1999, Dr. Roe joined Procter & Gamble (P&G) Pharmaceuticals to lead the in vitro metabolism group within the Drug Disposition Section. Her current position is in the Personal Health Care division at P&G. Dr. Roe has over twenty years of experience in studying drug/xenobiotic disposition, descriptive and regulatory toxicology, and risk assessment. Her current work is heavily involved in developing a common framework approach for assessing potential herb-drug interactions. She is a member of the Society of Toxicology and a Past President of the Ohio Valley Society of Toxicology. Dr. Roe is also an Adjunct Assistant Professor at the University of Cincinnati, Department of Environmental Health. She became a DABT in 2007.
J. Craig Rowlands, PhD, DABT
Dr. J. Craig Rowlands is a Senior Scientist at The Dow Chemical Company’s Toxicology and Environmental Research and Consulting Organization (TERC). He advises Dow businesses on their toxicology and risk assessment needs with a goal towards sustainable chemistry. Dr. Rowlands has a leadership role in the TERC Science and Research activities, directing the TERC Strategic Research Program that focuses on refinement and development of current and future toxicology testing and risk assessment capabilities, and directs his own research program on environmental pollutants and applied research in chemical risk assessment. Dr. Rowlands is an adjunct professor at Michigan State University, Center for Integrative Toxicology and holds leadership positions in the Society for Toxicology, the American Chemistry Council, and the International Life Sciences Institute, Health and Environmental Science Institute. Dr. Rowlands completed his PhD in Toxicology at Texas A&M University and performed postdoctoral research in molecular endocrinology at the Karolinska Institute in Stockholm, Sweden. Prior to coming to Dow, Dr. Rowlands worked at the US FDA. Dr. Rowlands is a Diplomate of the American Board of Toxicology (DABT) and a Fellow of the American College of Nutrition (FACN).
John E. Snawder, PhD, DABT
John E. Snawder is research toxicologist serving as the Leader of the Biomonitoring Research Team at the National Institute for Occupational Safety and Health. He received a Bachelor of Science in Zoology from the University of Louisville and he received his Masters of Science (1987) and PhD (1990) degree from Mississippi State University. He did his postdoctoral work in the National Center for Toxicological Research working on the role of variation in hepatic metabolism on drug toxicity and also the development of immunochemical assays to detect metabolites and molecular adducts. From 1992–2001 he worked at NIOSH as a research toxicologist. He continued his research on the role of metabolic variation on xenobiotic metabolism and collaborated with the US Air force, US Veterans Administration, Environmental Protection Agency and the University of Kentucky, College of Pharmacy to investigate genetic and patho-physiological mechanisms that play a role in hepatic metabolism and hepatotoxicity. In addition, he worked on the EMF-Rapid program, and continued to develop immunological tools for biological monitoring of inflammation, P450 phenotyping, hepatic and renal toxicity, stress protein response and biomarkers of exposure. From 2001 to present he has been in his present position. Dr. Snawder and colleagues are three-time recipients of the Alice Hamilton Award for Occupational Health and Safety Research. His present research is focused on the development of rapid, multiplexed immunoassays for biological monitoring and the design and application of direct reading instruments and methods and conducting exposure assessment and biomonitoring research for the NIOSH Health Hazard Evaluation Program as well as field studies on chemical exposures in oil and gas workers, asphalt paving workers, nanotechnology workers, military personnel and first responders. Dr. Snawder served on the Board of Directors of the American Board of Toxicology from 2008–2012. He served on the Risk Assessment Working Group of the CWA Demilitarization Program, the Chemical Laboratory Inter-Agency Group for Terrorism Response and was a member of the Chemical, Biological Organisms and Biotoxin Work Groups for preparation of EPAs SAM 3-5; he is a member of the CDC Emergency Deployment Program, the Greater Cincinnati Hazardous Materials Unit, Northern Kentucky Regional Hazmat and Grant County, Kentucky Emergency Management.
Raymond York, PhD, DABT, ATS, ERT
Dr. Raymond York is a formally trained toxicologist with 30 years of research experience. He earned his PhD in Toxicology at the University of Cincinnati and completed a two-year postdoctoral fellowship at Children’s Hospital’s Institute for Developmental Research in Cincinnati. He was board-certified as a Diplomate of the American Board of Toxicology in 1986 and has served four years on its Board of Directors. He is certified as a European Registered Toxicologist (2006) and as a Fellow of the Academy of Toxicological Sciences, as well as a Fellow for Toxicology Excellence for Risk Assessment. He has served as a study director on over 700 safety evaluation studies and published over a 100 manuscripts, review articles, book chapters, and abstracts.
Dr. York has been a member of the Society of Toxicology (SOT) since 1985 and the American College of Toxicology since 1998. He is currently President of the Reproductive and Developmental Toxicology Specialty Section of SOT. He has served as President of the Middle-Atlantic Regional Chapter (MASOT; 2012), the Midwest Teratology Association (MTA; 1989) and Mid- Atlantic Reproduction and Teratology Association (MARTA; 2004). Dr. York has been a member of the Teratology Society since 1984.
He has served as a reviewer for Toxicology and Applied Pharmacology and International Journal of Toxicology and as a member of the Editorial Board of Fundamental and Applied Toxicology. Dr. York is a peer consultant for assessment of the potential health-effect risks for a number of consulting and legal firms and recently served on a US Food and Drug Administration GRAS Panel for a food additive. Currently, he is on an US Environmental Protection Agency SAB panel for trimethylbenzene and an adjunct professor teaching Human Anatomy & Physiology at a college in Syracuse, New York.