= Members Only
Practical Reproductive and Developmental Toxicology
Hugh A. Barton, PhD
Dr. Hugh A. Barton is Associate Research Fellow with Biomedicine Design, Worldwide Research and Development, Pfizer Inc. where he is a modeler for preclinical ADME/Safety translational sciences. His focus in drug discovery has been on the application of systems pharmacology and toxicology modeling, physiologically based pharmacokinetic (PBPK) modeling, and pharmacokinetic pharmacodynamic (PKPD) modeling to oncology, cardiovascular and metabolic disease, and neurodegenerative diseases. He has more than 20 years’ experience in biological modeling, including nine years with the US EPA, developing computational models for use in biologically based dose-response analyses for chemical risk assessment. In addition to positions in government and industry, Dr. Barton has been adjunct professor at Boston University School of Public Health and in Toxicology at The University of North Carolina–Chapel Hill. He received a BS in Life Sciences from the Massachusetts Institute of Technology, Cambridge, MA in 1982 and a PhD in Toxicology from the Department of Applied Biological Sciences at MIT in 1988 working with Dr. Michael A. Marletta. Dr. Barton is Past-President of the Risk Assessment Specialty Section of the Society of Toxicology, and previously was President of the Biological Modeling Specialty Section. He has served as an invited peer reviewer for Health Canada, NIEHS, US EPA, and TERA. He is a member of the US EPA Science Advisory Board’s Chemical Assessment Advisory Committee, the NRC Committee on Inorganic Arsenic, and previously he served on the WHO IPCS PBPK Modeling Working Group. He is a reviewer for numerous scientific journals and serves on two editorial boards. Dr. Barton has published more than 50 articles in the scientific literature on physiologically based pharmacokinetic and pharmacodynamic modeling and received awards from US EPA and others for that work and its applications in pharmaceutical safety and risk assessment.
Christopher J. Bowman, PhD, DABT
Dr. Christopher J. Bowman completed his PhD in 2001 from the University of Florida Interdisciplinary Program in the Biomedical Sciences-Physiology/Pharmacology concentration; with a specialty in Toxicology. For the next two years as a postdoctoral fellow at CIIT, Centers for Health Research he worked on endocrine, reproductive, and developmental toxicology studies of antiandrogens. After his postdoctoral fellowship, Chris worked at WIL Research Laboratories as a Senior Toxicologist for almost five years where he served as a GLP study director on all manner of developmental and reproductive toxicity (DART) studies, including juvenile animal studies. In this position, Chris worked with several different chemical, industrial, pharmaceutical, and biotechnology companies to design, conduct, and interpret DART studies. Since 2008, Chris has been part of the senior staff in the Pfizer DART group and has been actively involved in regulatory and investigative strategies evaluating DART and nonclinical support of pediatric development. In addition to serving as a DART subject matter expert, Chris has also served and is currently serving as a drug safety representative on clinical phase drug development teams, including a monoclonal antibody and a therapeutic vaccine. Chris has also co-mentored a Pfizer summer intern and a postdoctoral fellow in DART. Over the past 15 years Chris has chaired sessions, presented, and participated at meetings of the Teratology Society, European Teratology Society, Society of Toxicology (SOT), BioSafe (part of BIO), Mid-Atlantic Regional Teratology Association (MARTA), ILSI-HESI (DART), and several regional meetings as well as being a guest lecturer at University of Rhode Island and participation on the International Council on Harmonization S5(R3) Expert Working Group. He is currently President of the Reproductive and Developmental Toxicology Specialty Section of SOT and a member of the BioSafe Leadership Committee. Chris was Board certified in Toxicology (Diplomate of the American Board of Toxicology) in 2005 and recertified in 2010 and 2015. Chris has over 35 publications in peer-reviewed journals and numerous book chapters. He has been and continues to be an enthusiastic leader and member of several industry working groups tackling various challenges associated with DART study strategy, design, interpretation, and human risk assessment.
Justin M. Conley, PhD
Dr. Justin Conley received his BS in Environmental Science and Biology from Warren Wilson College in Asheville, NC and MS in Environmental Science from the University of Tennessee–Chattanooga. He completed his PhD in Environmental Toxicology from North Carolina State University in 2014. Currently, he is a postdoctoral toxicologist in the Reproductive Toxicology Branch at the US EPA in Research Triangle Park, NC where he conducts in vitro and in vivo experiments on endocrine disrupting compounds, both individually and as mixtures, in the laboratories of Dr. Vickie Wilson and Dr. Earl Gray. His research primarily focuses on the effects of anti-androgenic chemicals on male reproductive tract development and the use of in vitro steroid hormone receptor assays as water quality monitoring tools to detect endocrine activity.
John M. DeSesso, PhD
Dr. John DeSesso is a Principal Scientist and the Director of the Alexandria Office for Exponent, a scientific and engineering consulting company. He received his AB in chemistry from Hamilton College and earned his doctorate in Anatomy and Teratology from the Medical College of Virginia, Virginia Commonwealth University. Dr. DeSesso has 40 years of postdoctoral experience specializing in the areas of developmental and reproductive toxicology, general toxicology, risk assessment, and human health effects of environmental agents and pharmaceuticals. His research interests include normal and abnormal development, with emphasis on the mechanisms by which chemical and physical agents influence developing organisms. He has published over 100 papers and chapters, two of which were selected as the Outstanding Published Paper Demonstrating an Application of Risk Assessment by the Risk Assessment Specialty Section of the Society of Toxicology. Dr. DeSesso was elected President of the Teratology Society, MARTA, and the Risk Assessment Specialty Section of the Society of Toxicology. He has been an ad hoc reviewer for more than 40 toxicology-related journals and has served on the editorial board of Reproductive Toxicology. He has trained four doctoral and one masters student. He is currently an adjunct Professor of Biochemistry and Cellular, and Molecular Biology at Georgetown University School of Medicine where he has taught embryology, teratology, and anatomy for over 30 years. He has been honored with numerous teaching awards including five Golden Apple (best teacher of the year) awards from Georgetown University School of Medicine, the Geza M. Illes award for outstanding teaching in Gross Anatomy, and the Narsingh Agnish Fellowship from the Teratology Society.
Jamie DeWitt, PhD, DABT
Dr. DeWitt is an Associate Professor in the Department of Pharmacology & Toxicology in the Brody School of Medicine at East Carolina University. Her research program explores relationships between biological organisms and their responses after exposure to environmental contaminants with a specific focus on the immune system and its interactions with the nervous system during development and adulthood. Dr. DeWitt’s research program has a particular focus on emerging environmental contaminants, especially per- and polyflouroalkyl substances (PFAS). She received doctorate degrees in Environmental Science and Neural Science from Indiana University-Bloomington and completed postdoctoral training in immunotoxicology at the US Environmental Protection Agency in partnership with the University of North Carolina at Chapel Hill. She is the author or co-author of 36 peer-reviewed articles, 11 reviews/commentaries, and 12 book chapters. She edited the first comprehensive book on PFAS toxicity, is the co-editor of a book on immunotoxicity testing, and is series editor for Molecular and Integrative Toxicology. She has been active in the Society of Toxicology since graduate school and she is the current president of the Immunotoxicology Specialty Section and serves on the CRAD as well as the SS-CCG. She also has served as the postdoctoral representative, counselor, and vice-president of the Immunotoxicology Specialty Section and is a past president of the North Carolina Regional Chapter.
Gerald B. Grunwald, PhD
Gerald B. Grunwald, PhD, Dean of the Jefferson College of Biomedical Sciences. A Jefferson faculty member since 1985, Dr. Grunwald assumed his current position in September 2010. In addition to serving as Dean of JCBS, he is currently tenured Professor in the Department of Pathology, Anatomy, and Cell Biology, in the Sidney Kimmel (formerly Jefferson) Medical College. Dr. Grunwald was born in Brooklyn, NY and attended public schools there and later in Port Washington, NY. He received his BA cum laude in Biology from Cornell University and his MS and PhD in Zoology from the University of Wisconsin. Prior to joining Jefferson, he was engaged in postdoctoral studies as a Senior Staff Fellow at the National Institutes of Health.
As Dean of the Jefferson College of Biomedical Sciences, Dr. Grunwald serves as the chief academic and administrative officer of the school, with responsibility for the planning and execution of its education and training mission. Dr. Grunwald has been active in research and training in the field of cell and developmental biology of the eye. His work has been published in over fifty peer-reviewed papers and invited book chapters, with research support provided primarily by the National Eye Institute of the NIH. His laboratory has served as a training venue for many graduate students and postdoctoral fellows. He has served on numerous research grant review panels for federal and private agencies, including as Chair of the Visual Sciences C study section of the NIH. Additional research recognition has included his election as Chair of the Gordon Conference on Cell Contact and Adhesion and appointment to a Burroughs Wellcome Visiting Professorship.
Dr. Grunwald has a strong record as an academic leader and his commitment to education is well recognized by students and senior administrators alike. In his thirty years at Jefferson, he has been instrumental in the development and delivery of educational and training programs in both the Sidney Kimmel Medical College as well as the Jefferson College of Biomedical Sciences. He has served as director of MS and PhD graduate programs, as director of numerous graduate and medical college courses, and in development of policies for postdoctoral training. Recognition of his role in education has included the Lindback Foundation Award for Distinguished Teaching, Honorary Life Membership in the Jefferson College of Biomedical Sciences Alumni Association, the Dean’s Citation for Significant Contributions to the Advancement of Education at Jefferson Medical College, the Faculty Award for Neuroscience Education of the PhD Program in Neuroscience, the Distinguished Mentor Award of the Jefferson Postdoctoral Association and Office of Postdoctoral Affairs, the Teacher of the Year Award from the Freshman Class of Sidney Kimmel Medical College, and the SKMC Senior Class Portrait in 2014.
Dr. Grunwald has served on and chaired numerous committees within JCBS and SKMC, and is currently chair of the university’s Institutional Biosafety Committee and the Committee on Conflict of Interest and Commitment. He has also served as chair of the SKMC Committee on Research, and has held leadership positions on several committees dealing with accreditation and strategic planning efforts.
Alan M. 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.
Michael Hsieh, MD, PhD
Michael Hsieh, MD, PhD, is a urologist at Children’s National Health System. Dr. Hsieh has experience in laparoscopic and robotic surgery for urologic conditions, and specializes in bladder diseases affecting children and young adults. He is board certified in urology and holds the certificate of added qualification in pediatric urology.
Dr. Hsieh was recruited to Children’s National and the George Washington University to serve as Director of Transitional Urology. This joint venture is the East Coast’s first clinical program dedicated to the care of adolescents and young adults with congenital urologic disorders. Many of these patients have chronic cystitis and are at increased risk of bladder cancer, diseases which dovetail with Dr. Hsieh’s research interests. Dr. Hsieh also is the Stirewalt Endowed Director of the Biomedical Research Institute near Children’s National’s satellite facilities in Rockville, MD, where he runs a bladder biology research group and is developing a broader microbiology research program across multiple laboratories.
Dr. Hsieh has been a Recognized Doctor on the Healthgrades Honor Roll and Best Doctors in America. He has been featured several times in the New York Times for his work in robotic surgery and bladder inflammation.
He attended Stanford University and returned to the East Coast for medical school at Thomas Jefferson University. During medical school, Dr. Hsieh also obtained a PhD in immunology and afterwards began exploring what would eventually become his long-term interest—the role of bladder inflammation in urinary tract infections and development of bladder cancer. He completed his urology residency training at the University of California–San Francisco and pediatric urology fellowship training at Texas Children’s Hospital. As a pediatric urology fellow, Dr. Hsieh began studying how the commensal microbiome, the collection of naturally occurring, nonpathogenic bacteria in and on our bodies, may prevent urinary tract infections. Following fellowship training, he was an Assistant Professor at Stanford University, where he founded an NIH-funded research group focused on bladder inflammation, urinary tract infections, and bladder cancer. Dr. Hsieh was the Administrative Director for Stanford’s Children’s Hospital Prenatal Urology and Minimally Invasive Surgery Programs.
E. Sid Hunter III, PhD
Dr. Sid Hunter is Chief of the Systems Biology Branch, Integrated Systems Toxicology Division, National Health and Environmental Effects Research Laboratory (NHEERL) in the Office of Research and Development in the US Environmental Protection Agency (US EPA). Dr. Hunter earned a BS in Chemistry and MS in Toxicology. His PhD is in Anatomy and Embryology from the University of North Carolina–Chapel Hill, and he joined the Reproductive Toxicology Division of NHEERL at US EPA in 1993 as a Research Toxicologist. He presently holds an appointment of Faculty Affiliate at University of North Carolina–Chapel Hill in the Toxicology Curriculum.
Dr. Hunter’s research interests and activities have focused on understanding the mechanisms responsible for chemically-induced developmental toxicity. He used the whole embryo culture technique to study neural tube closure and early craniofacial development and evaluated the morphological, metabolic, transcriptional, and proteomic effects of chemicals. The Hunter lab used an adherent mouse embryonic stem cell culture model to evaluate the effects of ToxCast compounds and selected chemical libraries on stem cell differentiation and proliferation. These data are being used to determine signaling pathways important in embryogenesis and stem cells. As part of the US EPA’s virtual tissues research program, the Hunter lab is working to establish organotypic culture models of early human heart and neurovascular development to evaluate chemical effects and contribute to the creation of computer and predictive models of chemical effects on human development.
Aileen Keating, PhD, MS
Dr. Keating is an Associate Professor at Iowa State University, where she conducts research on the impact of chemical exposures on female reproductive health. She received her doctorate in Biochemistry from the National University of Ireland, Galway in 2003 and was a postdoctoral fellow at the University of Alberta from 2004–2006, and the University of Arizona from 2006–2010. She has served on the Trainee Affairs Committee and the Committee on Reproduction and the Environment for the Society for the Study of Reproduction. She is author or co-author of 47 peer-reviewed articles, nine review papers and eight book chapters. She has been a member of the Society of Toxicology since 2006 and has served the SOT in the following capacities: Counselor for the Central States chapter of SOT (CS-SOT; 2011–2012), CS-SOT President (2012–2014) and Early Career Counselor for the RDTSS (2014–2016). In 2016, she was the administrator of the RDTSS Angelo Furgiele Young Investigator Technology Award Fund. She organized and chaired the 2013 CS-SOT chapter meeting in Ames, Iowa. She has also served twice as the early career reviewer for the National Institutes of Health, Cellular Molecular and Integrative Reproduction (CMIR) study section. Her research investigates: 1) the mechanisms by which ovotoxicants compromise ovarian function; 2) the ovarian protective response to ovotoxic xenobiotic exposures; and 3) the ovarian biotransformation processes that contribute to ovotoxicity. The ultimate aim of these studies is to minimize female reproductive dysfunction that is a consequence of ovotoxic chemical exposures.
Thomas B. Knudsen, PhD
Thomas B. Knudsen, PhD (Thomas Jefferson University, 1981) is a Developmental Systems Biologist at the US Environmental Protection Agency’s National Center for Computational Toxicology. He is a member of the ToxCast research team and lead of the Virtual Tissue Models research project, focusing on multi-scale systems models to integrate high-throughput screening data with extant biological knowledge of embryogenesis for predictive/mechanistic modeling of developmental toxicity.
Susan B. Laffan, PhD
Dr. Susan Laffan is currently in the Reproductive Toxicology group of Mechanistic Safety and Disposition at GlaxoSmithKline (GSK); she has over 11 years of pharmaceutical industry experience. She is PhRMA representative as a topic expert to the ICH S11 work group. Within GSK, she is a head of the Nonclinical Pediatric Advisory Panel and serves as a nonclinical representative on GSK’s Medicine for Children Advisory Network. In these roles, she has a direct influence and impact on several pediatric drug development plans, reviews regulatory documents and nonclinical study reports and writes internal guidance documents. In 2012, Susan co‑authored a book chapter titled: “Approaches to Nonclinical Juvenile Toxicity Studies in the Rat” in Nonclinical Pediatric Drug Development. She is an invited speaker on the topic of juvenile toxicity for the Society of Toxicology, American College of Toxicology and the Mid‑Atlantic Reproduction and Teratology Association (MARTA); often representing the pharmaceutical industry alongside government representatives. Susan was recently invited on the SOT Speaker Bureau for her continuing education course on nonclinical juvenile toxicity study designs and participated in the drafting of the ICH S11 concept paper. She is a past president of MARTA. She has been directly involved in the conduct of several rodent juvenile toxicity and investigative studies as the study director. Susan received undergraduate degrees at the University of Wisconsin in Madison in chemistry and business and a doctorate in toxicology from the University of North Carolina at Chapel Hill. She conducted her dissertation research at the US Environmental Protection Agency, Reproductive Toxicology Division.
Robert Lipinski, PhD
Dr. Robert Lipinski is an Associate Professor in the Department of Comparative Biosciences in the School of Veterinary Medicine at the University of Wisconsin. He received his BS in Biology and PhD in Molecular and Environmental Toxicology from the University of Wisconsin, followed by postdoctoral training in embryology with Dr. Kathleen Sulik at the University of North Carolina at Chapel Hill. Dr. Lipinski’s research program investigates the interaction of genetic and environmental factors in etiologically complex craniofacial birth defects, including cleft lip and palate, and holoprosencephaly. These studies focus in part on the Sonic Hedgehog signaling pathway, which is required for morphogenesis of the forebrain and face and sensitive to both genetic and environmental disruption. In addition to research, Dr. Lipinski directs a Developmental Anatomy course for first year DVM students and teaches developmental toxicology in the Molecular and Environmental Toxicology graduate curriculum at the University of Wisconsin.
Anna B. Lowit, MS, PhD
Dr. Anna B. Lowit received her PhD in Environmental Toxicology from the University of Tennessee in 1998 where she was a Graduate Fellow in Sustainable Waste Management. Dr. Lowit began her career with US EPA in 1998 with the Office of Pesticide Programs, where she remains today. Dr. Lowit is currently the Senior Science Advisor at the US EPA’s Office of Pesticide Programs where she advices senior managers and leads multidisciplinary teams on a variety of cross-cutting topics. She is currently one of the Co-Chairs of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM is composed of representatives from 15 US Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information and whose purpose is to promote and facilitate the 3Rs of toxicity testing (reduce, refine, replace) in regulatory toxicity testing. Dr. Lowit has extensive experience in developing cumulative risk assessments for groups of pesticides which share a common mechanism of toxicity (e.g., organophosphates, N-methyl carbamates). She also has interest in the integration of science along multiple lines of evidence (epidemiology, in vivo and in vitro experimental toxicology). She has particular interest in improving the use of quantitative approaches in human health risk assessment such as use of meta-analysis in deriving benchmark dose estimates and linking PBPK models with probabilistic exposure models.
Susan L. Makris, MS
Susan Makris received her undergraduate degree in Genetics from the University of Wisconsin and her graduate degree in Environmental Toxicology from American University in Washington, DC. Between 1974 and 1991, she gained technical and managerial experience in developmental and reproductive toxicology at several CROs. In 1991, Susan joined the US Environmental Protection Agency. She served from 1991–2004 as a senior toxicologist in the Office of Pesticide Programs, where she evaluated hazard and risk characterization for numerous pesticides and participated as a member of Health Effects Division peer review committees. In 2004, she joined the US EPA Office of Research and Development, National Center for Environmental Assessment, where she is currently a senior staff scientist in human health risk assessment. Her regulatory career has focused on developmental and reproductive toxicity testing and risk assessment guidelines, guidance, and policy, with an emphasis on issues relevant to the evaluation of pre- and postnatal developmental toxicity and children’s health risk assessment. She maintains an active role in US EPA scientific and regulatory activities, providing leadership on multiple committees and projects, and has served on advisory committees and working groups for other Federal Agencies and international organizations. Over her career, she has received nearly two dozen US EPA distinguished-service medals and awards, she has served as an invited speaker at numerous conference events, and she has a broad catalog of publications and book chapters in her portfolio. Susan is a participating member of the Teratology Society, European Teratology Society (ETS), Developmental Neurotoxicology Society (DNTS), MidAtlantic Reproduction and Teratology Association (MARTA), Society of Toxicology (SOT), Society for Risk Analysis (SRA), and ILSI/HESI Developmental and Reproductive Toxicology (DART) Technical Committee.
Aldert Piersma, PhD
Aldert H. Piersma PhD is a professor of reproductive toxicology at the Institute for Risk Assessment Sciences (IRAS) of Utrecht University in the Netherlands since 2007, and is employed as a senior scientist at the National Institute for Public Health and the Environment (RIVM) in the Netherlands since 1988. His work combines fundamental research in reproductive toxicology with advisory work in national and international advisory committees, such as of the Dutch Health Council, EU, OECD, and WHO. Main theme is the innovation of hazard and risk assessment methodology in reproductive and developmental toxicology, including the design and implementation of animal-free alternative methods and molecular and computational approaches towards mechanism of action based understanding of toxicity. He is known for his work on alternatives to animal testing in developmental toxicology, using animal-free assays with embryonic stem cell lines, as well as zebrafish and rat embryos. He applies molecular approaches to understand mechanisms of action and to identify adverse outcome pathways, facilitating the understanding, and implementation of alternative methods. He also invests in the design of alternative testing strategies, combining assays, and applying computational systems toxicology approaches to enhance the prediction of developmental toxicity and to reduce and replace animal use in chemical and pharmaceutical risk assessment. He published over 200 original scientific papers, over 300 abstracts and around 10 book chapters. He is associate editor of Reproductive Toxicology.
John M. Rogers, PhD
Dr. John Rogers is the Director of the Toxicity Assessment Division, National Health and Environmental Effects Research Laboratory, US Environmental Protection Agency, Research Triangle Park, NC. Prior to that he served as Chief of the Developmental Biology Branch, and he has been with US EPA for 32 years. Dr. Rogers is also a graduate faculty affiliate in the Curriculum in Toxicology, University of North Carolina–Chapel Hill, and Adjunct Professor at North Carolina State University College of Veterinary Medicine. He received his PhD in Biology from the University of Miami (FL), and was a National Eye Institute postdoctoral fellow at the University of California–Davis. Dr. Rogers’s research addresses mechanisms of abnormal development, including maternally-mediated developmental toxicity, maternal nutrition, and the developmental origins of health and disease. Dr. Rogers is a past president of the Teratology Society, a member of the Society of Toxicology (SOT), past president of the Reproductive and Developmental Toxicity Specialty Section of SOT, and a member of the International Society for Developmental Origins of Health and Disease (DOHaD). Dr. Rogers has published over 125 peer-reviewed papers, invited reviews and book chapters, and has edited two books. Dr. Rogers has received 13 US EPA Scientific and Technical Achievement Awards for his published works and three Bronze Medals for service to US EPA. He has two sons and a step-daughter, and lives with his wife in Raleigh.
Donald G. Stump, PhD, DABT
Dr. Stump earned a BS in toxicology from the Philadelphia College of Pharmacy and Science (1985). In addition, Dr. Stump received a PhD in biochemistry from Vanderbilt University (1990) and postdoctoral training at the National Institutes of Health. He is employed at Charles River Laboratories–Ashland and his current title is Senior Director, Toxicology. In this role, he oversees the General Toxicology, Developmental and Reproductive Toxicology, and Pharmacology and Discovery Services departments. Dr. Stump has published numerous research articles, book chapters, and abstracts. He has also made several presentations at regional and national meetings including meetings hosted by the American College of Toxicology, Society of Toxicology, Teratology Society, Korean Society of Nonclinical Study, and the North American Congress of Clinical Toxicology. He is currently on the journal editorial board for both Birth Defects Research and Congenital Anomalies. In addition, he is currently serving on the NTP Board of Scientific Counselors. He is a diplomate of the American Board of Toxicology (1999) and a member of the Teratology Society, the European Teratology Society, the Japanese Teratology Society, the Society of Toxicology, the American College of Toxicology, and the Japanese Society of Toxicology.
Charles V. Vorhees, PhD
Charles V. Vorhees, PhD, is Professor of Pediatric Neurology, Cincinnati Children’s Research Foundation & University of Cincinnati College of Medicine. He received his BA with Honors in Psychology/Biology from the University of Cincinnati and MA and PhD in Neurobiology from Vanderbilt University. He has worked on the developmental effects of anticonvulsants, amphetamines (methamphetamine, MDMA, fenfluramine, and “Foxy”), manganese, stress, PCBs, and pyrethroids and on genetic LOF models of Pde1b, Npas3, Lphn3, Slc6A8, Slc3010A, Lphn3, Cyp1a2, and others. He has served on advisory panels for NRC, US FDA, US EPA, and ILSI. He was a regular member of an NIH study section for four years and has served as an ad hoc member on 32 other study sections. He has also reviewed grants for US FDA, Oak Ridge National Laboratory, US EPA, Wellcome Trust, UK MRC, New Zealand, Israel, Ireland, Canada, March of Dimes, Azerbaijan, American Chemistry Council, NSF, and the VA. He has reviewed manuscripts for 78 different journals. He is a faculty member of graduate programs in Neuroscience and in Molecular & Developmental Biology. He has been advisor to 15 doctoral and 17 postdoctoral fellows. He teaches in graduate courses on neuroscience, teratology, pharmacology, and developmental biology. He has published >300 papers and book chapters and been funded by NIH, NSF, US FDA, and DOD and other sources for >35 years. He is PI of an NIH T32 training grant in its 40th year. He was Director of Graduate Studies for the Neuroscience Graduate Program for 4 years, and held positions in the Molecular and Developmental Biology Graduate Program for 15 years, including last six as Program Director. He was Editor-in-Chief of Neurotoxicology & Teratology for nine years and Section Editor for 12 years. He is a founding member of the Developmental Neurotoxicology Society and has served as President twice, and served as Treasurer, Finance, Constitution, and Nominations committees, on Council and is the current Secretary. He is a member of the Teratology Society (since 1977), Society for Neuroscience, Society of Toxicology, International Behavioral Neuroscience Society, and AAAS.
Tacey White, PhD
Dr. Tacey White is a Senior Consultant at Aclairo Pharmaceutical Development Group where she is the Lead for Developmental, Reproductive, and Juvenile Toxicology. She received her PhD in Toxicology from the University of Rochester and completed postdoctoral fellowships at the University of Rochester and Fox Chase Cancer Center. Dr. White has been a consultant since 2012, advising pharmaceutical and biotech companies on nonclinical safety assessment strategies, placing and monitoring studies, developing human risk assessments for toxicology issues, addressing regulatory questions, and contributing to regulatory documents. Dr. White has deep regulatory and investigative expertise in developmental and reproductive toxicity (DART), and juvenile toxicity, and assists clients with FDA Pregnancy Labeling (PLLR), and pediatric development plans for EMA (PIP) and FDA (PSP). Dr. White spent 14 years in the pharmaceutical industry where she was a DART study director, the director of an investigative DART laboratory, and a safety assessment project team representative. She was also Global Director of Small Animal DART at Covance Labs. Dr. White is a Past President of the US Teratology Society (Vice President: 2014–2015, President: 2015–2016), and actively participates in the ILSI/HESI DART working group, including co-organization of the FDA Pregnancy and Lactation Label Rule workshop (2015), and participation in the Neonatal Pediatric Therapeutics workgroup.