eLearning Seminar
Basic Topics in Toxicology

Speaker Bios

Amy M. Avila, PhD

Dr. Avila earned her Bachelor of Science degree in Biochemistry from the University of Delaware. She then received her PhD in pharmacology from Georgetown University, with a focus in neuropharmacology. Her thesis research involved the study of neuronal nicotinic acetylcholine receptors and their functional regulation by nicotine and nerve growth factor. After receiving her PhD, she conducted postdoctoral research at the National Institute of Neurological Disorders and Stroke at the National Institutes of Health. She worked in the Neurogenetics Branch studying the neuromuscular disease Spinal Muscular Atrophy and investigating possible pharmacological therapies using cell-based models and transgenic mouse models. In 2006, Dr. Avila joined the Food and Drug Administration where she is currently serving as a pharmacologist/toxicologist reviewer in the Division of Psychiatry Products in the Center for Drug Development and Research (CDER). She is an active member of the Committee for Advanced Scientific Education in CDER, was a member of the Education Subcommittee of the Pharmacology/Toxicology Coordinating Committee and has contributed to the development of a training course for new pharmacologist/toxicologist reviewers. Her areas of interest are psychopharmacology, and assessment of seizures in nonclinical drug development.

Lorrene A. Buckley, PhD, DABT, ATS

Dr. Buckley is a board-certified toxicologist with over 30 years of experience in the active practice of toxicology. She earned her Masters degree in Toxicology at the University of Arizona and a doctorate, also in Toxicology, at the University of North Carolina in Chapel Hill in collaboration with the laboratories of the National Institute of Environmental Health Sciences and the US Environmental Protection Agency.

Dr. Buckley’s diversity of professional experience as a toxicologist is reflected in her work spanning basic and applied toxicology research and risk assessment in the industrial chemical, agrochemical, and pharmaceutical industries. In her current position as a Senior Research Fellow at Eli Lilly & Company, she is responsible for the design and execution of nonclinical safety assessment programs, including general and other toxicology studies, as well as for nonclinical aspects of global regulatory submissions and interactions for a variety of drugs in the development and commercialization phases. Dr. Buckley has authored the pharmacology/toxicology sections of numerous regulatory documents including briefing documents, INDs/IMPDs, BLAs/NDAs, investigator brochures, annual reports, as well as safety information on product labels/package inserts.

Dr. Buckley has also authored numerous journal articles and book chapters concerning the toxicologic assessment of environmental contaminants as well as approaches to pharmaceutical safety assessment. She has served on the Boards of the American Board of Toxicology (ABT) and on the Academy of Toxicological Sciences (ATS), and on the Councils of the American College of Toxicology (ACT) and the Society of Toxicology (SOT). She is board certified by the ABT and is a Fellow of the ATS.

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 EPA 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.

A. Wallace Hayes, PhD, DABT, ATS, FIBiol, FACFE, ERT

Dr. Hayes is a toxicologist with over 35 years of experience in industry and academics. He holds degrees from Auburn University (PhD and MS) and Emory University (AB). Dr. Hayes was a NSF predoctoral fellow at Auburn University, a NIH individual postdoctoral fellow at the Vanderbilt University School of Medicine, a NATO Senior Scientist at the Central Veterinary Laboratory in Weybridge, England and held a NIH Research Career Development Award.

Dr. Hayes has held tenured Professorships at the University of Alabama, the University of Mississippi Medical Center and Wake Forest University School of Medicine. Dr. Hayes has served on committees and expert panels for the National Academy of Sciences, the National Institutes of Health, the Environmental Protection Agency and the Department of Defense. Dr. Hayes has served on a number of GRAS Expert Panels. He currently serves on the US FDA Food Safety Committee.

Dr. Hayes has authored more than 225 peer-reviewed publications, is the editor of Hayes’ Principles and Methods of Toxicology, 6th edition, Human and Experimental Toxicology, Cutaneous and Ocular Toxicology and co-editor of the Target Organ Toxicity Series. He is the Editor-in-Chief, Food and Chemical Toxicology. Dr. Hayes is a past Secretary-General of IUTOX (two terms), past treasurer and board member of the American Board of Toxicology, a past president of the American College of Toxicology, the Toxicology Education Foundation, and the Academy of Toxicological Sciences and a past member of the council of the Society of Toxicology. Dr. Hayes is a diplomate of the American Board of Toxicology, the Academy of Toxicological Sciences, the American Board of Forensic Medicine, and the American Board of Forensic Examiners. He is a Fellow of the Academy of Toxicological Sciences, the Institute of Biology (UK), the American College of Forensic Examiners and the American College of Nutrition. Dr. Hayes is a registered toxicologist in the European Union (ERT) and a certified nutrition specialist (food safety). Dr. Hayes was honored by the Society of Toxicology in 2006 with the Society’s Merit Award, by the Mid-Atlantic Society of Toxicology with its Ambassador Award in 2012, by the American College of Toxicology in 2012 with its Distinguished Scientist Award and by the International Dose-Response Society in 2013 with its Outstanding Leadership Award. Dr. Hayes was named a Distinguished Fellow by the American College of Toxicology in 2013.

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.

Debie J. 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 started her career at GlaxoSmithKline where she held a variety of roles in Medicine Safety. She was responsible for the nonclinical product development strategy and execution as well as regulatory interactions and submissions for new therapeutic entities. She then joined Boehringer-Ingelheim Pharmaceuticals where she functioned in several diverse roles including therapeutic product development and toxicology operations. Dr. Hoivik currently works at Akebia Therapeutics where she has oversight for the nonclinical safety team. Dr. Hoivik has authored five invited book chapters and 29 publications. She has served ACT and SOT in a variety of roles as well as 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 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.

Timothy McGovern, PhD

Dr. Timothy McGovern is a co-founder and Principal Consultant of White Oak Regulatory Tox, LLC, where he provides advice to pharmaceutical companies related to all aspects of nonclinical programs intended to support pharmaceutical drug development from first in human clinical trials to marketing applications. He is a Past President of ACT and has supported ACT in a variety of activities including serving as a President, Secretary, Councilor, and coordinator of the Toxicology for Pharmaceutical and Regulatory Scientists course.

Dr. McGovern recently completed a 22-year career at the US Food and Drug Administration (FDA) where he spent the past 11 years as an Associate Director for Pharmacology and Toxicology in the Office of New Drugs (OND) of the Center for Drug Evaluation and Research (CDER). He served as a member of the Pharmacology/Toxicology Senior Leadership Team within OND and was responsible for the development of policy and guidance related to nonclinical and regulatory issues including FDA and International Council for Harmonization (ICH) guidance initiatives. He was also a standing member of CDER’s Executive Carcinogenicity Assessment Committee as well as CDER’s Genetic Toxicology and Pharmacology/Toxicology Education Subcommittees.

Dr. McGovern was a member of multiple ICH Expert Working Groups including S1B (Testing for Carcinogenicity of Pharmaceuticals), M7 (DNA reactive impurities), Q3C (Residual Solvents), and Q3D (Elemental Impurities), serving as Topic Lead and Rapporteur. Dr. McGovern was also a member of CDER’s Task Force on Nitrosamines in Drug Products providing nonclinical expertise in developing policies, addressing clinical safety issues, and interacting with other Drug Regulatory Agencies and Industry stakeholders. He participated in drafting FDA’s Guidances “Control of Nitrosamine Impurities in Human Drugs” and “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)” and served as Chair of the CDER Pharm/Tox Nitrosamines Working Group.

Dr. McGovern earned a doctorate degree in inhalation toxicology from New York University and first joined OND’s Division of Pulmonary and Allergy Products (DPAP) as a primary reviewer. He later supervised review teams in DPAP as well as the Division of Anesthetic and Critical Care Products.

Mark Powley, PhD

Mark received a PhD in toxicology from Purdue University and completed postdoctoral training at the University of North Carolina. He was subsequently employed in the pharmaceutical industry where his responsibilities included serving as study director, providing toxicokinetic support, and contributing to in silico evaluations for predicting mutagenicity. In 2009, Mark moved to US FDA Center for Drug Evaluation and Research (CDER) where he currently works as a pharmacology/toxicology reviewer in the Office of New Drugs (OND). In addition to reviewing nonclinical data, Mark is involved with the Computational Toxicology Consultation Service and co-chairs the CDER Pharmacology/Toxicology Genetic Toxicology and Computational Toxicology Subcommittees. He is also a past Chair of the Genetic Toxicology Association Board of Directors.

Brian M. Roche, PhD, DSP, DABT

Dr. Brian Roche is the General Manager at Charles River Laboratories' Kansas site. He has more than 25 years of experience in preclinical drug development, through multiple roles, with a focus on conducting research from early pharmacology through GLP safety pharmacology studies. In his previous role as the Executive Director of Global Safety Pharmacology at Charles River Laboratories, he provided scientific expertise and leadership on behalf of the Global Safety Pharmacology portfolio.

Dr. Roche received his doctorate in cardiovascular physiology from Ohio State University in 2000 under the mentorship of Dr. Robert Hamlin. He continued his education at Ohio State as a postdoctoral research fellow until 2002. He is an active member of the international scientific community and served as President of the Safety Pharmacology Society in 2021.

Dr. Roche is dual boarded as both a Toxicologist (DABT) and Safety Pharmacologist (DSP), has published 25 peer-reviewed scientific papers and a book chapter.