Advanced Comprehensive Toxicology Course

Dr. Udayan Apte is a tenured professor at the Department of Pharmacology, Toxicology and Therapeutics at University of Kansas Medical Center in Kansas City, KS. Additionally, he serves as the Associate Director of the University of Kansas Liver Center and the Director of the Cells, Tissues, Bioanalysis and Biostatistics (CTBB) Core of Kansas Center for Metabolism and Obesity (KC-MORE). He also serves as Scientific Advisor to SciQra LLC, a toxicology consulting firm. Dr. Apte’s NIH-funded research is focused on mechanisms of drug-induced liver injury and regeneration, and adverse effects of environmental contaminants on the liver. He has published over 115 original research articles, written several reviews and book chapters, and edited a book on Liver Regeneration. He has mentored numerous undergraduate students, 8 PhD students, 1 MS student, and several postdocs. He lectures PhD and medical students in toxicology and liver biology.

He is deeply involved in service to several Scientific organizations including the American Association for the Study of Liver Diseases (AASLD), Society of Toxicology (SOT), and American Society of Investigative Pathology (ASIP). He is a frequent member of several NIH study sections and grant review panels of other international funding agencies on liver diseases and environmental toxicology. He is an associate editor for Scientific Reports and Journal of Cellular and Molecular Medicine and on the editorial board of several other journals including Hepatology, Toxicology and Applied Pharmacology, Toxicology and American Journal of Pathology. He is a permeant member of the EPA’s Science Advisory Committee on Chemicals (SACC) and helps in risk assessment of various chemicals.

Dr. Simon 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 an MBA in corporate finances and management. Dr. Authier is a Principal Director of Scientific Operations at Charles River Laboratories Laval, where he overviews the work of a team of scientists and veterinarians specializing in preclinical research. He has been an invited speaker at various scientific conferences, including the American College of Toxicology, the Safety Pharmacology Society, the Japanese Society of Safety Pharmacology, the American Association of Laboratory Animal Science, and the US Food and Drug Administration. Dr. Authier has authored +150 peer-reviewed articles and book chapters addressing drug development and regulatory pharm/tox assessments. To date, Dr. Authier has provided scientific overview for more than 1,600 preclinical studies and was involved in the development of +30 approved drugs, cell products and vaccines. He has served as an ACT Councilor and has collaborated as an elected member of the ACT Education Committee, and over the years, he has volunteered and participated in various ACT initiatives, including educational sessions. He served as President, Treasurer, Secretary and Board member for the Safety Pharmacology Society and remains active in various safety pharmacology initiatives.

Dr. Leanne Bedard received her PhD in Pharmacology and Toxicology from Queen’s University (Kingston, ON, Canada) in 2004. She began her career in pharmaceutical research in 2006 at Merck Frosst in Montréal where she was the recipient of a Special Achievement Award for her contribution to the discovery of PIFELTRO™, a non-nucleoside reverse transcriptase inhibitor, now marketed for the treatment of HIV. Dr. Bedard then joined AstraZeneca R&D Montréal as a DMPK Drug Design Leader. Since 2012, Dr. Bedard has worked as an independent consultant in nonclinical drug metabolism, pharmacokinetics and toxicology. She has worked with over 100 biotech and small pharmaceutical companies located in Canada and in the US. She has contributed to the discovery, nonclinical development, and successful regulatory filing of several small molecule investigational new drugs and marketing authorizations in jurisdictions worldwide (USA, Europe, UK, Canada, Australia, and Japan). Dr. Bedard has also served as a Nonclinical Pharm/Tox Reviewer for over a dozen New Drug Submissions to the Pharmaceutical Drugs Directorate at Health Canada.

Dr. Bedard is a Diplomate of ABT and holds a certification in Regulatory Affairs. She is the sole author of the book chapter on Toxicokinetics for the revised 7th edition of the quintessential toxicology textbook, Hayes’ Principles and Methods of Toxicology. Dr. Bedard is also a speaker in ACT’s Toxicology for Pharmaceutical and Regulatory Scientists course and was an invited speaker in the Drug Discovery in Neuroscience seminar series at Harvard Medical School/Boston Children’s Hospital. She has served on ACT’s Program Committee and is currently an ACT Councilor. In the past, Dr. Bedard has also served other scientific societies in various roles, including the Society of Toxicology, the Society of Toxicology of Canada, the International Society for the Study of Xenobiotics, and the Roundtable of Toxicology Consultants.

Dr. Todd Bourcier is a regulatory pharmacologist with over 25 years of experience in nonclinical drug development, regulatory science, and translational research. He is currently the co-founder and principal consultant at White Oak Regulatory Tox, LLC, where he advises pharmaceutical and biotechnology companies on designing and executing nonclinical development strategies. Prior to consultant work, Dr. Bourcier held several leadership roles at the US Food and Drug Administration (FDA), most recently as Director of the Division of Pharmacology and Toxicology in the Office of Cardiology, Hematology, Endocrinology, and Nephrology (CDER/OCHEN). Dr. Bourcier was a core member of the FDA’s Senior Leadership Team for pharmacology and toxicology and served as the FDA topic co-lead to the ICH S1B(R1) Expert Working Group, which developed a weight-of-evidence framework to modernize carcinogenicity assessment for pharmaceuticals. Dr. Bourcier earned his PhD in Pharmacology from New York Medical College and conducted postdoctoral research at Brigham and Women’s Hospital and Harvard Medical School. He has authored numerous peer-reviewed articles, book chapters, and regulatory reports, and has received FDA and CDER honors, including the Frances O. Kelsey Drug Safety Excellence Award.

Dr. Ewa Budzynski is a board-certified toxicologist with over fifteen years of pharmaceutical development. Ewa is a toxicology consultant with Akkeri Associates, where she provides toxicology strategy, study planning and monitoring, regulatory interaction and submission support for pharmaceutical development. She received her PhD in Biomedical Engineering from Northwestern University in retinal physiology. Following a post-doctoral fellowship in mammalian genetics, with concentration on retinal diseases, at Jackson Laboratory, Dr. Budzynski moved to the drug development industry. She held pharmacology positions at Bausch&Lomb and Acucela. She transitioned to toxicology over 10 years ago, joining Covance Laboratories (now Labcorp Early Development Laboratories Inc.) as study director in the Ocular Safety Assessment Group. While at Covance, Dr. Budzynski supported the development of different products including devices, small molecules, oligonucleotides, and biologics (e.g., monoclonal antibodies, gene and cell therapy). She also was a Project Toxicologist at REGENXBIO and PTC Therapeutics supporting gene therapy product development with focus on ocular diseases. Dr. Budzynski is an active member of the American Collage of Toxicology, where she serves on the Education Committee and of the Ocular Toxicology Specialty Section at Society of Toxicology.

Dr. Lydia Cox is the founder of LRC Consulting, an advisory firm specializing in toxicology and regulatory strategies for the agrochemical industry. Prior to founding LRC Consulting, Dr. Cox served as Vice President of Regulatory & Scientific Affairs at Nichino America, Inc., a subsidiary of Nihon Nohyaku Co. Ltd., Japan's oldest agrochemical company. She retired from this position in 2024. At Nichino, she led the regulatory affairs team and focused on the development, registration, and stewardship of products for the crop protection sector in the US, Canada, and Mexico. 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, Dr. Cox 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.

Dr. Greg Finch is currently an independent research toxicologist following his retirement from Pfizer’s Drug Safety Research and Development group in Groton, CT. He earned his PhD in Chemical Ecology from the University of California, Davis, and then joined the Lovelace Respiratory Research Institute in Albuquerque, NM. Dr. Finch’s research at Lovelace focused on the use of animal models to characterize respiratory tract responses to inhaled materials, the disposition of these materials from the respiratory tract, and application to human health risk assessment. He subsequently joined Pfizer, where his research initially focused on inhaled drug development and in characterizing the safety and fate of inhaled macromolecules in the lung. He was part of a team that gained regulatory approval for the first inhaled insulin drug product. Dr. Finch has been a Drug Safety team leader in numerous projects in oncology, respiratory, and antiviral therapeutic areas, and has participated in advancing several drugs through registration. He conducted due diligence reviews of potential licensing candidates and safety evaluations of novel drug development technologies. Dr. Finch represented Pfizer in several external pharmaceutical industry groups. He is a member of the Society of Toxicology and was a Diplomate of the American Board of Toxicology (1990–2025), with service on the ABT Board of Directors. He currently contributes to the advancement of toxicological science by volunteering for special projects (ABT, ACT) and as a journal reviewer.

Dr. Mary Beth Genter is a board-certified toxicologist with an interest in all areas of toxicology, and a special interest in neurotoxicology, particularly the olfactory system, as a target for toxicant-induced damage, as a model to study neurogenesis, and as a route of drug delivery. Prior to joining the University of Cincinnati Department of Environmental Health (now the Department of Environmental and Public Health Sciences), Dr. Genter received her PhD from the Integrated Toxicology Program at Duke University, received postdoctoral training at CIIT, and was an Assistant, then Associate Professor in the North Carolina State University Department of Toxicology. At NC State, she served as the toxicologist for the North Carolina Cooperative Extension Service and as a member of the North Carolina Secretary's Scientific Advisory Board on Toxic Air Pollutants. Dr. Genter has published over 80 peer-reviewed manuscripts and served as an advisor to the US EPA during the reevaluation of the IRIS naphthalene document. Dr. Genter served on the ABT Board of Directors (2004–2008) and was named a Fellow of the Academy of Toxicological Scientists in 2012. She is currently (2009–present) Editor-in-Chief of International Journal of Toxicology, the official journal of the American College of Toxicology, where she also serves as a member of Executive Council. Dr. Genter has recently retired from full-time work at the University of Cincinnati as a Professor Emerita, while continuing her online teaching. She is a member of the Toxicology in Vitro Editorial Board and served on the National Toxicology Program Board of Scientific Counselors (2013–2017). 

Dr. Mark Johnson is experienced in environmental and occupational toxicology where he has authored over 150 peer-reviewed publications, book chapters, and technical reports. He is the current president of the Society of Environmental Toxicology and Chemistry, North America, and is the past Director of Toxicology of the Defense Centers for Public Health – Aberdeen, where he worked extensively in the evaluation of the toxicity of military unique compounds. He served on several NATO and EPA panels and is an ad hoc member of the Science Advisory Committee on Chemicals. Dr. Johnson is a charter member of the International Board of Environmental Risk Assessment (IBERA) where he is co-chair of the Exam Committee and chair of the Eligibility Committee. He has been a member of the Society of Environmental Toxicology and Chemistry since 1994 and the Society of Toxicology since 2009. He currently is a member of the editorial board of Integrated Environmental Assessment and Management.

Dr. Johnson is a fellow and a member of the Board of Directors of the Academy of Toxicological Sciences, Past chair of the Tri-Service Toxicology Consortium (TSTC), past Steering Committee Chair of the Joint Army-Navy-NASA-Air Force (JANNAF) Subcommittee on Safety and Environmental Protection, the past president of the American Board of Toxicology (ABT). 

Dr. Thomas 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.

Dr. Elise M. Lewis, a native of Alabama, holds both a Bachelor’s degree and a Doctorate from The University of Alabama, Tuscaloosa. Initially aspiring to become a medical professional specializing in obstetrics, she discovered her passion for toxicology during graduate school. As a recipient of the Future Faculty Fellowship for minority students, she found a unique way to blend her interests in medicine and prevention by researching human health hazards that impact embryonic, fetal, and postnatal development. Her work focuses on identifying risks, including birth defects and growth impairments, caused by exposure to chemicals or drug products. Dr. Lewis joined Charles River Laboratories in 2001 as a Study Director specializing in Reproductive, Developmental, and Juvenile Toxicology. Over the years, she has advanced through the ranks to her current role as Principal Director of Toxicology at the Horsham, Pennsylvania site, overseeing specialized services in toxicology. Her work is critical to regulatory approvals of pharmaceuticals, medical devices, vaccines, and environmental safety products. With over 100 publications, book chapters, and contributions to leading research in toxicology, Dr. Lewis co-edited Nonclinical Pediatric Toxicology, published in 2012. She has delivered numerous presentations at national and international conferences and was recognized in 2021 as a living legend in STEM and biomedical research in the Philadelphia area. In 2024, she was named a Fellow of the Academy of Toxicological Sciences.

Dr. Lewis is deeply involved in scientific leadership and mentorship, holding roles in numerous national and international organizations. She is a Past President of the Society for Birth Defects Research and Prevention (BDRP) and the Philadelphia Chapter of the Association for Women in Science (AWIS-PHL). She has served on various committees for BDRP (membership, nominations, DEI&A, sponsorship, and constitutions and bylaws), AWIS-PHL (secretary and mentor), council for the European Teratology Society, and currently serves on the Board of Trustees and finance committee for the Health and Environmental Sciences Institute (HESI). She also serves as Vice President-Elect for the Reproductive and Developmental Toxicology Specialty Section (RDTSS) of the Society of Toxicology and was recently installed as the Vice Chair for the Chapters Advisory Committee for the national AWIS organization.

Beyond her scientific contributions, Dr. Lewis is passionate about fostering the next generation of STEM leaders. She actively mentors young scientists, sharing insights from her unique career path, and is committed to empowering future leaders in toxicology and related fields. In addition, Dr. Lewis is an active member of several professional organizations, including the Society of Toxicology, the American College of Toxicology, Society for Birth Defects Research and Prevention, European Teratology Society, Health and Environmental Sciences Institute, Philadelphia Women’s Leaders (The Philadelphia Chapter of the Women Leaders Association) and the Mid-Atlantic Reproductive Toxicology Association. She has extensive experience with strategic planning for nonprofit scientific organizations. Her journey exemplifies a commitment to advancing science, mentoring future talent, and contributing to global health through innovative toxicological research.

Dr. David 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 and Drug Administration in 2016 and is now a Master 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.

Dr. Laine Peyton Myers is a supervisory interdisciplinary scientist at US Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research and team lead for antiviral products. Dr. Myers received his PhD in immunotoxicology from the Department of Cellular Biology and Anatomy at Louisiana State University Health Sciences Center. Dr. Myers is a board-certified toxicologist with almost 20 years of experience at US FDA regulating pharmaceuticals and has been involved in writing multiple guidance documents for industry. He has been recognized for his expertise in “animal rule” reviews for potential bioterrorism agents as well as in immunotoxicology. In his role as an “animal rule” expert, he and his team were awarded the prestigious US Health and Human Services Secretary’s Award for Distinguished Service in May of 2019.

Dr. Myers has served on multiple US FDA Pharm/Tox subcommittees (Immunotoxicology SC, Oligonucleotide SC, Biologics SC) and is the current co-chair of the CDER PTCC Computational Toxicology SC. Outside of his FDA activities, Dr. Myers also serves in several professional societies and is the past president of the Immunotoxicology Specialty Section of the Society of Toxicology (SOT) and the past chair of the SOT Membership Committee.

Dr. Myers has been a member of the American College of Toxicology (ACT) for 17 years. He has served in multiple committees since 2014. Dr. Myers was elected to ACT Council from 2021–2023 and served in the Communications track. Dr. Myers was elected to the ACT Presidential chain in 2024 and currently serves as the ACT President-Elect and the Program Committee Chair.

Dr. Leslie Recio is an independent consultant for genetic and investigative toxicology. Dr. Recio was Chief Scientific Officer at ScitoVation April 2022 to June 2025. Prior to ScitoVation, Dr. Recio was the Chief Scientific Officer, Director of Toxicology, and the Genetic and Investigative Toxicology group at Integrated Laboratory Systems (ILS) 2004 to 2022. From 2002 to 2024 he was head of the bacterial mutation (Ames) lab for Merck safety assessment. Dr. Recio obtained his BS in Microbiology, MS, and PhD in Toxicology from the University of Kentucky, is a Diplomat of the American Board of Toxicology (DABT) since 1997 and is a Fellow of the Academy of Toxicological Sciences (ATS).

Dr. Recio has over 35 years of investigative toxicology research including the conduct of inhalation genetic toxicology/transcriptomics in rodents, 3D human respiratory tract, and regulatory genotoxicity assessments. He has served on the OECD Genetic Toxicology Expert Working Group since 2014 and was on the writing teams for OECD 490 and OECD 470. His research program at ScitoVation focused on the development of human-relevant New Approach Methodologies (NAM) focused on liver and lung integrating histopathology with molecular toxicology approaches to examine mode-of-action, identify predictive biomarkers of adverse outcomes, and the development of toxicogenomics data useful for benchmark dose analysis to derive point of departure estimates used in risk assessments.

At ILS, Dr. Recio was the principal investigator on a contract to oversee the National Toxicology Program (NTP) genetic toxicology testing program for seventeen years. His laboratory qualified and GLP-validated several test systems for regulatory use and conducted interlaboratory qualifications of a NAM using the liver cell line HepaRG™ cells. His laboratory was focused on the development of multiple endpoint genetic toxicology NAM using HepaRG™ cells, assessment of 3D respiratory tract NAMs and Air: Lung Interface (ALI) aerosol exposures, and development of error corrected next generation sequencing supported by Small Business Innovative Research grants for use with in vitro test systems. In 2023, Dr. Recio was appointed to the US EPA councilors for a review of the EPA Transcriptomic Assessment Product. Dr. Recio has been appointed to the editorial boards of Mutagenesis, Toxicological Sciences, and Mutation Research Reviews. He was appointed as an Associate Editor for Toxicological Sciences from 2016 to 2019. He is a member of the Society of Toxicology and the Genetics and Environmental Mutagenesis Society.