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Education Course
Advanced Comprehensive Toxicology

Speaker Bios

Simon Authier, DVM, MSc, MBA, PhD, DSP

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 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 is also an Associate Professor at the Faculty of Veterinary Medicine at University of Montreal, where he is involved with clinical immunology and pharmacology, and he has authored +140 peer-reviewed articles and book chapters. To date, Dr. Authier has provided scientific overview for more than 1,400 preclinical studies. He is currently 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.

Leanne Bedard, PhD, RAC, DABT

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. For over a decade, she has worked as an independent consultant in nonclinical drug metabolism, pharmacokinetics and toxicology. She has worked with over 100 biotech and small pharma 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 Therapeutic Products Directorate at Health Canada.

Dr. Bedard is a Diplomate of ABT and holds a certification in Regulatory Affairs. She is currently Past President of the Roundtable of Toxicology Consultants. 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 currently serving the ACT as a Program Committee member. She is also a speaker in ACT’s Toxicology for Pharmaceutical and Regulatory Scientists course. She has served the Society of Toxicology of Canada as Councillor on the Board of Directors and as Program Committee Chair.

Todd Bourcier, PhD

Dr. Todd Bourcier is the Director of the Division of Pharmacology and Toxicology in the Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN) in the Center of Drug Evaluation and Research of the US Food & Drug Administration. His team evaluates nonclinical programs conducted in support of the development and eventual approval of pharmaceuticals in the therapeutic areas regulated by OCHEN. Dr. Bourcier and his staff participate in development of domestic and international guidelines that provide a regulatory and scientific framework for industry in the nonclinical development of pharmaceuticals within and beyond the borders of the US. Dr. Bourcier received a PhD in pharmacology from New York Medical College and was an Instructor in Medicine at the Brigham & Women’s Hospital and Harvard Medical School, focused on investigating immune mechanisms of vascular cell biology and atherosclerosis, prior to joining the FDA in 2004.

William Brock, PhD, DABT, ATS

Dr. Bill Brock received his PhD in toxicology from the University of Kentucky (1983), and did a postdoctoral fellowship in the UK. From his postdoctoral fellowship, he joined DuPont’s Haskell Laboratory and spent 17 years in various research, testing and management roles. He was the Director of Toxicology for Otsuka Pharmaceuticals until 2015. In 2004, he became an independent toxicology consultant. 

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 drug-induced liver injury (DILI) associated with human exposures to xenobiotics. Dr. Brock has authored or co-authored more than 50 publications and has authored or coauthored several book chapters and is a co-editor on two toxicology and regulatory books. He served as a member and in a leadership capacity for several national and international toxicology organizations.

Dr. Brock is a Diplomate of ABT, a Fellow of ATS, and has served as a Board member and President for both ABT and ATS. Dr. Brock has served in various leadership capacities or as a member of various professional organizations and committees for the ACT, SOT and others. Dr. Brock is a reviewer for several main-stream toxicology journals.

Ewa Budzynski, PhD, DABT

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.

Lydia Cox, PhD, DABT

Dr. Lydia Cox is the Vice President of Regulatory and Scientific Affairs at Nichino America, Inc., a wholly owned subsidiary of Nihon Nohyaku Co. Ltd., Japan’s first and oldest agrochemical manufacturing company. In her current role, she leads the regulatory affairs team based in Wilmington, DE and is focused on the development, registration, and stewardship of products for the crop protection sector in the US, 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.

Gregory L. Finch, PhD, DABT

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 is 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.

Mary Beth Genter, PhD, DABT, ATS

Dr. Mary Beth Genter has been an academic toxicologist since completing graduate studies in the Integrated Toxicology Program at Duke University and postdoctoral studies at the Chemical Industry Institute of Toxicology in 1990. Dr. Genter’s background is in neurotoxicology, and she has a special interest in the olfactory system, both as a target for toxicant-induced damage and as a route of drug delivery. Prior to joining the University of Cincinnati Department of Environmental Health, Dr. Genter was employed by the North Carolina State University Department of Toxicology, where, among other responsibilities, she served as the toxicologist for the North Carolina Cooperative Extension Service. She also served as a member of the North Carolina Secretary’s Scientific Advisory Board on Toxic Air Pollutants. Dr. Genter has published over 70 peer-reviewed manuscripts, and served as an advisor for the USEPA during the reevaluation of the IRIS naphthalene document. Dr. Genter is a diplomate of the American Board of Toxicology (ABT; 1992–present) and served on the ABT Board of Directors (2004–2008). She was named a Fellow of the Academy of Toxicological Scientists in 2012. She is currently (2008–present) Editor-in-Chief of International Journal of Toxicology, the official journal of the American College of Toxicology, where she also serves as a Councilor. Dr. Genter is also a member of the Toxicology In Vitro Editorial Board, and a reviewer for approximately two 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.

Debie Hoivik, PhD, DABT

Dr. Debie Hoivik received her PhD in toxicology from the University of Connecticut and conducted her postdoctoral research at Texas A&M. Since then, she has spent over the last 25 years as a regulatory toxicologist in the pharmaceutical industry (GlaxoSmithKline and Boehringer-Ingelheim) where she was responsible for the nonclinical product development strategy and execution as well as regulatory interactions and submissions for new therapeutic entities. Dr. Hoivik is currently Vice president, Early Development at Akebia Therapeutics where she is the Program Executive for programs in the Discovery to Clinical Proof of Concept phase of development as well as having accountability for the toxicology and DMPK disciplines. Dr. Hoivik has authored five invited book chapters, and over 50 manuscripts and abstracts. She has served ACT in a variety of roles (e.g. Councilor, Secretary, Continuing Education Committee, Nominating Committee, Program Committee); she has also been Chair of the SOT Education Committee and served on the SOT Communication Committee; and President of the Northeast Society of Toxicology. Dr. Hoivik has also served on multiple pharmaceutical consortiums and workgroups. She has been a member of the Editorial Review Board for the International Journal of Toxicology and served as a reviewer for Toxicological Sciences. Dr. Hoivik was certified by the American Board of Toxicology in 1999.

Mark S. Johnson, PhD, DABT, ATS

Dr. Mark Johnson has worked extensively in the evaluation of the toxicity of military unique compounds and development and evaluation of a phased approach to the gathering toxicity data for new compounds under development.  He has authored over 130 peer-reviewed publications, book chapters, and technical reports and serves on several NATO and EPA panels. He has been a member of Society of Environmental Toxicology and Chemistry (SETAC) since 1997 and is the current vice president for SETAC North America. He previously served on the Science Advisory Committee on Chemicals for the USEPA and is also a member of the Wildlife Toxicology Interest Group and the World Science and Education Committees for SETAC and SETAC North America. Dr. Johnson is also a charter member of the International Board of Environmental Risk Assessment (IBERA). He has been a member of 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).

Thomas A. Lewandowski, PhD, DABT, ERT

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.

Owen McMaster, PhD

Dr. Owen McMaster is a Pharmacologist in the Division of Pharmacology/Toxicology for Infectious Diseases in the Center for Drug Evaluation and Research at the US Food and Drug Administration. He has spent over 30 years at the agency in several divisions, including the Division of Antiviral Products, the Division of Special Pathogens and Immunologic Drug Products, the Division of Antiinfectives, and the Division of Pharmacology Toxicology for Infectious Diseases. He reviews the nonclinical Pharmacology, Toxicology, and Pharmacokinetic studies submitted to the agency in support of Investigational New Drug Applications (INDs), Pre INDs, Biologics License Applications (BLAs), and New Drug Applications (NDAs). He earned his PhD in Pharmacology and Toxicology from the University of Maryland Baltimore, School of Pharmacy, a Master of Science degree in Biochemical Pharmacology from Southampton University in England and a BSc. degree in Zoology and Biochemistry from the University of the West Indies in Jamaica. His Interests include neuropharmacology, infectious diseases, and carcinogenicity.

David McMillan, PhD, DABT

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 & 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.

Leslie Recio, PhD, DABT

Dr. Leslie Recio is the Chief Scientific Officer at ScitoVation. 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, ATS

Dr. Amy Roe has 30+ years of experience as a practicing toxicologist in government, pharmaceutical and consumer product industries, through positions at both the FDA and The Procter & Gamble Company. Her professional experience is in general, descriptive, and regulatory toxicology as well as specialized expertise in drug/xenobiotic metabolism and pharmacokinetics. Her industry experience is quite broad and includes toxicology support of drugs, medical devices, herbal/dietary supplements, foods, and water filtration devices. As a project leader, she has led multi-disciplinary drug development teams. Dr. Roe is a board-certified toxicologist (DABT) and a Fellow of the Academy of Toxicological Sciences (ATS). She is well-recognized externally in her field as evidenced by her service on a number of professional boards and committees including as Chair of the USP Dietary Supplement Admission Evaluation & Labeling Expert Committees, a member of the USP Probiotic Expert Panel, and USP Council of Experts. She has served the SOT as the Regulatory & Safety Evaluation Specialty Section (President), and current Food Safety Specialty Section (Vice-President). Dr. Roe is on the Steering Committee of the Botanical Safety Consortium (BSC), a public-private consortium led by FDA and NIEHS and serves as co-chair of the hepatotoxicity/ADME sub-committee of the BSC. She is on the Advisory Board of the American Botanical Council (ABC) and serves on the Editorial Board of Applied In Vitro Toxicology, Toxicological Sciences, and Journal of Dietary Supplements.

Robert Roy, PhD, DABT, ATS

Dr. Robert Roy retired from 3M as a Corporate Staff Scientist in July 2023. At 3M, he supported the global toxicology efforts of many of 3M divisions. Some of these activities included the placing, monitoring and evaluation of both short-term and longer-term toxicity studies, the preparation of human health risk/safety assessments for industrial and consumer products, the derivation of health-based OELs, NSRLs/MADLs, DNELs/DMELs and ADIs. Dr. Roy was the Chair of the 3M OEL committee for over 25 years. He is a Diplomate of the ABT, a Fellow of ATS and a member of SOT and ACT. Dr. Roy teaches and advises graduate students at the University of Minnesota where he is an Adjunct Professor in the School of Public Health (Toxicology Graduate Program). He serves on the editorial boards of four toxicology journals, is actively involved in development and presentation of CE toxicology courses, is a 25+ year member of the national OEL-developing Workplace Environmental Exposure Levels (WEEL) Committee, is a past member of the NIOSH Board of Scientific Counselors (BSC) and serves/has served on several ACC, University of Minnesota, AIHA, ATS, ECETOC-sponsored committees and work groups. In 2023, Dr. Roy started his own consulting firm, Northland Toxicology Consultants, LLC, that focuses on providing toxicology services/support for the industrial chemical, consumer product, pharmaceutical and medical device sectors.

Katie Sokolowski, PhD, DABT

Dr. Katie Sokolowski is a Principal Toxicologist at Denali Therapeutics. At Denali, she is a project toxicologist and pharmacology technical team leader responsible for nonclinical safety assessment strategies and regulatory interactions for large and small molecules in the neurodegenerative disease therapeutic area. She has six years of experience in drug regulation as a senior toxicologist in the Division of Pharmacology/Toxicology for Neuroscience (DPTN) in the Center for Drug Development and Research (CDER), FDA. At FDA, she was responsible for nonclinical review of INDs and NDA/BLAs while actively participating in the Neurotoxicity Assessment Subcommittee and the Extractable and Leachable Subcommittee, spearheading the intramural DABT study group, and developing lectures for the Education Subcommittee of the Pharmacology/Toxicology Coordinating Committee. She is a member of the Society of Toxicology (SOT), the American College of Toxicology (ACT), and the Society of Toxicologic Pathology (STP). Within ACT, she was a member of the Early Career Professionals Subcommittee and actively co-chairs symposium, workshops, and continuing education courses. She completed a postdoctoral fellowship at the Center for Neuroscience at Children’s National Medical System, Washington, DC, holds a PhD in toxicology from the Joint Graduate Program in Toxicology (JGPT), Rutgers University/UMDNJ, and is a Diplomate of the American Board of Toxicology.