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.
Dr. Leanne Bedard received her PhD in Pharmacology and Toxicology from Queen’s University (Kingston, ON, Canada) in 2004. Dr. Bedard 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, Dr. Bedard 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 hold 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. She has served on ACT’s Program Committee and is currently an ACT Councillor. Leanne has served the Society of Toxicology of Canada as a Councillor on the Board of Directors and as Program Committee Chair.
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 U.S. 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 Ph.D. 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 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.
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. 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.
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. 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.
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.
Dr. Laine Peyton Myers is a supervisory interdisciplinary scientist at US Food and Drug Administration 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 Vice President (2025) and Awards 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.
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.
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.
Dr. Katie Sokolowski is an Associate Director and Principal Toxicologist at Denali Therapeutics. At Denali, she functions as a project toxicologist and pharmacology/toxicology technical team leader responsible for nonclinical safety assessment strategies and regulatory interactions for biologic and conjugated oligonucleotide programs in the neurodegenerative disease and oncology 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 is the current chair of the Podcast 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; is a Diplomate of the American Board of Toxicology (DABT) since 2019 and a Diplomat of Safety Pharmacology (DSP) since 2024.
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