Education Course
Toxicology for Pharmaceutical and Regulatory Scientists

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 +100 peer-reviewed articles and book chapters. To date, Dr. Authier has provided scientific overview for more than 1,100 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.

Amy M. Avila, PhD

Dr. Amy 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.

Leanne Bedard, PhD, RAC, DABT

Dr. Leanne Bedard received her PhD in Pharmacology and Toxicology from Queen’s University in Kingston, Ontario, 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 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 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 Advanced Comprehensive Toxicology 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. 

Todd Bourcier, PhD

Dr. Todd Bourcier is a regulatory pharmacologist with over 25 years of experience in nonclinical drug development, regulatory science, and translational research. He is a 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.

Lorrene A. Buckley, PhD, DABT, ATS

Dr. Lorrene Buckley is a board-certified toxicologist with over 30 years of experience in the active practice of toxicology. She earned her degrees in Toxicology, an MS from the University of Arizona, and a PhD from the University of North Carolina at Chapel Hill, in collaboration with the laboratories of the NIEHS and US EPA. She is certified by the American Board of Toxicology (ABT) and is a Fellow of the Academy of Toxicological Sciences (ATS).

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 Vice President at Eli Lilly & Company, she is responsible for the design and execution of nonclinical safety assessment programs as well as for nonclinical aspects of global regulatory submissions and interactions for 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.

Her contributions to the profession of Toxicology include service on the Boards of the ABT and the ATS (past President) and on the Councils of the ACT (past President) and the SOT.

Florence Burleson, PhD

Dr. Florence Burleson received her PhD from the Department of Microbiology at the University of Notre Dame, and a Master of Science in Financial Management and Technology Commercialization from North Carolina State University (NCSU). She has more than 30 years of professional experience in government, pharmaceutical, and contract research. She is the co-founder of Burleson Research Technologies, Inc. (BRT), a CRO specializing in immunotoxicology. Dr. Burleson has served as a Study Director conducting GLP-compliant studies for immunological, functional, and host resistance immunotoxicity assessments. As Executive VP and Senior Director of Nonclinical Studies, she provides oversight and direction for nonclinical studies programs and is responsible for budgets and financial management at BRT.  
 
Dr. Burleson is a member of the American College of Toxicology (ACT) and Society of Toxicology (SOT), and a Fellow of the Academy of Toxicological Sciences (ATS). She was elected to the ACT Outreach committee in 2013 and ACT Council in 2016. She was Vice-President, President-Elect, and President (2022–2023) of ACT. She has also served on the SOT Finance Committee and is a past-President of the SOT Immunotoxicology Specialty Section. Dr. Burleson was Chair of the Scientific Liaison Coalition (SLC), a coalition of societies to increase the impact of the science of toxicology to improve public health. She currently serves on the Editorial Board of the International Journal of Toxicology and on the Editorial Board of Toxicology Research Application. 

Mary Beth Genter, PhD, DABT, ATS

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).

Hanan Ghantous, PhD, DABT

Dr. Hanan Ghantous is the Division Director for Pharmacology/Toxicology for Infectious Diseases (DPT-ID) at the US Food and Drug Administration (US FDA). She joined US FDA as a pharmacology/toxicology reviewer in 2001, and since 2007, she has been the Pharmacology/Toxicology supervisor at the Division of Antiviral Products, Center for Drug Evaluation and Research. Dr. Ghantous has presented at national and international scientific and regulatory meetings, has served on several US FDA committees, has been involved in writing Guidance documents, and has represented the agency at various public forums. She has been mentoring local and international pharmacy interns since she joined US FDA. Before coming to US FDA, Dr. Ghantous worked at the DuPont Company for approximately 10 years.

Dr. Ghantous has been a member of ACT since 2000. She has served on many committees over the years, as well as on Council (2011–2013) and as ACT Vice President-Elect, Vice President, President, and Past President (2014–2017). She also has been a member of the Society of Toxicology (SOT) since 1989. She served on the Continuing Education Committee of SOT (2010–2013). Dr. Ghantous is one of the founders of the Biotechnology Specialty Section and served as Vice President-Elect, Vice President, President, and Past President of the Specialty Section (2010–2013). She also served as a member of the Board of Directors of the American Board of Toxicology (ABT) (2010–2014) and was the President of the board for 2013–2014. She was recognized by ACT as the first recipient of the prestigious ACT Mildred Christian Women’s Leadership in Toxicology Award in 2018.

Dr. Ghantous received a BSc in pharmacy from the University of Baghdad, Iraq; an MSc in pharmacology from the University of Strathclyde, Scotland; and a PhD in toxicology from the University of Uppsala, Sweden. She was a postdoctoral fellow in the Department of Anesthesiology, University of Arizona, and received her board certification as a Diplomate of the American Board of Toxicology (DABT) in 1995. Dr. Ghantous has over 30 years of combined experience in general and regulatory toxicology.

Melanie T. Hartsough, PhD

Dr. Melanie Hartsough received her PhD in Pharmacology from Pennsylvania State University, College of Medicine. After a postdoctoral fellowship at NIH, she joined US FDA’s Center for Biologics Evaluation and Research (CBER), Division of Therapeutic Proteins, as a full-time product reviewer where she performed chemistry, manufacturing, and controls (CMC) and immunogenicity reviews for biotechnology-derived products. In 2004, Dr. Hartsough transferred to the Division of Biologic Oncology Products, Center for Drug Evaluation and Research (CDER), as a pharmacology/toxicology reviewer. During this time, she also performed consult reviews for the Office of Vaccines Research and Review and Office of Blood Research and Review, CBER. In 2006, she left the US FDA and joined Aclairo Pharmaceutical Development Group, Inc as a consultant. In 2007, she left Aclairo and joined the Biologics Consulting Group, Inc. In 2017, Dr. Hartsough founded Hartsough Nonclinical Consulting, LLC to provide scientific, regulatory and strategic advice associated with nonclinical pharmacology, pharmacokinetic and toxicology development of biologic biopharmaceuticals and small molecule products.

Dr. Hartsough is a member of ACT and American Society of Gene and Cell Therapy and has served on the ACT Nominating Committee. She has been a guest speaker for a variety of courses and scientific meetings and has authored or coauthored book chapters covering topics such as therapeutic vaccines, biopharmaceutics, immunogenicity, peptide and protein nonclinical development and relevant species selection.

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

Dr. A. Wallce Hayes is a toxicologist with over 40 years of experience in industry and academia. His academic journey includes degrees from Auburn University (PhD and MS) and Emory University (AB). Dr. Hayes’ educational and professional journey includes stops as an NSF predoctoral fellow at Auburn University, an NIH individual postdoctoral fellow at the Vanderbilt University School of Medicine, a NATO Senior Scientist at the Central Veterinary Laboratory in Weybridge, England, and an NIH Research Career Development Award at the University of Alabama.

Dr. Hayes has held tenured Professorships at the University of Alabama, the University of Mississippi Medical Center, and Wake Forest University School of Medicine. His industrial experience includes Rohm and Hass (Director of Toxicology and Regulatory Affairs), RJR Nabisco (Vice President), and the Gillette Company (Corporate Vice President). He has also served on committees and expert panels for the National Academy of Sciences, the National Institutes of Health, the Environmental Protection Agency, the Food and Drug Administration, and the Department of Defense. Dr. Hayes currently serves on the US FDA NAMs Committee.

Dr. Hayes has authored more than 420 peer-reviewed publications, is the editor of Hayes’ Principles and Methods of Toxicology, 7th edition, Human and Experimental Toxicology, Cutaneous and Ocular Toxicology, and co-editor of the Target Organ Toxicity Series. He is the co-author of Loomis Essentials of Toxicology, 4th & 5th editions. Dr. Hayes is a past Secretary-General of the International Union of Toxicology (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 Royal Society of Medicine (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, by the International Dose-Response Society in 2013 with its Outstanding Leadership Award, and by The American Academy of Toxicology with its Mildred S. Christian Career Achievement Award in 2021. Dr. Hayes was named a Distinguished Fellow by the American College of Toxicology in 2013 and a Fellow by the American Association for the Advancement of Science in 2014.

Alan M. Hoberman, PhD, DABT, ATS

Dr. Alan Hoberman is the President of Argus International Inc. since 2009 providing consultant serviced for DART and Juvenile Toxicity Evaluations. He has been employed by Charles River Laboratories, Preclinical Services, Pennsylvania (formerly Argus Research Laboratories, Inc.) since 1981. He is a Diplomat of the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, with over 100 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 Past President. He has also been a member of the Society for Birth Defects Research and Prevention since 1978 and is a Past 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. 

Natalie Holman, PhD, DABT

Dr. Natalie Holman is a board-certified toxicologist at Eli Lilly and Company. As a Toxicology Project Leader at Lilly, Dr. Holman is responsible for nonclinical safety assessment strategies and regulatory interactions supporting discovery- and clinical-stage assets in multiple therapeutic areas. Her role also includes due diligence assessments for in-licensing opportunities and contributing to development of platform approaches for toxicity assessment of novel therapeutic modalities. Prior to joining Lilly, she was a project toxicologist at Altavant Sciences and its affiliate Roivant Sciences, where she supported molecules across the portfolio of several subsidiaries. Dr. Holman serves on cross-industry working groups and is an active member of several professional toxicology societies. As a member of ACT, she has served as a speaker and chair for symposia and CE courses, held elected positions on multiple committees, chaired the ACT Early Career Professionals Subcommittee, and received the ACT Early Career Professional Award. Dr. Holman received her PhD in Toxicology and Certificate in Translational Medicine from the University of North Carolina Chapel Hill School of Medicine. She conducted her doctoral research in mechanistic hepatotoxicity at The Hamner Institutes for Health Sciences (formerly Chemical Industry Institute of Toxicology, CIIT).

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.

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.

Kazuhisa Miyakawa, BVSc (DVM), PhD, DACVP, DABT

Dr. Kazuhisa (Kaz) Miyakawa is a board-certified veterinary clinical pathologist (DACVP) and toxicologist (DABT) with over 10 years of experience in safety assessment, specializing as a toxicology clinical pathologist and compound leader.  

He earned his BVSc (equivalent to DVM) and worked as a private practice veterinarian in Japan for seven years. After relocating to the United States, Dr. Miyakawa completed the ECFVG program at Purdue University, a clinical pathology residency at Michigan State University, and earned his PhD in Pathology and Toxicology from Michigan State University. His previous roles include positions at Toxikon (now Labcorp) and Merck. Currently, he is a target clinical pathologist within the Clinical Pathology and Safety Biomarkers team in the department of Predictive Safety and Translational Sciences at Johnson & Johnson. 

His primary research interest lies in translational fluid biomarkers applicable to both nonclinical species and humans. 

Arianne Motter, PhD, DABT

Dr. Arianne Motter is a board-certified toxicologist with 15 years of expertise in the field. She currently serves in the Division of Pharmacology and Toxicology for Infectious Diseases within CDER at the FDA, where she is responsible for reviewing pre-IND, IND, EUA, NDA, and BLA submissions related to antiviral products. In addition to these duties, Dr. Motter contributes to educational initiatives, serves on both the neurotoxicology and pharmacokinetic subcommittees, and assists in the development of resources to support SEND submissions. Before joining the FDA in 2014, she was a toxicologist with the Armed Forces Medical Examiner. Dr. Motter holds a BS in Chemistry from West Chester University in Pennsylvania and earned her PhD in Pharmacology from Georgetown University in 2011. She is also an associate professor in the Department of Pharmacology and Physiology at Georgetown University, where she lectures on drug toxicity to medical and graduate students.

Melissa Rhodes, PhD, DABT

Dr. Melissa Rhodes is the Chief Operating Officer at Avalyn Pharma, a clinical-stage biopharmaceutical company focused on development of targeted inhalation therapies for life-threatening pulmonary diseases. Prior to joining Avalyn, she held the position of Chief Development Officer at Kriya Therapeutics (a gene therapy company), at Aerami Therapeutics (an inhaled biologics company) and at Altavant Sciences (a rare respiratory disease company). Previously, Dr. Rhodes served as Senior Vice President of Nonclinical Research at Roivant Sciences. She spent almost 10 years at GSK in Safety Assessment and started in drug development at a biotech university spin-out in oncology. Dr. Rhodes completed a postdoctoral fellowship at the National Toxicology Program at the National Institute of Environmental Health Sciences, holds a PhD in pharmacology and toxicology from Duke University Medical Center, and is a Diplomate of the American Board of Toxicology. 

Zhanna Sobol, PhD

Dr. Zhanna Sobol is an applied genetic toxicologist with over 17 years of experience in the pharmaceutical industry. She holds a Bachelor of Science degree in Microbiology and Molecular Genetics and PhD in Molecular Toxicology from University of California, Los Angeles. During her graduate work, she studied mechanisms of DNA damage and repair while incorporating key concepts and tools of applied Genetic Toxicology.

In 2008, Dr. Sobol joined Pfizer Worldwide Research and Development where she developed as a Subject Matter Expert (SME). In 2021, she joined Merck Research Laboratories as the Director of the Genetic Toxicology Group responsible for scientific strategy, overseeing the conduct of exploratory and GLP genetic toxicology studies, and providing input at all stages of drug discovery and development.

Over the years, Dr. Sobol has participated in various organizations and working groups, including HESI-Genetic Toxicology Technical Committee, the Genetic Toxicology subcommittee of the Oligonucleotide Safety Working Group, the Genetic Toxicology Association and Environmental Mutagenesis and Genomics Society, where she served in various leadership positions. Her work includes risk management of positive genotoxicity findings, risk assessment of novel therapeutic modalities, testing strategy for mutagenic impurities (including nitrosamines), and application of new tools and concepts to address challenges in applied genetic toxicology.

Debra Tokarz, DVM, PhD, DACVP

Dr. Debra Tokarz is a senior veterinary pathologist at Experimental Pathology Laboratories (EPL), Inc in Durham, NC. She provides pathology support for commercial and academic toxicology studies and the National Toxicology Program. This support includes gross and microscopic pathology evaluation for safety, efficacy, and investigative studies, as well as study design and protocol development. Dr. Tokarz did her professional training at Michigan State University (DVM), University of California-Davis (residency in anatomic pathology), and North Carolina State University (PhD). Her expertise includes neuropathology, gene therapy, and artificial intelligence applications for pathology.