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.

Leanne Bedard, PhD, RAC, DABT

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, Leanne 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 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 Advanced Comprehensive Toxicology course. She has served the Society of Toxicology of Canada as Councillor on the Board of Directors and as Program Committee Chair.

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 the Society of Toxicology (SOT). She was elected to the ACT Outreach Committee in 2013 and the ACT Council in 2016. She was Vice-President, President-Elect, and President of ACT (2022 2023). She has also served on the SOT Finance Committee and is 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 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 Biologic 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, biopharmaceutical 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.

Kenneth L. Hastings, DrPH, DABT, ATS

Dr. Kenneth Hastings received his Doctor of Public Health degree from the School of Public Health, University of North Carolina at Chapel Hill, in 1987. He completed his doctoral research at the Chemical Industry Institute of Toxicology under the direction of Dr. Jack Dean. Dr. Hastings then served as a US Peace Corps Volunteer in Fiji under the Permanent Secretary for Health. From 1988–1991 Dr. Hastings completed a postdoctoral fellowship and was then appointed Research Associate in the Pharmacology/Toxicology Research Laboratory, Department of Anesthesiology, College of Medicine, University of Arizona, under the direction of Dr. A. Jay Gandolfi. From 1991–2007 Dr. Hastings worked in the Center for Drug Evaluation and Research, US Food and Drug Administration, in various positions: pharmacology/toxicology reviewer in the Division of Anti-viral Drug Products (1991–1997), pharmacology/toxicology supervisor in the Division of Special Pathogen and Immunologic Drug Products (1997–2003), and as an Associate Director in the Office of New Drugs (2003–2007). Dr. Hastings served on numerous committees and working groups while at FDA, including lead representative for CDER/FDA on the ICCVAM validation of the murine local lymph node assay and as lead negotiator on ICH S8 (Immunotoxicology Evaluation of New Drugs). From 2007–2014 Dr. Hastings was Associate Vice President for Regulatory Policy, Sanofi US, serving as corporate representative on numerous industry working groups dealing with regulatory science and policy. Dr. Hastings has served in many professional societies (President, Society of Toxicology Immunotoxicology Specialty Section; President, American College of Toxicology; President, SOT Regulatory and Safety Evaluation SS). Dr. Hastings served as President of the American Board of Toxicology and has numerous publications, included editor of books on use of mini-pigs in biomedical research and international standards for nonclinical safety evaluation of medical products. Dr. Hastings is currently an independent consultant specializing in toxicology studies in drug development.

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 has been employed by Charles River Laboratories, Preclinical Services, Pennsylvania (formerly Argus Research Laboratories, Inc.) since 1981, serving as Study Director, Director of Reproductive Toxicology and currently as Executive Director, Global Developmental, Reproductive and Juvenile Toxicology. Prior to joining Argus Research, Dr. Hoberman was the Head of Reproductive Toxicology at Hazleton Laboratories in Vienna, Virginia. He received his BS in Biology from Drexel University and was a graduate student in Anatomy at the University of Virginia before moving to Arkansas and completing a MS in Interdisciplinary Toxicology from the University of Arkansas and a PhD in Toxicology from Pacific Western University.

He is a Diplomat of the American Board of Toxicology since 1988 and a Fellow of the Academy of Toxicological Sciences since 2006, with over 85 publications and book chapters. He is the co-editor of “Pediatric Non-Clinical Drug Testing, Principles, Requirements, and Practices” published in January 2012.

Dr. Hoberman has been a member of Birth Defects Research and Prevention since 1978 and is a Past President. He is also a member of the European Teratology Society since 1982 and past councilor. He has been a member of the American College of Toxicology since 1979 and is a Past President. He is a Past President of the Reproductive and Developmental Toxicity Specialty Section of the Society of Toxicology, the Middle Atlantic Reproductive and Teratology Association, and the Arkansas Biotechnology Organization. He currently represents the 3Rs Collaborative on the Scientific Liaison Collation.

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 an Associate Director for Pharmacology and Toxicology in the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA) and serves as a member of the Pharmacology/Toxicology Senior Leadership Team within OND. He participates in the development of policy and guidance related to nonclinical and regulatory issues including FDA and International Council for Harmonization (ICH) initiatives. He is a standing member of CDER’s Executive Carcinogenicity Assessment Committee and a member of CDER’s Genetic Toxicology and PharmTox Education Subcommittees.

Dr. McGovern has been active in policy and guidance development. He is a member of the ICH Expert Working Groups for the S1B (Testing for Carcinogenicity of Pharmaceuticals), Q3C (Residual Solvents), Q3D (Elemental Impurities) and M7 (DNA reactive impurities), serving as Rapporteur for the S1B EWG. Dr. McGovern also serves as 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. He participated in the development of the FDA’s Guidances “Control of Nitrosamine Impurities in Human Drugs” and “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).” He also serves as Chair of the CDER PharmTox Nitrosamines Working Group.

Mark Powley, PhD

Dr. Mark Powley received a PhD in toxicology from Purdue University and completed postdoctoral training at the University of North Carolina – Chapel Hill. From 2004 to 2009 he worked in the general toxicology, biochemical toxicology, and genetic toxicology groups at Merck & Co. In 2009 he moved to the US FDA Center for Drug Evaluation and Research (CDER), Office of New Drugs. In addition to reviewing nonclinical data, Dr. Powley co-chaired CDER pharmacology/toxicology subcommittees focused on genetic toxicology as well as computational toxicology. He was a member of the Genetic Toxicology Association Board of Directors from 2009–2012, serving as chair in 2011–2012. Dr. Powley rejoined Merck & Co. in 2017 and is currently a Distinguished Research Scientist within the Nonclinical Drug Safety organization. His primary role involves supporting mutagenic and non-mutagenic impurity safety assessment efforts.

Lila Ramaiah, DVM, PhD, DACVP

Dr. Lila Ramaiah is a board-certified veterinary clinical pathologist with 16 years of experience in safety assessment, having worked at Envigo, Bristol-Myers Squibb and Pfizer. Dr. Ramaiah completed a BSc (Molecular and Cellular Biology, Arizona State University), a DVM (Laboratory Animal Medicine, University of Montréal), a clinical pathology residency (Michigan State University), and a combined residency/PhD (Pathology, Colorado State University). Dr. Ramaiah currently serves as a Global Head of Clinical Pathology and Safety Biomarkers, in the department of Predictive Safety and Translational Sciences, at Johnson and Johnson. Her passion and vision is to improve patient health by advancing medical data science and enabling AI-driven nonclinical safety intelligence, through the development of innovative tools that incorporate relational big data analyses and known mechanisms of efficacy and toxicity.

Melissa Rhodes, PhD, DABT

Dr. Melissa Rhodes is the Chief Operating Officer at Avalyn Pharma, a clinical-stage biopharmaceutical company focused on the 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.

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), and North Carolina State University (PhD). Her expertise includes neuropathology, gene therapy, and artificial intelligence applications for pathology.