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Advanced Comprehensive Toxicology Speakers
Simon Authier, DVM, MSc, MBA, PhD, DSP
Deputy Chief Scientific Officer, Senior Director of Scientific Operations and Veterinary Science, CiToxLAB Dr. 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 a MBA in corporate finances and management. Over the past years, Dr. Authier investigated methodologies in nonclinical regulatory safety pharmacology studies with the objective of improving study designs for optimal sensitivity and decision making in this field. Dr. Authier overviews the work of a team of scientists and veterinarians specialized preclinical research for IND, BLA and NDA filing with a focus on safety pharmacology. He participated in face-to-face US FDA pre-IND meetings and overviewed conduct of preclinical studies for a number of small and large molecules over the last 14 years working at CIToxLAB North America. He was an invited speaker at various scientific conferences including the US Food and Drug Administration (FDA), Canadian Society of Quality Assurance, the Safety Pharmacology Society, American College of Toxicologists (ACT), Japanese Society of Safety Pharmacology and the American Association of Laboratory Animal Science to name a few. For the last seven years, Dr. Authier was an invited professor in immunolgy and pharmacology at University of Montreal, Canada. To date, Dr. Authier has provided scientific overview for more than 800 studies assessing cardiovascular, respiratory, neurological, gastrointestinal, and renal safety pharmacology.
William J. Brock, PhD, DABT, ATS
Dr. Bill Brock received his PhD in toxicology from the University of Kentucky (1983), and did a postdoctoral fellowship at UK. From his postdoctoral fellowship, he joined DuPont’s Haskell Laboratory and spent 17 years in various research, testing and management roles. Subsequently, Bill joined Unilever, a worldwide consumer product company, and then the international consulting firm Environ. In 2004, he became an independent toxicology consultant. He is the Director of Toxicology for Otsuka Pharmaceuticals.
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 toxicity 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 has served as a member and in a leadership capacity for several national and international toxicology organizations. Dr. Brock is currently an expert reviewer for IPEC’s Excipients Panel.
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 an Associate Editor for the International Journal of Toxicology, and a reviewer for Food and Chemical Toxicology, Toxicological Sciences, Toxicology and Industrial Health, Current Eye Research and other leading toxicology journals.
Mary Ellen Cosenza, PhD, DABT, ATS, RAC
Mary Ellen Cosenza is a regulatory consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. Most recently, she served as the Executive Director, U.S. Regulatory Affairs, at Amgen, Inc. During her 20-year tenure at Amgen, she led the International Emerging Markets Regulatory Department and served as an Executive Director of Global Regulatory Affairs and Safety. In addition to her leadership roles in Regulatory Affairs, she also served as the Senior Director of Toxicology at Amgen. Prior to joining Amgen, she served as a Principal Scientist for the Medical Research Division of American Cyanimid Company (now Pfizer).
She is also an instructor at the University of Southern California where she teaches a graduate level course on Food and Drug Toxicology. Mary Ellen received her PhD from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.
Mary Ellen is a Diplomat of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, member of the Society of Toxicology (SOT), Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS), and holds Regulatory Affairs Certification for both the U.S. and EU. Mary Ellen has been a member of ACT since 1988, serving as an active speaker and session chair. Most notably, she developed the first Study Director Training Course in 2001 and has served as a member of the ACT Education Committee, as Councilor, and as Treasurer. Mary Ellen is a recent Past-President of ACT.
Lydia Cox, PhD, DABT
Lydia is the Director of Regulatory 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 and Canada. 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, Lydia 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.
David C. Dorman, DVM, PhD, DABVT, DABT, ATS
Dr. David Dorman is a professor of toxicology in the Department of Molecular Biomedical Sciences at North Carolina State University (NCSU). Dr. Dorman’s research interests include neurotoxicology, nasal toxicology, pharmacokinetics, and cognition and olfaction in animals. He completed his undergraduate training in chemistry at the University of San Diego and he pursued additional graduate training in organic chemistry at the University of Colorado-Boulder. Afterward she received a DVM from Colorado State University and then completed a combined PhD and veterinary toxicology residency program at the University of Illinois at Urbana-Champaign followed by completion of a postdoctoral fellowship at the Chemical Industry Institute of Toxicology (CIIT). He is a diplomate of the American Board of Veterinary Toxicology and the American Board of Toxicology. He is a former Hamner Institutes for Health Sciences Division Director and Associate Dean of Research and Graduate Studies at the NCSU College of Veterinary Medicine. He has chaired or served on numerous National Research Council (NRC) committees and is a National Associate of the NRC. He has served on other advisory boards for the US Navy, the National Aeronautics and Space Administration, the US Department of Agriculture, and is a former member of the National Toxicology Program Board of Scientific Counselors. His research accomplishments have been recognized through his receipt of the Society of Toxicology’s Achievement Award, the Zoetis Award for Research Excellence, and being elected as a Fellow of the American Association for the Advancement of Science. Dr. Dorman is also a fellow of the Academy of Toxicological Sciences. He was the recent recipient of a Fulbright Specialist Program Award where he will lecture at the host institution, the University of Adelaide, on chemical risk assessment during mid-2018.
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 2 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.
Lynne Haber, PhD, DABT
Dr. Haber is an associate professor at the Risk Science Center (RSC, formerly TERA Center), Department of Environmental Health, University of Cincinnati. She has more than 20 years of experience in development of human health risk assessment and in risk assessment methods development, with a focus on hazard characterization and dose response, and including consideration of mechanism/mode of action. She has led the development of numerous assessment documents, including primary author of more than 30 major documents for multiple US EPA offices, CPSC, other government agencies, and private sponsors, and has been a coauthor or reviewer of 100’s more. She has served as a panel chairperson or panel member for scientific peer reviews organized by TERA, US EPA, CPSC, and other US and foreign government agencies. She has also served on two panels for the NAS/NRC. Dr. Haber is active in communicating her findings to the broader scientific community through participation in professional societies, routine publication of her work, authoring book chapters, service as an editorial reviewer for scientific journals, and through presentation of invited lectures. She was the lead author of the chapter on noncancer risk assessment for Patty’s Toxicology (2001, 2011). Her work on risk assessment methods has included two general areas: improving methods for extrapolating from the available data to safe exposures, and designing approaches to address challenging risk assessment questions. For example, she coauthored a framework for evaluating intermittent exposure scenarios and has investigated the use of biomarkers to improve quantitative aspects of risk assessment. She has also conducted research on whether children are adequately protected using current methods, or under what conditions modifications need to be made.
She served as chair, vice president, and councilor of the SRA Dose-Response specialty group and as an officer of the SOT Risk Assessment Specialty Section (RASS), and Ethical Legal and Social Issues (ELSI) Specialty Section, and is a Diplomate of the American Board of Toxicology. She received her doctorate in biology from MIT in 1990. She is active in teaching basic and advanced risk assessment methods to diverse groups of risk assessors and at professional society meetings. She is one of the lead teachers of TERA’s (now the RSC’s) Dose-Response Assessment Boot Camp, and has taught the full course or shorter versions to more than 600 students, including presentations in five different countries.
Kenneth L. Hastings, DrPH, DABT, ATS
Dr. Hastings joined the US Food and Drug Administration in 1991 as a pharmacology/toxicology reviewer in the Division of Antiviral Drug Products, where he was involved in review and approval of several drugs for the treatment of HIV/AIDS. In 1997, Dr. Hastings was appointed Pharmacology/Toxicology Supervisor in the Division of Special Pathogen and Immunologic Drug Products, where he was involved in review of several marketing applications for drugs to treat tuberculosis, malaria, serious bacterial and fungal diseases, and for use in transplant medicine. In 2003, Dr. Hastings was appointed Associate Director for Pharmacology and Toxicology in the Office of New Drugs. In this position, he served as tertiary reviewer for various review divisions. Dr. Hastings served on many committees and working groups while in government service, including several guidance committees (immunotoxicology, safe start dose, nonclinical studies for pediatric clinical trials, phototoxicity, metabolites in safety testing, biologic counterterrorism, and phospholipidosis). Dr. Hastings was lead CDER representative for the ICCVAM validation of the murine local lymph node assay, acting director of the International Regulatory Issues Staff in the Office of Regulatory Affairs, acting US FDA safety coordinator for ICH, and lead US FDA negotiator for ICH S8.
He has served in several professional societies, including the American Board of Toxicology (Past President), the American College of Toxicology (Past President), the Society of Toxicology (Past President of the Immunotoxicology Specialty Section), board member of the Biotechnology Industry Organization BioSafe Leadership Team, and past Co-Chair of the Nonclinical Special Interest Community of the Drug Information Association. Dr. Hastings is a Fellow in the Academy of Toxicological Sciences. Dr. Hastings received his Doctor of Public Health degree from the University of North Carolina, School of Public Health in 1987, where he completed his doctoral research at the Chemical Industry Institute of Toxicology.
Dr. Hastings served as a Peace Corps volunteer in Fiji, where he was a special assistant to the Permanent Secretary for Health. Following this, he completed a postdoctoral fellowship and was then appointed Research Associate in the Pharmacology/Toxicology Research Laboratory, Department of Anesthesiology, University of Arizona prior to his position at US FDA/CDER.
From 2007 to 2014, Dr. Hastings was Associate Vice President for Regulatory Policy, Sanofi. His responsibilities included serving as inhouse advisor to corporate management on drug development regulatory policy, primarily concerning US FDA and ICH. He served as corporate liaison with numerous scientific and industrial groups, including PhRMA and BioSafe. Dr. Hastings is currently an independent consultant.
Alan M. Hoberman, PhD, DABT, ATS
Dr. Hoberman has been employed by Charles River Laboratories, Preclinical Services, Pennsylvania (formerly Argus Research Laboratories, Inc.) since 1981. Currently he is Executive Director, Global Developmental, Reproductive, and Juvenile Toxicology. He is a Diplomat of the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, 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 the American College of Toxicology since 1979 and is currently the Treasurer. He has been a member of the Teratology Society since 1978 and is currently the Vice-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, as well as past president of the Arkansas Biotechnology Organization.
Bruce J. Kelman, PhD, DABT, ATS, ERT
Dr. Kelman has held positions as principal toxicologist and president of Veritox®, Inc. since 1998. He has served as a consultant and expert in investigations across North America, South Korea, and the United Kingdom. Dr. Kelman has evaluated numerous claims of personal injury and health impacts from many chemicals and drugs, and has presented a variety of health risk concepts to policy makers, government regulators, citizen groups, and individuals.
Dr. Kelman has been certified by the American Board of Toxicology since 1980, was named a Fellow of the Academy of Toxicological Sciences in 2006, and is admitted as a European Registered Toxicologist in both the United Kingdom and EUROTOX registries. He holds a PhD from the University of Illinois (1975) and completed a postdoctoral study in toxicology (University of Tennessee, 1976). Dr. Kelman held positions as assistant professor (University of Tennessee at Oak Ridge), senior research scientist through department manager (Battelle, Pacific Northwest Laboratory), manager, (Battelle Memorial Institute International Toxicology Office), managing scientist (Failure Analysis Associates, Inc.), and national director, Health and Environmental Sciences (Golder Associates, Inc.).
Dr. Kelman’s research has focused on components of health risk models including mechanistic studies aimed at quantifying exposure of critical organ systems. He has experience with both chemical and physical agents (including asbestos, pesticides, solvents, vapors, metals, microbial agents, and electric and magnetic fields), exposure scenarios (including environmental, occupational, residential, and clinical), and routes of exposure (including inhalation, oral, and percutaneous). Dr. Kelman has conducted health evaluations of a variety of contaminated environmental sites and has experience with numerous air and water quality issues.
Dr. Kelman served on the Board of Directors of the American Board of Toxicology (2011–2015). He is a member of the Society of Toxicology (SOT), British Toxicology Society, American College of Occupational and Environmental Medicine (ACOEM), American College of Toxicology, and American Society for Experimental Pharmacology and Therapeutics. Dr. Kelman served as a member of the NRC/NAS Committee on Possible Effects of Electromagnetic Fields on Biologic Systems. He has received best paper awards from the Society for Experimental Biology and Medicine, American Industrial Hygiene Association, and Society of Toxicology Nanotoxicology Specialty Section. Dr. Kelman was an author of the evidence-based position statement “Adverse Human Health Effects Associated with Molds in the Indoor Environment” issued by ACOEM from 2002 until 2015.
Richard W. Lane, PhD, DABT
Dr. Richard W. Lane is Director of Corporate Scientific Affairs at PepsiCo where he serves as a scientific advisor to PepsiCo’s businesses in the areas of toxicology, safety assessment, exposure evaluation, product safety, and regulatory affairs. His responsibilities include providing strategic technical input to senior management and interacting with PepsiCo’s legal, toxicology, and food safety experts globally. He serves as the PepsiCo liaison for food chemical safety to major trade associations and scientific organizations.
Prior to joining PepsiCo he was employed by Unilever’s foods business for 17 years. He also has experience in toxicology and safety evaluation in the flavor and fragrance, pharmaceutical, and petrochemical industries.
Dr. Lane is certified in general toxicology by the American Board of Toxicology and is an active member of the Society of Toxicology where he has been the President of the Food Safety Specialty Section. He was a member of the editorial board of Food and Chemical Toxicology for ten years. He has authored and coauthored papers and book chapters on toxicology and its application to the safety of food additives and contaminants.
Dr. Lane received a bachelor’s degree in chemistry from Dartmouth College and a doctorate in pharmacology from the Medical College of Virginia of Virginia Commonwealth University.
Ranulfo Lemus, ScD, DABT
Dr. Ranulfo Lemus is a Diplomat of the American Board of Toxicologists, and member of the Society of Toxicology and the American College of Toxicology; with expertise on metals, inhalation, combustion, and genetic toxicology. He obtained his Doctor of Science degree from Tulane University, and conducted postdoctoral studies at the University of Pittsburgh.
During his tenure from 2001 until 2007 as an Associate Principal Scientist for Philip Morris USA he managed a testing program that conducted in vivo micronucleus, smoke chemistry, bacterial and mammalian mutagenicity, mammalian cytotoxicity, and 90-day rat-inhalation studies. In addition, he managed the evaluation of direct and indirect materials used in the production of tobacco products.
From 2007 to 2013 as Principal Toxicologist at ARCADIS US Inc., Dr. Lemus provided Global Product Stewardship Services by assessing the human health risks from exposure to metals and consumer products. He registered nine tungsten substances under the European Union regulatory framework for the Registration, Evaluation and Authorization of Chemicals (REACH). In February 2013, Dr. Lemus was appointed the HSE Director of the International Tungsten Industry Association and in September 2013 he joined Advanced Testing Laboratories Inc. as Principal Toxicologist.
Dr. Lemus is the author of twenty-seven published peer review research papers (seven as first author) and a recipient of the 2003 NIOSH’s Alice Hamilton Award for Occupational Safety and Health in the Biological Science Category.
Leslie Recio, PhD, DABT
Dr. Leslie Recio is the ILS Chief Scientist, leader of the ILS Genetic and Molecular Toxicology group. The ILS Genetic and Molecular Toxicology group offers GLP/OECD-compliant genetic toxicology test battery and investigative toxicology-based research. 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.
Jane P. Staveley, MSPH
Ms. Staveley has more than 35 years of experience in environmental toxicology, ecological risk assessment, and product stewardship, working with clients in both the public and private sector on a broad variety of environmental issues. She has extensive experience in ecotoxicology testing and risk assessment for pesticides, industrial chemicals, pharmaceuticals, and effluents and is well versed in testing guidelines and risk assessment approaches developed under a variety of worldwide regulatory programs.
With significant volunteer service to several scientific organizations, Ms. Staveley is a recognized leader and consensus builder in the professional scientific community. She served on the Society of Environmental Toxicology and Chemistry (SETAC) World Council from 2006–2011, acting as president during 2010. In 2016, she was recognized as a SETAC Fellow.
Ms. Staveley has prepared a number of environmental assessments for veterinary and human pharmaceuticals to meet regulatory requirements in the U.S. and Europe. She has monitored ecotoxicology testing programs, prepared Data Evaluation Reports, and prepared successful waivers from testing for various clients pursuant to pesticide registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). She has evaluated ecotoxicology tests and prepared weight-of-evidence arguments submitted under the U.S. EPA’s Endocrine Disruptor Screening Program. She has managed various submissions for the U.S. EPA’s High Production Volume (HPV) Chemical Challenge Program, including the development of read-across strategies, preparation of robust summaries, and development of test plans. She is experienced in predictive tools for environmental fate and effects modeling used in Toxic Substances Control Act (TSCA) programs. She has assisted a number of clients in complying with REACH, including preparation of data gap analyses, endpoint study records in IUCLID, and Chemical Safety Reports.
Laura S. Van Winkle, PhD
Laura S. Van Winkle is Professor of Respiratory Toxicology at UC Davis in the School of Veterinary Medicine, Department of Anatomy, Physiology and Cell Biology and has a research appointment in the UC Davis John Muir Institute’s Center for Health and the Environment. Following completion of graduate studies at UC Davis in Pharmacology and Toxicology in 1995, she completed a postdoctoral training in respiratory biology and medicine in 1997. Her research focus is on respiratory toxicology including air pollution and inhaled and ingested pulmonary toxicants with a special focus on exposures that target the distal conducting airway epithelium, and Club cells, of the lung. Dr. Van Winkle is the co-leader of the Pilot Project Program for UC Davis’ Environmental Health Sciences P30 Core Center and is also a member of the UC Davis Comprehensive Cancer Center, Air Quality Research Center as well as both the Pharmacology and Toxicology and Integrative Pathobiology Graduate Groups. Dr. Van Winkle has been active in the Society of Toxicology, previously serving as an IRSS Councilor and Secretary. She is known for her expertise on naphthalene metabolism, airway epithelial injury and repair as well as for her work on the respiratory toxicology of indoor and outdoor air pollutants. She has co-authored over 80 research publications. She is a Diplomate of the American Board of Toxicology (DABT 2002–present) and recently completed five years of service to the American Thoracic Society (ATS) as a member of the Environmental Health Policy Committee. Dr. Van Winkle is an active member PI of the NIEHS consortium on nanomaterials health effects and has served on local, state, US EPA, and NIH review groups and panels. Dr. Van Winkle is a standing member of the NIH study section Systemic Injury from Environmental Exposures (SIEE) and is an associate editor of the journal Toxicological Sciences.
Tracy M. Williams, PhD, DABT
Dr. Tracy M. Williams has over 17 years of experience within pharmaceutical research and development. After receiving her doctorate in Pharmaceutical Sciences from the University of Connecticut, she completed postdoctoral training at the Chemical Industry Institute of Toxicology. Currently, she is Senior Director of Drug Disposition at Eli Lilly and Company with responsibility for nonclinical and clinical ADME science supporting the Lilly portfolio. Prior to her current role, she held numerous scientific and administrative responsibilities within the Toxicology and Pathology organization at Lilly.
She is a Diplomate of the American Board of Toxicology and a member of the Society of Toxicology, the American College of Toxicology and the American Association of Pharmaceutical Scientists. She previously served on the SOT Career Resource and Development Committee (Chairperson), the SOT Worldwide Web Committee, the ACT Outreach Committee, the American Association of Pharmaceutical Scientists: Indiana/Ohio Discussion Group (Secretary), the National Kidney Foundation of Indiana (Chairperson) and the Lilly representative to the International Life Sciences Institute: Health and Environmental Sciences Institute. She currently is a member of ACT Council and serves on the Early Career Professionals Committee. Additionally, she serves on the International Consortium for Innovation and Quality in Pharmaceutical Development Drug Metabolism Leadership Group (DMLG) Steering Committee as well as holds the role of DMLG DruSafe liaison.
John A. Wisler, PhD, DABT
Dr. John A. Wisler is vice president of toxicology and pharmacokinetics at the California Institute for Biomedical Research (Calibr). Prior to Calibr, he was director of toxicology at Dart Neuroscience; scientific director of toxicology at Amgen in Thousand Oaks, California; toxicology of director at Allergan; senior toxicologist at The Procter and Gamble Company; associate director at a toxicology CRO (IRDC/ MPI); and was a National Research Council postdoctoral fellow at the US Army Medical Research Institute of Chemical Defense. Dr. Wisler earned his PhD in toxicology from Indiana University (1988). He has been a diplomate of the American Board of Toxicology (ABT) since 1992.
Dr. Wisler has more than 28 years of industry experience leading nonclinical drug development projects ranging from discovery safety evaluations through post-marketing regulatory activities for both large and small molecule modalities. He has experience in nonclinical drug development of oncology, inflammation, cardiology, and neurology therapeutics. He has experience as preclinical oncology safety therapeutic area leader and evaluating external oncology licensing opportunities (Amgen). As a CRO study director he conducted more than 400 toxicology studies including 6 carcinogenicity studies. As an industry toxicologist he has authored or reviewed more than 40 INDs and 4 NDAs / BLAs.
Dr. Wisler is a member of the Society of Toxicology (33 years); the American College of Toxicology (10 years) and the Society of Toxicological Pathologist (3 years). He has served in leadership roles in the Society of Toxicology (SOT) as president Drug Discovery specialty section and president Southern California regional chapter; and National Councilor. He served on the ABT board of directors and as president of ABT. He has a passion for supporting toxicology education as exemplified by seminars/ lectures in the USA, Asia, and India given at national and regional chapter toxicology meetings; local colleges; universities; hospitals; and BioSafe.