HESI is governed by a Board of Trustees, which is always comprised of at least as many public sector representatives as private sector representatives. The Board provides scientific, strategic, and financial oversight for the organization. The HESI Assembly, which is comprised of public and private sector scientists from HESI’s scientific committees, the Board of Trustees, and HESI Emerging Issues Committee Science Advisors, elects the governing Trustees and provides input on new scientific and strategic objectives for the organization.
Prof. Dr. Martin van den Berg is an Emeritus Professor in Toxicology, former deputy director of the Institute of Risk Assessment Sciences of the University of Utrecht, and a European Registered Toxicologist (ERT). He is currently Chair of HESI.
He is an honorary professor in environmental toxicology at the University of Queensland (Brisbane) and a visiting professor at the Royal Chulabhorn Research Institute and Graduate School in Bangkok. In 2006 he received an honorary doctorate from the University of Umea, Sweden, for his research on mixture toxicity of dioxin-like compounds. He has published over approximately 375 peer-reviewed scientific articles, short papers, and conference proceedings.
Prof. van den Berg has been and is an advisor to many national and international organizations (Dutch National Health Council, WHO, FAO, IARC, EU, and US) involved with (eco)toxicological risk assessment of environmental and food contaminants and pesticides.
He is Co-Editor-in-Chief of Regulatory Toxicology and Pharmacology and Current Opinion in Toxicology (Elsevier). From 2008 to 2018 he served as a member of the Dutch Committee of Appeal from the Board of Authorisation of Plant Protection Products and Biocidal Products. During the last decades he was also an advisor to the chemical and pharmaceutical industry for the registration and sustainable use of new products.
Dr. Ruth A. Roberts is Chair and Director of Drug Discovery at Birmingham University, UK, and Cofounder of ApconiX, an integrated toxicology and ion channel company that brings together a team of world-renowned nonclinical safety experts with over 300 years of drug discovery and development experience. Before that, Ruth was Global Head of Regulatory Safety at AstraZeneca and Director of Toxicology for Aventis in Paris, France. She is currently Vice Chair of HESI. She chaired the HESI Emerging Issues Committee from 2015 to 2016, joined the HESI Board in 2019, and has co-chaired the HESI Biomarkers of Neurotoxicity scientific committee since its inception in 2015.
Dr. Roberts received her BSc in biochemistry and her PhD in medical oncology from the University of Manchester, UK. She is former president of EUROTOX, former president of the British Toxicology Society (BTS), and a Fellow and past president of the Academy of Toxicological Sciences (ATS) and was elected Fellow of the Royal College of Pathologists in 2012 and of the Royal Society of Biology in 2014.
Dr. Roberts was the recipient of the SOT Achievement Award in 2002, the EUROTOX Bo Holmstedt Award in 2009, and the SOT 2018 Founders Award, given in recognition of outstanding leadership in fostering the role of toxicological sciences in safety decision making. With over 150 publications in peer-reviewed journals, she is interested in developing and implementing innovative models in drug discovery and development.
Jon C. Cook is Chief Toxicology Scientist/Vice President for Scientific Research for Drug Safety Research and Development (DSRD) for Pfizer Inc. He leads DSRD’s Portfolio Issue Management Teams, co-chairs the Portfolio Safety Review Committee, and leads the Science & Technology Team. He currently is Vice President of the Health and Environmental Sciences Institute (HESI) and chairs the Finance Committee. He joined the HESI Board in 2017, served on the Emerging Issues Committee from 2014 to 2016, and has participated in/co-chaired several HESI scientific committees over the past 30 years.
Previously, he was Senior Director of Investigative Toxicology at Pfizer Inc. He has worked on numerous early and late-stage drug development teams throughout his 21 years at Pfizer. Prior to joining Pfizer Inc., he was a Senior Research Toxicologist at DuPont-Haskell Laboratory and a Postdoctoral Fellow at the Chemical Industry Institute of Toxicology.
Dr. Cook received his BS in physiology from the University of California, Davis, and his MS and PhD degrees in toxicology from North Carolina State University. He is Diplomate of the American Board of Toxicology and Fellow of the Academy of Toxicological Sciences.
Dr. Cook has been active in the Society of Toxicology (SOT) throughout his career. He was elected to the Presidential Chain of the SOT serving as vice president-elect, vice president, president, and past president from 2009 to 2013 and to Council serving from 2002 to 2004. He has served on numerous SOT committees as well as been elected to the Presidential Chain of the SOT Carcinogenesis Specialty Section (2001–2005).
Dr. Anthony Holmes is Director of Science and Technology at the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs; www.nc3rs.org.uk). He has strategic oversight of the science and technology supported through NC3Rs, ensuring that the NC3Rs has a long-term and sustainable strategy for supporting the best science and technology and its use in practice to achieve 3Rs and wider scientific and economic benefits. He also leads the CRACK IT open innovation program. Anthony is a member of the UK BioIndustry Association (BIA) Science and Innovation Advisory Committee, and a member of the iGEM Foundation’s Safety and Security Committee. Anthony has a PhD from the University of Cambridge and worked as a postdoctoral researcher at the Babraham Institute, Cambridge, exploring the molecular mechanisms behind calcium signaling pathways and their role in human health and disease.
Givaudan Fragrances Corporation
Greg Adamson trained at Murdoch University in veterinary biology and completed his PhD in biochemical toxicology in 1990 at the University of Western Australia. He completed a two-year postdoctoral fellowship at the University of Nevada where he published the effects of cytokines in hepatotoxicity in collaboration with Genentech in San Francisco.
After 10 years in varying toxicology roles across Baby Care and Personal Care businesses at Procter & Gamble, he accepted the position of Director of Product Safety & Regulatory Affairs at Avon Products where he managed the toxicology and regulatory groups for Global R&D.
In 2005, Greg joined Givaudan and is currently the Senior Vice President of Global Regulatory Affairs, Product Safety, & Sustainability. He has been a member of a number of trade association committees, including International Fragrance Association, Research Institute for Fragrance Materials, Cosmetics EU, Personal Care Products Council, and Household & Commercial Products Association (HCPA). He is currently the Vice Chairman and past treasurer of the HCPA Board. He is also a member of the Boards of Trustees of the Health and Environmental Sciences Institute and of the Personal Care Products Council.
Karissa Adkins is an experienced toxicologist with broad expertise in both investigative and regulatory toxicology, currently employed at Sanofi. She received her Bachelor of Arts degree in chemistry from Concordia College in Moorhead, Minnesota, and her PhD in pharmacology and toxicology from the University of Arizona in Tucson.
Karissa started her toxicology career as a postdoctoral fellow at Phase I Molecular Toxicology in Santa Fe, New Mexico, working in the field of toxicogenomics, and spent 4 years working in the biotechnology industry before starting her pharmaceutical career by joining the Exploratory Toxicology department of Wyeth Research in Andover, Massachusetts. At Wyeth, she managed the Molecular Toxicology group and served as the drug safety representative on various project development teams for antibody and vaccine therapeutics. Following Pfizer’s acquisition of Wyeth, she became a Director of Investigative Toxicology within Pfizer’s Drug Safety Research and Development department in Groton, Connecticut, where she continued to lead and manage an investigative group while supporting product development teams. Notable during her time at Pfizer is her innovative work in nonclinical pharmacogenomics and support of the licensure of the meningococcal B vaccine Trumenba®. After 15 years at Wyeth and Pfizer, Karissa spent a brief tenure in the Development group in the Drug Safety Research and Evaluation Department of Takeda Pharmaceuticals in Cambridge, Massachusetts, where she provided nonclinical safety support for their vaccine portfolio and served as the Head of Toxicology. She is currently the Global Head of Investigative Toxicology in Global Preclinical Safety, located in Framingham, Massachusetts, where she oversees groups in France, Germany, and the United States, and is a member of the Preclinical Safety leadership team.
Karissa is a member of the Society of Toxicology and is actively involved in BioSafe, the IQ consortium, and IMI. She has numerous publications, patents, and speaking engagements to her credit, a highlight of which was having one of her publications awarded the best publication award for 2015 by the Society of Toxicology. Karissa is an avid reader and self-declared oenophile in her spare time.
Procter & Gamble Company
Scott Belanger is presently a Research Fellow in Procter & Gamble’s Corporate Global Product Stewardship safety organization where he has broad leadership responsibilities for environmental toxicology, science, and technology guidance from an environmental perspective. He holds degrees from the University of Wisconsin (BS), Bowling Green State University (MS), and Virginia Tech (PhD and postdoctoral appointment). Prior to joining P&G in 1989, he was an Assistant Professor in Environmental Toxicology at the University of Louisiana-Lafayette. During his early tenure at P&G, Scott led research programs on the highest volume surfactant ingredients used in consumer products at P&G’s model ecosystem facility. Today, he has overall responsibility for the company’s environmental toxicology function and leads P&G’s environmental animal alternatives programs. Scott is a recognized authority in the responses of aquatic life to man-made and natural stressors and has authored over 100 published scientific articles, books, and book chapters on these topics. He has served on numerous national and international panels providing advice to organizations such as the US Environmental Protection Agency, the OECD, the European Commission, the Japanese Ministry of Environment, Trade and Industry, and Environment Canada. In 2017, Scott was elected as a Science Fellow of the Society of Environmental Toxicology and Chemistry.
Imperial College London
Alan Boobis is Emeritus Professor of Toxicology at Imperial College London. He was Professor of Biochemical Pharmacology and Director of the Toxicology Unit (supported by Public Health England and the Department of Health) at the college until June of 2017, when he retired after over 40 years at Imperial. His main research interests lie in mechanistic toxicology, drug metabolism, mode of action, and chemical risk assessment. He has published around 250 original research papers (h-index of 80). He is a member of several national and international advisory committees, the Committee on Toxicity (chair), the WHO Study Group on Tobacco Product Regulation (TobReg), JECFA (veterinary residues), and JMPR. He has been a member of the UK Advisory Committee on Pesticides, Committee on Carcinogenicity, the EFSA CONTAM Panel, and the EFSA PPR Panel. He is a member and a past chairman of the Board of Trustees of HESI and of ILSI. He is a member and a past president/vice president of the Board of Directors of ILSI Europe. He sits on several international scientific advisory boards, in both the public and private sectors. Awards include honorary fellow of the British Toxicology Society, fellow of the British Pharmacological Society, the BTS John Barnes Prize Lectureship, honorary membership and Merit Award of EUROTOX, the Royal Society of Chemistry Toxicology Award, the Arnold J Lehman Award from the SOT, the Toxicology Forum Philippe Shubik Distinguished Scientist Award, and Officer of the British Empire (OBE).
National Institute of Environmental Health Sciences
Warren Casey, PhD, is acting Chief of the US National Toxicology Program’s Biomolecular Screening Branch, National Institutes of Environmental Health Sciences (NIEHS). He also serves as the executive director of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The mission of ICCVAM, which is composed of representatives from 16 US federal regulatory and research agencies, is to promote the regulatory acceptance of test methods that protect human and animal health and the environment while reducing, refining, or replacing the use of animal tests. Dr. Casey also serves as an Adjunct Associate Professor in the Department of Microbiology at North Carolina State University and is Diplomate of the American Board of Toxicology. Prior to joining NICEATM, Dr. Casey served as a Captain in the US Army and Army National Guard during the Gulf War; and he was the Manager of Pharmaceutical Microbiology at Glaxo Inc. from 1994 to 1999; Head, Biomarker Development at GlaxoWellcome, Inc., from 1999 to 2002; and a Senior Scientist, Discovery and Investigative Toxicology at GlaxoSmithKline, Inc., from 2002 to 2009. He is the author or co-author of over 28 publications in peer-reviewed journals, holds three patents, and has made presentations at scientific meetings. Dr. Casey received his undergraduate degree in biochemistry and his PhD in microbiology from North Carolina State University.
University of Washington
Dr. David Eaton received his PhD in pharmacology from the University of Kansas Medical Center (KUMC) in 1978. He joined the faculty of the University of Washington (UW) in 1979. He served as Dean and Vice Provost of the UW Graduate School from 2013 to 2018, and currently serves as Professor of Environmental and Occupational Health Sciences, Professor of Public Health Genetics, and adjunct Professor of Medicinal Chemistry. Prior to becoming Dean and Vice Provost of the UW Graduate School in 2013, he served as Associate Vice Provost for Research for the UW from 2006 to 2013, and as the Associate Dean for Research in the School of Public Health from 1999 to 2005. Nationally, he has served as Secretary, and later as President, of the Society of Toxicology, and serves on numerous scientific advisory boards for other centers and program grants. He served on the NAS/NRC Board of Environmental Studies and Toxicology and on numerous NAS/NRC/IOM Committees related to controversial public health issues in toxicology. He currently chairs the Research Committee for the Health Effects Institute, and recently completed a term as a member of the National Advisory Environmental Health Sciences Council. He served as Founding Director of the NIEHS Core Center, the Center for Ecogenetics & Environmental Health, for 18 years, and also directed the UW NIEHS Superfund Research Program. Dr. Eaton maintained his own active research and teaching program focused in the area of the molecular basis for environmental causes of cancer and the development of human “liver-on-a-chip” technologies for toxicological assessment, with an emphasis on how chemical carcinogens are metabolized in the liver. He has published approximately 200 scientific articles, book chapters, and edited books in the field of toxicology and risk assessment. He is an Elected Fellow of the American Association for the Advancement of Science (1995), the Academy of Toxicological Sciences (2000), and the National Academy of Medicine (formerly the Institute of Medicine) of the National Academies of Science (2011). He retired from full time activity at the UW in 2018, and currently maintains an Emeritus Professor appointment at UW and an Affiliate Professor appointment at the University of Arizona College of Pharmacy. Over his more than 40 years in toxicology, he has received several awards and recognitions for his work, including the Society of Toxicology (SOT) Achievement Award (1993), the SOT AstraZeneca International Lectureship Award (1995), the SOT Public Communications Award (2014), and the PhRMA Foundation Lifetime Excellence in Pharmacology/Toxicology Award (2015). He currently serves as Chair of the Board of Scientific Councilors for the National Toxicology Program, and on the Board of Trustees and as Treasurer of the Health and Environmental Sciences Institute (HESI).
University of Wisconsin
Dr. Patrick Guiney has 42 years of broad-based experience in human health and ecological risk assessments. He currently teaches graduate-level courses in environmental toxicology, endocrine toxicology, and risk assessment at University of Wisconsin-Madison. He is also the Past President of the Society of Environmental Toxicology and Chemistry (SETAC) World Council, and the Past Secretary of the Health and Environmental Sciences Institute (HESI) Board of Trustees Executive Committee. He worked as an environmental toxicologist for the Gulf Oil Corporation and U.S. Steel Corporation and retired from S.C. Johnson & Son, Inc. as Director of their Environmental Safety Department after 28 years of service. He has conducted research into the transport, bioaccumulation, and fate of toxic substances at various levels of biological organization (molecular/biochemical to field studies). His current research interest includes the application of molecular-based models for screening and prioritizing potential endocrine disrupters, quantitative structure-activity relationships for investigating mechanisms of toxicity, ecological exposure assessment modeling for risk assessment, and alternative methods for predicting the bioaccumulation of persistent chemicals. He holds an adjunct faculty appointment at the University of Wisconsin-Madison and has published over 55 peer-reviewed scientific papers in these areas of research. He is also President and Principal Scientist of his own company, ECOTOX-Guiney Consulting, LLC, where he provides various types of environmental consulting to clients in the areas of ecotoxicology testing, risk assessment, strategies for product stewardship, regulatory compliance, and science-based policy advocacy.
S.C. Johnson & Son, Inc.
Ellison Institute for Transformative Medicine of USC
Dr. Lee is an Associate Professor of Clinical Medicine and Chemical Engineering & Material Sciences at the University of Southern California Keck School of Medicine and Viterbi School of Engineering. As the Chief Science and Innovation Officer for the Lawrence J. Ellison Institute for Transformative Medicine of USC, he provides leadership, guidance, vision, and development of research capabilities for executing the institute’s research projects and will be responsible for planning, implementing, and evaluating scientific direction, projects, and funding to sustain high-impact programs in support of a bold vision to transform cancer research in the 21st century.
Prior to joining USC, Dr. Lee served for more than a decade as a Health Sciences Director within the National Cancer Institute’s Office of the Director. Through direct support and use of public-public/public-private partnerships, he deployed programs focused on the integration of advanced technologies, trans-disciplinary approaches, infrastructures, and standards, to accelerate the creation of publicly available, broadly accessible, multi-dimensional data, knowledge, and tools to empower the entire cancer research continuum for patient benefit.
In 2016, Dr. Lee was assigned to Office of the Vice President to serve as the Deputy Director for Cancer Research and Technology for the White House Cancer Moonshot Task Force. A few key efforts he helped coordinate include the Applied Proteogenomics OrganizationaL Learning and Outcomes (APOLLO) Network, international collaborations to share molecular characterization datasets, and the Blood Profiling Atlas in Cancer pilot, as well as co-chairing an interagency group focused on cancer data and technology policy issues.
Dr. Lee has co-authored over 40 papers, five book chapters, and one book. He is a member of the Department of Veterans Affairs’ National Research Advisory Council, the National Academies Board on Science, Technology, and Economic Policy’s Innovation Policy Forum, and the Health and Environmental Sciences Institute’s Board of Trustees. Dr. Lee earned his BS degree in biomedical engineering and PhD in chemical and biomolecular engineering from Johns Hopkins University.
Bristol-Myers Squibb Company
Dr. Lois Lehman-McKeeman is currently Vice President, Pharmaceutical Candidate Optimization at Bristol-Myers Squibb (BMS) in Princeton, New Jersey, where she has worked since 2001. In this capacity, Dr. Lehman-McKeeman leads departments of Discovery Toxicology, Metabolism and Pharmacokinetics, Discovery Pharmaceutics, and Bioanalytical Sciences to support early drug candidate selection, optimization, and issue resolution.
Dr. Lehman-McKeeman received a BS degree in toxicology from the University of the Sciences in Philadelphia and holds a PhD in toxicology from the University of Kansas Medical Center. She has maintained active research interests broadly in biochemical mechanisms of toxicity and has published extensively in these fields.
Dr. Lehman-McKeeman is active professionally in the Society of Toxicology (SOT) serving as President in 2013–2014. She also held the position of Editor of Toxicological Sciences from 2003 to 2011. She has served on numerous national and international advisory committees for USEPA, NIH, and IARC. She is a Fellow in the Academy of Toxicological Sciences and was elected as a Fellow of the American Association for the Advancement of Science (AAAS) in 2008.
University of Connecticut
José E. Manautou is the Department Head of Pharmaceutical Sciences, Assistant Dean of Graduate Education and Research, and Professor of Toxicology at the University of Connecticut (UConn) School of Pharmacy. His long-term research interests are in biochemical and molecular mechanisms of xenobiotic-induced hepatotoxicity and defining compensatory responses to liver injury that enhance tissue resistance to toxicant re-exposure. Dr. Manautou has published over 200 original research articles, abstracts, commentaries, and other reports. He has been the principal and co-investigator of numerous extra- and intramural grants. His exemplary service to UConn has been recognized with the Provost’s Outstanding Service Award. His service to the scientific community and to the discipline of toxicology are equally commendable. In 2003, Manautou was elected councilor of the Society of Toxicology (SOT) and has served in key committees and task forces of the society. He currently serves as SOT Undergraduate Diversity Program Coordinator. In 2006, he was the recipient of the SOT Achievement Award. He is also a Fellow of the Academy of Toxicological Sciences. His involvement in the review of extramural and intramural science for the National Institutes of Health (NIH) also has been significant. He was member of the NIH Xenobiotic and Nutrient Disposition and Action Study Section, NIH College of CSR Reviewers, and the NIEHS Board of Scientific Counselors. He also served as member of the National Advisory Environmental Health Sciences Council and on three separate committees for the National Academies of Sciences, Engineering and Medicine. At HESI, he is a member of the Board of Trustees and Executive Committee. He is also a member of HESI’s Communications Committee and Global Outreach Task Force. Dr. Manautou also chaired the Emerging Issues Committee. He is Co-Editor-in-Chief of the journal Current Opinion in Toxicology and the President-Elect of the International Union of Toxicology. In 2019, he was named recipient of the Purdue University School of Health Sciences Distinguished Alumnus Award. He obtained his BS in pharmacy from the University of Puerto Rico, a PhD in pharmacology and toxicology at Purdue University in 1991, and postdoctoral training at the University of Connecticut. He also conducted sabbatical training at the Academic Medical Center in Amsterdam.
University of Arizona
Charlene A. McQueen is currently an Adjunct Professor at the University of Arizona. She was a Senior Scientist at the National Health Effects Research Laboratory of the USEPA (2017) and the Director of the Integrated Systems Toxicology Division (2011–2016). Prior to that, she held positions at the Harrison School of Pharmacy, Auburn University (2007–2011), and the Department of Pharmacology and Toxicology at the University of Arizona (1990–2007). Dr. McQueen received a MS in pharmacology from New York University and a PhD in human genetics from the University of Michigan. She has a particular interest in the genetic basis for response to xenobiotics. Her work with the arylamine N-acetyltransferase polymorphism has demonstrated that this genetic variation can affect drug efficacy as well as toxicity of aromatic amines and hydrazines. She was the Editor-in-Chief of the second (2007) and third (2017) editions of Comprehensive Toxicology. She also served as a member of the Editorial Board for Reference Modules in Biomedical Sciences (Elsevier Science) (2014–2017) and Editor-in-Chief of that board (2017–2019). Dr. McQueen is an American Association for the Advancement of Science Fellow and a Fellow in the Academy of Toxicological Sciences (ATS). Dr. McQueen received the Society of Toxicology (SOT) Public Communications Award and the SOT AstraZeneca Traveling Lectureship Award and has served on numerous SOT committees. She was on the Environmental Health Sciences Committee of the National Institute of Environmental Health Sciences, the Board of Scientific Councilors of the National Toxicology Program, and the National Institutes of Health Cancer Etiology Study Section. Dr. McQueen is a member of the Health and Environmental Sciences Institute (HESI) Board of Trustees.
Dr. Gary Minsavage is the Senior Environmental Health Advisor for ExxonMobil Corporation, where he provides corporate leadership and strategic direction regarding environmental health matters. Minsavage is involved in identifying emerging challenges and opportunities, leading collaborative networks and research projects, and contributing to the advancement of risk assessment methods development. Minsavage received his PhD in toxicology from the University of Rochester and Masters of Business Administration from Rutgers University. He completed postdoctoral training as a US National Research Council Fellow at the US Army Medical Research Institute of Chemical Defense before joining ExxonMobil Biomedical Sciences, Inc. (EMBSI). Minsavage is a Diplomate of the American Board of Toxicology and an active member of the US Society of Toxicology where he serves on the Risk Assessment Specialty Section Executive Committee, and also serves on the Board of the Health and Environmental Sciences Institute. Minsavage serves as a Liaison for the National Academies’ Environmental Health Matters Initiative where he helps the world’s leading scientists prioritize and tackle complex environmental health challenges and opportunities. He held a number of leadership roles at ExxonMobil, including Division Manager for the Global Product Stewardship Services Division at EMBSI, responsible for supporting product stewardship issues and opportunities, as well as safety data sheet authoring for all of ExxonMobil; Section Head for the Epidemiology, Health Surveillance, and Quality Assurance Section at EMBSI, responsible for coordinating epidemiology and QA programs for ExxonMobil global business units and external collaborations; and Section Head for the Toxicology Section at EMBSI, where he led toxicology research programs and initiatives. From 2008 to 2011, Minsavage was on assignment in Brussels, Belgium, as the Science Executive for Health Programs at the European refining industry’s technical association for health, safety, and the environment (CONCAWE). In this role, he was the EU REACH Project Manager responsible to deliver all petroleum product risk assessments for the 2010 registration period and was responsible to coordinate research in various areas including community health impact of air pollution and epidemiologic assessments of industry workers. Minsavage enjoys driving strategic thinking at work and hanging out with his family on and off sports fields.
Dr. Moffat is currently Vice President of Amgen’s Translational Safety and Bioanalytical Sciences (TS&BA) function, located in Thousand Oaks, California. Within that role, Dr. Moffat is accountable for the operational and scientific excellence of TS&BA across six global locations to enable effective end-to-end pipeline decision making and robust human risk assessments that ensure patient safety.
TS&BA provides nonclinical safety sciences expertise including exploratory and regulatory toxicology, pathology, laboratory, and animal sciences to support programs from discovery through post‐marketing and bioanalytical assessment of nonclinical and clinical studies encompassing the full spectrum of Amgen’s multi-modality pipeline.
In addition to these functional leadership roles, Dr. Moffat is Amgen’s Institutional Official and is accountable for upholding the highest ethical and scientific standards for all animal research conducted at Amgen. Dr. Moffat is also the co-chair of Amgen’s Research Safety Governance Board and is responsible for leading by example and setting the highest standards possible for workplace safety for all Global Research staff.
Externally, Dr. Moffat co-chaired the Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology (DART) Technical Committee from 2015 to 2018 and was elected to the HESI Board of Trustees in 2019. Dr. Moffat has also represented Amgen on the Preclinical Development Expert groups at both the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
Prior to joining Amgen in 2007, Dr. Moffat spent 12 years at Syngenta (formerly AstraZeneca) in the United Kingdom where he held several positions of increasing responsibility, including the Head of Developmental and Reproductive Toxicology. Dr. Moffat received his PhD in the fields of molecular biology and immunology from the University of Glasgow, Scotland, and was a Postdoctoral Fellow at Scripps Clinic, La Jolla California, and the Imperial Cancer Research Fund Biomedical Research Centre in Dundee, Scotland. Dr. Moffat has served on numerous external scientific committees and has published over 30 peer-reviewed research articles.
University of Buenos Aires
Dr. Eliana Munarriz is a researcher at the National Council of Scientific and Technical Research (CONICET) and a Senior Assistant Professor of the Faculty of Agriculture at the University of Buenos Aires in Argentina. She holds a degree in biological sciences from the University of Buenos Aires, an MBA from “Torcuato Di Tella University” in Argentina, and a PhD in molecular and cellular biology from the University of Rome “Tor Vergata” in Italy. She completed her first postdoctorate in the Medical Research Council Toxicology Unit in Leicester, United Kingdom, and a second postdoctorate at the New York University System Biology Center in New York in the United States. In addition, she was invited as an expert in the field to do short-term research stays in different laboratories in Argentina and Europe.
Since her return to Argentina in 2012, Dr. Munarriz has directed her own laboratory in applied nematology. Her group focuses on using the nematode Caenorhabditis elegans as a biological model to study environmental and molecular toxicity, with a particular interest in pesticides. As a result of the outstanding quality of this research, Dr. Munarriz received a first-place National Food Safety and Quality Service (SENASA) Award.
More recently, Dr. Munarriz become an active member of the Risk Analysis and Toxicology group at ILSI Argentina and coordinates RISK21 activities, including workshops in Spanish for academic, industry, and government audiences. Currently, Dr. Munarriz is leading an FAO project to promote and build capacities to risk assessment in Argentina and was appointed by the Argentinean Government as a technical expert on the Chemical Review Committee of the Rotterdam Convention.
Dr. Marc Pallardy received a PharmD in 1982 and a PhD in toxicology in 1987. He has been Full Professor and Head of the Department of Toxicology, Faculty of Pharmacy, University of Paris-Saclay, since 1997. He has been Dean of the Faculty of Pharmacy at University Paris-Saclay since 2015 and Head of Team 2 (“Drug and Chemical Allergy, Immunotoxicology and Immunopathology”) for INSERM UMR 996. Since 2004, he has served as Director of the Toxicology and Pharmacovigilance master’s program at University Paris-Saclay (25 students/year).
Dr. Pallardy headed the INSERM laboratory UMR-S 996 (“Cytokines, Chemokines and Immunopathology”) from 2011 to 2015 (60 permanent and non-permanent personnel, four teams). Marc Pallardy has been the co-coordinator of the Innovative Medicines Initiative (IMI) project ABIRISK (Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the Risk, 39 partners from academia and industry). He has been Vice Dean and Research Director of the Faculty of Pharmacy (2000–2015) and Director of the “Therapeutic Innovation Ecole Doctorale” (PhD program) at University Paris-Sud (2006–2015).
He is coordinator of the education committee of LABEX LERMIT, a French research network dedicated to therapeutic innovation.
Marc Pallardy has 153 publications in international peer-reviewed journals and has given more than 100 invited presentations and chaired international and national meetings, seminars, and conferences. He is Associate Editor of Toxicological Sciences and Regulatory Toxicology and Pharmacology. He is a current a member of the HESI Immuno-Safety Technical Committee and has also served on the HESI Board of Trustees since 2018.
Marc Pallardy has been a member of the committee for marketing authorization of medicinal products (French agency for medicinal products), chairman of the preclinical working party (French agency for medicinal products), co-chairman of the gene therapy working party (French agency for medicinal products), and member of the clinical trials authorization and cellular therapy working party (French agency for medicinal products). He has also been a member of the safety working party at EMA.
Takeda Pharmaceutical Company
William (Bill) Pennie is Global Head, Preclinical and Translational Sciences at Takeda Pharmaceuticals. Bill received his PhD from the University of Glasgow, Beatson Institute for Cancer Research in the field of molecular oncology with subsequent postdoctoral fellowships at the National Cancer Institute, National Institutes of Health (researching gene regulation mechanisms and epigenetic transcriptional control).
Bill started his industrial career at the Central Toxicology Laboratories (CTL) of Zeneca in Macclesfield, England (including research in nuclear hormone receptor biology and transcriptional responses to toxicological insult). He joined Pfizer in 2002, led the Molecular and Investigative Toxicology group, and was the Research Site Lead for Drug Safety Research and Development in Groton, Connecticut. He joined Pfizer Worldwide Medicinal Chemistry in 2009 to build and led the Compound Safety Prediction group, a function which aimed to further develop mechanistic understanding of toxicity, build predictive models for toxicity mechanisms, and partner to integrate them into early design cycles of medicinal chemistry.
He joined Takeda in 2014 and now leads a broad research function, Preclinical and Translational Sciences, spanning drug safety, DPMK, imaging, modeling and simulation, clinical biomarkers, nonclinical regulatory writing and submissions, comparative medicine, and strategy/operations. These functions engage across Takeda’s R&D footprint in Boston, San Diego, and Shonan, Japan and with partners globally.
Bill has a longstanding research interest in multifactorial models of toxicity and has served on numerous international consortia and committees promoting partnership in these areas, including the National Academies of Sciences, the New York Academy of Sciences, and the International Life Sciences Institute. He was a recipient of the Doerenkamp-Zbinden Honour Award for Alternatives in Biomedicine in 2009 and the Johns Hopkins CAAT Recognition Award (alternatives to animal testing) in the same year.
Dr. Nathan Price is Co-CEO of Onegevity Health. In 2019, he was named as one of the 10 Emerging Leaders in Health and Medicine by the US National Academy of Medicine. He is also an (on leave) Professor at the Institute for Systems Biology, co-director with Lee Hood of the Hood-Price Lab for Systems Biomedicine, and Affiliate Faculty at the University of Washington in Bioengineering, Computer Science and Engineering, and Molecular and Cellular Biology. He is a Camille Dreyfus Teacher-Scholar, received the 2016 Grace A. Goldsmith award for his work pioneering scientific wellness, and received a Catalyst Award in Healthy Longevity from the National Academy of Medicine in 2020. His has co-authored more than 180 peer-reviewed scientific publications and given over 200 talks and keynotes. He is active in entrepreneurship, having co-founded two companies: Arivale and Aevum Aging (acquired by Onegevity). He is a Trustee of the Health and Environmental Sciences Institute, a Fellow of the American Institute for Medical and Biological Engineering, a Fellow of the European Society of Preventive Medicine, and on the Board of Advisors for the American Cancer Society (Pacific Northwest). He also served as Chair of the NIH Study Section on Modeling and Analysis of Biological Systems (MABS).
University of Tokyo
Dr. Yuko Sekino is currently a project professor, organizing the Endowed Laboratory of Human Cell-based Drug Discovery of the Graduate School of Pharmaceutical Sciences, University of Tokyo. Dr. Sekino is now a member of the HESI Board of Trustees and contributing to its outreach activity.
Dr. Sekino obtained a bachelor’s degree in pharmaceutical science from the University of Tokyo and a PhD for physiology from Tokyo Women’s Medical College. She was a postdoctoral fellow in electrophysiology at the National Institute for Physiological Sciences and the Tokyo Metropolitan Institute for Neuroscience and became a pioneer in investigating the neural network of the limbic system by applying optical measurements using voltage-sensitive dyes. After her postdoctoral position, she became a Principal Investigator of the Japan Science and Technology Agency PRESTO (Precursory Research for Embryonic Science and Technology) Program. She was appointed as an assistant professor and promoted to an associate professor in the Department of Behavior and Neurobiology at Gunma University, and moved to the Division of Neuronal Network at the University of Tokyo. In 2010, she assumed the position of the Head of the Division of Pharmacology, National Institute of Health Sciences (NIHS). While she was with NIHS, she organized Japan iPS Cardiac Safety Assessment (JiCSA), a consortium of academia, industry, and regulatory researchers for evaluating the possible application of human iPS-derived cardiomyocytes as safety pharmacology tools. She started a validation study of the application using human iPS-derived cardiomyocytes in 2012. The study was funded by the Japan Agency for Medical Research and Development (AMED) in 2014, and she led a large consortium of more than 100 researchers from 10 universities, 15 private companies, and two national laboratories. She was a member of the Steering Committee for CiPA (Comprehensive In vitro Proarrhythmia Assay) initiated by the US Food and Drug Administration for the ICH S7B Guidelines. She played an important role in facilitating collaboration between JiCSA and CiPA. Through this activity, she has a long-lasting relationship with the HESI Cardiac Safety Committee. Since leaving NIHS, she has been working on establishing new test methods for the safety of pharmaceuticals and chemicals. Thus, Dr. Sekino made a tremendous contribution in standardization and validation of the test system using human iPS-derived cardiomyocytes and promoted application of the iPS technology for regulatory science of safety pharmacology.
Dr. Kathleen Shelton, Vice President and Chief Technology Officer for FMC Corporation, joined FMC in November 2017 with the FMC-DuPont transaction. As the global leader of the company’s robust discovery and development pipelines, Dr. Shelton leads an organization of nearly 800 scientists located around the world, with laboratories in India, Brazil, France, Denmark, and the United States. The largest site, located in Newark, Delaware, United States, has over 350 employees working in chemistry, biology, regulatory sciences, engineering, and analytical science. Under her leadership, the FMC Crop Protection Research and Development organization won the prestigious 2018 Agrow Award for the “Most Innovative Pipeline” in the agricultural industry.
Prior to her current role, Dr. Shelton was the Director of DuPont Crop Protection Research and Development. She held several leadership roles in businesses across DuPont, both in Wilmington, Delaware, United States, as well as Geneva, Switzerland. Dr. Shelton earned a doctorate in microbiology at Drexel University, and continued her research in a postdoctoral position at the University of Pennsylvania.
Outside of work, Kathy is a member of the United Way of Delaware Board of Directors and the Franklin Institute Corporate Executive Board.
Angus Chemical Company
Dr. Pamela “Pam” Spencer is the Vice President of Regulatory, Product Stewardship & Quality at ANGUS Chemical Company, in Chicago, Illinois. Prior to this role, she worked for the Dow Chemical Company for 30 years, retiring as the Scientific Director of Dow’s Toxicology Environmental Research & Consulting function. Dr. Spencer actively works to promote the concepts of safer product design with regulatory agencies, industry, academia, and nongovernmental organizations particularly as it relates to the application of New Approach Methods (NAMs). She is the inaugural President of the Association for the Advancement of Alternatives Assessment (A4), serves on the Board of Directors for the Center for Contemporary Science (CCS), and is a Diplomate of the American Board of Toxicology. She received her doctorate from the Department of Toxicology, School of Public Health, University of Michigan and her Master of Science in biology from Central Michigan University. She has extensive experience in regulatory toxicity testing and research to define human health risks, with numerous publications to date in the areas of neurotoxicology, genetic toxicology, carcinogenicity, and green chemistry.
Dr. Douglas Wolf graduated in 1981 from the University of Missouri with a Doctor of Veterinary Medicine degree and, after 6 years in clinical veterinary practice, attended Purdue University where, in 1991, he completed a pathology residency and received a research PhD in veterinary pathology. Doug was a staff scientist for 6 years at the Chemical Industry Institute of Toxicology (CIIT) where he studied chemical carcinogenesis. From 1997 until 2013 Doug held various positions with the US Environmental Protection Agency, initially as a Principal Investigator at the National Health and Environmental Effects Research Laboratory (NHEERL), where he continued research in chemical carcinogenesis and molecular pathology. Dr. Wolf held several formal leadership roles at USEPA as a Branch Chief in the Environmental Carcinogenesis Division, as Director of the Toxicology Assessment Division, as Assistant Laboratory Director in NHEERL, and as Director of the Endocrine Disruptor Screening Program in the Office of Chemical Safety and Pollution Prevention. He received numerous awards for innovative work at the USEPA to provide solutions to improve regulatory science and decision-making. In November 2013 he joined Syngenta Crop Protection as Regional Lead for Toxicology and Health Sciences in North America. Doug is currently a Senior Syngenta Fellow where he leads international efforts to advance the science of risk assessment focusing on crop protection chemicals. Dr. Wolf has authored or co-authored over 145 journal articles, book chapters, and technical reports and has presented at numerous national and international scientific meetings. In 2004 he was elected a Fellow of the International Academy of Toxicologic Pathology and in 2007 a Fellow of the Academy of Toxicological Sciences.
European Chemicals Agency
Dr. Watze de Wolf, ERT, received his PhD in 1992 from the Institute of Risk Assessment Sciences (IRAS, Utrecht University, the Netherlands) following studies on quantitative structure-activity relationships, mixture toxicity, and the impact of biotransformation on the bioaccumulation behavior in fish of organic chemicals. After a postdoctoral period at Haskell Laboratories (Newark, Delaware) on inhalation toxicology of fluorinated substances, Dr. de Wolf registered as a European Registered Toxicologist (ERT) and has held this registration since 1998. In May 2020, he completed the International Law MicroMasters Program (20 CSE) at the University Catholique de Louvain La Neuve, Belgium.
He worked at Procter & Gamble (Belgium) as an Environmental Toxicologist and Section Head of Regulatory Affairs, and at the DuPont Coordination Center (Belgium) as Director of Health and Environmental Sciences. In the latter period, he was a member of the ECETOC Scientific Committee and the Cefic LRI Steering Group. In 2010, he joined the European Chemicals Agency (ECHA, Finland) as Head of Unit and he has chaired the REACH Member State Committee since 2014.
Since 1985, Dr. de Wolf has been a member of the Society of Environmental Toxicology and Chemistry (SETAC). He served as President of the SETAC World Council in 2006 and received its prestigious Herb Ward Award for exceptional services in 2012. Dr. de Wolf is the lead author of over 30 peer-reviewed publications, numerous scientific and technical reports, and conference presentations.
University of Ottawa
Dr. Carole Yauk is the lead scientist of the Genomics Laboratory in the Environmental Health Science and Research Bureau at Health Canada and an adjunct professor of Biology at Carleton University in Ottawa, Ontario. She has over 25 years of experience in genomics/genetic toxicology. She began a new position as full professor in the Department of Biology, University of Ottawa, in September 2020. Her research focuses on the development and implementation of genomic tools for human health risk assessment of environmental exposures, and on improving regulatory assessment of heritable genetic effects. She has over 180 publications in these research fields.
Carole has been an active and enthusiastic member of HESI programs for more than a decade. She was previously co-chair of the Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee and has contributed to various projects within eSTAR. She is also very involved in a diverse array of projects within HESI’s Genetic Toxicology Technical Committee (GTTC). Internationally, Carole participates in, and leads, a wide range of activities associated with advancing the use of novel genomic approaches in human health risk assessment. She has served as Canadian delegate to the Organisation for Economic Cooperation and Development (OECD) Extended Advisory Group for Molecular Screening and Toxicogenomics since 2012. Within the OECD she is highly active in the Adverse Outcome Pathways program and is co-chairing a project to develop Omics Reporting Frameworks. She has been a leader (chair and co-chair of workshops) in the International Workshops on Genotoxicity Testing (IWGT). She is incoming president of the Environmental Mutagenesis and Genomics Society and will co-chair the International Conference on Environmental Mutagens in 2021. She is a member of three Editorial Boards and has contributed to various research oversight committees and review boards.