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.
Chair of Board
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.
Vice Chair of Board
University of Ottawa
Carole Yauk was the lead scientist of the Genomics Laboratory in the Environmental Health Science and Research Bureau at Health Canada for 18 years. She joined the University of Ottawa’s Department of Biology as a professor in September 2020, where she holds the Canada Research Chair in Genomics and the Environment. Her research broadly focuses on the development and implementation of genomic tools for human health risk assessment of environmental chemicals. Toward this, she is involved in numerous working groups within HESI’s Emerging Systems Toxicology in the Assessment of Risk (eSTAR) and Genetic Toxicology Technical (GTTC) Committees. She has served as a Canadian delegate to the Organisation for Economic Co-operation and Development (OECD) Extended Advisory Group for Molecular Screening and Toxicogenomics since 2012, where she is co-leading the developing of omics reporting framework and involved in the Adverse Outcome Pathway program. She is Past-President of the Environmental Mutagenesis and Genomics Society, co-chair of the upcoming International Conference on Environmental Mutagens in August 2022, and an editorial board member of several journals focused on mutagenesis and genetic toxicology.
Proof of concept and a roadmap for error-corrected sequencing in regulatory toxicology
Evaluation of a substance’s potential to cause mutagenicity is a critical component of human and environmental health risk assessment. Regulatory agencies worldwide have developed test guidelines to determine whether chemicals cause mutations. These tests suffer from critical limitations. First, we continue to rely on bacterial mutagenicity as the gold standard. Second, current in vivo tests generally measure mutations in one reporter gene and/or require transgenic rodent models and standalone experiments. Third, the present assays do not generally provide mechanistic insight into mutagenicity without extensive follow-up studies. Duplex Sequencing (DS) is an error-corrected next-generation sequencing (ecNGS) technology that enables highly precise quantification of mutation frequency and characterization of spectrum in potentially any species, tissue, and cell culture model. The HESI ecNGS working group of the Genetic Toxicology Technical Committee is collaborating to catalyze the adoption of this important technology for regulatory mutagenicity assessment. Foundational studies from our laboratory and others using in vivo and in vitro models that are contributing to these efforts will be reviewed in this presentation including: (a) exploring mutagenic responses by DS to confirm performance across different genotoxic modes of action and diverse tissues/models; (b) establishing degree of qualitative and quantitative concordance relative to conventional mutagenicity endpoints; (c) defining optimal experimental designs; and (d) investigating the added-value of the mechanistic information produced by DS. The work thus far indicates a robust ability to detect mutations by DS for prototypical mutagenic exposures in numerous models, concordance of DS mutation frequencies with conventional endpoints, and remarkable cross-laboratory agreement. The ecNGS working group is developing a roadmap to accelerate the adoption of DS and other ecNGS technologies for both the near-term (e.g., complement existing assay) and long-term (e.g., replace conventional mutagenicity tests). This work sets the stage for the modernization of mutagenicity testing to protect human and environmental health.
President of Assembly
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.
Vice President of Assembly
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.
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).
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.
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.
Universidade de São Paulo
Dr. Roger Chammas is currently Professor of Oncology at Universidade de São Paulo. He completed his studies in medicine at Universidade de São Paulo in 1988 and received his PhD in biochemistry from the same university, working at the Ludwig Institute for Cancer Research, São Paulo branch. He then trained in cancer glycobiology at the University of California, under Ajit Varki’s supervision, from 1994 to 1997. He returned to to São Paulo in 1998; he was a visiting researcher at Universidade Federal de São Paulo and Universidade de São Paulo Medical School, where he obtained a tenure position in 2001.
Dr. Chammas is presently Deputy Dean of the Medical School at Universidade de São Paulo and Chair of the Center for Translational Research in Oncology at Instituto do Câncer do Estado de São Paulo, a public Cancer Center associated with the university. He was elected a member of the Brazilian Academy of Sciences in 2013 and serves on the subcommittee for International Affairs of the American Association for Cancer Research, promoting interdisciplinary cancer research events and symposia in Brazil. He is a member of the American Association for Cancer Research and the Brazilian Society of Cell Biology and a life fellow of the Union for International Cancer Control (UICC).
His research focuses on the functional significance of aberrant glycosylation patterns often found in tumors, with emphasis on the role of glycan binding proteins, such as galectins, in tumor cell interactions with their microenvironment and in the control of tumor-associated vascular function.
Past President of Assembly
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).
Bristol Myers Squibb
Dr. Myrtle Davis is the Vice President for Discovery Toxicology in the Pharmaceutical Candidate Optimization (PCO) organization. Dr. Davis joined BMS from the National Cancer Institute where she was the Chief of the Toxicology and Pharmacology Branch of the Developmental Therapeutics Program. Myrtle has previous experience as a Research Advisor in the Drug Safety group of Lilly Research Laboratories. In both roles, she contributed critical expertise to the advancement of several drugs candidates and to the understanding of toxicological mechanisms. She also has several years of academic experience as an Associate Professor in the Department of Pathology in the School of Medicine at the University of Maryland.
Dr. Davis is currently responsible for leading the scientific efforts in Discovery Toxicology to provide target and molecular hazard identification and risk assessments for issues identified in discovery research. She also leads and oversees the investigative toxicology efforts needed to support mechanistic understanding of compound- or target-mediated toxicities in discovery and development.
Dr. Davis is a Fellow of the Academy of Toxicological Sciences, an active member of the Society of Toxicology (and serves as the current President), and a member of the Society of Toxicologic Pathology. She served on the Board of Scientific Councilors of the National Toxicology Program, and the Board of HESI. She served as a reviewer for the Assay Development and Screening Technologies Laboratory of the National Center for Advancing Translational Sciences (NCATS). Myrtle also served as an Associate Editor for Toxicological Sciences and Toxicologic Pathology, and served as Editor-in-Chief of the ILAR Journal (Institute for Laboratory Animal Research of the National Academy of Sciences). She has authored several book chapters and co-authored peer-reviewed publications on a range of topics including apoptosis, toxicant-induced cell signaling, and biomarkers of tissue injury. She has also developed course content and lectures for medical and graduate student education.
A native New Yorker, Dr. Davis completed a postdoctoral fellowship in Toxicologic Pathology at the University of Maryland. She earned a PhD in Toxicology from the University of Illinois Champaign-Urbana and obtained her Doctor of Veterinary Medicine degree from Tuskegee University School of Veterinary Medicine. She also completed undergraduate work in Chemistry and Math at Tuskegee University. Myrtle attended Tuskegee University where she pursued a BS degree in Chemistry and Mathematics followed by a Doctorate of Veterinary Medicine.
Merck & Co.
Dr. Patricia Escobar is an Executive Director in Non-Clinical Safety Assessment and Laboratory Animal Resources at Merck & Co., leading groups of scientists that focus on genetic toxicology, in vitro safety pharmacology, and in vitro toxicology assessments. Dr. Escobar is an internationally recognized genetic toxicologist with experience in academia, a contract laboratory, and the pharmaceutical industry, and she is a frequent participant in international collaborative workshops and enterprises such as development of OECD guidelines. Dr. Escobar joined Merck in 2015 as the Director of Genetic Toxicology, responsible for screening and bringing forward the best drug candidates from discovery, for GLP regulatory genotoxicity testing, and for developing follow-up strategies and application of new technologies for screening and for understanding mechanisms of genotoxicity to support compound selection and risk assessment. She is the co-chair of the Mutagenic Impurities Council at Merck.
Dr. Escobar received a BSc in microbiology and an MSc in genetic toxicology from the Universidad de los Andes in Bogotá, Colombia, and her PhD in molecular toxicology from the University of Pittsburgh. She then completed her postdoctoral training in the Gene & Environment Laboratory at University of California, Berkeley. Following her postdoc, Dr. Escobar worked at BioReliance as a Genetic Toxicology Study Director. In 2008, she joined Boehringer Ingelheim Pharmaceuticals in the Nonclinical Drug Safety group at the US site, where she had a series of roles with increasing responsibility for managing and leading the predictive toxicology group, while also serving as the genetic toxicology scientific lead for this group and as a toxicologist in drug discovery teams.
Dr. Escobar has contributed widely to international efforts in genetic toxicology, such as the International Working Groups on Genetic Toxicology (IWGT) and the Expert Working Group on the OECD In Vivo Mammalian Alkaline Comet Assay, and the OECD group working on the Bacterial Reverse Mutation testing guideline. Dr. Escobar is a former board chair and member of the Genetic Toxicology Association (GTA) and a council member of the Environmental Mutagenesis and Genomics Society (EMGS), and she was also a council officer in the Northeast Chapter of the Society of Toxicology. For EMGS she has chaired the Alexander Hollander Committee and special interest groups on Applied Genetic Toxicology and on New Technology. Currently, she is a member of the Tox Forum Program Planning Committee, the OECD Genetox expert working group, the HESI Genetic Toxicology Technical Committee (GTTC), and the HESI Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee Dr. Escobar is author/co-author of more than 20 publications, including peer-reviewed articles and/or book chapters.
Bayer Crop Science
Dr. Nina Hallmark is currently working in the Environment Safety organisation of Bayer AG Crop Science Division in Germany. This role includes investigating the potential risk to terrestrial vertebrates, such as birds and mammals, to pesticides used in the landscapes where these wild creatures live and feed. Previously, Nina worked as a Human Safety expert for Bayer In France, using her interest and experiences in human toxicology to explore potential developmental, reproductive or endocrine-mediated toxicity from pesticides using laboratory mammalian test systems. This built on similar work with industrial chemicals during 8 years with ExxonMobil in Brussels, Belgium and Houston, Texas, USA. This opportunity followed her PhD in reproductive and developmental toxicology from the University of Edinburgh, Scotland. Originally Nina studied Biochemistry at the University of Birmingham, England which led to a MSc in Forensic Science at the University of Edinburgh in bonny Scotland. This course revealed the science and art of regulatory toxicology, leading to her becoming an in vivo Study Director for a CRO (today known as Charles River), before embarking on the PhD program and subsequent roles within the global chemical and pesticide industries. This fusion of academic, industry and CRO experiences have shaped Nina’s interests in safety sciences. These have matured into a focus on the potential inter-play between human and environment protection testing and assessment approaches. She is also curious about and fascinated by the changing technologies available to investigate potential hazard and exposure profiles which can enable effective, realistic safety profiling and assessment of the different chemistries which are integral to our 21st century lifestyles. Nina believes in cross-disciplinary collaboration to identify and address the key safety science questions we face today and is greatly looking forward to supporting HESI with their mission as the Health and Environmental Sciences Institute to engage with diverse scientific minds of the HESI strategic partners to bring their many different experiences and perspectives into the discussions and together, to foster collaborative, holistic, science-based solutions.
Shell Health - Americas
Dr. Sarah Hughes is a Senior Ecotoxicologist at Shell Oil Company in the Risk Science Team in Houston, Texas, and has been with the company for 13 years. Dr. Hughes obtained a BSc from University of Guelph (Canada) and an MSc and PhD from the University of Saskatchewan (Canada) in Ecotoxicology.
In her role, Dr. Hughes provides expert ecotoxicology advice and services to Shell’s global businesses and stakeholders relating to operating assets, projects, technology, and products. Dr. Hughes drives the development or evaluation of tools, methods, and best practices in ecotoxicology through internal and joint industry R&D as well as the responsible development of safe and sustainable products and processes for Shell. Topics of research interest include the development of new approach methodologies (NAMs) for ecotoxicology as well as non-vertebrate methods for whole effluent toxicity assessment, and she is an active member of the HESI Animal Alternatives in Environmental Risk Assessment Committee. Her current research is focused on supporting the global energy transition through evaluating the environmental risks of carbon capture and renewable energy technologies as well as low carbon fuels. Dr. Hughes is adjunct faculty at the University of Saskatchewan (Canada) as well as Clemson University and Texas Christian University (United States). Dr. Hughes is also an elected member on the North American Board of Directors for the Society of Environmental Toxicology and Chemistry (SETAC) and the Canadian Ecotoxicity Workshop (CEW).
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.
Norwegian Institute for Water Research (NIVA)
Dr. Adam Lillicrap is the Research Manager for the section of Ecotoxicology and Risk Assessment which employs 24 dedicated research scientists and several PhD students and post-Doctoral scientists. He is also NIVA’s GLP Manager and has been project managing and study directing regulatory ecotoxicity tests according to Good Laboratory Practice (GLP) for over 20 years. Adam is a EUROTOX Registered Toxicologist (ERT) and is involved in numerous international committees and expert working groups. Adam is the Norwegian representative at the OECD validation management group for ecotoxicity test methods (VMGEco). Adam is also the Norwegian expert for fish within the OECD and the Norwegian representative for ISO Water Quality test standards. Adam has been working with zebrafish embryos for ecotoxicity assessments for over 20 years and was an industry nominated expert to the OECD regarding the implementation of the Fish Embryo Toxicity (FET) test guideline. Subsequently, Adam was elected as an independent advisor for the validation management group of the ring trial of the FET test. Over the years, Adam has been very active in the field of animal alternatives for ecotoxicity testing, chairing many sessions at SETAC and currently chairs the SETAC global animal alternatives interest group. He has been actively promoting the use of alternative methods for hazard assessments of chemicals at a regulatory level and was the project lead for the newly adopted ISO standard and OECD test guideline for a cytotoxicity assay (RT-gill W1 cell line). Adam was also the chairperson for the Cefic LRi Research Liaison Team for the project CELLSens and is currently leading the Cefic LRi project (ECO 51) entitled Strengthening Weight of evidence for FET data to replace acute Fish Toxicity (SWiFT). Adam was also the coordinator for a JPI Oceans Knowledge Hub for contaminants of emerging concern in the marine environment. Adam has a thorough understanding of the regulatory complexities regarding the adoption of alternative test methods and the need for a weight of evidence approach to gain regulatory acceptance. Adams main interests involve understanding how chemicals are regulated within an environmental context, and how to influence policy making decisions for regulatory frameworks.
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. Moffat is currently Vice President of Amgen’s Translational Safety and Bioanalytical Sciences (TS&BA) function, located in Thousand Oaks, CA. Within that role, Dr. Moffat is accountable for the scientific and operational excellence of TS&BA across 5 global locations to enable effective end-to-end pipeline decision making and robust human risk assessments that ensure patient safety.
TS&BA provides translational 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 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. Previously, Dr. Moffat has also served as Amgen’s Institutional Official, accountable for upholding the highest ethical and scientific standards for all animal research conducted at Amgen.
Externally, Dr. Moffat co-chaired the Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology (DART) Technical Committee from 2015-2018 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 UK 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 CA 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
Researcher of the National Council of Scientific and Technical Research (CONICET) and Senior Assistant Professor of the Faculty of Agriculture of the University of Buenos Aires (UBA). Degree in Biological Sciences from the University of Buenos Aires (UBA), Doctor in Molecular and Cellular Biology from the University of Rome “Tor Vergata” (Italy) and Master in Business Administration from the “Torcuato Di Tella University” (Argentina). I have completed a first post-doctorate in the Toxicology Unit of the Medical Research Council in Leicester (United Kingdom) and second in the NYU System Biology Center in New York, USA. In addition, I was invited as an expert in the field to do short-term research stays in different laboratories in the Argentina and Europe. Since my return to Argentina in 2012 I have directed my own laboratory in Applied Nematology. My group is focused on using the nematode C. elegans as a biological model to study environmental and molecular toxicity, with particularly interest on pesticides. As result of the outstanding quality of our research I was granted with 1st place of the National Food Safety and Quality Service (SENASA) Award. More recently, I become an active member of the Risk Analysis and Toxicology group at ILSI Argentina and coordinate RISK21 activities, including workshops in Spanish for academic, industry and government audiences. Currently, I am leading a FAO project to promote and build capacities to risk assessment in Argentina and have been appointed by the Argentinean Government as the technical expert at the Chemical Review Committee of the Rotterdam Convention.
Ghana Science and Technology Policy Research Institute
Dr. Rose Omari is a Senior Research Scientist at the Science and Technology Policy Institute, Council for Scientific and Industrial Research (CSIR-STEPRI), in Ghana. She has expertise in multidisciplinary and policy research in agriculture, food safety, nutrition, and health. Dr. Omari is a co-founder of EatSafe Ghana, an NGO that promotes public health through safe and healthy food. She is a member of the Partnership for Aflatoxin Control in Africa (PACA) and has contributed in many ways to the PACA program, which aims to make Africa free from aflatoxin. She is also a trainer/educator and has conducted several trainings in food safety, nutrition, and risk communication for varied audiences using different channels. Dr. Omari has a BSc in biochemistry and food science, a master’s degree in food science from the University of Ghana, and a PhD in rural sociology (food studies) from Wageningen University and Research Center, The Netherlands.
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.
Dr. Tracey Papenfuss has over 20 years of specialized experience in immunology, pathology, and related disciplines in both industry and academia. She previously worked as a pathologist (immunopathology specialization) in preclinical safety assessment at Charles River Laboratories. She previously directed an academic research laboratory in early discovery immunotherapeutics for inflammatory and autoimmune diseases and cancer at The Ohio State University. In addition to her current position in safety assessment in industry, she continues to serve as an adjunct faculty member in the College of Veterinary Medicine and College of Pharmacy where she collaborates with colleagues and continues to support the training and education of professional students, residents, and graduate students in translational pharmacology, comparative medicine, and drug development.
She has been a member of the HESI Immunosafety Committee since 2016. During that time she has actively participated in, contributed to, and led activities and projects within multiple working groups that support all of the key objectives in the Immunosafety Committee’s mission statement.
In addition, she maintains professional affiliations, gives scientific presentations, publishes peer-reviewed manuscripts and book chapters, and dialogs with scientists within the multiple disciplines (immunology, toxicology, pathology, regulatory science, etc.) that relate to immune safety and its translation to human health risk assessment. Immunosafety is a vibrant and rapidly advancing field which benefits from active collaborations and communications between scientists from academia, government, and industry.
Procter & Gamble Company
Dr. Stefan Pfuhler has been employed by the Procter & Gamble Company since January 2020, has held multiple positions for them, and has worked at several of their US and overseas locations. Currently he is a Research Fellow in the Global Product Stewardship division and is a global genotoxicity expert. He leads the company’s genotoxicity expert team and develops and executes their genotoxicity research program. He manages product and ingredient issues related to genetic toxicology and develops and supports testing strategies and policies across the entire company.
Dr. Pfuhler earned his MS in biology in 1993 and his PhD in 1997, both from the University of Ulm in Ulm, Germany. He is a member of the OECD Endpoint Expert Working Group on genotoxicity guideline revision and the OECD Expert Working Group on genotoxicity of nanomaterials and is involved in various other professional activities and memberships.
Dr. Sanderson has been employed both in industry as the Director for Environmental Safety, with Washington DC chemicals trade association (ACI formerly SDA), as well as in academia as a post-doctoral fellow in Canada – and currently as a senior researcher in Denmark. He has a broad background in environmental and public health of bioactive chemical risk assessment over the past two decades. He has served on NAS and WHO panels reviewing public health risks from trace level exposures to pharmaceuticals in drinking water. Dr. Sanderson currently serves on the WHO Chemical Risk Assessment Network – with a focus on developing countries capacity and needs to assess public risks of chemicals exposures. He has completed a 4 yr project exposure pathway modelling and cancer risk screening on Vieques. He has worked on projects from many different international organizations including WHO; NATO; EU; Cefic and produced several peer-reviewed publications from each project. Dr. Sanderson was the National Expert for Denmark to the EU Commission H2020 and now Horizon Europe Programme Committee Environment and Climate, Danish Research Council 2017- present. Since 2016, he has worked with the Danish EPA on projects related to Environmental Quality Standards of chemicals including pesticides and pesticide metabolites and developed and reviewed several EQS reports to the DK-EPA.
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.
Jean-Pierre holds a Ph.D. in Physiology & Pharmacology 1990, from the University of Montpellier, France. Following a post-doc at UCSF, Jean-Pierre joined the Pierre Fabre Research Centre (1992-98) where he contributed to the discovery and progression into development of 3 candidate drugs. He joined AstraZeneca to build from inception, develop and lead the Department of Safety Pharmacology where he contributed to the safety evaluation of ~200 candidate drugs across a wide range of therapy areas, leading to the development and successful registration of several marketed products. In February 2014 he joined UCB-Biopharma as Senior Director Head of Investigative Toxicology, based in Belgium supporting the entire portfolio across several therapy areas and modalities. He is an active member of several scientific societies; former President of the Safety Pharmacology Society; current co-chair of the HESI subcommittee on Proarrhythmia, and of the HESI Cardiac Steering Team. He is also Chair of the IQ-DruSafe Secondary Pharmacology Working Group; and he is representing the EFPIA on the ICH E14-S7B Implementation Working Group. He is involved in training, education and mentoring programs associated with several scientific societies, universities, and trade associations. He is author/co-author of several patents and >200 peer review publications and book chapters.
Past Chair of Board
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. Wolf graduated in 1981 from the University of Missouri with a Doctor of Veterinary Medicine degree (D.V.M.) 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. Dr. Wolf was a staff scientist for 6 years at the Chemical Industry Institute of Toxicology (CIIT) where he studied chemical carcinogenesis. From 1997 until 2013 Dr. Wolf held various positions with the U.S. 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 EPA 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 US EPA 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. Dr. Wolf is currently a Senior Syngenta Fellow where he leads international efforts to advance science-based risk assessment focusing on crop protection chemicals and progressing the development and qualification of new approach methods in the service of decreasing the use of animals in chemical evaluation. Dr. Wolf has authored or coauthored over 155 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 Pathologists and in 2007 a Fellow of the Academy of Toxicological Sciences.
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