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
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. She is also an adjunct professor of Biology at Carleton University in Ottawa. 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), where she is co-leading the development of the OECD Omics reporting framework and involved in the Adverse Outcome Pathway program. She is Past-President of the Environmental Mutagenesis and Genomics Society and an editorial board member of several journals focused on mutagenesis and genetic toxicology.
Vice Chair of Board
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.
President of Assembly
ExxonMobil Corporation
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.
Vice President of Assembly
National Institute of Environmental Health Sciences
Warren Casey is an accomplished scientist and strategic thinker with a proven track record of building and leading teams that successfully solve highly complex problems. He holds a Ph.D. in Microbiology and a B.S. in Biochemistry from North Carolina State University (NCSU) and has served as a Diplomat of the American Board of Toxicology since 2007. Currently, Dr. Casey is the Director of Strategic Partnerships in the Division of Translational Toxicology (DTT) at the National Institute of Environmental Health Sciences (NIEHS), where he is responsible for identifying strategic opportunities, recruiting key partners, securing funding, and managing collaborative programs that support the mission of DTT and NIEHS.
Dr. Casey has held several key leadership positions over his career, including Executive Director of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), Director of the NTP Interagency Center for the Evaluation of Toxicological Methods, and Acting Chief of Predictive Toxicology and Biomolecular Screening Branches. As Executive Director of ICCVAM, he provided strategic and scientific leadership across the U.S. government in modernizing the safety assessment of drugs and chemicals and served as the architect of the “Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States” (Roadmap), an effort that served as the impetus for the FDA’s Predictive Toxicology Roadmap and EPA’s New Approach Methods Workplan. The framework outlined in the Roadmap has now been adopted by multiple organizations and agencies throughout the world. In his role as Acting Branch Chief, he was responsible for the development, validation, and deployment of computational tools and systems toxicology models to predict human-relevant health effects. Dr. Casey continues to serve as the NIEHS representative and scientific advisor on national and international consortia, including Tox21 and ASPIS (Animal-free Safety assessment of chemicals: Project cluster for Implementation of novel Strategies).
In recognition of his accomplishments, Dr. Casey has received numerous awards, including the NIH Director’s Merit and Special Act awards, the Society of Toxicology’s Enhancement of Animal Welfare Award, a Special Certificate of Appreciation from the EPA Assistant Administrator, GlaxoSmithKline’s highest award for research (Gold Award), and was named as a Distinguished Alumnus by both the NCSU Department of Microbiology and the College of Agriculture and Life Sciences.
In addition to his career achievements, Dr. Casey was a Captain in the U.S. Army (Top Secret security clearance) and participated in Operation Desert Shield/Storm in Saudi Arabia from 1990-1992. He received the National Defense Service Medal and Southwest Asia Service Medal for combat operations in Operation Desert Storm.
Treasurer
University of Connecticut
José E. Manautou is the Boehringer Ingelheim Endowed Chair in Mechanistic Toxicology, Department Head of Pharmaceutical Sciences, 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 and Fellow of the American Society of Pharmacology and Experimental Therapeutics. 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 Health DataWell Advisory Board. Dr. Manautou also chaired the Emerging Issues Committee. He is Co-Editor-in-Chief of the journal Current Opinion in Toxicology and the President 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.
Sanofi
Karissa Adkins is an experienced toxicologist with broad expertise in both investigative and regulatory toxicology, currently employed at Sanofi pharmaceuticals. 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, AZ.
Karissa started her pharmaceutical career at Wyeth in Andover, Massachusetts where she was in the Exploratory Toxicology group. She managed the Molecular Toxicology group and served as the preclinical 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 still 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 oversaw nonclinical safety support for their vaccine portfolio and served as the Head of Toxicology. She is currently the Global Head of Investigative Toxicology in Preclinical Safety at Sanofi, located in Cambridge, Massachusetts, overseeing 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, IMI, and HESI. Her involvement with HESI dates back to her days at Wyeth and work with the genomics committee (now eSTAR), and has continued throughout her career. 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.
Health Canada
Dr. Tara Barton-Maclaren is a Risk Assessment Division Manager in the Existing Substances Risk Assessment Bureau, Healthy Environments and Consumer Safety Branch of Health Canada since 2012. As the focal point for hazard assessment expertise in the Bureau, the division follows advancements in toxicology and risk assessment and works toward the development of strategies for the integration of emerging data and novel methodologies for the assessment of chemicals existing in the Canadian marketplace. In support of the global transition to 21st Century toxicology and risk assessment, she participates in initiatives under the Organization for Economic Cooperation and Development (OECD) and engages in various scientific collaborations both nationally and internationally in the areas of QSAR, Adverse Outcome Pathways, Integrated Approaches to Testing and Assessment and new approaches to support regulatory decision-making.
Dr. Tara Barton-Maclaren joined Health Canada in the Existing Substances Risk Assessment Bureau in 2007 and has led various risk assessment files as well as hazard methodology initiatives. She obtained her BSc Honours from the University of Guelph with a specialization in Biomedical Science in 2000 and her PhD in Reproductive Toxicology from McGill University in 2007.
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 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 the 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 also serves as the founding director of the Comprehensive Center for Precision Oncology at Universidade de São Paulo. He was elected a member of the Brazilian Academy of Sciences in 2013, and serves on the Latin American subcommittee of the Global Affairs Office of the American Association for Cancer Research, promoting interdisciplinary cancer research in the region. 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 mechanisms of cancer therapy resistance, as a platform for innovative diagnosis and more precise treatments.
Boehringer Ingelheim
Dr. Myrtle Davis is the Senior Vice President and Head of Global Nonclinical Safety and DMPK for Boehringer Ingelheim.
Dr. Davis was previously the Vice President for Discovery Toxicology in the Pharmaceutical Candidate Optimization (PCO) organization at BMS. 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.
At BMS Dr. Davis was 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 led and oversaw 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.
Center for Space Medicine, Baylor College of Medicine
Click here to view Dr. Donoviel’s bio.
Merck & Co. Inc.
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.
AstraZeneca
Dr Mick Fellows is the Director of CVRM Cell Therapy Safety at AstraZeneca in Cambridge UK. He earned his Ph.D in Pharmacology and Toxicology investigating topoisomerase II inhibition at Liverpool University. In the mid 1980’s Mick joined Covance, where he developed a range of in vitro and in vivo genetox assays, becoming an authority on in vitro mutagenesis and phototoxicity.
In 2001, Mick joined AstraZeneca, initially as a genetic toxicologists. However, over the last decade, Mick’s research has focused on AstraZeneca’s advanced medicine safety platforms, including genome editing and modified RNA therapies. Mick’s current role is as the AZ biopharm cell and regenerative medicine safety lead. Mick has had the honour of serving as the president of the United Kingdom Environmental Mutagen Society and has worked on and chaired several international workgroups; including HESI, OECD, EFPIA and ICH.
BfArM Germany
Roland Frötschl studied molecular and cellular biology and got his PhD in biology from the University Stuttgart in 1995. He was postdoc researcher at the Institute for Clinical Pharmacology at the University Hospital Charité in Berlin and works for the BfArM since 2001 where he joined the unit of reproductive and genetic toxicology as a researcher and preclinical assessor.
His main task is the safety risk assessment of drugs, especially with respect to their mutagenic and carcinogenic potential and the risk assessment of impurities in pharmaceuticals. Roland Frötschl is a German Society of Pharmacology and Toxicology certified Toxicologist and European Registered Toxicologist.
He is active in research projects focused on the use of new in vitro approaches and development of biomarkers for the safety testing. He is active in HESI´s GTTC and eSTAR committee since many years and active in a number of working groups of both committees (e.g. TGx-DDI project, carcinogenomics project, MGRA, in vivo follow up) and also contributed to numerous HESI workshops. Roland Frötschl is an expert and member of the Nonclinical Working Party of CHMP at the European Medicines Agency. He is currently the European Commission´s expert and Topic Leader at the ICH expert working groups for M7, Q3D and Q3C guidances and the current rapporteur of Q3D and Q3C. He was a member of the USP elemental impurities advisory panel until 2015. Roland Frötschl is member of the Executive Committee of the European Environmental Mutagenesis and Genomics Society and member of the steering committee of the International Workshops on Genotoxicity Testing (IWGT). He is also active as a lecturer for preclinical safety assessment in the Master of Toxicology course of the Medical University Vienna the toxicology course of the German Society of Pharmacology and Toxicology, the master course for Drug Regulatory Affairs of the University Bonn and Pharmaceutical Medicine of the University Duisburg-Essen.
Past President of Assembly
NC3Rs UK
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.
Shell Global Solutions
Dr. Sarah Hughes is a Principal Ecotoxicologist at Shell in the Product Stewardship organization in Houston, Texas, and has been with the company for 16 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 active member of the Society of Environmental Toxicology and Chemistry (SETAC).
National Institute of Health Sciences, Japan
Dr. Kanda currently serves as Division head of Pharmacology at National Institute of Health Sciences (NIHS) Japan. His research area is regulatory science, which seeks to apply new approach methodologies (NAM) to the review process and bridge the gap between scientific innovation and safety issues.
He has coordinated the JiCSA (Japan iPS Cardiac Safety Assessment) consortium, including the development and validation of test methods using iPSC-derived cardiomyocytes, and has collaborated with HESI Cardiac Safety Committee, FDA, and Comprehensive In Vitro Proarrhythmia Assay (CiPA). He has worked with HESI NeuTox Committee in terms of seizure liability and other projects, such as PBPK, DART and CORA. In addition, he has contributed to OECD guidances (Good In Vitro Method Practice, Developmental Neurotoxicity, and PBPK) as an expert group.
He is a member of the Board of Directors of Safety Pharmacology Society (SPS) and Japanese Pharmacological Society (JPS). He is also a member of the Board of Directors of European Society of Toxicology In Vitro (ESTIV) and the Japanese Society for Alternatives to Animal Experiments (JSAAE) to promote the 3Rs. He serves as the Editorial Board Member of Scientific Reports, Cardiovascular Toxicology, Journal of Pharmacological Sciences. He has published over 100 peer-reviewed journal articles and book chapters related to assessing the safety and effectiveness of drugs and chemicals.
He received B.S. degree, M.S. degree, and Ph.D. degree from the University of Tokyo. After he worked as a research assistant professor in National Defense Medical College, he has worked on regulatory science research since joining the Division of Pharmacology, NIHS as a section head in 2008 and has been promoted as a Division head in 2017.
Corteva Agriscience
Click here to view Dr. LaRocca’s CV.
BASF
Robert Landsiedel is Vice President of special toxicology at BASF SE in Ludwigshafen am Rhein, Germany. He previously worked for BASF in development and management roles in the USA and in Japan. He is an associate professor (Privatdozent) at the Free University of Berlin and has further teaching positions in Leipzig and Landau.
His team at BASF is performing more than 500 regulatory toxicological studies per year under GLP, GIVIMP and ISO17020 as well as screenings for product development. In addition, they are developing new toxicological methods and testing strategies.
They have received more than 20 external grants (German BMBF- and EU-funded) and their work has been recognized by several awards including the German Research Award for the development of alternative methods, German GT-Toxicology Award, the Responsible Care Award of the European Chemical Industry Council (Cefic) and the Herbert E. Stokinger Awards of the American Conference of Governmental Industrial Hygienists (ACGIH).
Robert received a doctorate degree in chemistry (Dr. rer. nat.), a postgraduate degree in toxicology, and a habilitation in pharmacology and toxicology. He is a Diplomate of the American Board of Toxicology (DABT) and a Fellow of American Academy of Toxicological Sciences (FATS). He was appointed member of the European Commission’s Scientific Committee for Occupational Exposure Levels (SCOEL) where he chaired the methodology working group until the Committee’s decommissioning in 2019. Currently he is the chair for human toxicology of German National Hub within the “Partnership for the Assessment of Risk from Chemicals (PARC), the chairman of the German Toxicology Society (GT) and President of the German Society for experimental and clinical Pharmacology and Toxicology (DGPT).
Robert Landsiedel – Google Scholar
Robert Landsiedel (0000-0003-3756-1904) – ORCID
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.
Charles River Laboratories
Elise Madison Lewis, PhD, Principal Director of Toxicology, Charles River Laboratories, Inc., Horsham, Pennsylvania
Dr. Lewis is a native of Alabama, and she received both her Bachelor and Doctorate degrees from The University of Alabama in Tuscaloosa. As an undergraduate, she was patterning herself to be a medical professional, particularly an Obstetrician. However, she diverged from this path and literally embarked upon a road that is less traveled, the field of toxicology. While in graduate school she was recipient of a Future Faculty Fellowship for minority students, and through her training in the field of toxicology, Dr. Lewis found a way to marry her interests in the medical field with a passion to prevent birth defects from intentional or unintentional exposure to drug products or chemicals. Simply put, she spends much of her time researching human health hazards that could cause embryo-fetal death, birth defects, growth retardation, or functional deficits. Today, Dr. Lewis is employed by Charles River Laboratories, Inc., a contract research organization that focuses on improving human and animal health by advancing the search for drugs from discovery through market approval. Dr. Lewis joined Charles River Laboratories, Inc. in 2001 as a Study Director in the area of Reproductive, Developmental, and Juvenile Toxicology. In this role, she had the opportunity to oversee the technical conduct of nonclinical laboratory studies that are critical to environmental safety and the health care industry, and are necessary prior to consideration of new compounds for regulatory approval as drug products, medical devices, vaccines, pesticides, and other products to which humans might be exposed.
Over the years, she has successfully navigated her way through the scientific ranks within Charles River to become the Principal Director of Toxicology at the Horsham, Pennsylvania site with additional oversight of Reproductive, Developmental and Juvenile Toxicology specialty services within the East Coast Region of Safety Assessment. Dr. Lewis has authored or co-authored over 100 publications, books, and book chapters in various areas of developmental, reproductive, and juvenile toxicology, and has participated in numerous national and international speaking engagements. She is the co-editor of a book on Nonclinical Pediatric Toxicology that was published in January 2012. In 2021, Dr. Lewis was recognized as a living legend in celebration of Black History Month in the Philadelphia area for her significant contributions to STEM and biomedical research.
Dr. Lewis is involved in a number of national and international scientific organizations. She is a Past President for the Society for Birth Defects Research and Prevention (BDRP) and the current past President of the Philadelphia Chapter of the Association for Women in Science (AWIS). She currently serves on the Chapters Advisory Committee for the national AWIS organization, the nominations committee and constitution and bylaws committee for BDRP, and a BDRP representative for the Scientific Liaison Coalition and Friends of NICHD. She also served as a secretary and mentor for AWIS-PHL, council member of the European Teratology Society, and an ambassador, membership chair, member of the DE&I working group and sponsorship committee for BDRP. She has used her various roles within these scientific organizations to counsel and empower those who will follow in her footsteps and will be the scientific leaders of tomorrow. As a leader, Dr. Lewis has a great interest in investing in the next generation of trainees who are eagerly pursuing education in the area of STEM. She believes that mentors can play an important role in the success of young scientists, and she views herself to be in a unique position to provide career advice to those can benefit from learning about her unique career journey. In addition, she is a member of the Society of Toxicology, European Teratology Society, the American College of Toxicology, Philadelphia Women’s Leaders (The Philadelphia Chapter of the Women Leaders Association) and the Mid-Atlantic Reproductive Toxicology Association.
Amgen, Inc.
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
Eliana Munarriz is a researcher and academic with expertise in biological science, toxicology and regulatory science fields. She holds a degree in Biological Sciences from the University of Buenos Aires in Argentina, a PhD in Molecular and Cellular Biology from the University of Rome “Tor Vergata” in Italy and a Master’s in Business Administration from the “Torcuato Di Tella University” in Argentina. She also completed her post-doctoral training in toxicology at the Medical Research Council Toxicology Unit in the UK and her second postdoctoral studies at the Systems Biology Department at New York University. Since her return to Argentina in 2012, she has been working as a researcher at the National Council of Scientific and Technical Research (CONICET) and as a Biochemistry Professor at the School of Agriculture of the University of Buenos Aires (UBA). Her research focuses on molecular and environmental toxicology, specifically using the nematode C. elegans as a biological model for studying the effects of agrochemicals. In addition to her academic work, Eliana has served as a consultant for international organizations such as the Food and Agriculture Organization (FAO), the United Nations Environment Programme (UNEP), and the United States Agency for International Development (USAID). She is a specialist in risk assessment of chemical products and has been involved in the development of pesticide regulations in Latin America. Eliana is an active member of several committees and organizations related to health, environment, and toxicology, including RISK21, GRATC, TEA at the Health and Environmental Sciences Institute (HESI) where she is also a member of the Board of Trustees, and the Scientific Cooperation in Environment and Health (ICCAS). She has also served as a technical expert in the Committee for the Examination of Chemical Products of the Rotterdam Convention and was appointed as a member of the Joint FAO/WHO Meeting on Pesticide Management (JMPM).
Ghana Science and Technology Policy Research Institute
Dr. Rose Omari is a Principal Research Scientist and the Deputy Director at the Science and Technology Policy Institute, Council for Scientific and Industrial Research (CSIR-STEPRI), in Ghana. She has expertise in multidisciplinary research in food safety, nutrition, health, and science, technology and innovation (STI). She has participated in the development and review of several policies and regulations including STI and aflatoxin control policies for Ghana. Rose has experience in coordinating and implementing projects both at the national and continental levels and has worked with researchers from multi-disciplines and countries. Some of her current projects are Food Safety for Africa (FS4Africa); Shaping food environment in transitioning economies for healthy and sustainable diets (FETE); Consortium Europe Africa on Research and Innovation for Food Systems Transformation (CEA-FIRST), Strengthening Evidence-Based Policy Practice for Sustainable Food Systems under the EU-AU Partnership (StEPPFoS); Enhancing farmers’ uptake of digital technologies through empirical research, innovation and policy intervention (EFUDTRIPI); Understanding the impact of women’s time-use on household nutrition; Women’s participation in STI research, capacity building and mentorship programmes: the trends, barriers and enablers (WESTIR); and Assessment of systemic barriers to women’s participation in engineering education and careers. 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.
L'Oreal
Gladys Ouédraogo joined L’Oréal R&I in 2003 to establish a unit for predicting cancer without animal testing. During her career, she has created and led various research projects on technologies and emerging topics in the field of toxicity assessment. In doing so, she has contributed to molecular modeling, genotoxicity, endocrine modulation and systemic toxicity. In 2013, after three years in charge of teams working on alternative methods for predicting toxicity and efficacy, she managed several external collaborations and activities in areas such as repeat-dose systematic toxicity – an area she is also developing within L’Oréal R&I.
In addition to a Doctorate in pharmacy, Gladys Ouédraogo’s career also includes a Ph.D and a postdoctoral research fellowship in photobiology, along with 25 years of experience in the development of predictive approaches for toxicity. Starting in genotoxicity, she extended her sphere of expertise within L’Oréal R&I to encompass endocrine modulation and repeat-dose systematic toxicity. She also worked on efficacy predictions with new approach methodologies and helped with the deployment of numerous alternative methods and technologies to animal testing: molecular modeling, genotoxicity, systemic toxicity. In her position at L’Oréal R&I and as the chair of various scientific committees, she brings a strategic vision for developing solutions to assess toxicity with NAMs– and subsequently promotes them in the cosmetics industry, the scientific community, and other stakeholders. She is a diplomate of the American Board of Toxicology since 2018.
Université Paris-Saclay
Dr. Marc Pallardy received a PharmD in 1982 and a PhD in toxicology in 1987. He his Full Professor and Head of the Department of Toxicology, Faculty of Pharmacy, University of Paris-Saclay, since 1997. He is 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. From 2004 to 2015, he served as Director of the Toxicology and Pharmacovigilance master’s program at University Paris-Saclay (25 students/year).
He is now director of the interdisciplinary project HEALTHI “Health and Therapeutic Innovation” of the University Paris-Saclay composed of 130 research teams of the University. The objective is to promote interdisciplinary research in therapeutic innovation.
He is a current a member of the HESI Immuno-Safety Technical Committee and served on the HESI Board of Trustees since 2018. In 2022, he was appointed as member of the executive committe of EUROTOX and he is a member of the education committee of EUROTOX since 2020.
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).
Marc Pallardy has 182 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.
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.
Procter & Gamble Company
Dr. Stefan Pfuhler has been employed by the Procter & Gamble Company since 2003, has held multiple positions for them, and has worked at several of their US and overseas locations. He currently serves as R&D Senior Director Research Fellow in the Global Product Stewardship division, 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 serves as the chair of the genotoxicity WG of the International Consortium on Cosmetic Safety (ICCS), is a member of the OECD Endpoint Expert Working Group on genotoxicity, the OECD WG on genotoxicity of nanomaterials, and is involved in various other professional activities and memberships.
Past Chair of Board
ApconiX, Ltd.
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.
Aarhus University
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.
Pacific Northwest National Laboratory
Click here to view Dr. Teeguarden’s CV.
UCB
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
Utrecht University
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.
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