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.
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.
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.
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.
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
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.
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.
Merck & Co., Inc
Dr. Patricia Escobar is an Executive Director in Nonclinical Drug Safety at Merck & Co. Inc., 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.
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.
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).
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.
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.
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.
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