John “Jack” R. Fowle III PhD, DABT
EBTC Board President
Dr. John R. “Jack” Fowle III is the principal of Science to Inform, LLC, an independent consultant advising clients about the use of science to inform decisions regarding environmental risk and in the development and use of alternatives for animal testing.Prior to 2012 he was the Deputy Director of the U.S. Environmental Protection Agency’s (EPA) Health Effects Division in the Office of Pesticide Programs (OPP) in Washington, DC and was responsible for directing the health risk assessment activities supporting the re-registration of existing pesticides. Dr Fowle managed the integration of new toxicological approaches into OPP’s human health risk assessments. Before OPP, he was Director of EPA’s Neurotoxicology Division, as well as Assistant Laboratory Director, at the National Health and Environmental Effects Research Lab (NHEERL) in Research Triangle Park, NC helping to develop alternatives to animal approaches and to establish the Agency’s computational toxicology program. Dr Fowle has served as Deputy Director of EPA’s Science Advisory Board and as the Science Advisor to U.S. Senator Daniel Patrick Moynihan.Since retiring from EPA Dr Fowle serves on the Board of Directors for the Institute of In Vitro Sciences in Gaithersburg, MD, is President of the Board of Trustees for the Evidence Based Toxicology Consortium and is an AltTox Editor. He is Councilor for the American Society for Cellular and Computational Toxicology as well as President of the Society of Toxicology’s In Vitro and Alternative Methods Specialty section. Dr Fowle received his baccalaureate and doctoral degrees in genetics from George Washington University in Washington, D.C. and he is a board certified toxicologist.
Gerry Kenna, PhD
EBTC Board Vice-President
Dr. Kenna is Pharmaceutical Director of the Safer Medicines Trust, which is an independent UK charity. In this role, he is focused on developing and gaining regulatory acceptance of human biology-based methods that can improve human safety assessment of drugs and other chemicals. In addition, he is an independent Drug Safety Consultant who advises clients in pharmaceutical and biotech companies on how best to select and develop efficacious and safe new drugs, and to validate new predictive safety methods and strategies. Previously, he held scientific leadership roles as a toxicologist in the pharmaceutical and agrochemical industries (at AstraZeneca, Syngenta and Zeneca). These were preceded by academic faculty positions (at Imperial College School of Medicine, London UK; National Institutes of Health, MD USA; King’s College Hospital Medical School, London UK and the National Institute for Medical Research, London UK), in which he led research teams that explored mechanisms underlying human adverse drug reactions. He has authored or co-authored >100 peer reviewed scientific publications, is a member of the International Society for the Study of Xenobiotics and a Fellow of the British Toxicology Society. He received a BSc Hons in Biochemistry from the University of Leeds UK and a PhD in Biochemistry from the University of London UK
Dr Sebastian Hoffmann, PhD.
Secretary, Research Staff, European Affairs
Sebastian Hoffmann is a specialist in the validation and assessment of in vitro test methods, and the regulation of chemicals (REACH) and cosmetic ingredients. He has been supporting the EBTC secretariat since 2011. Previously, Sebastian has worked for the European Centre for the Validation of Alternative Methods (ECVAM) of the European Commission. His research activities focus on methodological challenges in the assessment of in vitro tests, the design and evaluation of integrated testing strategies, and the application of evidence-based approaches to toxicology. He is an appointed member of the European Commission’s Scientific Committee on Occupational Exposure Limits. Sebastian received his PhD from the University of Konstanz (Germany) in 2005 for his thesis Evidence-based In Vitro Toxicology.
James J. Freeman, PhD, DABT
EBTC Board Secretary
Dr. Freeman has a PhD in toxicology and retired after 34 years working for ExxonMobil Biomedical Sciences, Inc. Jim held many leadership positions during his career at ExxonMobil including Environmental Health Laboratory Director, Section Head in Toxicology and Product Stewardship, technical secretary to the ExxonMobil Occupational Exposure Limit committee and the toxicology staff representative to ExxonMobil’s Health Research Ethics Committee. He made multiple contributions to the company’s downstream businesses and published on the toxicology of asphalt, middle distillates and medicinal white oils. Dr Freeman began his career in Toxicology in the mid-1970s as a laboratory technician and joined ExxonMobil in 1985 after receiving his PhD. Externally, Dr. Freeman worked with industry and U.S. delegations to the United Nations on the application of the Global Harmonized System to petroleum hydrocarbons. He has served on expert science advisory panels in the US for the Environmental Protection Agency and the Interagency Coordinating Committee for Validation of Alternative Methods (ICCVAM), efforts related to validation of toxicity test methods by the Organization for Economic Coordination and Development (OECD), as an invited industry observer to the International Agency for Research on Cancer (IARC), and as Chairperson to the NTP Scientific Advisory Committee on Alternative Test Methods (SACATM). Jim is a past Chairperson of the external advisory board to the Center for Alternatives to Animal Testing (CAAT) and a past-president and treasurer of the Mid-Atlantic Chapter, Society of Toxicology.
Thomas Hartung, MD, PhD
EBTC Board Treasurer
Dr Hartung is the Director of the Center of Alternatives to Animal testing at Johns Hopkins University. Professor Hartung’s career is focused on the paradigm shift in toxicity testing for improving public health. In his previous role as head of the European Centre for the Validation of Alternative Methods of the European Commission (2002-2008), and his current leadership of the Johns Hopkins Center for Alternatives to Animal Testing (CAAT), he was involved in the implementation of the 2007 NRC vision document Toxicity Testing in the 21st Century: A Vision and a Strategy. Dr Hartung pioneered the concept of evidence-based toxicology and co-founded the EBTC in 2011 to further its implementation. Dr. Hartung has a broad background in clinical and experimental pharmacology and toxicology, and has authored more than 450 publications. His previous work centered on the immune recognition of bacteria, including pyrogen testing and the induced inflammatory responses, as well as the pharmacological modulation of these responses. In addition to being Director of CAAT, Dr Hartung has established a laboratory for developmental neurotoxicity research based on genomics and metabolomics, with the respective technologies made available by a “Thought Leader” award from Agilent Technologies
Emily S Sena, PhD
Dr Sena is a Research Fellow at the Centre for Clinical Brain Sciences, University of Edinburgh, Convener, CAMARADES. She has a background in neuroscience and is a research fellow specialised in the validity of preclinical studies. Her research interests are in the use of systematic review and meta-analysis of preclinical efficacy studies to increase the understanding of critical facets of translational medicine and developing new hypotheses for testing in the laboratory. Since 2015 Dr Sena has led the Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies (CAMARADES), a multicentre international research collaboration facilitating the pooling and analysis of data from a range of disease models across the basic sciences. To support this she has developed an internationally accessible database, similar to the Cochrane library, to facilitate interpretation of the preclinical data used to justify progression to clinical trial. Dr Sena's research has informed laboratory practice guidelines, editorial policy and the design of clinical trial protocols.
Kristina Thayer, PhD
Since January 2017, Dr Thayer serves as the Integrated Risk Information System (IRIS) Division Director, located within the US Environmental Protection Agency (EPA) National Center for Environmental Assessment (NCEA). IRIS assessments identify the potential for a chemical to cause cancer or non-cancer health effects in people and are considered the top tier source of toxicity information used by EPA and other agencies to inform national standards, clean-up levels at local sites, and set advisory levels. IRIS uses systematic review methods to evaluate epidemiological and toxicological literature and include consideration of relevant mechanistic evidence. Prior to joining EPA, Dr. Thayer was Deputy Division Director of Analysis at the National Toxicology Program (NTP) and Director of the NTP Office of Health Assessment and Translation (OHAT) located on the campus of the National Institute for Environmental Health Sciences (NIEHS). As Deputy Division Director of Analysis, she oversaw OHAT and the NTP Office of the Report on Carcinogens (ORoC). She has also worked in the NTP Office of Liaison, Policy, and Review, the NIEHS Office of Risk Assessment Research, and the NTP Center for the Evaluation or Risks to Human Reproduction (CERHR). Prior to joining the NTP/NIEHS, she was a senior scientist at the World Wildlife Fund and then at the Environmental Working Group. She is considered an expert on the application of systematic review methods to environmental health topics and the use of specialized software and automation approaches to facilitate conducting reviews.
Didier Verloo, PhD
Didier Verloo is working for the European Food Safety Authority (EFSA) since 2005 where he is heading the Assessment and Methodological Support Unit since 2008. This multidisciplinary unit leads and supports the development, implementation and review of evidence based risk assessment and decision support approaches in all fields within EFSA’s remit and was responsible for the EFSA guidance on Systematic Review in food and feed safety risk assessment and the EFSA guidance on Expert Knowledge Elicitations. Recently the unit developed and started to implement an overall framework for Promoting Methods for Evidence Use in Scientific assessments (Prometheus).Didier Verloo graduated as a Veterinarian in 1995 and started his professional career at the Institute of Tropical Medicine in Antwerp on the development of diagnostics, interpretation and medical decision making based on diagnostic test results in human and animal trypanosomosis (sleeping sickness) and worked from 2000-2005 for the Belgian government as an epidemiologist and Risk Assessor. Over those years he built up academic and hands on experience in biostatistics, epidemiology, risk analysis, test validation and provided risk analysis consultancy in public health, construction, finance and engineering.
Daniele Wikoff, PhD
Dr. Daniele Wikoff is the Director of ToxStrategies’ Health Sciences Practice. She specializes in the use of evidence-based methods in support of hazard and risk assessment applications for food ingredients and contaminants, industrial chemicals, and consumer products. She has successfully implemented a turn-key process for conducting systematic assessments at ToxStrategies, with a workflow facilitated by the combination of an experienced multidisciplinary team and use of systematic review software and tools. Dr. Wikoff has diverse experience in applying systematic mapping (scoping reviews) and systematic reviews as platforms for facilitating risk assessment, including development of health-based benchmarks as well as topic-specific application of various organizational concepts for mechanistic data, including key characteristics, adverse outcome pathways, and mode of action. Dr. Wikoff has particular interest in methods development related to the definition and evaluation of data quality, and how elements of internal, construct, and external validity can be used to transparently inform conclusions and provide critical information to decision makers. Dr. Wikoff is involved in a number of global collaborations to advance the practice of evidence-based toxicology, highlighted by her membership on the Board of Trustees and role as the Vice-Chair of the Science Advisory Council for the EBTC, membership on a National Academy of Sciences committee in the capacity of systematic review, co-authorship on the World Health Organization’s systematic review guidance (under development), and service as an Associate Editor for Toxicological Sciences and Regulatory Toxicology and Pharmacology.
EBTC staff members Drs. Katya Tsaioun, Martin L. Stephens, and Sebastian Hoffmann are non-voting members of the Board of Trustees.