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Evidence-Based Toxicology Collaboration

Board of Trustees

John Fowle

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.

Didier Verloo, PhD

Didier Verloo, PhD
EBTC Board Vice-President

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.

James J. Freeman, PhD, DABT

James J. Freeman, PhD, DABT
EBTC Board Secretary

Dr Feeman has a PhD in toxicology and is currently the lead toxicology contact to the ExxonMobil basestocks/specialties/asphalt business functions. He is also the technical secretary to the ExxonMobil Occupational Exposure Limit committee and the toxicology staff representative to ExxonMobil’s Health Research Ethics Committee. Dr Freeman began his career in Toxicology in the mid-1970s as a laboratory technician, and joined ExxonMobil in 1985 after receiving his PhD. He has held numerous positions, including Laboratory Director and other management positions in Toxicology and Product Stewardship. Dr Feeman has published on ExxonMobil and industry research activities related to the skin carcinogenicity of petroleum streams, the safety of medicinal- and food-grade mineral hydrocarbons, and 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 currently Chairperson of the external advisory board to the Center for Alternatives to Animal Testing (CAAT) and a member of the Board of Directors to the Evidence-based Toxicology Collaboration. Jim is also a past-president and treasurer of the Mid-Atlantic Chapter, Society of Toxicology.

Thomas Hartung, MD, PhD

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

Gerry Kenna, PhD

Gerry Kenna, PhD

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

Holger J. Schunemann

Holger J. Schünemann, MD, MSc, PhD, FRCPC

Holger Schünemann is Professor in the Departments of Health Research Methods, Evidence, and Impact (formerly “Department of Clinical Epidemiology and Biostatistics”) and of Medicine. He began his research career in respiratory and exercise physiology as a medical student in the Department of Physiology at the Medical School of Hannover and with an award from the German government at the University at Buffalo (UB), State of New York. He received an MD degree (1993) and a “doctor medicinae” degree (1994) from the Medical School of Hannover where he also completed an internship in internal and respiratory medicine. He went on to work in cellular and molecular lung biology at UB researching expression of cell adhesion molecules (integrins) in early postnatal lung development. Realizing the importance of high-quality skills in data analysis, general health research methods and developing a stronger sense for patient and population focused research he studied epidemiology and biostatistics during his postdoctoral fellowship (M.Sc. in Epidemiology, 1997). He then conducted population-based studies on the association between micronutrients, oxidative stress, and respiratory health leading to a Ph.D. degree (Epidemiology & Community Medicine, 2000) and completed training to qualify for certification in internal medicine and preventive medicine/public health at UB, where he joined the faculty in 2000.

From 2005 to 2009 he was at the Italian National Cancer Center in Rome, Italy, serving as interim chair of the department of Epidemiology from 2007 to 2009, before moving to McMaster University as full-time Professor and to become Chair of Clinical Epidemiology and Biostatistics in 2009, widely considered the birthplace of evidence-based health care and problem-based learning. In his second term as chair of this prestigious department, he has led its longitudinal strategic plan (AGENDA 2020) to refocus the department into the “Department of Health Research Methods, Evidence, and Impact (HEI)”. He completed his second and final term as chair in June 2019 and focuses now on research and implementation projects related to guidelines and systematic reviews, primarily with the World Health Organization’s global tuberculosis department and the development of certification and credentialing of guideline developers (INGUIDE.ORG).

His scientific work focuses on evidence synthesis, quality of life research and the presentation and development of health care recommendations spanning clinical medicine to public health. As a key contributor to the revised methods for World Health Organization (WHO) guideline development in 2006 and the Institute of Medicine statement on trustworthy guidelines in 2011 he has been a leader in reshaping of methodology for practice guideline development. He has authored or co-authored over 650 peer-reviewed publications, has been named by Thomson Reuters as one of the most influential 3,000 scientific minds of current times yearly since 2015, has an h-index of 140/101 (google scholar/web of science) and is on the list of the 1,000 most cited scientists of all times from agricultural science to zoology (www.webometrics.info). He has been advisor to the WHO, ministries of health, other governmental organizations and numerous professional societies for their knowledge synthesis and guideline programs and is co-chair of the GRADE working group(www.gradeworkinggroup.org) where he was instrumental in the development of its methods and dissemination and the creation of 17 GRADE centers and networks globally. His work also focuses on practical application of science by researchers and clinicians through co-inventing tools like the GRADEpro guideline development tool (www.gradepro.org) and pioneering the use of GRADE evidence to decision tables, now reworked as GRADE evidence to decision frameworks (www.decide-collaboration.eu). With his colleagues he has recently created a “go to” crowdsourcing portal for developers of health care recommendations in collaboration with the Guideline International Network (heigrade.mcmaster.ca/guidecheck.html). He is director of Cochrane Canada, co-director of the McMaster University WHO collaborating center for infectious diseases, research methods and recommendations and the McMaster GRADE center, co-chair of the Guidelines International Network (G-I-N) and International Network of Health Technology Agencies (GINATHA) working group and on the board of trustees of G-I-N. He has served as lead on over 50 international guidelines, including WHO expert guideline committees, European Commission, ARIA, American Society of Hematology, American Society of Respiratory and Critical Care Medicine, and the World Allergy Organization, and served as adviser to WHO member countries. Maintaining an active internal medicine practice fulfills his passion for patient care and ensures his research is people-oriented.

Emily S Sena, PhD

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

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.

Daniele Wikoff, PhD

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.