Board of Trustees
John “Jack” R. Fowle III PhD, DABT
Didier Verloo, PhD
James J. Freeman, PhD, DABT
Thomas Hartung, MD, 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. 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
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.
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.