SETAC Pharmaceuticals IG Steering Committee
Gerd Maack (Chair)
Jason Snape (Vice-Chair)
Mike Williams (Past-Chair)
Chris Van der Eede
Todd Davidson Fabiana Lo Nostro
Gerd Maack (Chair)
German Environment Agency (UBA) –Department of Pharmaceuticals
My main focus here at UBA is the assessment of the Environmental Risk Assessment of new applications of human and veterinary medicinal products with special interest are endocrine APIs and the respective test systems, including long term fish tests. In addition I am part of the team in charge for generating the pharmaceutical dossiers for the EU water framework directive (WFD). I was actively involved in the OECD Fish Framework project, a project to update the OECD fish tests, and in the OECD Guidance document for the diagnosis of Endocrine-Related Histopathology of fish gonads. I am supervising in-house and external UBA-projects dealing with e.g. the effects of mixtures of pharmaceuticals on different fish life stages.
I am a trained Marine Biologist and Aquatic Ecologist. After my PhD at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany, I went with an EU- Marie-Curie Individual Fellowship to the University of Exeter, UK, working on molecular effects of endocrine active compounds in fish and on fish populations.
Jason Snape (Vice-Chair)
Professor Jason Snape is the Principal Environmental Scientist within AstraZeneca where he has worked for 22 years. Jason trained as an environmental microbiologist and conducted his PhD at Cardiff University on the bacterial metabolism of nitrate esters that are widely used as explosives and cardiovascular drugs (1995). Whilst being based within AstraZeneca, Jason immediately followed his PhD with a three year post-doc to develop improvements to standardized regulatory approaches to assess biodegradability and persistence; this was funded by the UK Department of Environment (now Defra). Jason has published about 50 scientific papers in peer-reviewed international journals and has co-organized, co-chaired and co-sponsored numerous SETAC sessions and workshops on PBT assessment, the application of genomics in ecotoxiocology, pharmaceuticals in the environment, and the environmental dimension of antimicrobial resistance. Jason manages the AstraZeneca Safety, Health and Environment (SHE) Research Programme and is currently co-supervising six PhD and three post-doctoral scientists. Jason currently chairs the Environmental Risk Assessment Workstream of the EFPIA, Medicines for Europe, and AESGP Pharmaceuticals in the Environment Task Force. Jason is an Honorary Professor at the University of Warwick and sits on York Universities Environmental Sustainability Advisory Board.
Mike Williams (Past-Chair)
Commonwealth Scientific Industrial Research Organisation (CSIRO), Australia
Mike Williams is currently a research scientist with the Commonwealth Scientific and Industrial Research Organisation (CSIRO) based in Adelaide, Australia. He works in the Contaminant Biogeochemistry and Environmental Toxicology (CBET) Group within the CSIRO Land and Water Environmental Contaminants Mitigation and Technologies research program. He obtained his PhD in 2006 from the University of Adelaide after completing undergraduate degrees in chemistry and ecotoxicology. His research experience involves assessment of the fate and effects of trace organic contaminants and their transformation products in aquatic and terrestrial environments. He has the ability to integrate assessment of fate and effects to determine the potential ecological impacts of trace organic contaminants, including pharmaceuticals. He has extensive experience in the use of mass spectrometric techniques to quantify and identify trace residues of trace organic contaminants in a range of environmental matrices. He has a demonstrated capacity to work and interact with others across a range of disciplinary backgrounds, including environmental chemistry, ecotoxicology, pharmacology, hydrology and analytical chemistry. He has served as chair of the SETAC Pharmaceuticals Advisory Group since 2014.
University of Gothenburg, Sweden
Thomas Backhaus is Professor for Environmental Science at the University of Gothenburg in Sweden, coordinator of its Ecotoxicology Master Program and Director of its new Center for Future Risk Assessment and Management Strategies (FRAM). His main research interest is the toxicology and ecotoxicology of chemical mixtures and its regulatory assessment. He has been working with several regulatory authorities in Europe and elsewhere on the issue. In this context it is especially emerging pollutants such as pharmaceuticals that are of interest, as those chemicals often occur as complex mixtures of compounds at individually low concentrations. Thomas is currently co-leading the risk characterization work of the OECD project on combined exposures and is senior editor of Integrated Environmental Assessment and Management. In recent years he also served on the Council of SETAC Europe, as SETAC’s book editor and in several of SETAC’s advisory committees.
University of Leeds, UK
Laura Carter is a University Academic Fellow in Soil Science at the University of Leeds, UK. Laura’s research focuses on understanding the fate and uptake of emerging contaminants in the natural environment, with particular focus on soil-plant systems.
Since completing her PhD at The University of York under supervision of Prof. Alistair Boxall, Laura has spent time as a Risk Assessor at Unilever’s Safety and Environmental Assurance Centre (SEAC) and as a Postdoctoral Research Fellow at the Commonwealth Scientific Industrial Research Organisation (CSIRO) in Adelaide, Australia where she investigated the biological effects of pharmaceutical uptake into plants. Most recently, Laura has worked as a Postdoctoral Researcher at the University of York, UK where she contributed to the European iPiE project on the intelligent assessment of pharmaceuticals in the environment, developing soil sorption models and monitoring pharmaceuticals in river catchments.
Laura has presented her research at a number of international conferences, published her work in peer reviewed journals and co-authored a book chapter. Laura is also currently co-supervising a number of PhD projects investigating the uptake and toxicity of pharmaceuticals in aquatic, sediment and terrestrial systems whilst taking on an active role in the SETAC Pharmaceutical Global Interest Group.
United States (US) Food and Drug Administration (FDA), Center for Veterinary Medicine, Rockville, Maryland
Wesley serves as a toxicologist on the Environmental Safety Team for the United States (US) Food and Drug Administration’s Center for Veterinary Medicine (FDA/CVM) where he evaluates the potential environmental impact of new animal drugs prior to approval in the US. Wesley received his B.S. in Conservation Biology from Brigham Young University, Provo, in 2003 and a Ph.D. in Environmental Toxicology from the University of California—Riverside in 2009. He has been a member of SETAC since 2005 and has participated in the Pharmaceutical Advisory Group (PAG) since 2011.
Canadian Food Inspection Agency, Health Canada
I completed my Ph.D. in Environmental Biology at the University of Guelph in 2006 where I tested integrated pest management approachesfor black cutworm, which included working with neonicotinoids and genetically modified corn. During my doctoral studies I developed a keen interest in soil invertebrates and decomposition ecology which I pursued as a postdoctoral researcher at the University of Guelph and as a research coordinator for the Frost Centre Institute Research Group. In 2010 I joined the Environmental Impact Initiative Division at Health Canada where I was part of a team that is developing environmental assessment regulations and industry guidance for new pharmaceuticals and veterinary drugs. I am particularly interested in creating and validating regulatory tools for environmental risk assessment of pharmaceuticals and the international harmonization of technical requirements. I am currently working at the Canadian Food Inspection Agency on an integrated risk management team. I became involved with SETAC relatively recently but have found it to be a very rewarding and educational experience which has given me a deep appreciation for the importance of SETAC and especially the PAG.
Ms. Jane Staveley is a Senior Managing Scientist at Exponent, a scientific and engineering consulting firm. She has 35 years of experience in environmental toxicology, ecological risk assessment, and product stewardship, working with clients in both the public and private sector on a broad variety of environmental issues. She has extensive experience in conducting environmental assessments (EAs) of pharmaceuticals (both veterinary and human) for submission to the U.S. FDA and European regulatory authorities. These have ranged from simple Phase I assessments to complex watershed-scale evaluations. In her work for these submissions, she has handled issues involving endocrine disruptors, nanomaterials, and genetically modified organisms, and products for cattle, sheep, swine, and fish. Ms. Staveley has assisted clients with strategy development, data gap analysis, study placement and monitoring, agency presentations, and EA submissions. Ms. Staveley is a charter member of SETAC and formerly served on the steering committee of the Pharmaceuticals Advisory Group in its early years. She served on the SETAC North America Board of Directors from 2003-2008 and was President during 2007; she served on the SETAC World Council during 2006-2011 and was SETAC President during 2010. Ms. Staveley has a B.S. in Biology from the College of William and Mary and an M.S.P.H. in Environmental Chemistry and Biology from the University of North Carolina at Chapel Hill. She has over 20 peer-reviewed publications, books, and book chapters, and serves as a peer reviewer for several journals.
Bristol-Myers Squibb Company, US
Todd Davidson, Ph.D., DABT, is currently the Associate Director of the Environmental Fate and Effects Program at Bristol-Myers Squibb Company and has been a practicing environmental toxicologist since 2006. He has experience in both occupational and environmental toxicology. He received both his Ph.D. (2006) and his M.S. (2004) in toxicology from New York University where he investigated the health effects of metals, particularly nickel and chromium. His B.S. degree (2000) in Biology/Marine Biology is from the University of Miami. Prior to joining Bristol-Myers Squibb Company in 2011, he worked as a toxicologist at SafeBridge Consultants for about 5.5 years. Other external activities include the Society of Environmental Toxicology and Chemistry, BMS Pharmaceuticals in the Environment (PIE) Taskforce, EFPIA PIE taskforce and teaching at New York University.
Fabiana Lo Nostro
Universidad de Buenos Aires & CONICET, Argentina
Fabi Lo Nostro received her biology degree and PhD from Universidad de Buenos Aires (UBA) where nowadays is Professor of Animal Physiology, especially fish. She is also Independent researcher of the National Council of Scientific and Technical Research (CONICET), and director of the Aquatic Ecotoxicology Lab. Her lab centers on evaluating the endocrine disruption produce by several contaminants on ichthyic fauna (freshwater and marine species, including from Antarctica). Using fish model, they have studied the effect of exposure to pesticides, non-ionic surfactants, and plasticizers, assessing parameters related to development, reproduction, metabolism and behavior. Nowadays her team focuses in emerging pollutants such as pharmaceuticals (human and veterinary use) that are of interest due its environmental impact in her country. In collaboration with national and international groups, she uses multiple tools and approaches in an integrated way from a molecular, organismic and ecological scale. Fabi has published her work in reviewed journals, and in national and international meetings. She supervises a number of undergraduate and PhD students inside and outside her country. She has been member of SETAC since 2000 and has been working on the creation of the SETAC Argentinian chapter (the first chapter within SETAC Latin America geographic unit). She served on the council of SETAC Arg being also president and organizing many meetings and workshops within the region. She was one of the winners of the SETAC Global Partners Capacity Building Award 2018. She has just started in the SETAC Pharmaceutical Global Interest Group.
wca environment Ltd, UK
Dean is an environmental consultant and Director at wca environment Ltd, and environmental consultancy in the UK. Dean is an environmental toxicologist by training with over 20 years of experience in applied ecotoxicological research, ecotoxicological data assessment, chemical risk assessment, environmental monitoring and scientific project management. His specific areas of scientific expertise are ecotoxicology, test method development, the development of environmental standards for chemicals (for a wide range of international jurisdictions, particularly Europe and Canada), and chemical environmental risk assessment (recently he has specialised in the risk assessment of pharmaceuticals under European Medicines Agency (EMA) and US Federal Drugs Agency (FDA) guidance).
Dean started his career at a major Contract Research Organisation (CRO) undertaking ecotoxicological studies (1991 to 1996), moving to the UK Environment Agency in 1996 and, until 2008, was instrumental in establishing the Environment Agency’s ecotoxicology research laboratory in the UK. Dean joined wca in 2010.
University of York, UK
J. Brett Sallach is a newly appointed Lecturer (Assistant Professor) in the Department of Environment and Geography at the University of York (United Kingdom). His research focuses on the fate and transformation, bioavailability, and ecotoxicity of pharmaceuticals in the natural and agricultural environment. From laboratory to field scale, he is currently investigating the use of non-targeted and suspect screening approaches to evaluate the exposure and degradation of emerging contaminants in the agroecosystem and potential system wide effects of agroecosystem function. He received his PhD under the supervision of Professor Shannon Bartelt-Hunt in 2015 from the University of Nebraska-Lincoln and continued training as a post-doctoral researcher at Michigan State University under Stephen Boyd. At MSU, he studied the bioavailability of persistent dioxin compounds in soils and sediments. Brett recently completed Marie Curie Fellowship at the University of York with Professor Alistair Boxall investigating the impact of antibiotic mixtures on agroecosystems.