SETAC Pharmaceuticals AG Members
Mike Williams (Chair)
Mike Williams (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
Ohio University, US
Dr. Bowe’s research is at the interface of environmental science, chemistry, public health and surface chemistry where he applies analytical techniques to address questions ranging from heavy metal remediation to the detection and removal of persistent chemicals including pharmaceuticals from the environment. His scientific expertise is in two main areas: (1) Heavy Metal Remediation and (2) Detection of trace chemical agents in the environment. Dr. Bowe currently serves as program coordinator for the Environmental Engineering Technology program at Ohio University Southern and is a member of the Water, Pharmaceuticals and Metals groups for the Society of Environmental Toxicology and Chemistry, SETAC. Dr. Bowe has also served his peers as a reviewer for scientific journal publications. Dr. Bowe is junior co-author on a collaborative project that was awarded a United States patent, and is a member of Sigma Xi, the American Chemical Society, the Royal Society of Chemistry and SETAC.
University of York, UK
Laura Carter is a Postdoctoral Researcher in the Environment Department at the University of York, UK working with Professor Alistair Boxall. Laura is currently working on the European iPiE project on the intelligent assessment of pharmaceuticals in the environment. The iPiE project aims to develop a framework that will provide methodologies to prioritise new and existing medicinal compounds for a comprehensive environmental risk assessment. Laura’s research explores of the fate and uptake of pharmaceuticals in the environment, with particular focus on the terrestrial compartment. Since completing her PhD at The University of York, 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.
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 Advisory Group.
School of Public Health, Seoul National University in Seoul, Korea
Kyungho Choi is an environmental health professor at School of Public Health, Seoul National University in Seoul, Korea. Dr. Kyungho Choi was trained as a Doctor of Veterinary Medicine (1993), and holds Master of Public Health (1995) and PhD in Public Health (1998, Seoul National University). Before joining Seoul National University, he did his postdoc training at School of Public Health, University of Michigan at Ann Arbor, Michigan, USA (1998-2000), and later worked as a consultant (risk assessor and environmental toxicologist) at URS Corps (2001-2003, Chicago, Illinois, USA). He has published more than 100 research articles in peer-reviewed international journals in areas of environmental toxicology, risk assessment, and environmental epidemiology. His research interests are in understanding ecotoxicity of pharmaceuticals and personal care products, and in identifying adverse health effects of endocrine disrupting chemicals in human population using experimental models. He was an editor-in-chief of Environmental Health Sciences, an official journal of Korean Society of Environmental Health. He has also served on editorial boards of several scientific journals, including Environmental Management, Environmental Toxicology and Chemistry, and Journal of Occupational Health. Currently he is vice-president of Korean Society of Environmental Health, and a director of academic affairs of Korea Public Health Association.
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.
Commonwealth Scientific Industrial Research Organisation (CSIRO), Australia
Dr Rai Kookana is a Senior Principal Research Scientist with CSIRO Land and an Honorary Professor with the University of Adelaide. He obtained his PhD degree from the University of Western Australia (1989) and joined CSIRO as a research scientist in 1992. Dr Kookana’s research over last 30 years has mainly focused on understanding the risks and minimizing non-target impact of organic contaminants in the environment. Dr Kookana’s current research interests focuses on fate and behaviour of micropollutants (e.g. pharmaceuticals and personal care products - PPCPs), in the aquatic and terrestrial environments. He and his team are also working on organic chemicals associated with wastewater for water recycling and reuse.
Dr Kookana has published more than 200 journal articles and 20 book chapters and edited several books on environmental chemistry, eco-toxicology and ecological risk assessment of contaminants in both terrestrial and aquatic ecosystems. His work has been cited more than 6000 times in the scientific literature. His current H-Index (ISI) is 38. Dr Kookana was offered the highest recognition by the Soil Science Society of America in 2012 by electing him a Fellow. He currently is the Vice President of the Chemistry and the Environment Division of the International Union of Pure and Applied Chemistry (IUPAC).
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.
German Environment Agency (UBA) –Department of Pharmaceuticals
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.
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 and still am 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.
My SETAC involvements:
- SETAC Council member from 2010 until 2016
- Chair of SETAC-Europe membership and PR-Committee 2012- 2016
- Regular Session Chair of different Pharmaceutical and or Endocrine sessions at SETAC Europe since 2009
- Member of the Local organising Committee for the SETAC World in Berlin
- Member of the Scientific Committee for the SETAC Europe in Glasgow and Nantes.
American Water, US
Ruth Marfil-Vega is an Environmental Scientist at American Water’s Innovation and Environmental Stewardship group, the largest publicly traded water utility in US. Her expertise focuses in studying the fate and treatment of emerging and unregulated contaminants (i.e. hormones, pharmaceuticals, nitrosamines) in environmental systems, including drinking water, wastewater and water reclamation plants and developing new strategies to manage the risk associated with the presence of these chemicals in the environment for human health and ecosystems. Prior to joining American Water she was a postdoctoral fellow at the US EPA Office of Research and Development; her work aimed to develop a Mode of Action-based risk assessment of Endocrine Disrupting Chemicals in wastewater effluents, uniting Toxicity Identification Evaluation and Chemical Analysis. She received a PhD in Environmental Science from the University of Cincinnati; for her doctoral research she identified and characterized a novel sustainable strategy to minimize the risk associated with the presence of estrogenic chemicals in wastewater.
Cambridge Environmental Assessments (ADAS), UK
Steve Ruckman is Principal Toxicology Consultant with Cambridge Environmental Assessments, part of ADAS UK. His early career was with a major international contract research organisation, conducting toxicology studies for pharmaceuticals, agrochemicals and chemicals manufacturers. Moving on from toxicology to programme management, he managed full development programmes for two novel agrochemical active ingredients on behalf of international consortia, both of which received regulatory approval in the European Union, before eventually moving on to managing pharmaceutical programmes. During this time, he also became involved in the OECD programme for validating tests for endocrine disrupting chemicals in mammalian systems and became an international expert in the safety assessment of food ingredients, particularly novel ingredients for nutraceuticals, publishing in both spheres. He moved on to become Associate Director of Non-Clinical Drug Safety with a pharmaceutical company before taking up his current position with CEA/ADAS. He maintains a particular interest in furthering our understanding of the potential hazards arising from endocrine active substances and their potential impact upon human health, with a view to being able to influence regulatorybb decision making in this controversial area.
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.
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.
Envigo CRS, Switzerland
Name: Wess, R. Arno, Diplom-Biologe
Date and Place of Birth: April 27th, 1965; Frankfurt am Main (Germany)
Present Position: Expert Consultant, Technical Lead for Environmental Risk Assessment of Medicinal Products for Human use and Industrial Chemicals with Envigo CRS (Switzerland) Ltd. (formerly Harlan Laboratories Ltd.), Industry representative on the SETAC’s global Pharmaceuticals Advisory Group (PAG).
Professional Experience: Experience of about 15 years in the Chemical and Pharmaceutical industry, Performance of overall Risk Assessments of Chemical Molecules including idiosyncratic risk evaluation, Development of testing strategies in Regulatory Ecotoxicology, Scientific Knowledge Management/Intelligence, Publications, Lectures at Scientific Conferences, Contribution to German Dictionary of Ecotoxicology
Educational Background: University Education: Diploma in Biology, comparable to M.Sc., including exam in Toxicology with thesis on Drug Design with development of QSAR models, Qualifying Certificate in European Environmental Law, Andragogy Certificate, Postgraduate Study course for Diploma in Ecotoxicology
Advanced training: Participation on about forty-five chronic education courses including hands-on training on ERA of MPH
Memberships: SETAC, SGN