Collaborations and Projects
EU-Project Intelligence-led Assessment of Pharmaceuticals in the Environment (iPiE)
Active pharmaceutical ingredients (APIs) can be released to the natural environment during the manufacturing process, following use by patients or when unused medicines are disposed of in an incorrect manner. As APIs are biologically active compounds, concerns have been raised about the potential effects of APIs in the environment on human and environmental health. Over the past 25+ years, a substantial amount of work has been done to determine the occurrence, fate, effects and resulting risks of APIs in the environment and regulatory schemes have been developed requiring environmental risk assessments of all new APIs. However, for most APIs currently in use, only limited data are available on environmental risks, and for new APIs, the testing schemes may not always be optimal.
The aim of iPiE therefore is to develop frameworks that utilize information from toxicological studies, pharmacological mode of action and in silico models to support intelligence-based environmental testing of pharmaceuticals in development and to prioritise legacy pharmaceuticals (those authorized prior to 2006 enactment of Medicines Agency requirements) for targeted environmental risk assessment and/or environmental (bio) monitoring.
The Helmholtz Centre for Environmental Research (UFZ) is leading work package 4 on the development of methods for predicting environmental effects of APIs. A particular focus of UFZ’s activity is on the role of the speciation of organic acids and bases for ecotoxicity prediction models and the fish plasma model.
EU project SOLUTIONS
We are partners of the EU project SOLUTIONS through a NHMRC-EU grant to the University of Queensland. Dr. Peta Neale is the postdoc working in SOLUTIONS on the application of bioanalytical tools for water quality monitoring, with a particular focus on bioassays indicative of adaptive stress response pathways (e.g. oxidative stress). We will also contribute to SOLUTIONS through extraction techniques for biota, mixture toxicity modeling and cumulative risk assessment (CRA) techniques.
Understanding the hazards posed by microplastics in the sea requires understanding the changes they undergo as a result of various environmental weathering processes, like UV exposure, biofilm growth and physical stress. These processes will influence parameters such as their brittleness, density, size and surface charge, which can in turn affect their environmental fate as the microplastics undergo fragmentation, aggregation and ultimately sedimentation or mineralization. As these processes occur, there are a series of tradeoffs of hazard to the marine environment. Changes that lead to fragmentation or mineralization into benign fragments or molecules will reduce potential hazards; though changes that lead to the production of problematic size fractions (e.g. that can accumulate in gills) and release toxic chemicals will increase potential hazards. Similarly, the influence on mobility is also wide-ranging, as some fragments may be soluble while others form aggregates that settle on the seabed. The UFZ-coordinated WEATHER-MIC project assembles a multidisciplinary consortium of European experts from five institutes and four countries (UFZ Germany, ACES Sweden, NGI Norway, Fraunhofer IKTS Germany and KUL Belgium) that together will develop novel tools to tackle the complex implications of weathering of microplastics in a holistic manner.
Paving the way for QIVIVE: from nominal to free to cellular concentrations in in vitro assays
The project "Paving the way for QIVIVE: from nominal to free to cellular concentrations in in vitro assays” is running from 2017 to 2019 and funded by the CEFIC Long-range Research Initiative under the RFP LRI-ECO36 "Building improved in vitro exposure assessment capability”. The objective of this project is to progress exposure assessment in in vitro bioassays used for high-throughput screening (HTS). The expected outcomes are experimentally validated models to predict the freely dissolved and cellular effect concentrations for existing in vitro toxicity data, including ToxCast and published data that were based on nominal effect concentrations only, which will then make them amenable for QIVIVE. The long-term benefit of the project will be routine analytical tools that will improve exposure assessment in HTS tests in the future and could revolutionise the application of HTS in risk assessment. Project partners are Dr. Nynke Kramer from Utrecht University and Prof. Philipp Mayer from Technical University of Denmark.
For more information, see http://cefic-lri.org/projects/paving-the-way-for-qivive-from-nominal-to-free-to-cellular-concentrations-in-in-vitro-assays/
CHEMO-RISK - Chemometers for in situ risk assessment of mixtures of pollutants
In 2016, the European Research Council (ERC) selected the proposal