Periodic Reporting for period 4 - PREMIER (Prioritisation and Risk Evaluation of Medicines in the EnviRonment)
Berichtszeitraum: 2023-09-01 bis 2024-08-31
WP2: Significant progress on the development of new approaches for assessing exposure and effects of APIs. A new machine-learning based model for estimating the sorption behaviour of APIs in sludge, soil and sediment was developed. A draft desktop application of the ePiE model was developed for end users and is now available for testing. A large-scale study was performed to determine the spatial and temporal variability of concentrations of 56 APIs in river systems across Europe. The EcoDrug+ website was launched enabling user to determine the conservation of drug targets across species. A new tool ‘Virtual Extensive Read-Across’ (VERA) was developed and assessed for read-across for APIs. In-vitro effect models were applied to determine the uptake, hepatic clearance and pharmacological effects of APIs in a range of model systems. Work on the integrated effects models (WP2.3) has involved the curation and standardization of data on the toxicity and bioavailability of APIs in mammalian systems for use in the MAMTOX approach for deriving critical environmental concentrations for APIs. Ecotoxicity data has also been collated to support the development of the approach. Work on the development of an improved fish plasma model has involved the development of in-vivo data on two APIs in different fish species and the quantification of plasma protein binding for 16 APIs.
WP3: Focus on the design and development of the DAS. 1st internal version of the DAS was shared with the consortium. Data retrieval, check and assessment proceeded during RP4, so the data can later be imported and made available within the DAS. Connection with EMA was established, to discuss their possible role as maintainer of the DAS after the project.
WP4: Mature drafts of 3 guidance documents were generated and sent to the key user group to obtain feedback. D4.2 submitted-provides an overview of the overall guidance and includes the mature drafts as annexes. D4.6 was summarized into a scientific paper for wider outreach. Efforts were invested to provide an overview of new drug modalities and what would be their environmental impact (D4.7). A round of interviews with relevant stakeholders from the healthcare sector was conducted to evaluate the feasibility to incorporate environmental risks/hazards into procurement and/or prescription processes.
WP5: Maintaining the governance and management structure to effectively coordinate scientific and operational activities, including engagement with the SAB, planning and support for meetings (PMO, ExCom and GAMs). Organized virtual GAM#8 and prepared GAM#9. Diligently monitored task progress, deliverables, milestones, and risks while preparing for the Mid-term review. 2 newsletters and multiple social media campaigns were launched. Sustainability of project outcomes, especially the DAS, was reinforced by adopting an open-source approach and involving the EMA to ensure compatibility with EU systems.