The consortium strives to increase the use of the decision trees and tools developed in PREMIER by all stakeholders. This implies a stakeholder-driven strategy. In this WP, we will work with industry, regulators, water companies, NGOs, intergovernmental bodies such as OECD and UN Environment, and health organisations. In consultation with these stakeholder organisations, we will identify relevant issues and requirements that could be addressed by the PREMIER products (WP4.1). Possible examples include the prioritisation of APIs based on environmental risks in different management contexts, the identification of suitable risk management options along the development-production-use-emission-effect chain, the development of monitoring and assessment strategies for APIs, and the derivation of safe discharge targets for API manufacturing sites on a local scale. For a selected number of these stakeholder issues, we will draft guidance together with relevant stakeholders, integrating the tools and decision trees developed in PREMIER and taking other considerations into account where relevant, e.g. risk/benefit ratios, patient safety and socio-economic analysis.
An issue that will be specifically addressed in a targeted effort by the PREMIER project is the feasibility of greener drugs (WP4.2). We will identify key decision points where environmental considerations (API design and green chemistry) are currently made within drug development and identify potential opportunities to integrate the environmental tools and models developed in PREMIER earlier in drug development, should appropriate assays be available. The potential of emerging innovative therapies (e.g., precision or personalised medicines, biologics, nano-based medicines and antibody drug conjugates) to reduce environmental exposure and risk will be reviewed.
Industry partners will provide critical insights into the design principles commonly used in the development of new molecular entities to (i) increase biological stability such that the API can be delivered to the drug target, (ii) maximise oral adsorption, and (iii) minimise safety concerns and off-target effects, while other stakeholders and environmental experts will provide insights into their needs and wishes. Industry partners will engage with environmental chemists and environmental toxicologists to determine the feasibility of greener drug design.