Drug discovery and development experts of seven major pharmaceutical companies were interviewed by PREMIER members to explore the opportunities of incorporating environmental considerations into the pharmaceutical R&D process. The interviews showed that there are clear possibilities along the phases of API discovery, which require appropriate models and assays.
Active Pharmaceutical Ingredients (APIs) are essential for human “Good Health and Well-Being”. At the same time, residues of APIs are found as micropollutants in the environment. They can impact the living and physical-chemical environment. To tackle this issue the design of greener APIs (i.e. the design of APIs which have less impact on the environment) could be a long-term preventive measure and opportunity to protect the environment. Led by PREMIER partners at Leuphana University Lüneburg and Ecologic Institute, a study has been conducted to explore the opportunities of incorporating environmental considerations in the industrial drug discovery and development (R&D) process. The results from this work have been collated into Deliverable D4.5. In-depth interviews and a follow-up workshop with R&D experts of seven major pharmaceutical companies showed that the R&D process is very complex and needs to balance multiple parameters. At the same time, R&D is very flexible, and there are clear possibilities to include environmental considerations. Furthermore, some properties that reduce environmental risks go hand in hand with common desirable API properties related to their behaviour in the human body, and which are thus already being optimised in the R&D process.
Environmental properties (fate and ecotoxicity) can be considered in different phases during the discovery of new APIs: prediction models can be used in the early phases and in vitro studies in later phases. Environmental properties could be considered all the way up to the candidate selection phase (before preclinical trials), after which the molecular structure of the API is set. Besides efficacy, patient safety and patent issues, environmental properties could be one of the parameters that are optimised in API design. There is a need for the development of easy to use, high throughput methods that can be easily incorporated. In general, the attributes of new tools or assays (availability, throughput, costs, material amount) determine at which stage of the R&D process they may be applied.
Besides financial, social, and regulatory incentives, collaborations (e.g. on method development) within and across pharmaceutical companies and between industry, authorities, and academia are needed to fill identified knowledge-base and methodological gaps.