The iPiE (Intelligent Assessment of Pharmaceuticals in the Environment) project aims to develop frameworks to support the environmental testing of new pharmaceuticals and to help prioritise testing of legacy APIs.
This 4 year project is funded by the Innovative Medicines Initiative Joint Undertaking, a unique partnership between the European Community and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and is a collaboration of 12 pharmaceutical companies and 13 academics/SMEs.
The following points provide a greater insight into the iPiE project and Lhasa Limited's role within it:
- The iPiE database will be modelled on the eTOX database, which contains detailed information on the toxicity to preclinical species of many existing APIs and so includes data useful for read across to environmental species.
- Project focuses include:
- Identifying existing methods for carrying out pharmaceutical environmental risk assessments
- Compiling a database that will include information on both APIs and test organisms
- Developing new models for estimating exposure and ecotoxicological responses to APIs
- Validating the developed models, concepts and frameworks using targeted experiments
- Developing a software system that will support the intelligent testing of APIs in the environment and developing guidance on how the software system and associated predictive tools can be used
- Engaging with stakeholder groups throughout the project
- The consortium comprises EFPIA members, academics and SMEs. For more details, see the iPiE website.
- The iPiE roadmap, complete with work packages has been included below. Lhasa is predominantly involved in work packages 2 and 6.
On project completion (31/12/2018), the predictive system and database will be made more widely available to the scientific community.
Benefits will include:
- Early Identification of Environmental Impact:
- The software will make it easier for researchers to evaluate the potential environmental impact of new medicines in the earlier stages of development.
- Reducing Damage to the Environment:
- iPiE will facilitate the identification of medicines that have never undergone environmental assessment, yet could pose a risk to the environment. The software can then be used to prioritise the testing of these existing APIs.
- The project will contribute to the health of the natural environment by ensuring that APIs are developed and used in a sustainable way.
Lhasa Limited - an honest broker and trusted holder of data
Lhasa is a not-for-profit organisation and we believe that shared knowledge can lead to shared progress. Recognised as the original “honest broker”, Lhasa Limited has repeatedly been trusted with proprietary data and this can be seen with our involvement in other collaborative data sharing projects. These include:
- Aromatic Amines: Aims to improve the understanding and predictability of the Ames test outcome for primary aromatic amines.
- Elemental Impurities: Shares analytical data on the levels of trace metals within batches of excipients and aims to increase understanding of the level of risk posed by elemental impurities.
- EU-ToxRisk: An Integrated European ‘Flagship’ Programme Driving Mechanism-based Toxicity Testing and Risk Assessment for the 21st century.
- Vitic Excipients: Shares data on the effects of pharmaceutical excipients and aims to refine experiments and contribute towards a reduction of animal numbers required for testing.
- Vitic Intermediates: Shares data resulting from Ames mutagenicity assays performed on common Intermediates and compounds containing functional groups of interest.
Check out the iPiE website for more information on this project.
To find out more about data sharing opportunities at Lhasa Limited, please get in touch.
The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n°115735, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.