Initiated in 2012 and using the Vitic Nexus platform, MIP-DILI is a five-year IMI/EFPIA funded consortium concerned with the Mechanism Based Integration Systems for the Prediction of Drug Induced Liver Inury (MIP-DILI).
Drug Induced Liver Injury (DILI) is recognised as a major health problem, however is poorly predicted by methods currently used by the pharmaceutical industry. This poor predictivity has implications for patients, regulators and the pharmaceutical companies alike and the MIP-DILI initiative is looking to address this with the development of novel preclinical test systems.
The following points provide a greater insight into the MIP-DILI project:
- The five-year project is funded by the IMI and EFPIA and was launched in 2012.
- The project has outlined the following objectives*:
- To identify and validate an improved panel of in vitro "best practice assays" for predicting DILI in the human population.
- To explore and understand the relationship between in vitro assay signals and DILI in vivo, in preclinical test species and in man.
- To develop and validate novel Systems Modelling approaches that integrate multiple preclinical data types to improve prediction of DILI.
- To enhance shared understanding, between academia, pharma and regulatory agencies, of the value and limitations of new and existing approaches for DILI hazard identification and risk assessment.
- There are currently 26 participants from the pharmaceutical industry, SMEs and academia.
- Lhasa Limited is providing its experience in databases and data handling to supply the project with document management using both the Vitic Nexus platform and a bespoke option.
View some of the MIP-DILI publications in our library.
* Taken from the MIP-DILI website.
The pre-competitive project will help determine those test systems that are currently fit for purpose and provide clear requirements for development of new systems. This will ultimately aid in the design of new medicines that are both effective and safe.
- Improved efficiency - Drug Induced Liver Injury is a health concern that has implications for many. Development of new test systems that provide improved predictions, could help lead to a more efficient drug development process.
- Time and cost savings - Access to improved predictions early in development allows for informed decision making, providing opportunities to save costs on lengthy experiments for candidates that are considered inappropriate.
- Improved quality - Pre-competitive collaboration is enabling the development of innovative tools that will provide an improved prediction over existing tools.
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.
- iPiE Aims to develop frameworks to support the environmental testing of new pharmaceuticals and to help prioritise testing of legacy APIs.
- 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.
The MIP-DILI project has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115336, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/20072013) and EFPIA companies’ in kind contribution.