Created in 2006 and using Lhasa’s Vitic Nexus platform, Vitic Intermediates is one of several projects initiated by Lhasa Limited that enables pre-competitive data sharing.
The Vitic Intermediates project allows project members to share the results of Ames mutagenicity results (which counts for more than 99.5% of the data shared) and the results of the in vitro mammalian cell assays investigating both mutagenicity and clastogenicity of production intermediates.
The following points provide a greater insight into the Vitic Intermediates data sharing project:
- The data shared results mainly from Ames mutagenicity assays performed on common Intermediates and compounds containing functional groups of interest.
- Constant member contributions mean that the database is ever growing. Vitic Intermediates 2015.1.0 database consists of 1,088 compounds with 16,971 associated Genetic toxicity in vitro records.
- Lhasa Limited acts as an honest broker and expertly curates the data from participating organisations. This allows a level of anonymity, whereby the submitting companies are known to each other, but who submitted what is known to Lhasa Limited only.
- Data can be presented to regulatory bodies and treated as if it were the companies’ own, due to the fact that all donating parties are known to each other.
- To assist with submissions, or when simply querying the information held within the database, members of the group are able to request the raw data via Lhasa Limited.
Members of the Vitic Intermediates group include prominent members of the pharmaceutical industry and we are always happy to hear from interested parties. The benefits that can be achieved by joining the data sharing consortium include:
- Time and Cost Savings: The sharing of data in regards to common intermediates can act as an early predictor for genotoxicity, potentially avoiding the need for costly experiments later in development.
- Supporting Expert Review under ICH M7: The high-quality data found within the Vitic Intermediates database lends itself to the ICH M7 workflow, allowing you to retrieve relevant information quickly and potentially avoid the need for costly experiments.
- Utilise Proprietary Data: Joining this data sharing venture gives you the chance to make use of existing information that is not in the public domain.
- Access High-Quality Data: The systematic peer-review process guarantees a high-quality dataset that you can be confident using.
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.
To find out more about data sharing opportunities at Lhasa Limited, please get in touch.