Created in 2008 and using Lhasa’s Vitic Nexus platform, Vitic Excipients is one of several project initiated by Lhasa Limited that enables pre-competitive data sharing.
The Vitic Excipients project allows the anonymous sharing of excipient vehicle toxicity data amongst members of the project team. Data shared is predominantly from single and repeat dose studies.
The following points provide a greater insight into the Vitic Excipients data sharing project:
- Partners working on this project are sharing data on the effects of pharmaceutical excipients with the aim of refining experiments and contributing towards a reduction of animal numbers required for testing.
- Constant member contributions mean that the database is ever growing. Vitic Excipients 2015.1.0 database includes 975 records in the vehicle data table and 2,638 records in the single and repeat dose data table.
- 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 Excipients 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 excipients reduces duplication of data across companies, avoiding the need to repeat costly experiments.
- Supporting REACH Submission: The high-quality data found within the Vitic Excipients database lends itself to the REACH initiative, 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.
Examples from members
- The Excipients database has been used to expand an internal guide for studies in dogs. A query was run to return all excipients that had been used in dogs, and the XML report format used to export this in an easy to read format.
- The database has been used to provide recommendations on the use of excipients for in vivo studies. UCB have an internal vehicle working group that work on this and describe their work in this poster.
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 Intermediates Shares data resulting from Ames mutagenicity assays performed on common Intermediates and compounds containing functional groups of interest.
To find out more about data sharing opportunities at Lhasa Limited, please get in touch.