A database of Ames mutagenicity results for common intermediates.
- Created in 2006 and using Lhasa’s Vitic platform, Vitic Intermediates is one of several projects initiated by Lhasa Limited that enables pre-competitive data sharing.
- Partners share the results of Ames mutagenicity results and the results of in vitro mammalian cell assays.
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 2021.1 database consists of 1,837 substances with 31,462 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. 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 believes 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.
To find out more about data sharing opportunities at Lhasa Limited, please get in touch.
- Briggs, KA (2018) 'Is preclinical data sharing the new norm?', Drug Discovery Today, March 2018, Volume 23, Pages 499 - 502. https://doi.org/10.1016/j.drudis.2016.05.003
- Elder et al. 'Mutagenic Impurities: Precompetitive/Competitive Collaborative and Data Sharing Initiatives', Organic Process & Research Development, May 2015, Volume 19, Pages 1486 - 1494. https://doi.org/10.1021/acs.oprd.5b00128
- Briggs, KA (2019) 'The Honest Broker;s Challenge', presented by Katharine Briggs at a workshop in June 2019.
- Yeo, D (2019) 'Achieving Innovation Through Collaborative Progress', presented by Dr Dave Yeo at the AIChE Annual Meeting in November 2019.