Lhasa unveils new ICH M7 compliant data management tool
Date: 22 September 2017
Lhasa Limited, an educational charity which creates state-of-the-art in silico prediction and database systems, has unveiled Setaria, a data management workflow tool created for global healthcare company, GlaxoSmithKline (GSK) PLC.
Developed alongside scientists from GSK, Setaria is a bespoke solution designed to hold GSK’s compound data and replace its existing 15-year-old database, whilst adding new functionality.
Primarily designed to track internal and external Ames and carcinogenicity data, and ensure ICH M7 compliance, Setaria is also a platform for storing consensus Permitted Daily Exposure (PDE) and Acceptable Intake (AI) limits. The new workflow tool performs Derek Nexus predictions automatically when new compounds are uploaded, and it is hoped that in the next stage of its development it will also include Sarah Nexus predictions, making the ICH M7 submission process semi-automated and therefore quicker and easier to complete.
Crucially, one of the key benefits of the system is that it removes the potential for duplicate testing by tracking structures common to multiple projects; saving significant time and cost by speeding up the development of new compounds and allowing easy access to data across the business.
There are now approximately one hundred users of the Setaria system across GSK, from project team members completing regulatory submissions and computational toxicologists looking for gaps in (Q)SAR knowledge, to process and medicinal chemists.
As part of the next phase of Setaria’s development, Lhasa is planning to allow other pharmaceutical companies to sign up to a shared development scheme - a collaborative model which allows contributing commercial organisations to share the costs of the ongoing maintenance and development of the data management tool with other participating companies.
Jim Harvey, Head of Computational Toxicology & Toxicoinformatics at GSK, said: “Setaria saves significant time when searching for genotoxicity findings and has delivered improved visibility of our data across the business.”
Lhasa is inviting interested parties to collaborate on the next upgrade to Setaria’s capabilities. Those interested in participating should contact: firstname.lastname@example.org
For further press information contact Sarah Giangregorio, Eloise Garrett or Liam Southwell at The Right Agency 0800 910 1898
Notes to Editors:
Lhasa Limited was founded in 1983 as a not-for-profit organisation and educational charity to promote the use of computer-aided reasoning in chemistry and the life sciences. It facilitates collaborative data sharing projects with its members in the pharmaceutical and other life science industries.
Lhasa is a pioneer in the production of expert, knowledge-based systems for forward thinking scientists, and continues to draw on its 30 plus years of experience in knowledge development to create user-friendly, state of the art in silico prediction and database systems for use in metabolism, toxicology and related areas of science.
Lhasa Limited has unveiled Setaria, a data management workflow tool created for global healthcare company, GlaxoSmithKline (GSK) PLC.
- Collaborative Projects