Lhasa unveils new ICH M7 compliant data management tool

Lhasa, an educational charity that creates in silico prediction and database systems, has unveiled Setaria, a data management workflow tool created for global healthcare company, GlaxoSmithKline

Developed alongside scientists from GlaxoSmithKline (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 that 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.”

Companies