Lhasa is pleased to announce that it has signed an extension to its Research Collaboration Agreement (RCA) with the US Food and Drug Administration (FDA)
The title of the agreement is “Improvement of Lhasa Limited software to increase the reliability of in silico prediction in support of the FDA Critical Path Initiative”, and the signed agreement extends the existing research collaboration for another 5 years. The new RCA will last until the 29th November 2021.
Lhasa Limited will work cooperatively with FDA/CDER (Center for Drug Evaluation and Research) to develop toxicity, metabolism, chemical degradation and impurity purging prediction software that is consistent with FDA/CDER regulatory activities. Lhasa will contribute software and scientific expertise and the FDA/CDER will provide toxicological and human adverse effect information and scientific expertise.
The software and models will be made available to FDA/CDER scientists to aid regulatory and research decisions. Lhasa Limited members will also benefit from the advances and improvements to the Lhasa software as a result of the RCA.
Valuable achievements from past collaboration with the FDA include:
- Enhancement of Sarah Nexus for mutagenicity prediction consistent with the OECD principles for (Q)SAR validation
- Inclusion of negative predictions for mutagenicity in Derek Nexus
- Expansion of the coverage in Derek Nexus for the Urinary tract, Nephrotoxicity and Teratogenicity endpoints
FDA’s participation in the current RCA should not be interpreted to suggest a direct or indirect endorsement of any Lhasa product or service.