FDA RCA (Research Collaboration Agreement)
Sharing knowledge to benefit both the public and the broader scientific community.
- The FDA RCA (Research Collaboration Agreement) is a 5-year project between Lhasa Limited and FDA/CDER (U.S. Food and Drug Administration's Center for Drug Evaluation and Research).
- The agreement aims to make use of publicly releasable FDA data to make improvements to software from Lhasa Limited.
Insight
Initiated in November 2016, the FDA RCA (Research Collaboration Agreement) is a 5-year project between Lhasa Limited and FDA/CDER (U.S. Food and Drug Administration's Center for Drug Evaluation and Research).
Upon completion of the initial 5-year term agreed, the term of the RCA was extended for an additional 5-years, to November 2021. Effective from November 2021, the term of the RCA was extended again for an additional five years to the new expiration date of November 2026.
The RCA was initiated on culmination of previous 5-year agreements and aims to make use of publicly releasable FDA data to construct, improve and validate Lhasa's software for toxicity, metabolism, chemical degradation and impurity purge factor prediction.
The following points provide a greater insight into the collaboration between Lhasa Limited and the U.S. Food & Drug Administration (FDA):
- Lhasa Limited has always worked on the basis of 'shared knowledge, shared progress' and it is at the heart of our charitable purpose. Our collaboration with the FDA aligns with this premise, ensuring that the sharing of knowledge benefits both the public and the broader scientific community.
- The FDA shares publicly releasable data sets with Lhasa Limited. These data, combined with Lhasa curated data sets harvested from literature and Lhasa member data, are then used to train and improve Lhasa's models.
- The FDA then use their non-publicly releasable data sets to evaluate and provide feedback on the performance of Lhasa tools.
- To date, FDA/CDER has shared publicly releasable data with Lhasa for a variety of toxicity endpoints including:
- Rodent carcinogenicity
- Genetic toxicity
- Reproductive toxicity
- Urinary tract toxicity
- Cardiotoxicity.
- As part of this collaboration, the FDA provides feedback and guidance on Lhasa Limited developments from a regulatory perspective and these are shared with the scientific community through joint publications such as:
- Work carried out under this collaboration also includes exploitation of in vitro and other relevant data, in addition to in vivo DART* information towards the prediction of molecular initiating events relevant to teratogenicity. This initiative looks to provide predictions over a significantly wider chemical space.
* DART (Developmental and Reproductive Toxicology Database)
Benefits
There are numerous benefits to this collaboration including:
- Improved software -Because ofLhasa's collaboration with theFDA, you can be confident that the software being developed by Lhasa is consistent withFDA requirements. This offers peace of mind when submitting predictions from Lhasa software to regulators.
- The science explored and any corresponding features and findings generated from this collaboration are often shared with the wider scientific community through publications in journals or at relevant, well-targeted international conferences. Examples include:
- The science explored and any corresponding features and findings generated from this collaboration are often shared with the wider scientific community through publications in journals or at relevant, well-targeted international conferences. Examples include:
- Improved quality - Mining of publicly releasable FDA data sets has led to the development of new alerts in Derek Nexus, which provides users with a more robust prediction. Derek Nexus alerts prepared under this RCA and similar, previous agreements are as follows:
- Teratogenicity - 22 full alerts for teratogenicity and 25 full alerts for molecular initiating events linked to teratogenicity.
- Nephrotoxicity - 14 full alerts and 53 rapid prototype alerts (covering 6 urinary tract toxicity endpoints including nephrotoxicity).
- Cardiotoxicity - 8 rapid prototypes for bradycardia
- Endpoint development - Reproductive and developmental toxicity are complicated endpoints for which providing in silico toxicity prediction can be quite a challenge. Through our work with the FDA, Derek Nexus not only offers this possibility, it does so in a highly transparent knowledge base setting, allowing you to make informed decisions on future development.
Why Choose Lhasa?
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.
