Lhasa Limited shared knowledge shared progress

FDA RCA (Research Collaboration Agreement)

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).

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.

Insight

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 is at the heart of our charitable purpose. Our collaboration with the FDA aligns with this premise, ensuring that the sharing of knowledge benefits 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 our 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.

* Center for Drug Evaluation and Research

** DART (Developmental and Reproductive Toxicology Database)

Benefits

Benefits

There are numerous benefits to this collaboration including:

  • Improved software - Because of Lhasa's collaboration with the FDA, you can be confident that the software being developed by Lhasa is consistent with FDA requirements. This offers peace of mind when submitting predictions from Lhasa Limited to regulators.
  • 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 our previous CRADA agreement 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.

 

Shared Knowledge Shared Progress

Why Lhasa?

Lhasa Limited - an honest broker and trusted holder of data

Lhasa is a not-for-profit organisation and we believe 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. These include:

  • Aromatic Amines Aims to improve the understanding and predictability of the Ames test outcome for primary aromatic amines. 
  • Elemental Impurities Shares analytical data on the levels of trace metals within batches of excipients and aims to increase understanding of the level of risk posed by elemental impurities.
  • EU-ToxRisk An Integrated European ‘Flagship’ Programme Driving Mechanism-based Toxicity Testing and Risk Assessment for the 21st century.
  • iPiE Aims to develop frameworks to support the environmental testing of new pharmaceuticals and to help prioritise testing of legacy APIs.
  • Vitic Excipients Shares data on the effects of pharmaceutical excipients and aims to refine experiments and contribute towards a reduction of animal numbers required for testing.
  • Vitic Intermediates Shares data resulting from Ames mutagenicity assays performed on common Intermediates and compounds containing functional groups of interest.

Declaration

FDA’s participation in the current RCA should not be interpreted to suggest a direct or indirect endorsement of any Lhasa product or service. FDA/CDER also has RCAs with Leadscope Inc. and MultiCASE Inc., under which data-sharing, model development, and software access is facilitated.

Contact Us

© 2017 Lhasa Limited | Registered office: Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK Tel: +44 (0)113 394 6020
VAT number 396 8737 77 | Lhasa Limited is registered as a charity (290866)| Company Registration Number 01765239 (England and Wales).

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