Efficient and adequate safety assessment remains one of the main challenges in the drug discovery, development and submission process. Recent advances have shown that sharing of public & private pre-clinical data is achievable. In parallel, the electronic CDISC-SEND format has been chosen for file submission to the FDA. This offers the opportunity to generate and exploit a large amount of organised data to allow the in-depth assessment of the preclinical species predictivity to human.
The NexGETS project will:
The NexGETS project should aim to set world standards and act as the central partner to go to in terms of preclinical data handling, analysis and use for predictive toxicology
This approach will have an impact on the 3Rs
The same cause has also an incidence on the attrition rate which should logically equally improve overall.
This approach should also reduce the length of development before reaching patients.