NEXT GENERATION OF ELECTRONIC TRANSLATIONAL SAFETY – NEXGETS

Topic description

Specific Challenge:

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:

• Development of an internationally accepted guideline for data sharing
• Accrue large sets of d preclinical and high-level clinical safety data
• Conduct a retrospective data analysis to assess translation of preclinical to clinical safety outcomes
• Ensure that participating companies have similar or greater access to data as regulators to facilitate discussion
• Develop innovative tools for data mining, analysis, data display and prediction

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.