Non Human Primate study data management to correlate with human studiesSITUATION
- Emerging vaccine developer currently conducting one human study as well as an non human primate study on an investigational vaccine against a solid tumor cancer indication
- Goals of study: a) Utilize the NHP model to inform the clinical dosing regimen and dosing intervals to maximize the immune response over a short period of time b) acquire key data to support a comparison to human trail
- Datasets: ELISpot, Serum Cytokones, Serum Chemistry, Liver Function, Acute Phase reactants, CBC, ICS (flow cytometry) , single cell RNASeq/TCRSeq
- What is the maximum tolerated dose in NHP model that can predict a similar response in human
- What similarities or differences are there in immune response to vaccine between NHP and human data? Eg. Chemical and cytokine signatures between NHP and human?
- What is the functional profile of the activating T-Cell? Many such questions to be reviewed with integrated data
- In the process of setting up the user requirements to integrate multiple sources of data
- Evaluated several vendors that can integrate biomarker data and selected one leading vendor; developing a pilot solution
- Project at early stages of evaluation
