Primate models and Remote Clinical Trials: Strategy and Tactics for Minding Species Gaps in between Rodents and Human
Time: 3:40 pm
day: Day One
Details:
- Pharma history reminds us that the deepest valley of death lies in around Phase I/II trial.
- Primate models may avoid from “unexpected” failure at the stage due to the species differences.
- Human iPSC-based in vitro model can be utilized at any stage of the drug development; target ID, choice in the synthetic development and estimate of minimal effective concentration.
- In vivo non-human primate models offer a comprehensive and easy-handling reliable platform.
- Daily monitoring of hearing and balance in the early phase of clinical trial by remote data collection may reveal us “real-world” needs of patients, which should be reflected to the pipeline selection, choice of target molecules and clinical endpoints of the trials.