Learn More About the Regulatory Science Initiative I Projects
Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design: This project is examining the use of adaptive clinical trials. These non-traditional clinical trials have the potential to accelerate drug evaluation and improve participant outcomes, all while reducing the cost of clinical trials.
Development of a Replacement Ocular Battery (ROBATT): The objective of this project is to develop a novel strategy for testing ocular irritants that would obviate the need for the commonly used rabbit model. This non-animal testing strategy would result in thousands of animals no longer being needed for ocular irritancy assays and would potentially accelerate and expand capabilities for irritation assays.
Characterization and Bioinformatics-modeling of Nanoparticle-Complement Interactions: The goal of this project is to construct a method for predicting harmful effects of nanoparticles prior to their testing in human subjects. If this could be achieved, safety review of new candidate nanoparticle products and crafting of specific guidelines could be developed to facilitate the regulatory process.
Development of a Heart-Lung Micromachine for Safety and Efficacy Testing: This research is aimed at creating a 'Heart-Lung Micromachine’ as a screening platform that could replace animal assays currently used for development and regulatory review of drugs and nanotherapies.
View all of the funded research here