SBIR Phase II: Wirelessly Operated Implantable Micropump for On-demand Drug Administration in Laboratory Animals

This Small Business Innovation Research (SBIR) Phase II project couples the precision of microtechnology with low-power microfluidics to realize a fully-implantable micropump specifically tailored for drug delivery applications in rodents. Currently, drug administration is predominantly conducted by manual handling and needle injection which is labor-intensive, induces stress and other ?white-coat? effects and is limited to simple drug release profiles. There is a need for advanced drug administration capability in animals that enables new complex dosing profiles, provides automation for chronic studies, and improves scientific validity. Technical challenges include the development of a low-power inductively-powered pump actuator, ten-fold pump miniaturization and wireless control of a large number of implanted pumps. The research objectives are (1) to optimize pump performance and usability (2) to extend cage size compatibility and connectivity (3) to optimize software usability (4) to optimize system design and establish quality assurance processes for scale-up and (5) to conduct an in-vivo validation study. Successful demonstration of the remotely-controlled implantable infusion pump system will enable new dosing schemes, provide precise temporally controlled dosing for more reproducible results from acute and chronic studies, and enable new approaches to drug therapy that would not otherwise be possible. The broader impact/commercial potential of this project lies in uniquely improving scientific outcomes and facilitating the drug development/discovery process. Currently, only one in 10,000 drug candidates successfully attain FDA approval with a significant number of candidates failing or discarded due to inadequate drug administration. Rapid and accurate evaluation of efficacy, safety and toxicity early in the drug development process is improved through the fully automated, wirelessly-controlled drug dosing technology supported by this Phase II project. This project targets the international laboratory animal market estimated at $3.4B in 2012. Animal models are employed throughout the drug development pipeline and in particular, rodents are critical to drug candidate target validation, screening, and optimization. Included in this effort are several significant first-to-market capabilities such as chronic dosing capability in freely-moving, tether-free mice and high-throughput evaluation of multiple new drugs through automation. The controlled delivery of agents, including emerging biologics, siRNA, peptides, and small molecules, is an important capability in a multitude of clinical and preclinical research applications including neuroscience, pharmacology, toxicology, and physiology. More importantly, this project will enable drug studies that to be performed in a manner that will facilitate and enhance the translation of candidate therapies from animal to human.