SBIR-STTR Award

This SBIR Phase 1 project is aimed at providing technology to address the high costs of developing effective and safe drugs. Bringing a new drug to market typically involves screening 100?s of thousands of compounds for efficacy and toxicity utilizing cell, tissue and animal models to ultimately select a lead compound that will be tested in clinical trials. This process can take years, billions of dollars, and in the worse case leads to compounds that fail during clinical trials due to safety concerns. Advances in microfluidics and 3D-printing have enabled the construction of tissue culture devices with nearly unlimited numbers of tissue chambers and flow channel complexity. Combined with optical sensors with unprecedented sensitivity, instrumentation can be built that maintain large numbers of biopsied tissue samples, while assessing the effects of exposure of the tissue to libraries of drugs. This technological platform provides resolution of drug effects on human tissue with high sensitivity thereby reducing the cost of animal testing and the risk of bringing toxic drugs to clinical trials and the market. In addition, the technology will impact the fields of personalized medicine, where drugs could be tested on an individual?s own tumor or tissue, and environmental health. Measuring in vitro cellular responses to pharmaceutical compounds is critical for identifying toxic effects of candidate drugs prior to costly in vivo animal and clinical testing. To address this need, instrumentation to maintain and assess biopsied tissue in real time is being developed. The technology utilizes microfluidics for optimal maintenance of tissue viability and function, and optoelectronics to measure oxygen uptake with unprecedented sensitivity. The fluidics are driven by gas pressure, circumventing the need for unwieldy pumps, and the channels are fabricated by 3D printing, allowing for nearly unlimited numbers of chambers and flow channel complexity. The technological platform will aid in the selection of lead compounds for clinical trials, estimation of doses for first-in-human tests, and support applications to the FDA. In this Phase 1 SBIR proposal we will build 2 96-channel turnkey instruments for a contract research program and for beta testing by pharmaceutical companies. The functionality of a low-capacity (8-channel) system has been previously demonstrated. The funding will support scaling up the throughput of the system as well as enabling additional modes of operation. The instrumentation will be used for contract research and for direct sales to the large market of drug discovery within the pharmaceutical industry.

This STTR Phase 2 project is aimed at providing technology to address the high costs of developing effective and safe drugs. Bringing a new drug to market typically involves screening 100's of thousands of compounds for efficacy and toxicity utilizing cell, tissue and animal models to ultimately select a lead compound that will be tested in clinical trials. This process can take years, billions of dollars, and in the worse case leads to compounds that fail during clinical trials due to safety concerns. Advances in microfluidics and 3D-printing have enabled the construction of tissue culture devices with nearly unlimited numbers of tissue chambers and flow channel complexity. Combined with optical sensors with unprecedented sensitivity, instrumentation can be built that maintain large numbers of biopsied tissue samples, while assessing the effects of exposure of the tissue to libraries of drugs. This technological platform provides resolution of drug effects on human tissue with high sensitivity thereby reducing the cost of animal testing and the risk of bringing toxic drugs to clinical trials and the market. In addition, the technology will impact the fields of personalized medicine, where drugs could be tested on an individual's own tumor or tissue, and environmental health. Measuring in vitro cellular responses to pharmaceutical compounds is critical for identifying toxic effects of candidate drugs prior to costly in vivo animal and clinical testing. To address this need, instrumentation to maintain and assess biopsied tissue in real time is being developed. The technology utilizes microfluidics for optimal maintenance of tissue viability and function, and optoelectronics to measure oxygen uptake with unprecedented sensitivity. The fluidics are driven by gas pressure, circumventing the need for unwieldy pumps, and the channels are fabricated by 3D printing, allowing for nearly unlimited numbers of chambers and flow channel complexity. The technological platform will aid in the selection of lead compounds for clinical trials, estimation of doses for first-in-human tests, and support applications to the FDA. In this Phase 2 STTR proposal, the company will build two 96-channel turnkey instruments for a contract research program and for beta testing by pharmaceutical companies. The functionality of a low-capacity (16- channel) system has been previously demonstrated. The funding will support scaling up the throughput of the system as well as enabling additional modes of operation. The instrumentation will be used for contract research and for direct sales to the large market of drug discovery within the pharmaceutical industry. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.