Establishing the market-readiness of an in vivo technology for assessing drug toxicity-induced tissue damage

PROJECT SUMMARY In drug Randamp;D it is critical to be able to understand toxicity and to identify and eliminate overly toxic candidates. However, there is a significant technological gap for in vivo toxicity testing. To address this challenge, we developed a novel imaging-based approach that detects toxicity-induced tissue injury in a minimally invasive, whole body and dynamic fashion. The invention and development of the technology has had a substantial academic track record by our scientists; and its commercialization is driven by a strong market need, technical expertise and marketing know-how. The goal of the current Phase I STTR grant is twofold: 1) to determine the sensitivity and specificity of our imaging technology, and 2) to establish a user-friendly report system which summarizes and presents the findings to end users who have a general drug Randamp;D background. The accomplishment of our goal will enable us to launch a market-ready service package with user accessibility. Overall, this in vivo imaging approach identifies an important marker for drug toxicity on a personalized basis with an objective and quantitative metric. The early detection of drug toxicity in susceptible tissues will help make timely decisions in drug Randamp;D by prioritizing safe and efficacious candidates.PROJECT NARRATIVE The characterization of toxicity is essential to making timely decisions in drug research and development by prioritizing safe and efficacious candidates. We have identified an imaging-based approach for assessing drug toxicity in a whole body and dynamic fashion. The goal of the current Phase I STTR grant is to quantitatively establish the sensitivity and specificity of this technology and to develop a user-friendly report card, which will ultimately allow drug discoverers to more quickly determine the toxicity profile of a drug candidate.