SBIR Phase II: Predictive Ex Vivo Solid Tumor New Approach Method (NAM) for Screening Anticancer Agents

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project lies in development of a testing platform built on three-dimensional tissue engineering that better reflects the biological structure and behavior of solid tumors. By enabling identification of effective treatment candidates earlier and elimination of ineffective ones sooner, this technology has the potential to reduce the time and cost of bringing new therapies to market. The resulting platform is designed to serve pharmaceutical and biotechnology companies. This Small Business Innovation Research (SBIR) Phase II project addresses the persistent gap between laboratory screening and clinical outcomes in solid tumors. The proposed research develops a scalable platform that recreates key structural and biological features of tumor tissue outside the body for quantitative drug response testing. Phase II objectives include optimizing tissue preparation methods, expanding drug screening across multiple therapies, and integrating artificial intelligence and machine learning driven image analysis to standardize and scale measurement of treatment effects. The anticipated technical outcome is a standardized, scalable, and certified testing system capable of generating high-resolution, quantitative data. By strengthening the scientific foundation of preclinical drug evaluation, this project aims to reduce translational uncertainty and improve prioritization of effective therapies, ultimately bridging the gap between laboratory research and patient care. 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.