SBIR Phase I: An Innovative Full-Thickness Human Skin Model for Increased Throughput Screening in Drug Discovery

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This Small Business Innovation Research (SBIR) Phase I project proposes to develop a full-thickness in vitro human skin model in a format enabling increased-throughput screening of compounds. The project will 1) develop culture conditions for production of fibroblast-derived dermal equivalents, 2) use these methods to manufacture skin models in a higher-throughput format, and 3) characterize the biochemical, structural, and functional properties of these tissues. Establishment of this model system will provide a consistent in vitro test platform for drug screening, assessment of transdermal delivery methods, dermal toxicology testing, and development of skin-specific disease models (i.e. melanoma). The developed process improvements will facilitate automation of tissue production and may be scalable to even smaller tissue formats. The broader impact of this research resides in the ability to provide a more reliable, accurate, and cost-effective method of determining the effects of drugs and other chemical compounds on human skin. Biotechnology, pharmaceutical, and consumer product companies devote substantial resources to screening new products and their components for dermal toxicity and permeability. Currently, testing is typically performed using monolayer cells or animal models, despite a well-documented inability for those systems to accurately predict drug efficacy in humans, a problem that contributes to the costly, high failure rate of drug candidates in clinical trials. In vitro skin models show the potential to improve screening capabilities, but current models are expensive and relatively low-throughput. The proposed model will provide accurate, efficient, and cost-effective chemical screening, while avoiding the ethical and regulatory concerns associated with animal testing.