The broader impact/commercial potential of this project is a breakthrough innovation that will revolutionize preclinical drug testing, provide valuable information for the first-in-human clinical trials, rescue drugs, decrease time to optimize therapies, and reduce the incidence of safety hazards and adverse reactions. Clinical-Trials-on-a-Chip will serve as the pioneering platform for predictive in vitro testing of humanized biotherapeutics that have become first line therapies for cancer, inflammatory, autoimmune, infectious, cardiovascular and neurological diseases; a market worth $200 billion. The platform will also help rescue drugs by identifying genomic and molecular signatures of human sub-populations and disease sub-types for which these drugs are efficacious and safe; thus, saving pharmaceutical industry over $1 billion per failed drug and a decade of research while bringing safe drugs to patients. Lastly, the platform will serve in a $42 billion personalized targeted therapies market to optimize therapies of cancer patients at a lower cost and faster than is currently attainable using xenografts implanted in mice; thus, saving lives. Ultimately, this project will lower cost of bringing safe and efficacious drugs to market and expedite development of frontline therapies for the benefit of patients, health care and society.This Small Business Innovation Research (SBIR) Phase I project will provide Clinical-Trials-on-a-Chip platform for predictive efficacy and safety testing of humanized biopharmaceuticals; a market worth $200 billion. Due to lack of appropriate testing solutions, targeted therapy and immunotherapy drugs are tested in animals which immune system is compromised to be able to carry the disease. For example, cancer immunotherapeutics are tested in immunosupressed mice to avoid rejection of tumor grafts. Next, the correlation between animal and human studies is low because these drugs are humanized and active only in humans. Lastly, biopharmaceuticals are large molecules which cannot be appropriately tested in vitro either. In vitro platforms are made for testing small molecule, Tylenol-like, drugs clearing in 3-4 hours, not in 1-30 days like antibodies do. This project will solve this problem by providing novel in vitro platforms and methods for efficacy and safety assessment of high molecular weight therapeutics. Specifically, Clinical-Trials-on-a-Chip will enable drug researchers to mirror drug distribution, half-life elimination, and conduct repeat dose testing to better predict antibody specificity and efficacy in diseased organ models, cross-reactivity with normal tissues, and off-target organ liabilities such as unexpected off-target organ toxicity in a simple and easy to use research tool.
