Using the company he co-founded, SARcode, as an example, Dr. Tom Gadek tells us how one converts a novel idea into a successful company. He walks us through the discovery of Lifitegrast to treat dry eye syndrome, the founding of SARcode in 2006, and the subsequent clinical trials. In his first talk, Gadek highlights the financial challenges a company faces during its development and stresses the importance of presenting the company as a valuable investment to venture capital groups. While describing the process of developing a company, Gadek offers three main points of advice: surround yourself with people that work well with you, get good lawyers, and always do quality science and publish your results.
In his second lecture, Gadek reviews the molecular mechanism of dry eye syndrome, focusing on the role of inflammation and T-cells in this disorder. By analyzing clinical trial data from other drugs developed to treat dry eye, Gadek and colleagues confirmed the importance of LFA-1 as a possible target. LFA-1 is a surface protein on T-cells that binds to ICAM-1 on antigen presenting cells, T-cells, and epithelial cells and causes inflammation. Gadek and his colleagues developed Lifitegrast, a small molecule that serves as an ICAM-1 mimetic. By binding to LFA-1 on T-cells, Lifitegrast inhibits the binding of ICAM-1 and therefore inhibits the inflammation associated with dry eye syndrome.
In his third lecture, Gadek outlines Lifitegrast clinical trials, from Phase 1 to Phase 3, and presents evidence of Lifitegrast’s safety profile in normal individuals as well as the efficacy of the drug in treating dry eye syndrome. Lifitegrast’s story shows the different layers of drug development and the steps that companies go through to take a drug from the laboratory to the patient’s bedside and ultimately to the market.
Dr. Tom Gadek received his undergraduate degree in Chemistry at the University of Colorado Boulder and then earned his PhD in Organic Chemistry from the University of California Berkeley. Gadek has had a lifelong interest in developing small molecule antagonists of protein-protein interactions. He joined Genentech in 1988 and over the next 15 years, he… Continue Reading