Year: 2015-16
Company: City of Hope
Liaison(s): Arthur Riggs David Horne James Figarola Jyotsana Singhal Jyotirmoy Kusari Sharad Singhal
City of Hope (COH) is a private, not-for-profit clinical research center, hospital, and graduate medical school that is best known for its cancer treatment center. It has been designated as a Comprehensive Cancer Center by the National Cancer Institute. COH’s location in Duarte recently unveiled a new diabetes and metabolic research institute, the Leslie and Susan Gonda Diabetes and Genetic Research Center, with the goal of expanding on diabetes research to help combat the growing diabetes epidemic. COH is committed to research in patient centered care and for the advancement and tradition of exceptional care for all. COH SR4 is a novel compound synthesized at City of Hope that can target and treat drug-resistant cancers, including non-small cell lung cancer (NSCLC), hepatocarcinoma and melanoma, and metabolic disorders, such as diabetes and obesity. The goal of this Team Master’s Project is to conduct a market assessment of opportunities for SR4. This will include: review of the technical profile and IP status of commercialized and pipeline therapies; disease prevalence and patient profile; practitioner preferences and trends in standard of care; growth in NSCLC, melanoma, obesity and diabetes; potential partners; reimbursement and more. Given the preclinical data about SR4 in vitro and in vivo models, the team was tasked to explore requirements for filing an investigational new drug application (IND) with the Federal Drug Administration (FDA) for SR4. Moreover, in order to choose the best indication for the IND, the team performed a detailed market assessment of possible indications provided by COH, namely non-small cell lung cancer, melanoma, diabetes, and obesity. As such, the team designed a single dose toxicity study and consulted those regarding future requirements. The team also performed market analyses of obesity, melanoma, diabetes, and NSCLC markets and assessed IP issues regarding SR4. Future goals include examination of these intellectual property issues, an orphan drug recommendation for melanoma, and future clinical trial design.