Year: 2016-17

Company: Regulus Therapeutics

Liaison(s): Steven Lockton, April Simora

Regulus Therapeutics is a publicly traded, clinical-stage biotech company based in La Jolla, California. Recently, through promising research in companion diagnostics, Regulus has established the MicroMarker® division which is focused on identifying microRNAs as biomarkers of human disease. Regulus’s strategic vision is to establish meaningful diagnostic tests that will change patient health outcomes for the better. The resulting developed tests can in turn provide maximum value to Regulus by implementing optimal commercialization and partnering strategies. Investigating disease diagnostic opportunities utilizing the MicroMarker technology is what brought Regulus to KGI.

Our Regulus TMP team began our project by creating two scoring methodologies to filter diseases and narrow the focus to ideal disease targets. Criteria included biological applicability, as well as commercial, market, and technological feasibility. Through the process of defining criteria and applying it to diseases, we constructed a database that ranked many diseases based on our methodology. We started with this broad look, and then reduced candidates to the top ten based on our scoring procedure and liaison analysis of the results. From there, the choices were further refined and narrowed to five diseases. Following this was an in-depth market analysis and business plan for each candidate disease to help Regulus determine which disease( s ) to pursue. This included collecting information on competitors, market size, regulatory requirements, potential partners, and for product development, the accessibility of patient samples in a biorepository.