Clinical Development

Our development group is comprised of experienced professionals with the expertise to quickly move our development candidate compounds from preclinical testing to investigational new drug (IND) status and through phase 3 clinical trials. The development group possesses critical expertise in the areas of chemistry, manufacturing, and controls (CMC), translational medicine, pre-clinical testing, pharmacokinetics, drug safety, biostatistics, clinical trial design, management, and analysis, and regulatory affairs. The team's proficiency and productivity are remarkable assets that have enabled us to advance thirteen compounds from lead candidate to the clinic in three years.

The critical mass and speed of our research and drug discovery operations generate significant momentum toward the clinic. We have now built similar capabilities in our development operations to generate and manage the clinical data that will carry our product candidates toward the market. Our strategy is to conduct rigorous and focused phase 2 clinical programs that explore the utility of our compounds in the most promising indications, either as single agents or in combination or comparison with other regimens, and evaluate various dosing schedules. These extensive clinical programs are enabling us to make data-driven decisions about how to advance our compounds into pivotal registration trials.