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 From bench to bedside, Exelixis’ R&D operations strive toward the highest standards of quality and productivity. By fostering communication between the laboratory and the clinic, we are able to apply new scientific and clinical insights to optimize each step of the drug development process. We are committed to developing innovative therapies that have the potential to significantly improve patient outcomes for cancer. We have built a portfolio of compounds that have first-in-class or best-in-class potential through our own research and development initiatives. Recognizing the importance of an integrated approach to the R&D process, we utilize high-throughput methods, bioinformatics, structural biology, early in vivo testing, and assessment of clinical biomarkers to enable continued incorporation of new data and disease insights into every step of the development continuum. As a clinical development-stage company, we have strategically built 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 1 and phase 2 clinical programs that explore the utility of our compounds, either as single agents or in combination or comparison with other regimens, in the most promising indications. These clinical programs enable us to make data-driven decisions about how best to advance individual compounds. Our development group is comprised of experienced professionals with 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 generate the data we need to make rapid yet highly informed decisions. Our robust discovery platform allows us to identify and optimize multiple drug candidates in parallel, supporting the continued growth and replenishment of the Exelixis pipeline. Our discovery operation has the infrastructure and expertise to screen and optimize large numbers of compounds very rapidly while retaining stringent selection criteria. Our ability to optimize lead compounds in a parallel fashion creates a pool of extensively qualified candidates from which we can select the few that meet our high standards for pre-clinical safety, bioavailability, potency, specificity, and efficacy. |
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