Molecular targeted therapy and immunotherapies hold the promise of providing new, more effective treatment options for solid tumor patients. Significant strides have been made in identifying subsets of patients with defined genetic alterations that benefit greatly from these therapies. However, the genetic and molecular heterogeneity of solid tumors suggest that the application of novel molecular therapies will not be a ?one size fit all?. The pharmacodynamics effects of these treatments as well as the underlying biology of the tumor are likely to contribute to the effectiveness of current treatments, and careful evaluation of these parameters are likely to give rise to novel biomarkers. The first step in this process is the integration of high quality, innovative correlative studies into our clinical trials so we can learn from these valuable patient samples. This application outlines a program, the Solid Tumor Translational Science Shared Resource (STTS-SR), that I established within the Ohio State University Comprehensive Cancer Center to drive the development of novel biomarker assays and incorporate them into Phase I/II clinical trials. Thus providing an opportunity to better understand the biology of the tumors we are treating and insight into which pathways to explore next. At the same time, I utilize my expertise in drug development and the ever-evolving molecular techniques to help basic and translational scientists explore pre-clinical hypotheses and move their findings from the laboratory to the clinic in order to make a meaningful contribution to the care of our cancer patients. My training in cancer biology and unique background working in the pharmaceutical and diagnostic industry has provided me with the experience and expertise to successfully direct this laboratory and develop the following four objectives: 1) to work closely with clinical and translational investigators in the design and management of correlative studies in Phase I/II clinical trials, 2) to coordinate specimen acquisition and drive novel biomarker assay development 3) to integrate the results of the molecular assays with the clinical data and 4) foster the translation of findings from basic biology research programs to the clinic.
The incorporation of innovative and high quality correlative studies into clinical trials is imperative for gaining insight into the biology of a tumor and the response to novel therapeutics. I propose that having a point person to design and coordinate these studies will ensure their success thus leading to better drug development and patient care.
