L5.3 Building an Information Platform for New Drug Discovery

Abstract

Acceleration in the continuum of discovery, translation and delivery of personalized cancer care requires an integrated network information system to utilize the overwhelming amount of information being generated in basic, translational and clinical research. The stakeholders themselves: researchers, clinicians, administrators and patients must be part of developing and delivering a rapid learning, knowledge-based health system that creates value for the stakeholder, and provides evidence-based alternatives. For example, by having access to a large prospective database of patients, clinicians would be able to find patients most suitable for clinical trials based on their clinical and molecular characteristics which would result in shortening the time to reach adequate patient accrual, and patients would be most suitably matched to the “right” trial. In 2003, the Moffitt Cancer Center in Tampa, Florida launched an initiative in personalized cancer care that has now expanded to 18 health institutions in 10 states, called Total Cancer CareTM (TCC). Critical to the pursuit of personalized medicine is the development of a large regional cancer biorepository in parallel with the development of a relational data warehouse and an information system containing patient's clinical and molecular data. The Total Cancer CareTM Protocol, now with >89K consented patients, >32K tumors and >16K genetic profiles, provides the mechanism to accomplish these goals. A Health and Research Informatics platform facilitates the rapid identification of patient subjects eligible for specific trials. Several pre-clinical projects to define biomarker prevalence, concordance between gene expression and protein expression, and to validate biomarkers, are underway using the TCC database. Specific cohorts of subjects with various cancers identified at Moffitt and within the TCC consortium have been found to be clinically and molecularly eligible for trials involving a variety of biomarkers and targeted agents. Enrollment on these early phase studies that use CLIA defined biomarkers is well underway. This approach has the potential to dramatically decrease trial accrual times, require fewer subjects per trial, and result in increased response rates by specifically targeting molecular alterations in patient tumors.