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INDUSTRY LEADER insights large volumes of diverse molecular pro- filing data. This rise of Big Data in clinical medicine has created the need for new education and decision-support tools for physi- cians and payers. It is impossible for these stakeholders to remain aware and interpret the exponential growth in published literature. New services for literature aggregation, analysis, and ranking services will be required to set, and constantly update, evidentiary cri- teria for treatment and reimbursement decisions, together with automated tools to guide clinical decisions. More than 1.5 million new cancer cases will be diagnosed and over 800,000 cancer patients will die in the U.S. in 2014. The value proposition for molecular profil- ing in cancer, as in other data-intensive settings, is the generation of accurate, patient-customized, actionable infor- mation that enables physicians and patients to make better–informed, real- time care decisions. Oncology has been in the vanguard of molecular profiling, but the value is not limited to cancer and extends across the entire spectrum of human disease, including profiling neurodevelopmental disorders that arise during fetal development. In addition to providing the intellectual foundation for precision medicine to improve patient care, the economic case for molecular profiling is equally compelling. By enabling high-cost treatment to be directed to only those patients likely to benefit and by eliminating futile interventions, molecular profiling can help determine how to balance infinite demand for care versus finite resources and how to control cost while improving patient care and outcomes. L There's no doubt that a spectrum of tumor-profiling technologies is need- ed to provide oncologists with the most comprehensive information on which to decide treatment options. Comprehensive molecular profiling of this kind is data-intensive, already generating up to a terabyte of data per patient. Refined insights will also come from comparison of individual patient data with the profiling and treatment response data from larger patient pop- ulations and from using large-scale analytics to iteratively improve the accuracy of actionable drug to molecu- lar target associations. Thus, adoption of molecular profiling as a routine standard in cancer care will require sophisticated annotation, analysis, and secure curation of petabyte- and potentially exabyte- scale databases. The opportunities for market expansion are dramatic, but making this a reality will involve a com- plex interplay of technical, clinical, and economic forces. The bottleneck no longer resides with profiling technologies; the challenge today is the data processing and corre- sponding analytics (e.g., identifying new molecular targets for diagnosis, prog- nostic assessment, and treatment selec- tion). In turn, leveraging the full value of profiling requires integration with a patient's clinical history and lifestyle data. Doing so helps identify confounding factors that may alter severity of disease and/or therapeutic responses. Currently, however, these data sets are fragmented in disparate systems often with incom- patible formats that limit facile interop- erability. Additionally, most electronic medical records are not yet designed for seamless extensibility to accommodate Precision Oncology: Big Data And Analytics Come To Cancer Care D R . G E O R G E P O S T E ancer care is creating a new era of precision oncology. Profiling the molecular altera- tions in a patient's tumor can identify changes that correlate with likely response or resistance to par- ticular therapies. This type of molecular profiling also can lead to more precise treatment, replacing historical "one-size- fits-all" approaches. Advanced analytical technologies are revealing how different genetic mutations in cancer disrupt the molecular signaling (information) path- ways that regulate normal cell function and produce specific pathway alterations in different cancers, subtypes of the same malignancy, and individual patients. Dr. George Poste is vice chairman of Caris Life Sciences and director of the Complex Adaptive Systems Initiative at Arizona State University. C PRECISION ONCOLOGY: BIG DATA AND ANALYTICS COME TO CANCER CARE By Dr. G. Poste 49 LIFESCIENCELEADER.COM JANUARY 2015