Introduction

Personalized cancer medicine is defined as medical care based on the particular biological characteristics of the disease process in individual patients. By using genomics and proteomics, individuals can be classified into subpopulations based on their susceptibility to a particular disease or response to a specific treatment. They may then be given preventive or therapeutic interventions that will be most effective given their particular characteristics.

In oncology, personalized medicine has the potential to be especially influential in patient treatment because of the complexity and heterogeneity of each form of cancer. However, the current classifications of cancer are not as useful as they need to be for making treatment decisions; current cancer classification evolved from morphology and may be misleading because it does not take into account abnormalities at the molecular level. As a result, treatment needs to evolve toward a focus on targeted treatments based on individual characterizations of the disease.

Although this concept has great promise, a number of policy issues must be clarified and resolved before personalized medicine can reach its full potential. These include technological, regulatory, and reimbursement hurdles. To explore those challenges, the National Cancer Policy Forum held a workshop, “Policy Issues in the Development of Personalized Medicine in Oncology,” in Washington, DC, on June 8 and 9, 2009. At this workshop experts gave presentations and commentary on the following areas:



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Introduction P ersonalized cancer medicine is defined as medical care based on the particular biological characteristics of the disease process in indi- vidual patients. By using genomics and proteomics, individuals can be classified into subpopulations based on their susceptibility to a particular disease or response to a specific treatment. They may then be given pre- ventive or therapeutic interventions that will be most effective given their particular characteristics. In oncology, personalized medicine has the potential to be especially influential in patient treatment because of the complexity and heterogeneity of each form of cancer. However, the current classifications of cancer are not as useful as they need to be for making treatment decisions; current cancer classification evolved from morphology and may be misleading because it does not take into account abnormalities at the molecular level. As a result, treatment needs to evolve toward a focus on targeted treatments based on individual characterizations of the disease. Although this concept has great promise, a number of policy issues must be clarified and resolved before personalized medicine can reach its full potential. These include technological, regulatory, and reimbursement hurdles. To explore those challenges, the National Cancer Policy Forum held a workshop, “Policy Issues in the Development of Personalized Medicine in Oncology,” in Washington, DC, on June 8 and 9, 2009. At this workshop experts gave presentations and commentary on the following areas: 

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 PERSONALIZED MEDICINE IN ONCOLOGY • The current state of the art of personalized medicine technology, including obstacles to its development and use by clinicians and patients. • The current approaches to test validation, including analytic valid- ity, clinical validity, and clinical utility. • The regulation of personalized medicine technologies, including the approaches’ shortcomings. • Reimbursement hurdles that can hamper both the development and use of personalized medicine technologies. • Potential solutions to the technological, regulatory, and reimburse- ment obstacles to personalized medicine. This document is a summary of the conference proceedings, which will be used by an Institute of Medicine (IOM) committee to develop consensus-based recommendations for moving the field of personalized cancer medicine forward. The views expressed in this summary are those of the speakers and discussants, as attributed to them, and are not the con- sensus views of the participants of the workshop or of the members of the National Cancer Policy Forum.