therapies and how they point to the need for systematic changes. Dr. Chabner noted, “The growth of molecular science and targeted therapies and targeted risk assessment is rapidly transforming everything, and has to pervade everything that happens at NCI from Cooperative Groups to preventive research, to early diagnosis. The issue here is, do the NCI’s structure and its programs really address the need to fully exploit this molecular science and targeted therapies?”

Recognizing the importance of genomics to cancer research, NCI recently created a new Center for Cancer Genomics, Dr. Varmus pointed out. “The creation of the center reflects not only the emphasis I see the NCI placing on genomics over the next decade in the research arena, but also the centrality of genomics in practice, with the need to incorporate education in genetics into the training of oncologists,” he said. Dr. Varmus also noted that the genomic revolution is creating the need for interagency interactions—especially with CDC and FDA—and more oversight, including the need for regulations that govern the use of diagnostics and other biomarkers and new ways to conduct clinical trials.

NCI is also exploring how best to further translational research within NIH’s Clinical Center, according to Dr. Varmus. He noted that NCI also plans to play a significant role in the Cures Acceleration Network called for in the healthcare reform legislation (Bruckbauer et al., 2010).

Dr. Chabner reported that the National Cancer Advisory Board would soon be releasing its report that assesses the major NCI programs and recommends future priorities for the institute. This report suggests changes for NCI that are responsive to the advent of molecularly targeted therapies, new investment by industry in the cancer drug and diagnostic discovery and development field, and fiscal restraints on the NCI budget (NCAB, 2010).

FDA REGULATION OF CANCER DRUGS AND DIAGNOSTICS

The FDA is also reorganizing the way in which it reviews oncology products, Dr. Pazdur noted. The original structure of the Office of Oncology Drug Products (OODP) included three divisions that evaluated oncology products—Biologics, Drugs, and Imaging. In 2011, the name will be changed to the Office of Hematology and Oncology Products (OHOP), with a new structure encompassing four divisions (Goldberg, 2010):

  1. The Division of Hematology Products (DHP)

  2. The Division of Hematology Oncology Toxicology (DHOT)



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