In April, while testifying before the Senate Appropriations Subcommittee on Labor, Senator Arlen Specter (R-Pa.) asked me an important question: What would it take to accelerate by 5 years the achievement of the 2015 goal of eliminating the suffering and death due to cancer? I want to share the National Cancer Institute's response to Senator Specter so that the cancer community can better understand what we hope to achieve and how we hope to achieve it.

You have requested information on the amount of money necessary for the National Cancer Institute (NCI) to achieve its 2015 goal by 2010. It should be noted, though, that these funding estimates for additional resources were developed without taking into consideration overall fiscal constraints and other competing priorities of the National Institutes of Health (NIH), the Department of Health and Human Services (HHS), or the rest of the Federal government over this 5-year time period. The current annual NCI budget is nearly $5 billion and the resources discussed below would be in addition to this base.

NCI has established an ambitious goal of eliminating the suffering and death due to cancer by 2015 by sustaining and integrating progress in the discovery, development, and delivery of more effective interventions based on molecular mechanisms of cancer. We estimate that expenditure of an additional $4.2 billion above the NCI base of nearly $5 billion over the next 5 years could accelerate progress. While the elimination of suffering and death due to cancer may not be fully achievable by 2010, there would be significant progress toward narrowing the gap between 2015 and 2010.

This $4.2 billion estimate reflects an additional upfront allocation of $2.5 billion to be expended over 5 years for a National Advanced Technology Initiative for cancer (NATIc) to accelerate the emerging disciplines of molecular oncology, nanotechnology, and bioinformatics for use in creating a pipeline of new personalized cancer diagnostics and therapeutics. This would also reflect an annual increase of $171 million over current base NCI levels for 5 years to deploy a modern integrated cancer clinical trials infrastructure and an annual increase of $164 million for 5 years to expand and integrate the NCI-designated Cancer Centers program from 60 existing centers to 75. In addition to resources, additional legislative authorities related to exemptions from specific parts of current procurement, grant review and processing, and licensing and patenting rules would also help speed progress toward an accelerated cancer goal.

Three decades ago there were 3 million U.S. cancer survivors; today that number has increased to over 10 million. Today, each minute of every hour of every day, 1 American dies from cancer: 570,280 lives will be lost this year due to this disease. Despite this fact, there has been remarkable progress in understanding the cancer process and applying that knowledge. Today, 65 percent of patients diagnosed with cancer can expect to survive. If we had the ability to apply what we know today to every cancer patient, we could have an immediate impact on survival, largely through the NCI Cancer Centers. Incremental improvements in survival will continue toward our 2015 goal, but we can accelerate these gains. Even improving the overall survival rate to 90 percent by 2010 could mean an additional 850,000 lives saved. The impact of this strategy could produce annual changes in the first 2 years of around 2 to 3 percent with larger increases occurring in 2008-10.

For most cancer patients, survival is greatly influenced by early detection. The rapid deployment of advanced imaging, nanotechnology-supported early detection platforms, and targeted therapies will change the face of diseases such as ovarian, lung, colon, and breast cancers, where survival is low because we can not currently detect them before they spread. Ovarian cancer, which is very difficult to detect and diagnose in its early stages, has over 25,000 new cases diagnosed annually and over 14,000 deaths; the mortality rate is nearly 85 percent. Imaging and detection techniques presently under development and broadly applied could reverse that mortality rate to be an 85 percent survival rate. Lung cancer, with approximately 170,000 expected deaths this year, would see a significant reduction in the number of deaths if the application of new technologies combined with other interventions could be universally applied in an accelerated manner.

The challenge to achieving the goal of eliminating the suffering and death due to cancer by 2010 is daunting, but with the authorities and appropriations commensurate with the task, the pace of progress could be accelerated, and the gap between 2015 and 2010 narrowed. The following reflects a brief overview of how such funds, if available, could be applied.

• Rapid Deployment of a National Advanced Technology Initiative for Cancer: $2.5 billion one-time appropriation with commensurate authorities.
• Deployment of a Modern Integrated Clinical Trials Infrastructure: $171 million addition to the NCI base budget.
• Expansion and Integration of the Cancer Centers Program: $164 million addition to the NCI base budget.
• Mechanisms and Flexibilities: streamlined procurement and review processes to acquire materials and services; coordination of licensing and patenting activities.

A National Advanced Technology Initiative for cancer (NATIc) could provide a linkage between the National Cancer Program and research and development (R&D) initiatives being developed in selected national laboratories and advanced technology facilities located in more than 40 states and regions. Connected in real time through a common bioinformatics grid, NATIc could serve as a "network of networks" of science, technology, and treatment to accelerate the emerging discipline of molecular oncology to create a pipeline of new personalized cancer diagnostics and therapeutics from bench concept to bedside and community delivery. In the next few years, such an initiative could:

• Accelerate the implementation of a nationwide high-end information technology grid for bioinformatics that could be uniquely adapted for real-time data sharing. NCI's pilot version, the Cancer Biomedical Informatics Grid, called caBIG, is currently being implemented among 50 cancer centers, the Food and Drug Administration (FDA), and other organizations.
• Develop a comprehensive biomarker discovery and validation program.
• Foster the application of emerging technologies, such as nanotechnology, and integrate molecular agents with advanced imaging devices.
• Accelerate a nationwide "real-time" medical information electronic system for research and medical data sharing using technologies and devices currently employed by the banking industry and large-scale commercial enterprises.
• Enhance the discovery and validation of new targets of genes and proteins critical to cancer development.

NCI could deploy a more modern and integrated infrastructure for cancer clinical trials. This clinical research infrastructure could:

• Strengthen collaborations with industry, FDA, the Centers for Medicare and Medicaid Services, and other public, private, academic, and patient advocacy organizations to oversee the conduct of cancer clinical trials.
• Develop new infrastructure and procedures to standardize, coordinate, and track clinical trials development and accrual across all NCI-supported clinical trials.
• Increase utilization of imaging tools in screening and therapy trials, evaluate new imaging probes and methodologies, enable access to the imaging data from trials in an electronic format, and facilitate evaluation of image-guided interventions.
• Expand access and improve the timeliness for completion of the highest priority clinical studies.
• Foster the development of a cadre of established clinical investigators who could work between bench and bedside.
• Pilot new approaches and develop prototypes for clinical trials networks that could improve the efficiency, coordination, and integration of our national efforts.
• Develop a common clinical trials informatics platform that could be made available to the full range of investigators working within the cancer clinical trials system.

NCI could accelerate the expansion and integration of the NCI-designated Cancer Centers program, including the addition of 15 new cancer centers, increasing the number of centers from the current 60 to 75. The Cancer Centers program could:

• Implement progressive bioinformatics and communication systems to achieve horizontal integration.
• Fund additive programs in collaborative, multidisciplinary research and require integration and sharing of results.
• Broaden the geographic impact of the centers, networks, and consortia and vertically integrate them with community and regional health care delivery systems.
• Improve the access of minority and underserved populations to state-of-the-art research and resources.
• Create and strengthen partnerships with government agencies and community organizations.
• Broadly provide expertise and other resources to caregivers, patients and families, and appropriate health agencies.

In addition to appropriations, flexible legislative authorities related to exemptions from specific parts of current procurement, grant review and processing, and licensing and patenting rules could also help accelerate progress. A streamlined procurement process could facilitate the acquisition of materials and services to support the R&D activities. Technology development could also be enhanced by sufficient flexibility and integration to enable interactions among a wide array of laboratories and other entities. Expedited review procedures and work flow processing could help to award funds in sequence as needed. This might include direct solicitation from known laboratories or other sources of technology, and the capability to terminate funding instruments at the convenience of the government with limited appeal processes so that funds could be redirected from low-performing consortia to more productive venues.

Coordination of the licensing and patenting activities among grantees, contractors, and the intramural program could also be useful for many of the multicomponent technology platforms that could be created through this effort. An accelerated process for Determination of Exceptional Circumstances (DEC) and deviations from appropriate Federal Acquisition Regulation (FAR) clauses, when deemed valuable to the broad research enterprise, could be utilized.

Dr. Andrew C. von Eschenbach
Director, National Cancer Institute