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“I think this is a turning point in biomedical research and I think it could be a turning point in medicine. I am sure that it will be a turning point for cancer research,” said Anna D. Barker, PhD, deputy director of NCI, at a December news conference announcing the project. “The new interventions that derive from this program will not be ‘one size fits all.’ They will be designed around specific changes in genes that will lead us toward targeted therapies and personalized medicines.”
To test the feasibility and to address anticipated technical and operational challenges of the full-scale endeavor, TCGA will begin as a three-year, $100 million pilot. During this initial phase, the genomes of a handful of cancer types will be sequenced. Although TCGA directors have not yet announced the number or types of cancers to be studied, a white paper presented by NCI’s National Cancer Advisory Board in February 2005 said that the pilot would focus on five cancers. It said that during the full-scale project, approximately 50 cancer types would be sequenced.
According to NCI and NHGRI, TCGA will build upon the new, high-throughput screening technologies that emerged during other recent large-scale genetic-sequencing programs. In 2003, the Human Genome Project completed a catalog of the human genome. In 2005, the International HapMap Consortium published a catalog of human genetic variation. However, the scope of these pursuits pales in comparison to current efforts. When TCGA is ramped up to full-scale operation, project directors say that it could be the equivalent of thousands of Human Genome Projects.
Because of the project’s breadth, NCI and NHGRI will actively seek technology partners from both the public and private sectors. This funding will come in the form of grants and Small Business Innovation Research (SBIR) programs. According to Barker and the other program directors, the integration of data sets from multiple groups will produce clinically relevant information that will empower both pharmaceutical and diagnostics companies.
“The project will be fostering methods, processes, and standards development that will be extensible to small businesses involved in single-molecule sequencing and genomic characterization through such methods as gene-expression profiling,” explains Gregory J. Downing, DO, PhD, director of the Office of Technology and Industrial Relations at NCI. He says that a number of IVD companies have already been involved in project meetings so far. In addition, Downing says, “NCI and NHGRI are working on bioinformatics platforms and human subjects issues that will also have extensive impact on private-sector technology development and commercialization activities.”
Although NCI and NHGRI directors contend that recent sequencing breakthroughs have made this a ripe moment to undertake a program of TCGA’s magnitude, the launch also comes at a time of NIH budget constraint. According to estimates from the American Association for the Advancement of Science, the agency’s budget appropriation for fiscal 2006 fell 0.1% from 2005, the first decrease in funding since 1970. Cancer R&D has fared worse, with a budget decline of 0.7%, to $4.8 billion. The TCGA white paper estimates that full funding would require a 3% increase in the combined annual budget of NCI and NHGRI.
At the December news conference, NHGRI director Francis S. Collins, MD, PhD, said that the final cost of the program is impossible to predict at this time. “We obviously count upon the fact that having a pilot of this sort will be a strong inspiration for the development of new technologies and the optimization of existing ones, just as was the case for the genome project,” he said. “And so we would hope for a sharply downward curve in the cost-per-unit data point in the course of the next few years.” Even so, an NIH spokesperson confirms that during the pilot, the agency will seek out supplementary funding sources for the ramped-up project in both the public and private sectors.
Still, Collins and other NIH officials have made assurances that the financial needs of TCGA would not impinge on other agency responsibilities. In particular, they have said that preserving the number of R01 investigator-initiated grants is a priority. “We certainly recognize that a scale-up, if it were to involve a very substantial investment of research dollars, would need to be balanced against all of the other important research that NIH is trying to do,” Collins said.
Additional information about TCGA can be accessed through the project’s Web site at http://cancergenome.nih.gov.
