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Bush s Budget (Finally) Seeks Funding for Critical Path as NIH Eyes Cash for Gene/Disease Research

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Pharmacogenomics technology and application development could see some additional funding next year if President Bush's fiscal 2007 budget request is approved by Congress.

Broadly, the budget would for the first time set aside money for the US Food and Drug Administration's vaunted Critical Path Initiative, while the US National Institutes of Health would be able to pay for a new program aimed at identifying genes linked to certain diseases.

Though details of specific programs, whether planned or ongoing, have not been disclosed, general information provided as part of the budget shows that research into biomarkers in general, and personalized medicine in particular, will likely play a funded role at the FDA and the NIH in 2007.

As part of the President's $2.8 trillion federal budget for fiscal 2007, the FDA stands to receive approximately $1.95 billion, which is a 3.8-percent increase year over year. The National Institutes of Health, meantime, will get around $28.4 billion, which is largely unchanged from fiscal 2006.

The FDA

If the budget is approved as is, the FDA said it would spend $5.9 million of its $1.95 billion on the Critical Path plan. Though it is far less than the $10 million that Initiative officials requested, the cash represents the first time the program will receive formal federal funding since it was created in March 2004 http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf (it received $743,000 in fiscal 2006 in "external funding").

With this budget, the FDA proposes to fund its Critical Path for Personalized Medicine Initiative, which is "designed to make personalized medicine a reality and to translate discoveries in medical science into safe and effective new medical treatments," the FDA said in a statement on Feb. 6, the day President Bush unveiled his budget http://www.fda.gov/bbs/topics/news/2006/NEW01310.html.

In a document accompanying the President's budget, the FDA reiterated earlier statements that productivity in the medical product industry is "low and not improving," and said again that the Critical Path Initiative can "stimulate industry-wide efforts to identify the essential biomarkers and improved clinical trial designs that will accelerate product development. … Without clinically proven biomarkers and innovative trial designs, we cannot modernize medical product development and realize the potential of personalized medicine."

To be sure, "biomarker" has many definitions, and it was not immediately clear how much of the Critical Path budget would go to SNPs, protein- or gene-expression research, or imaging data derived from CT or MRI scans.

According to the document, the FDA would "expand, stimulate and manage scientific partnerships and targeted research that will modernize medical product development. The goal is to stimulate a new generation of scientific tools to: 1) enable product sponsors to predict and evaluate the safety and effectiveness of candidate products, 2) make product development less risky, and 3) enable individualization of therapy to improve effectiveness and avoid side effects."

The FDA said that "projects supported by these funds will produce an array of outputs, ranging from new biomarkers to technical standards; from the creation of publicly available databases and computer modeling tools, to new FDA guidances to assist industry with drug development."

The agency also said that it would deliver to industry "concept papers and draft guidances for industry on the framework for qualifying new safety and efficacy biomarkers for drug development, such as genomic and proteomic assays."

The FDA said that if it were not to win these funds, "an inability to achieve the benefits of personalized medicine" would be the result.

Officials from the FDA did not return multiple calls seeking comment.

The NIH

As far as the NIH is concerned, $68 million of its $28.4 billion proposed budget would go to a new program called the Genes and Environment Initiative that aims "to accelerate discovery of the major genetic factors for diseases that have a substantial public health impact. Additionally, the initiative will accelerate the development of technology, which will help make clear the connection between genes and the environment on human health," the NIH said in a statement.

In addition, HHS said it was launching a public-private partnership called the Genetic Association Information Network to accelerate genome association studies. Entities in the partnership are NIH, Foundation for the National Institutes of Health, Pfizer, and Affymetrix.

If approved by Congress, the federal funding would begin in FY 2007 and continue for multiple years, HHS said. Of the first year's funding, $26 million will go to genetic analysis and $14 million for the development of tools to measure environmental exposures affecting health.

GEI genotyping studies will be done for several dozen common diseases to be selected by peer review. The genotyping will be managed by an NIH coordinating committee under the usual government rules, subject to competition between research facilities, and begin in FY 2007.

The primary private-sector contributor to the GAIN partnership is Pfizer, which has donated $5 million to set up the project's management structure and committed $15 million worth of laboratory studies to determine the genetic contributions to five common diseases. Affymetrix will contribute lab resources for two additional diseases, expected to cost about $3 million each, said HHR. Affymetrix would not confirm the financial amount of its in-kind contribution.

Genotyping supported by Pfizer and donated to the GAIN project will be produced by Perlegen and will start in late summer 2006, according to the statement. A similar arrangement will be worked out with Affymetrix.

The GAIN initiative proposes to raise $60 million in private funding for additional genetic studies of common diseases, and the project is actively seeking additional partners.

Investigators may submit applications to have genotyping performed on existing DNA samples from patients with specific diseases and control individuals in case-control studies.

GAIN will be an FNIH-managed partnership that includes NIH, industry, foundations, individuals and advocacy groups. Governance will include an executive committee, a steering committee and peer review, and data access committees.

The National Center for Biotechnology Information at NIH will develop databases to manage the genetic, medical and environmental information resulting from these initiatives. All data will be placed in the public domain.

— Kirell Lakhman ([email protected])

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