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FDA Releases Pharmacogenomics Data Submission Guidance

The US Food and Drug Administration this week released its Pharmacogenomics Data Submissions guidance.

Released in draft form in November 2003, and then delayed numerous times before being released in its final form, the guidance may encourage drug makers to use pharmacogenomics technologies in their drug-discovery efforts. This in turn may spur greater investment in SNP-genotyping, gene expression, RNAi, and gene sequencing technologies and services.

The FDA hopes the guidance, which can be found on the FDA site, will bring drug research "one step closer to 'personalizing' medical treatment," said Janet Woodcock, deputy director for operations at the FDA, and a chief architect of the document.

The 28-page guidance aims at clarifying how the FDA plans to evaluate pharmacogenomic data during the drug-discovery and drug-development process. The document also "describes what data will be needed during the marketing application review process, the format for submissions, and the data that will be used during regulatory decision making," the FDA said in a statement.

As expected, the guidance also describes a way for industry to voluntarily submit certain research data to "further the scientific exchange of information as we move into more advanced areas of pharmacogenomic research," the agency said.

These will be reviewed by an internal, agency-wide group and "will not be used for regulatory decision making," the FDA stressed. Rather, they "will help FDA and industry gain valuable experience as this new field continues to evolve."

Dennis Gilbert, chief scientific officer at Applied Biosystems, said: "These guidelines provide the industry with much-needed guidance on how to employ [pharmacogenomics] technology to advance targeted medicine."

NSF Funds International Team To Create RNA Ontology

An international team of scientists has formed a consortium to create a common vocabulary for RNA researchers, the researchers said this week.

Funded with $500,000 over five years from the National Science Foundation, the RNA Ontology Consortium, headed by Neocles Leontis, a professor of chemistry at Bowling Green State University in Ohio, plans to develop a common vocabulary and scientific concepts relating to RNA structure and function.

The researchers plan to identify all RNA motifs in the literature and write a definition for each motif. Their results will be available to researchers on the web through servers hosted at BGSU.

The consortium includes researchers from Stanford University, Duke University, Yale University, Rutgers University, Georgia Tech University, the University of Calfornia Berkeley, the University of North Carolina, the University of Rochester, the University of Montreal, Lawrence Berkeley National Laboratory, the Institut de Biologie Moleculaire et Cellulaire in France, and the Scripps Research Institute.

NHLBI to Issue Proposals for
Large-Scale Genotyping Center

The National Heart, Lung, and Blood Institute will begin soliciting proposals in early April for the creation of a Large-Scale Genotyping Center that will perform high-throughput genotyping for candidate gene association studies and a genome-wide association study.

NHLBI expects to award one four-year contract for the center, and said in a presolicitation notice that the RFP should be available "on or about" April 4.

Proposals will be due in early July. NHLBI did not disclose the expected amount of funding for the center.

The center "must have the capacity to generate at least 850 million genotypes over two years with an error rate of no more than 1 percent," NHLBI said in the presolicitation notice. NHLBI has set a maximum cost of $0.01 per genotype, which is expected to "decrease as technologies evolve."

The proposed candidate gene association studies will involve the characterization of more than 1,700 candidate genes, with 8-10 SNPs per gene region, on approximately 50,000 study members in heart, lung, blood, and sleep studies. The study is expected to result in more than 850 million genotypes.

NINDS to Fund Research Core Facilities,
Including Genomics, with up to $2.5M Each

The National Institute of Neurological Disorders and Stroke plans to fund a number of centralized resources and facilities at research institutions, including those offering genomic technologies, to support neuroscience research, the institute said last week.

Under the program, called "NINDS Institutional Center Core Grants to Support Neuroscience Research," NINDS will support core facilities shared by investigators with existing NINDS-funded research projects. Cores can receive up to $500,000 per year in direct costs for up to five years. NINDS did not specify the number of awards or total amount of funding it plans to disburse.

Eligible research cores include those providing assay development, DNA sequencing, mass spectrometry, microarrays, proteomics, and protein crystallography.

To view the complete program announcement, click here.

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