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NHGRI, FDA, PerkinElmer, Gene Network Sciences, Cornell University, University of California, Nuvelo, Sequenom, Orchid BioSciences

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NHGRI’s Collins to Lead Roundtable Into Race Terms and Genomic Trials

Francis Collins, director of the National Human Genome Research Institute, will lead a closed roundtable discussion next month on ways in which racial information — a frequent component in genotyping and gene-expression research — can be used to better design genomics studies, according to a person familiar with the discussion agenda.

Pilar Ossorio, an assistant professor of law and medical ethics at the University of Wisconsin Law School, said the roundtable is part of the NHGRI’s “ongoing effort … to come up with some document that would help them think about race, ethnicity, and the design and reporting of their studies.”

She made her remarks during a two-day conference at Louisiana State University that covered genomics and legal issues in general, and discussed the International HapMap Project in particular. In fact, one speaker, Kenneth Kidd, professor of genetics at Yale, blasted the HapMap as “scientifically unworthwhile” on the basis of population delineation.

An NHGRI spokeswoman confirmed that Collins is to speak at the March 8 event, which will be held on the NIH campus in Bethesda, Md. She added that it will be organized by the NHGRI’s Education and Community Involvement Branch, which was put in place last fall. Vince Bonham is its director.

“There is an ongoing effort to continue thinking about [race and genomics studies], and how to do studies that are least likely to do harm and most likely to do good,” Ossorio told SNPtech Pharmacogenomics Reporter.


FDA, Seizing PerkinElmer IVD Products, Said Firm ‘Continually’ Violated GMP Standards

The US Food and Drug Administration late last week seized PerkinElmer Life Sciences’ neonatal chemistry and isoelectric focusing diagnostic kits because the kits were “adulterated under the federal Food, Drug, and Cosmetic Act,” the agency said in a statement.

The move affects a product line that generated almost $10 million in revenue for PerkinElmer. However, the company said the FDA’s move “is not expected to have a material financial impact.” PerkinElmer generated around $1.5 billion in 2003, the company said on its website.

In the statement, which can be seen here, the FDA said that the US District Court for the Northern District of Ohio had given it a warrant to seize the kits in PerkinElmer’s Norton, Ohio, facility, and that the US Marshal’s service had executed the warrant Feb. 4.

The agency said the kits, which are used to screen for genetic diseases such as sickle cell anemia and multiple sclerosis, “were not manufactured in accordance with FDA’s good manufacturing practice quality system regulation.”

“FDA inspections of PerkinElmer revealed that the firm has continually failed to follow the requirements of the quality system regulation when manufacturing in-vitro diagnostic kits,” the statement reads. “FDA sent PerkinElmer a letter citing these unacceptable practices, giving the company an opportunity to correct the violations, but the company failed to take appropriate corrective actions.”

In a written response one day later, PerkinElmer said it ”believes the products affected by today’s FDA action are safe.” The company also said it had been working with the FDA on the issue of GMP at the Norton facility, and that it “believes it has made significant progress in addressing FDA concerns, and intends to continue to work with the FDA to ensure that its manufacturing practices for regulated products are fully compliant with FDA regulations.”

PerkinElmer said it would help its customers find other sources of IVD supplies. Also, PerkinElmer said it will be transferring products made in the Norton facility to another space as part of a previously planned move.


Gene Network Sciences, UCSD, Cornell Team Get $2M For Heart Modeling Project

Gene Network Sciences, Cornell University, and the University of California at San Diego will use a $2 million bioengineering research grant from the National Heart, Lung, and Blood Institute to develop a computer model of the canine ventricle, the groups said last week.

In the project, Robert Gilmour’s lab at Cornell will initially characterize ionic currents of single heart cells, then a team at Ithaca, NY-based Gene Network Sciences led by Jeffrey Fox will construct computer models for the heart cells, and incorporate them into a 3-D computer model of a canine ventricle. Wouter-Jan Rappel of UCSD will then lead efforts to use the model to test candidate mechanisms for the development of ventricular fibrillation, as well as refine techniques to handle the computational demands of the project and contribute models of intracellular calcium dynamics.

“Our goal in creating the 3-D computer model is to better understand the underlying mechanisms for [ventricular fibrillation] and to eventually have a significant impact on the diagnosis and treatment of deadly heart rhythm disorders,” Gilmour said.


Nuvelo’s Q4 Revenues Drop Sharply; Net Losses Narrow

Nuvelo, the company that emerged form the merger of Hyseq and Variagenics, last week reported a sharp drop in fourth-quarter revenues and narrowed net losses.

Revenues for the period ended Dec. 31 tanked to $350,000 from $3.5 million one year ago. Meantime, R&D spending fell to $6.7 million from $9.3 million during the year-ago period.

Fourth-quarter net loss shrank to $9.4 million, or $.12 per share, from $16.5 million, or $.72 per share, during the same period last year. As of Dec. 31, Nuvelo said it had $34.7 million in cash, cash equivalents, short-term investments, and restricted cash.


Sequenom Posts Slight Rise in Q4 Revenues, Net Losses Fall

Sequenom this week reported a mild hop in fourth-quarter revenues atop decreased R&D spending and narrowed losses.

Total receipts for the period ended Dec. 31, 2003, inched up to $8 million from $7.7 million one year ago. Broken down, Sequenom's Genetic Systems business grew by $500,000 to $7.7 million in the quarter, while revenues from the company's nascent pharmaceuticals business fell by $200,000 in the quarter to $300,000.

Meantime, fourth-quarter R&D spending decreased to $7 million from $8 million year over year, and Sequenom said that net loss for the quarter shrank to $10 million, or $.25 per share, from $45.8 million, or $1.16 per share, in the fourth quarter of 2002

As of Dec. 31, 2003, Sequenom held cash, cash equivalents, short-term investments, and restricted cash totaling $67.5 million.


Orchid Converts Preferred Stock in first Capital-Restructuring Effort

Orchid BioSciences this week has converted all of its outstanding convertible preferred stock into common stock in the first step that’s part of a broader effort to restructure its capital position.

Orchid had around 94.7 million common shares outstanding as of Feb. 9, the company said.

 

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