By Randall Osborne

West Coast Editor

With $6 million from the first round of venture capital financing, and $21 million committed, a new company is on its way to analyzing 52 years worth of data from the largely government-funded Framingham Heart Study, sponsored by Boston University.

"One of the problems of the Framingham study for many years is that the data is not really accessible," said Fred Ledley, chief scientific officer of the company, called Framingham Genomic Medicine Inc. "There's an incredible wealth of information, but it's been hard to get at."

Ledley, former CEO of Cambridge, Mass.-based Variagenics Inc., said the new firm will not sell information - which always has been available free to researchers, and will continue that way - but will digitize and analyze it for pharmaceutical and biotech customers.

"We've made a commitment not to do exclusive deals," Ledley said.

Although Boston University has been running the heart study under contract, it also has a grant from the government to conduct research using the data, and is allowed to keep and commercialize any of its derived findings.

University spokesman David Lampe said officials are still determining what belongs to whom.

"You have three generations of clinical observations here," he said. "All of the data that have been available will continue to be available; that's the strength of the study. What extra data will be available is at issue. We're not changing any rules. We're just at a frontier where there are more questions."

The advent of bioinformatics practically demands the application of high-throughput technology to heart study data, Lampe said.

Skirmishes over ownership are "possible," he conceded. "The fact is, as you sift through the data, you gain new insights, and you generate derived data," Lampe said. "The question is, who owns that? The answer traditionally has been, the people who do the investigating. We all agree it has to be resolved, and has to be resolved soon."

Inventions are inventions, and they are proprietary - regardless of the source of the data used to come up with them or the site where they are made, he said.

"It's a fact of life," Lampe said. "Suppose we had invented Gatorade, like the University of Florida did?"

Although investigators at the university are barred from owning interest in the new firm, one of the investors is the school's Community Technology Fund, which has helped establish spinouts based on academic inventions.

Oxford Bioscience Partners led the first round of financing. Other investors include Abingworth Venture Management Ltd., Domain Associates, Venrock Associates and S.R. One Ltd.

"[Framingham Genomic Medicine] is an intermediary company," Lampe said. "The idea is to increase the access to this data, and make it more useful. Any pharma company can come along and propose a contract," he added - and any other company could perform its own analysis of the publicly available data.

"Whether there wants to be competition at the intermediary level is another question," he said, although the new genomics firm would have the jump on any such effort.

Ledley said digitizing and organizing the heart data with computers is the first order of business.

"We think this is a $10 million to $12 million problem," and will take six to nine months, he said. Another $20 million will be spent on genotyping each subject in the study.

Confidentiality of the study participants will be carefully protected, Ledley said. A trust fund has been established for the city of Framingham, and an ethics board will oversee the new firm, he added.

"We've taken extraordinary steps to address the issues," he said. "This is a very serious effort in difficult territory."

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