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Monday, July 5, 2010

Glaxo Tries a Linux Approach

Drug Maker Shares Its Research Data Online in Test of Open-Source Principles

A decade ago, the Linux operating system helped spark a revolution in how software is developed. A move by GlaxoSmithKline PLC could test how well similar open-source principles work for developing new drugs.
The pharmaceutical giant last week opened to the public the designs behind 13,500 chemical compounds that it said may be capable of inhibiting the parasite that causes malaria.
Glaxo and others hope that sharing information and working together will lead scientists to come up with a drug for treating the mosquito-borne disease faster than the company could on its own. Other researchers "may look at these structures in quite a different way and see something that we don't," said Nick Cammack, head of Glaxo's Medicines Development Campus in Spain.
GlaxoSmithKline
Two government websites and one private site will host Glaxo's data. Above, containers used by Glaxo researchers to test the effect that chemical compounds have on the malaria parasite.
The move is one of the largest experiments yet by the pharmaceutical industry to apply techniques of open-source development to drug discovery, based on the idea that collaboration by volunteers will create products that aren't owned by a single company.
In software, the approach has spawned the Linux operating system, MySQL database and an array of other programs. Those community-born technologies now compete with products from Microsoft Corp., Oracle Corp. and other traditional, commercial software makers. Open-source developers share programming instructions called source code that software companies traditionally kept confidential.
Similarly, large pharmaceutical companies tightly guard their formulas for drugs and other intellectual property. Any given chemical compound holds the potential to be a blockbuster drug—and a cash cow, like Microsoft's Windows software. But diseases like malaria afflict mainly poor populations, and drugs to treat them don't hold the promise for such a big payoff—making experiments like Glaxo's less risky.
The Glaxo effort builds off earlier open-source drug efforts that included a nonprofit organization called Tropical Disease Initiative and a project started last year that opens compounds from Pfizer Inc. to researchers at a nonprofit called Drugs for Neglected Disease Initiative.
The Glaxo data will be hosted by three websites, two of which are government-funded (one in the U.S. and one in Europe). The third is a Silicon Valley company called Collaborative Drug Discovery Inc. CDD, as it is called, was spun off in 2004 from drug maker Eli Lilly & Co. and has funding from the Bill & Melinda Gates Foundation and Founders Fund, a venture-capital firm.
CDD's Web service combines elements of a Facebook-like social network with an Oracle-style database. Any researcher who registers on the CDD site will be able to see graphical depictions of Glaxo's compounds and relevant chemical and biological data. The database will allow them to upload their own data to be viewed by other researchers.
The service is free of charge. If a researcher wants to combine the data with proprietary information, CDD alsooffers a fee-based, secure version of its site that allows researchers to lock up information they want to keep secret.
Developing a new drug is a trial-and-error process of testing which chemical compounds produce a certain effect on a biological target. In the case of malaria, the target can be the Plasmodium parasite that causes the deadly disease or human red-blood cells that it needs to survive. Over the past year, Glaxo has tested two million compounds, culling the 13,500 molecules that it says have some effect. However, narrowing down the compounds to a handful that might yield a drug is an increasingly complex process.Any compound that proves promising in the current effort will take years of testing and investment to turn it into a malaria drug.
Glaxo says that it won't seek patents on any malaria drug that the compounds yield, and hopes other researchers will also donate their intellectual property to a patent pool for so-called neglected diseases like malaria. If the Glaxo compounds are used to develop a drug for other types of diseases, then the company "would consider" the intellectual-property issues, a Glaxo spokeswoman said.
Researchers including James McKerrow, a professor at the University of California, San Francisco, have used CDD since 2007 to share data about diseases including malaria and schistosomiasis, a parasite that can cause liver and kidney damage. The group shared data on tens of thousands of compounds to speed up the process of picking a handful of compounds (for diseases such as malaria) that are the best options to try on animals, Dr. McKerrow said.
Barry Bunin, CDD's chief executive, believes that the work on neglected diseases is a precursor for big pharmaceutical companies to eventually use the open-source techniques for developing commercial drugs.
Some drug experts doubt that will happen. The reasons include the nettlesome problem of managing intellectual property and various uncertainties. Any given compound, for example, could wind up affecting more diseases than expected and turn out to be more valuable than expected. Glaxo, for instance, found that drugs that inhibited growth of the parasite that causes malaria were of a type that is also marketed to treat cancer.
"I think that's a potentially interesting model but I don't think for-profit institutions would participate," says Brendan O'Leary, general partner at Prism Venture Management, a venture-capital firm that invests in life-sciences companies.
Yet Glaxo'sMr. Cammack doesn't rule it out. He hopes the open-source work will influence Glaxo more broadly in the future, particularly given the challenges big pharmaceuticalcompanies face in launching new drugs. "The pharmaceutical industry needs to look at lots of ways of doing business in the future," he said.

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