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 이성욱 ( 2011-06-27 11:31:24 , Hit : 2400
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 NIH's Secondhand Shop for Tried-and-Tested Drugs



Double duty. NIH researchers have found new uses for several therapeutics.

CREDITS: (PHOTO) JB REED/LANDOV; (SOURCE) NIH

Science 24 June 2011:
Vol. 332 no. 6037 p. 1492
DOI: 10.1126/science.332.6037.1492

Jocelyn Kaiser

Although the U.S. National Institutes of Health (NIH) has made waves with a proposed new center aimed at translational research, so far the main innovation has been to put scattered existing programs under the same roof. But this month NIH Director Francis Collins unveiled something fresh: an effort to persuade drug companies to open up their troves of abandoned drugs to academics, who would look for new uses.

The drug rescue and repurposing project, Collins told his advisory committee earlier this month, is a concrete example of what the National Center for Advancing Translational Sciences (NCATS) will do. The project shows how NCATS could be “quite game-changing,” he added. It would be a “comprehensive effort to identify appropriate abandoned compounds,” “match partners,” and “make data and resources available,” Collins explained in a comment in the June issue of Nature Reviews Drug Discovery.

Finding new uses for drugs is not a novel idea, however. Thalidomide, a drug for morning sickness that was taken off the market because it caused severe birth defects, later found new life as a treatment for leprosy and multiple myeloma. And many companies already have drug-repurposing efforts. Academia is also getting involved. For example, under a 1-year-old deal between Pfizer and Washington University in St. Louis, university researchers have access to a database of 500 Pfizer drugs and failed candidates that they test in animal models.

But NIH officials think there's merit in a more systematic effort. One reason is efficiency, NIH Associate Director for Science Policy Amy Patterson explained to the NIH board this month. Although only 1 in 10,000 potential therapeutic compounds will become a drug, the majority fail in late trials because of lack of efficacy, not safety. That means toxicity often isn't a barrier, Patterson said. She cited an estimated success rate of 30% for repurposed drugs. And NIH says that genomics projects have yielded a wealth of new disease targets.

Most of the therapeutic mother lode lies in the thousands of abandoned compounds in pharmaceutical companies' vaults. Companies face obstacles to sharing data on these drugs, however, Patterson noted. They may have to digitize paper records, and often the company's expert on that drug has moved on. Testing can be a worry because it could reveal new safety problems for drugs on the market. In addition, intellectual property agreements need to be worked out.

NIH is working on a draft “master agreement” between companies and academics that addresses intellectual property and issues such as data sharing. NIH may also propose modifying patent laws to give companies financial incentives, Collins says. But this would be a “tremendous undertaking,” according to Patterson; for now, the agency is looking for leeway in existing laws.

As for logistics, the agency has made a small start. In April, NIH's intramural Chemical Genomics Center unveiled a public database listing all 8000 or so approved drugs along with structural data (Science Translational Medicine, 27 April, http://scim.ag/chem-genome). Researchers can apply to have the center test their cell or molecular assays against the drugs to look for “hits,” or possible biological activity.

For unapproved drugs, Patterson says, NIH envisions a system of databases that would allow researchers to “window-shop” by viewing public data. If they see a compound that interests them, they might access a company's proprietary data through service companies.

NIH hopes to complete the model master agreement within 6 to 8 months, Patterson says. The drug rescue and repurposing project will be led by a team at NCATS as “an integral part of what NCATS does,” Patterson says. Some promising projects will then be handed off to other NIH institutes.

Some academic researchers are enthusiastic. “Provided all the details can be worked out, I think it's a win for all sides,” says pharmacologist Bryan Roth of the University of North Carolina, Chapel Hill.

Several industry researchers who attended an April roundtable that discussed the plan did not respond to a request for comment. But William Chin, a former research leader at Eli Lilly who is now executive dean for research at Harvard Medical School in Boston, says companies should be interested because often their own repurposing efforts haven't been very fruitful. NIH's “hope is that the ‘wisdom of the crowd’ will result in a new way to use an old molecule,” he says. “If the majority of companies joined in this effort, it potentially would generate a stockpile of potential assets” and a few “valuable therapeutics.”








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