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April 15, 2003 | Frank Sistare runs the division of applied pharmacology research in the Center for Drug Evaluation and Research (CDER), the FDA branch that reviews new drugs. Sistare knows how long it takes to measure toxicological effects. He'd like that to change, and in March fired up a new database developed at Iconix Pharmaceuticals. It will teach the FDA how to manage and evaluate toxicological data about drugs from microarrays.

Sistare thinks that over the next few years, databases and microarrays will be able to help biopharma companies anticipate scientific issues to monitor in animal and human studies. "It will flag things," he says of microarray data. "It will say, 'This may be your rate-limiting step' or 'This may be what could derail you.'"

Microarray data are notoriously difficult to reproduce from one lab to the next, but Sistare believes that challenge is closer to being solved than some recognize. He's working with Affymetrix and Rosetta and hopes to publish some of these results and present them at conferences. "The careful scientist can get very reproducible data," he says. "It is very achievable. The platforms themselves are getting better."

Sistare knows the pharmaceutical industry is worried about competitive comparisons of microarray data between drug companies — or even not-ready-for-prime-time techniques being used prematurely to block a drug from reaching the market. He says he hopes such concerns will vanish once the scientists inside the industry understand that the technology will be robust. Over the next year, the agency may be able to formalize a "safe harbor," a research exemption that keeps microarray data subject to scientific interpretation off limits from adverse regulatory action. To those who are skeptical, he says: "We can set up a system, a procedure, that can prevent that."

—Mark D. Uehling 

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