Marrying Drugs to Diagnostics

Companies and regulators see codevelopment as the best medicine

Written byRandall C. Willis
| 5 min read

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In medicine, it is obvious that good diagnostics go hand-in-hand with proper treatment. The business world as well as Food and Drug Administration regulators are increasingly building this understanding into product development by supporting codevelopment of new drugs with diagnostics.

?As therapies become more receptor- or pathway-­specific, the more important it becomes to demonstrate that the intended patient will be effectively and safely treated,? says Russ Bell, executive vice president of Fullerton, Calif.-based Beckman Coulter, a clinical diagnostics company.

Just over a year ago, Beckman Coulter announced the signing of an exclusive licensing agreement with Critical Therapeutics, a biopharmaceutical company based in Lexington, Mass., for intellectual property and patent rights to its High Mobility Group Box Protein 1 (HMGB1) technology. Critical Therapeutics is looking at HMGB1, a pro-inflammatory cytokine, as a potential therapeutic target for health issues that include sepsis. It licensed the technology to Beckman Coulter in the hope ...

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