Concurrent Dx/Rx Review Will Require More Collaboration at FDA and More Outreach by Industry

Scientia Advisors' managing partner Harry Glorikian, is featured in the July 22nd, 2011 issue of Genetic Engineering & Biotechnology News in an article titled:"Concurrent Dx/Rx Review Will Require More Collaboration at FDA and More Outreach by Industry."

In this article, Glorikian provides caution "that if the FDA ultimately requires that a diagnostic be approved and in kit form before a drug is approved, that test has to be ready for use before Phase III trials, since the FDA must be able to look at data in which patients are stratified using the exact same technology in clinical trials that will be used once the drug is on the market."

"This implies that there will be an even greater hurdle to drugs being developed for launch with a companion diagnostic, and pharma companies will be even more reluctant to take this path," Glorikian told GEN. "Ultimately, it will result in a net increase in the time and cost of drug development."

The article can be accessed on the Genetic Engineering & Biotechnology News website here.