New J&J Drug Candidates Don't Go It Alone: Companion Dx Are Standard
This article was originally published in The Pink Sheet Daily
Executive Summary
The drug giant is trying to partner with assay technology makers as early as possible in the development cycle, Centocor VP-biomarkers Dracopoli said at BIO.
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Johnson & Johnson's drug business could be a particularly productive partnering site for molecular diagnostics firms over the next several years, statements from one company executive suggest. All new drug candidate programs within J&J/Centocor, which houses J&J's biotechnology, immunology and oncology drug R&D franchises, include a strategy for linking the medicine from its earliest inception to a biomarker that identifies the most appropriate treatment population, according to Nicholas Dracopoli, VP-biomarkers of Centocor. "We are now firmly committed in new programs entering into our portfolio that there is an integrated diagnostics strategy that is evaluated ... from preclinical into early clinical testing and into approval," Dracopoli said May 5 at the Biotechnology Industry Organization annual meeting in Chicago. To make this a reality, the drug giant is trying to partner with assay technology makers as early as possible in the development cycle, he explained. "We are looking to do selective partnering with companies, often for specific platforms, technologies and assays," he said, noting that "there really is no single global provider to address all of [our] issues." On the other hand, Dracopoli stressed that the company is not, in general, attempting to incorporate diagnostics into mid-stage development programs that got off the ground previously without a biomarker program. The history of trying to "retrofit" tests into already established R&D programs is "not very successful," he said. J&J drug developers are embracing companion diagnostics as FDA continues to map out the regulatory process. Commissioner Margaret Hamburg has raised expectations that a draft guidance addressing drug-diagnostic co-development will be issued by year-end (Also see "FDA Plans Guidance This Year On Co-Development Of Diagnostics And Drugs" - Medtech Insight, 1 Mar, 2010.). At BIO, FDA in vitro diagnostics office staffer Elizabeth Stafford said she and her colleagues are "very serious" about meeting that deadline. -David Filmore ( [email protected]) [Editor's note: This story appears courtesy of the editorial staff of 'The Gray Sheet,' your source for coverage of devices and diagnostics. For a free trial, call customer service at 800-332-2181.] |