Two years and change ago, drugwonks raised the issue of companion diagnostics as part of the NDA process. The result was a collective yawn.
That was then, this is now.
At last week’s Windy City BIO bar mitzvah, Nicholas Dracopoli, VP-biomarkers at Centocor commented that all new drug candidate programs within J&J/Centocor (home to J&J's biotechnology, immunology and oncology drug R&D programs) will include a strategy for linking the medicine from its earliest inception to a biomarker that identifies the most appropriate treatment population.
According to Dracoploi. "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 …We are looking to do selective partnering with companies, often for specific platforms, technologies and assays.”
And, per the Pink Sheet, “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."
On the FDA front, Peggy Hamburg has raised expectations that a draft guidance addressing drug-diagnostic co-development will be issued by year-end. At BIO, FDA in vitro diagnostics office staffer Elizabeth Stafford said she and her colleagues are "very serious" about meeting that deadline.
Can you hear me now?
That was then, this is now.
At last week’s Windy City BIO bar mitzvah, Nicholas Dracopoli, VP-biomarkers at Centocor commented that all new drug candidate programs within J&J/Centocor (home to J&J's biotechnology, immunology and oncology drug R&D programs) will include a strategy for linking the medicine from its earliest inception to a biomarker that identifies the most appropriate treatment population.
According to Dracoploi. "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 …We are looking to do selective partnering with companies, often for specific platforms, technologies and assays.”
And, per the Pink Sheet, “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."
On the FDA front, Peggy Hamburg has raised expectations that a draft guidance addressing drug-diagnostic co-development will be issued by year-end. At BIO, FDA in vitro diagnostics office staffer Elizabeth Stafford said she and her colleagues are "very serious" about meeting that deadline.
Can you hear me now?
