The New Math of Drug-Device Convergence
In combination products that span the device and pharmaceutical industry, one plus one doesn't necessarily equal three. Speaking at "Convergence: the Drug/Device Summit," Paul LaViolette, chief operating office of Boston Scientific, recounts the intricacies of getting Taxus, the largest combination product in history, to market. For all the success BSC has had, both with Taxus and generally speaking--a huge infrastructure, billions of dollars in revenues, and 18 PMA approvals under its belt-the first lesson it learned from its drug-eluting stent program was, "As hard as you think it may be, it's harder than that."
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A handful of recent biotech-device company deals have highlighted the potential of drug-device convergence as natural extensions of the ever-popular repurposing and drug delivery models espoused by investors aiming to reduce the risks associated with drug discovery. Venture capitalists are eager to get in on the game, but drug and device hybrid business models are few and far between. True convergence start-ups remain thin on the ground, a fact VCs say reflects the additive nature of drug risk and device risk.
Although Nexviadyme has been approved, the French group is still unhappy about the EMA's view that the Pompe disease therapy should not be classified as a new active substance.