Richard Pazdur - FDA

'Breakthrough' backer takes drug development personally

Name: Richard Pazdur
Title: Director, Office of Oncology and Hematology Products

Early on in the FDA's new breakthrough therapy designation (BTD) program in 2013, it became clear that Richard Pazdur, the cancer drug czar at the agency, had thrown his considerable weight behind the initiative. Imbruvica and Gazyva both made an appearance on the list before their approval. MK-3475, the PD-1 drug from Merck ($MRK), and palbociclib from Pfizer ($PFE) were added to the list as two of the most closely watched oncology programs in the clinic.

Cancer drugs quickly became one of the most prominent disease categories in the BTD arena. And Pazdur made a highly public commitment to usher these therapies through the approval process.

Developers who won breakthrough designations could rely on a "different communication structure," Pazdur promised cancer drug executives at last summer's big ASCO gathering in Chicago, "with much more of a continuous dialogue with sponsors."

Pazdur is definitely someone you want on your side. And it's clear that he takes drug development personally.

When he dressed down the executives at Aveo ($AVEO) for what the agency formally determined was an "uninterpretable and inconclusive" set of data for tivozanib, he didn't hold back at all. Pazdur takes every opportunity that comes his way to send a message. And sometimes, as with Aveo, he uses a bullhorn to get the message across.

The first cancer drugs to make it through the "breakthrough" process shaved a few months off the usual timelines companies face. But it's clear that for the companies that pass muster with him--a select group that tends to lean toward the giants in the industry--the designation could wind up snipping years out of the process.

Pazdur's position at the FDA gives him an unprecedented amount of clout with developers at a unique time for the agency. That kind of influence will open up markets, determine winners and losers, and change the standard of care at a time of extraordinary progress for patients.

Ignore him at your peril.

-- John Carroll (email | Twitter)

For more:
The jury's still out on the FDA's 'breakthrough' designation
U.S. rep rips the FDA's effort to speed up drug approvals
Analysts score the winners in the FDA's new 'breakthrough' category

Richard Pazdur - FDA
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