FDA's Pazdur Jumps Over To New 'Moonshot' Role
Richard Pazdur has been tapped to run the FDA's new Oncology Center of Excellence, which is being created under the White House's National Cancer Moonshot initiative. That means Pazdur, who has been at the FDA since 1999, will be setting aside his duties, for the time being, running the Office of Hematology and Oncology Products – leaving that job in the interim to someone else.
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Even though the White House's "moon shot" initiative is focused on cancer, a key component of the program – a new multimillion-dollar FDA "virtual" center for excellence intended to expedite the development and regulatory review of new combination therapies – may be the force to lift the agency out of its silos so that drugs, devices and diagnostics intended to be used together for other types of diseases are not forced to undergo time-consuming separate assessments, said Ellen Sigal, founder and chair of the advocacy group Friends of Cancer Research (FOCR).
The White House on Feb. 1 said President Barack Obama plans to spend $1bn to jumpstart his "moon shot" initiative to end cancer – a project being led by Vice President Joe Biden, who lost a son last year to a brain tumor.
As with any big new initiatives announced by US presidents during their State of the Union (SOTU) addresses, questions quickly arise about what such proposals mean for Americans and the various sectors of society and commerce: Who's going to be involved, what are the benefits or risks to pursuing the scheme, how much is it going to cost and who's paying for it – with members of Congress almost always jumping on the latter of those in demanding quick answers.