When the White House earlier this year said it wanted to create a new Oncology Center of Excellence at FDA as part of the National Cancer Moonshot initiative, a $1bn effort being run by Vice President Joe Biden, it was widely speculated Richard Pazdur would be tapped for the job – that is, if he wanted it.

And apparently, Pazdur does – at least, for the time being.

The White House revealed on June 29 Pazdur will be stepping away from his duties as the director of the FDA's Office of Hematology and Oncology Products (OHOP) to set up the Oncology Center of Excellence (OCE), which is being created to expedite the development and regulatory review of new combination therapies to treat various forms of disease.

Pazdur will serve as the acting director of the OCE, meaning someone else will take over at the FDA's OHOP in the interim. "More details about that transition will be shared once that selection has been made," the agency said.

It's currently unclear how long Pazdur will remain in the OCE acting chief's role or when – or if – he will return to OHOP once he's got the new center up and smoothly running. Pazdur’s position as acting director of OCE is a 120-day detail with option for renewal and reports to the FDA Commissioner, the agency noted.

"As the framework of the OCE evolves, we will continue to assess the timeline and process for identifying the permanent director," FDA said. "The internal selection does not preclude a national search for the director at a later time."

Pazdur's appointment to lead the OCE was one among several measures announced to coincide with an all-day summit convened on June 29 by the White House at Howard University in Washington, where hundreds of representatives from industry, government, academia, patient advocacy groups and other stakeholders are gathering to participate in workshops, discussions and other events focused on how to advance the moonshot effort.

Becoming A 'Regulator-Advocate'

Pazdur came to the FDA in 1999 after spending many years at MD Anderson Cancer Center at the University of Texas. He has said that the recent loss of his wife to ovarian cancer has made him an "regulator-advocate."

The oncology chief and his team of 150 oncologists, toxicologists and other specialists have been highly praised for facilitating rapid development of cancer medicines and approving numerous products well-ahead of their user fee action dates, particularly treatments for non-small-cell lung cancer, like the programmed death-1 immune checkpoint inhibitors from Opdivo (nivolumab) from Bristol-Myers Squibb Co. and Keytruda (pembrolizumab) from Merck & Co. Inc. – two medicines Pazdur has seemed especially enthusiastic about allowing onto the US market.

But Pazdur hasn't always been so warmly embraced by the public in his role at OHOP.

Indeed, he was ridiculed a decade ago for his opposition to certain cancer drugs, including Dendreon Corp.'s Provenge (sipuleucel-T), now owned by Valeant Pharmaceuticals International Inc. – even called a "Dr. No," a "one-man death panel" and a "murderer" by some critics and patient advocates.

The White House, which first announced its intentions to create the OCE on Feb. 1, said the idea behind the new FDA center is to leverage the combined skills of regulatory scientists and reviewers with expertise in biopharmaceuticals and devices to support an integrated approach to evaluate products to prevent, screen for, diagnose and treat cancer.

FDA has embraced the integration idea and pledged to carry it out regardless of the fate of the larger Moonshot project ([A#14160420001]).

Among the White House's goals for the OCE is for it to develop and promote the use of methods created through precision medicine – the focus of another of President Barack Obama's initiatives, which was launched early last year.

FDA's Pazdur Jumps Over To New 'Moonshot' Role

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