FDA names Pazdur head of new Oncology Center of Excellence

[June 29, 2016]  By Toni Clarke

WASHINGTON (Reuters) - The U.S. Food and Drug Administration's high-profile cancer drug director, Dr. Richard Pazdur, has been named head of a newly created Oncology Center of Excellence that will coordinate the review of all the agency's cancer therapeutics.

The announcement was made on Wednesday by Vice President Joseph Biden during a summit to discuss the latest developments in the White House's $1 billion "Moonshot" project to accelerate cancer research.

Companies currently submit new product applications to different divisions in the FDA, depending on the whether the product is a drug, device or biologic. Pazdur oversees cancer drugs within the drugs division.

The new center will coordinate all cancer therapeutics and comes as scientific advances in diagnostics allow for greater tailoring of drugs to an individual's genetic profile. The director will report directly to FDA Commissioner Robert Califf.

A series of initiatives, investments and collaborations among government agencies, the private sector and academic institutions were also announced at the summit in an effort to advance one of the moonshot goals of making a decade's worth of scientific and treatment progress in five years.

"I've never seen so much support for anything as I've seen for the moonshot," executive director Greg Simon told reporters on a conference call.

One initiative announced on Wednesday involves creation of an "easy to use" cancer trials website to better enable doctors and patients to find and enroll in suitable clinical studies of new treatments.

The FDA move is the first in what could be a series of initiatives aimed at reorganizing the agency around disease areas. A bill moving through Congress known as 21st Century Cures has proposed creating four Centers of Excellence, which would also focus on infectious diseases, cardiovascular health and neurodegeneration.

"This shows that the FDA and its leadership are committed to innovation, adapting to the changing scientific landscape and understands the need for the agency to better reflect how patients are being treated," said Ellen Sigal, chair of the advocacy group Friends of Cancer Research, which was involved in developing the Centers of Excellence concept.

Pazdur joined the FDA in 1999 and was named director of the office of oncology drug products in 2005. He has been credited with speeding the review process for dozens of cancer drugs and is known as much for his advocacy, driven in part by the death of his wife from ovarian cancer, as his regulatory expertise.

(Reporting by Toni Clarke in Washington and Bill Berkrot in New York; Editing by Dan Grebler, Bernard Orr)

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