Oncology drug tsar Dr. Richard Pazdur–who earlier this month despaired at biopharma’s “me-too” approach to cancer development–has been named as the interim leader of a new Oncology Center of Excellence that will be run out of the FDA.
The new Center aims to coordinate the reviews coming from the Agency’s work on cancer treatments.
The announcement, as quoted by Reuters, was made this morning and came as VP Joe Biden spoke about the latest work from the government’s $1 billion “cancer moon-shot” program.
Under the current process, biotech and pharmas submit their new product apps to different divisions within the FDA, depending on the whether the product is a drug, device or biologic. Pazdur oversees cancer drugs within the drugs division.
The big new idea, which forms part of a restructure at the Agency to focus on certain disease areas more sharply, will coordinate all cancer therapeutics under one center. Pazdur will report directly to the FDA Commissioner Robert Califf.
Dr. Pazdur will however only be the acting director of the Oncology Center of Excellence, and not its long-term head. An FDA spokesperson told FierceBiotech: “This is a position intended to get the OCE up and running in this initial development phase.
“As the framework of the OCE evolves, we will continue to assess the timeline and process for identifying a permanent director. The internal selection does not preclude a national search for the director at a later time.”
Califf said: “Establishing a Center of Excellence in a disease as complex as cancer requires a thoughtful approach and we recognize that the framework of the OCE will evolve. At the same time, we remain committed to the sense of urgency that is central to the Cancer Moonshot.
“That is why we determined the best way to accelerate the formation of the OCE without disrupting the ongoing work within the FDA’s centers would be to appoint an internal leader in an acting capacity who can focus on bringing together oncologists across the FDA.
“After a competitive internal search, I can think of no one more qualified to shepherd the agency into a new era of regulation over oncology products than the FDA’s own Dr. Richard Pazdur, who has led the FDA for nearly 20 years in reshaping and modernizing the review of cancer treatments.”
Ellen Sigal, chair of the advocacy group Friends of Cancer Research, which was involved in developing the Centers of Excellence concept, added: “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,.”
Pazdur joined the FDA 17 years’ ago and has been the director of the office of oncology drug products for just over a decade.
But Pazdur has been known for speaking his mind, saying at the recent ASCO cancer conference that companies need to stay focused on cutting edge research–and lose the “me-too” drugs in the cancer pipeline.
“People should ask themselves … would we be better off spending those resources into looking at more novel drugs?” Pazdur told Reuters at ASCO. Going after the same objectives with very similar therapies is all “about reduction of risk,” he added.
http://www.fiercebiotech.com/biotech/fda-s-pazdur-named-as-head-new-onc…
