Pazdur Named Head of New Oncology Center of Excellence

Richard Pazdur, MD

Richard Pazdur, MD, has been named the acting director of the FDA’s newly created Oncology Center of Excellence (OCE), which is aimed to expedite the development of novel combination products and support an integrated approach to oncology research, FDA commissioner Robert Califf, MD, announced in a statement.

The OCE is a component created from Vice President Joseph Biden’s National Cancer Moonshot Initiative, which aims to double the current rate of cancer research and make a decade of advances in prevention, diagnosis, and care in 5 years. The OCE will be comprised of a cross-center regulatory approach to enhance the coordination of clinical review across oncology-related drugs, biologics, and medical devices. “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,” said Califf in his statement. “Dr Pazdur is the person the FDA needs to get the OCE up and running, because of his in-depth understanding of the inner workings of the FDA, his deep expertise in treating this complex disease and his ability to move the agency forward in this complicated task.”

As acting director, Pazdur will also play a critical role serving as the central point of engagement for oncology stakeholders, including professional associations, patient-focused advocacy groups, and industry, academia, and sister agencies, such as the National Institutes of Health (NIH). Pazdur will be responsible for facilitating and streamlining this engagement and collaboration. The Cancer Moonshot Task Force was formed in 2016 to unite federal agencies that carry roles in the fight against cancer. In February, the White House announced a $195 million investment at the NIH in their 2016 fiscal year for a proposed $1 billion budget initiative for the Cancer Moonshot.

The announcement was made in conjunction with the Cancer Moonshot Summit, which was defined as a national day of action that was telecast at 270 events across the United States. The aim of the project was to double the rate of progress in the understanding, prevention, diagnosis, treatment, and care of cancer. Biden spoke for the event on June 28 at Howard University in Washington, DC.

Pazdur previously served as director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, which was formed in 2005 to consolidate the review of drugs and therapeutic biologics for the diagnosis, treatment, and prevention of cancer, as well as the review of drugs and therapeutic biologics for hematologic diseases and for medical imaging.

“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,” Califf said in his statement. “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.”

Prior to his FDA position, Pazdur was a professor of Medicine at The University of Texas MD Anderson Cancer Center; there, he was also assistant vice president for Academic Affairs, associate director of Clinical Trials Administration in the Division of Medicine, and director of Educational Programs, also in the Division of Medicine. He also served as faculty at Wayne State University from 1982 to 1988.

Pazdur has received a number of awards; most recently he was named to “The One Hundred” list by Massachusetts General Hospital Cancer Center. The American Association has also recognized him with the Distinguished Public Service Award for Cancer Research in 2015. He was also given the Service Recognition Award by ASCO in 2009.

In a statement, Daniel F. Hayes, MD, president of ASCO, commended Califf for selecting Pazdur to lead the OCE.

“In his nearly 20 years with the FDA, Dr Pazdur has worked innovatively to dramatically reduce the amount of time to review new products and increase the number of safe and effective oncology products available to cancer patients,” stated Hayes. “He consistently demonstrates the necessary leadership and commitment to improving cancer care for directing this new center to carry out its mission. ASCO applauds the remarkable success of the FDA in regulating oncology products. However, we believe a more coordinated approach will further streamline and organize evaluation of oncology products—both therapeutic and diagnostic.”

Leaders from other FDA centers will be called upon to create the design and implementation of the OCE, such as directors from the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

“We look forward to Dr Pazdur’s and the center directors’ work to lead the FDA in rapidly implementing the cross-cutting efforts of the OCE in this initial phase,” Califf concluded.