FDA’s cancer drug director to lead Oncology Center of Excellence

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation, has been named acting director of the agency’s new Oncology Center of Excellence.

The center — proposed as part of the national cancer moonshot initiative — is intended to consolidate, coordinate and expedite the review of all cancer treatments.

Richard Pazdur

The goal is to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices, according to FDA Commissioner Robert Califf, MD.

“Establishing a center of excellence in a disease as complex as cancer requires a thoughtful approach, and we recognize that the framework of the [center] will evolve. At the same time, we remain committed to the sense of urgency that is central to the cancer moonshot,” Califf said in a press release. “We determined the best way to accelerate the formation of the Oncology Center of Excellence 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,” Califf added.

Pazdur joined the FDA in 1999 and has served as director of the Office of Hematology and Oncology Products since 2005.

He is the ideal person to oversee the launch of the center of excellence due to 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,” Califf said.

In an entry posted this morning on the FDA Voice blog, Pazdur described the center of excellence as “a place where the combined skills of regulatory scientists and reviewers with oncology clinical expertise in drugs, biologics and devices will come together to support an integrated approach to the advancement of cancer treatment.”

“The Oncology Center of Excellence emulates both academia and cancer care centers, which are increasingly organized in multidisciplinary models to enhance collaboration, which is so essential when confronting a complex disease like cancer,” Pazdur wrote. “Such a collaborative approach — the sharing of ideas, information and best practices — closely fits my own vision for oncology at the FDA.”

The center will continue to incorporate patient views in regulatory decision-making, as well as leverage the talents of FDA staff, Pazdur wrote.

“The very first thing I plan to do as acting director is to meet with those involved in oncology medical product development and review across centers to hear their ideas for the Oncology Center of Excellence and how we can work together to enhance our efforts across the agency,” Pazdur wrote. “Developing the structure of the OCE is an ongoing process. ... I look forward to guiding the agency through this initial phase, building our cross-disciplinary review staff, providing external outreach to diverse stakeholders and streamlining administrative processes to ensure rapid review of important cancer products to the American public.”