FDA Launches Oncology Center of Excellence, Appoints Pazdur As Director
By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has officially launched its Oncology Center of Excellence (OCE) to coordinate the clinical review of drugs, biologics, and devices across the agency’s three medical product centers. Dr. Richard Pazdur, FDA's cancer drug director since 2005, will lead OCE.
Former U.S. Vice President Joe Biden announced the creation of OCE in June, as part of the key programs under the Cancer Moonshot Initiative to speed cancer research and therapies. OCE is tasked with coordinating collaboration between the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH), using "an innovative, yet seamless cross-center regulatory approach to enhance the coordination of clinical review across oncology-related drugs, biologics and medical devices."
The FDA centers' directors — with help from leading oncologists, scientists, and experts in drugs, biologics, and devices (including diagnostics) — are expected to support innovation and expedited market access to new anti-cancer products through a collaborative framework fostered by OCE.
"While the review criteria and application requirements for medical products, as well as the work of review staff in the centers will not change, uniting experts to collaborate on the clinical review of oncology products will enhance the agency’s work in approving safe and effective cancer products," outgoing FDA Commissioner Robert Califf said in a news release.
Califf confirmed as director of OCE Dr. Richard Pazdur, who was named acting director of OCE when it was announced in June. Califf said at the time that, "after a competitive internal search," FDA decided that its long-serving oncology expert was most qualified to lead the new center, which makes oncology the first disease area to have a coordinated clinical review from three FDA centers.
"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," Califf said.
Pazdur joined FDA in 1999 and was named director of the office of oncology drug products in 2005, reported Reuters. He has been credited for streamlining the regulatory process for dozens of cancer drugs during his nearly 20 years at FDA, with the last 12 as director of the Office of Hematology and Oncology Products (OHOP) at FDA’s CDER. OHOP was created 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.
"As director of OHOP, Pazdur facilitated coordination of oncology activities across all FDA Centers and ensured an ongoing outreach and collaboration between the FDA, the National Cancer Institute, and other cancer-related organizations within and outside of the government," stated FDA. At OCE, he has a similar responsibility "to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review."
Prior to being appointed at OHOP, Pazdur was the director of FDA's Division of Oncology Drug Products from 1999 to 2005. He was a professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas from 1988 to 1999.