CRANBURY, N.J.--(BUSINESS WIRE)--During his 18 years at FDA, Richard Pazdur, MD, has worked to balance the needs of patients anxious for new cancer cures with the agency’s standards that protect them from harm. In January, Pazdur took on a new role—director of the new Oncology Center of Excellence (OCE), which was borne of the National Cancer Moonshot’s call for greater collaboration among those charged with speeding the arrival of new cancer-fighting products.
Pazdur outlines how OCE will function—and how it bring a stronger patient voice to FDA’s decisions—in a special issue of Evidence-Based Oncology,™ (EBO™); the issue features coverage from the spring 2017 Oncology Stakeholders’ Summit, which focused on regulatory issues.
“This new center leverages the combined skills of regulatory scientists and reviewers with oncology clinical expertise across the FDA, emulating the multidisciplinary organizational model of academia and cancer care centers and building on the integrative approach to medical product development that the agency’s broader oncology community has embraced over the past decade,” Pazdur writes.
Since 2005, when he became director of the Office of Hematology and Oncology Products (OHOP) within FDA, Pazdur has overseen the arrival of faster pathways to approval, which tracked the rise of new treatment methods, including immunotherapy. As he explains, OCE builds on that record but with some key additions. “An important aim of the OCE is to facilitate incorporation of the patient view into regulatory decision-making,” he writes.
A key feature of the OCE calls for new submissions to head to a clinical review team that draws from three medical product centers. The team will make recommendations, which will head to Pazdur for review and sign-off. Other aspects of FDA review remain with their traditional centers, he explains. The OCE will embrace new trial designs, with the goal of making research simpler and requiring fewer data points.
“These initiatives will allow us to expedite drug development and approval of truly novel agents that will have a major impact on our patients, while allowing us to make thoughtful decisions regarding the risk-benefit of oncology drugs,” Pazdur writes.
Pazdur remains the acting director of OHOP while taking on his new role.
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