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Pink Sheet – Oncology Center Of Excellence Comes Of Age at US FDA

Pink Sheet – Oncology Center Of Excellence Comes Of Age at US FDA

Executive Summary

Our infographic details organizational structure and management of FDA’s first inter-center institute; five of 11 associate director positions are being filled on an acting basis.


The US FDA Oncology Center of Excellence’s (OCE) organizational structure reflects the cross-cutting nature of the two-year old office established to expedite the development and clinical evaluation of drugs, biologics and medical devices intended to treat, diagnose or cure cancer.


OCE was formally established in January 2017 as the agency’s first inter-center institute under the 21st Century Cures Act. It was tasked with expediting the availability of new cancer therapeutics and diagnostics by integrating reviews and policy development across FDA’s medical product centers.


Office of Hematology and Oncology Products Director Richard Pazdur was tapped to serve as OCE’s first permanent director. However, the make-up of the rest of OCE leadership team and structure has only slowly been coming into focus. (Also see “FDA’s Oncology Center Of Excellence On Equal Terms With CDER In New Org Chart” – Pink Sheet, 28 Jul, 2017.)


OCE’s inaugural annual report released in March provides the clearest picture to date of its organizational structure, review and policymaking activities, and external outreach.


The center’s management committee encompasses Pazdur, Deputy Director Gideon Blumenthal, and 11 associate directors who head up various program areas, such as immunotherapeutics, informatics, in vitro diagnostics, and cell and gene therapy. (Story continues after the organizational chart.)


Oncology Center of Excellence Organizational Structure (March 2019)


The management committee’s responsibilities include:

  • Identifying approaches to optimize efficiency of the medical oncology clinical review process, especially pertaining to cross-center, collaborative reviews; and
  • Organizing and prioritizing oncology-specific research and policy initiatives to minimize redundancy and optimize collaboration.

However, the organizational structure reflects the still relatively young age of the office, as five of the 11 associate director positions currently are being filled on an acting basis, FDA told the Pink Sheet.


In addition, OCE lost one of its deputy directors in February when Amy McKee left the agency to become vice president of regulatory consulting services as Parexel International Corp..

Executive Committee Oversight

The composition of the executive committee also is evolving.


The committee – which provides oversight, and strategic and policy direction – comprises the OCE director, the heads of the drugs, biologics and device centers, as well as the director of the Office of Medical Products and Tobacco.


However, the medical products office was formally eliminated with the recently completed reorganization of the Office of the Commissioner. (Also see “US FDA Reorg: Defining The “Central” Purpose Of A Commissioner” – Pink Sheet, 22 Mar, 2019.)  FDA said a replacement on the OCE executive committee will be discussed as part of the implementation of the commissioner’s office reorganization.


The organizational structure also includes a Science Council, an internal group of FDA staff with nonclinical backgrounds who advise the OCE director on emerging science and research relevant to oncology product development.


At a March 2018 stakeholder listening session, representatives from Friends of Cancer Research pressed for details about the office’s organizational structure and urged FDA to annually report on metrics related to approvals, processes and external activities. (Also see “US FDA’s Cancer Review Staff Should All Move To Oncology Center of Excellence, Advocates Say” – Pink Sheet, 15 Mar, 2018.)


The annual report includes metrics for oncology product approvals, expedited program submissions and pediatric oncology written requests in 2018. (See table below.) The report also reflects the approval of four products through the Real-Time Oncology Review pilot program.  (Also see “Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot” – Pink Sheet, 11 Mar, 2019.)…