Oncology Center of Excellence Grows Leadership Structure, With A Vacancy Remaining
Executive Summary
A deputy center director position remains open and four new associate director positions were added over the last year.
In less than a year, the US Food and Drug Administration’s Oncology Center of Excellence has undergone a significant leadership shake-up with several additions and subtractions from the ranks.
Between March 2019 and January 2020, five existing positions changed hands and another was not filled following a departure. At the same time, four new positions appear to have been created. (See table below.)
Among the most prominent OCE leaders to leave the agency recently was Deputy Center Director Gideon Blumenthal, who left on 31 January for a vice president position at Merck & Co. Inc.. OCE Director Richard Pazdur would not say 5 February who would replace Blumenthal, indicating that a formal announcement of a new deputy center director was upcoming. Paul Kluetz moved from associate director for patient outcomes to deputy center director, according to the new annual report, although that appears to be as the replacement for former deputy center director Amy McKee, who left in February 2019. (Also see "Oncology Center Of Excellence Comes Of Age at US FDA" - Pink Sheet, 1 Apr, 2019.)
Sean Khozin, who had been associate director for informatics and in founding director of the OCE Information Exchange and Data Transformation (INFORMED) program, also left the agency in 2019 and now is global head of data strategy at Janssen R&D LLC. His position has not been filled, and Pazdur said his duties running INFORMED would be divided between others in the oncology program.
The OCE executive committee membership also has not changed since losing a member. The head of the Office of Medical Products and Tobacco had sat on the committee, but the position was eliminated as part of a 2019 FDA reorganization, creating a vacancy. (Also see "US FDA Reorg: Defining The “Central” Purpose Of A Commissioner" - Pink Sheet, 22 Mar, 2019.)
Patricia Keegan, who spent many years in the Office of New Drugs’ Division of Oncology Products II, took one of the new OCE positions created in 2019, and now is its associate director for medical policy. Her move was prompted by the ongoing OND reorganization. (Also see "US FDA Oncology Leadership Shuffle Moves Patricia Keegan To OCE; Gootenberg Takes On Recruitment" - Pink Sheet, 13 Nov, 2019.)
OCE also added Joohee Sul as associate director of neuro oncology, Dianne Spillman as associate director of global regulatory outreach, and Jennifer Gao as associate director for education. Gao was listed as acting associate director in the annual report, but the agency said her title now is permanent.
OCE celebrated its third birthday during a 5 February public workshop on envisioning oncology product development in 2025. Among the discussions was expanding Project Orbis, OCE’s program allowing collaborative and simultaneous review of applications with Canadian and Australian authorities. (See sidebar.)