This year’s lunch conversation was between the Director of the FDA Oncology Center of Excellence (OCE), Dr. Richard Pazdur and FDA’s Dr. Gideon Blumenthal and Dr. Amy McKee. The conversation focused on the OCE and how it is revolutionizing and streamlining cancer product review. There was a focus by all three participants in cultivating disease experts since it assists with internal communication and functions at FDA and allows for consistent advice to be disseminated to industry across therapeutic areas. There was also an emphasis on the need to get the OCE “right” since it is the pilot project for other Centers of Excellence at FDA, and it was stated that so far, the Center has run well and accomplished what it set out to do: yield results for patients in an efficient and streamlined manner.
