Ode to Bob. ODE1 to Ellis.

Update on the Office of the Center Director and Office of Drug Evaluation1

CDER Staff:

I want to update you on recent changes in my Immediate Office to further enhance medical and scientific decision-making across CDER.  These changes also affect the Office of Drug Evaluation 1 (ODE1), Office of New Drugs.

I have asked Robert (Bob) Temple, M.D., to give up his role as the Acting Director of ODE1, so that he can devote more of his time and vast expertise to his other role as the Deputy Center Director for Clinical Science.  Ellis Unger, M.D., currently the Deputy Director of ODE1, will serve as Acting Director of ODE1.  Bob will continue as Acting Deputy Director of ODEI and plans to maintain substantial (but somewhat less) involvement in ODEI activities.

In November 2009, due to the growth of the Center’s responsibilities, I appointed Bob as the Deputy Center Director for Clinical Science with primary responsibility for high level initiatives and programs related to clinical science and clinical trial methodology issues.  At that time, Bob agreed to wear two hats and continue as Acting Director of ODE1.

As Deputy Center Director for Clinical Science, Bob has played and continues to play a major role in directing and executing many cross-cutting CDER functions, which enhance the quality and consistency of our operations.  Now he will have more time to further provide valuable regulatory input and methodological assistance across the Center.

I am grateful to Bob for serving ODE1 with excellence and superb leadership. I also am grateful that we have someone like Ellis to step in and assume the Office Director position on an Acting basis.  Ellis has been with CDER since 2004, serving in various leadership roles, and in the ODE1 Deputy Director capacity since August 2008.  I am confident that he will continue to serve ODE1 exceptionally well.

Janet Woodcock