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Spielberg Farewell

Tue, Jan 22, 2013 | Peter Pitts

From: A Message from the Commissioner

Sent: Tuesday, January 22, 2013 10:54 AM

To: FDA-Wide

Subject: Personnel Announcement for the Office of Medical Products and Tobacco

Dear FDA Colleagues:

I wanted to make you aware of the upcoming departure of Dr. Stephen Spielberg, Deputy Commissioner for Medical Products and Tobacco.  Due to a family medical issue, Dr. Spielberg will be leaving FDA on February 15 to return home to the Philadelphia area.  In March, he will assume the role of editor-in-chief of “Therapeutic Innovation and Regulatory Science”, a new journal launched by the Drug Information Association.

For the past year and a half, Dr. Spielberg has been a terrific spokesperson for the Agency and a key member of  my senior management team, supporting the invaluable work performed across the Centers for drug, biologics, medical devices, and tobacco products and the Office of Special Medical Programs.  He has been an important partner in helping the agency toward a more integrated approach to medical product evaluation across the Directorate, in working together with Center leadership to address the rapid changes in human biology and therapeutic interventions, and in helping optimize FDA’s approach to evolving areas such as personalized medicine.

We will miss the leadership and wise counsel he has provided during his time at the agency.

I am pleased to announce Leona Brenner-Gati, MD, has graciously agreed to serve as Acting Deputy Commissioner for Medical Products and Tobacco.  Dr. Brenner-Gati is currently the Associate Commissioner for Medical Products and Tobacco and comes with twenty years of experience in the private healthcare sector, where she has focused on emerging technologies and complex product development.  She has extensive experience leading multi-disciplinary, cross-functional teams spanning pharmaceuticals, devices, diagnostics and consumer sectors, and has applied highly integrative scientific and administrative expertise to foster the development of groundbreaking medical products.

Dr. Brenner-Gati spent seventeen years at Johnson & Johnson, where she held senior leadership positions in Science and Technology, Clinical Research and Development, Global Project Management, Medical Affairs, and Business Development in the Pharmaceuticals and Medical Devices & Diagnostics Groups and Corporate Headquarters  As a champion of Regenerative Medicine product development and initiatives, she founded J&J’s cell therapy for diabetes program, and chaired the Scientific Advisory Board and served on the Management Board.  She was also Vice-Chair of J&J’s Human Pluripotent Stem Cell Committee, helped found and served as an officer and board member of the Alliance for Regenerative Medicine, and was a member of the FDA/California Institute of Regenerative Medicine Roundtable on Regenerative Medicine. Prior to J&J, Dr. Brenner-Gati led the Internal Medicine Clinical Research Therapeutic Area at Sandoz Pharmaceuticals and achieved successful registration of several products.

Dr. Brenner-Gati graduated from Princeton University, magna cum laude in Biology, Phi Beta Kappa, and received her medical degree from Harvard Medical School. She obtained her postgraduate medical training at New York University/Bellevue Hospital Medical Center, and held academic appointments at Cornell University Medical Center/New York Hospital, where she performed basic science and clinical research, taught medical students and had a medical practice. While at Cornell, Dr. Brenner-Gati was a clinical investigator for seven years in the landmark NIH Diabetes Control and Complications Trial. She is board certified in Internal Medicine and Endocrinology & Metabolism and holds medical licenses in New York and New Jersey.

Please join me in extending a warm welcome to Dr. Brenner-Gati as she takes on this new role, and please join me in thanking Dr. Spielberg for his significant contributions to our public health mission.


Margaret Hamburg, MD

Commissioner for Food and Drugs