Spielberg To Begin Work At FDA In Late September

The prominent pediatric researcher will take over as Deputy Commissioner for Medical Products and Tobacco two months after his new role was announced.

Incoming FDA Deputy Commissioner for Medical Products and Tobacco Stephen Spielberg will take up his post Sept. 25, a little over three weeks after leaving his current position at Children's Mercy Hospital effective Aug. 31.

Under FDA's recently announced reorganization, the directors of the drug, biologic and device centers will report to Spielberg, rather than reporting directly to FDA Commissioner Margaret Hamburg as they did before (Also see "FDA's Spielberg To Focus On Cross-Center Collaboration, Hamburg Says" - Pink Sheet, 1 Aug, 2011.).

Spielberg also will have responsibility for the Center for Tobacco Products and the Office of Special Medical Programs, which houses offices that oversee combination products, orphan product development, pediatric therapeutics and good clinical practice.

His transition from FDA advisor to insider appears to have already begun; he is no longer listed on the roster of the Science Board Advisory Committee.

Spielberg, formerly dean and vice president for health affairs at Dartmouth Medical School and a prominent specialist in pediatric pharmacology, has done basic research on pharmacogenetics for Merck and oversaw pediatric clinical trials internationally for Johnson & Johnson.

He has also focused on personalized medicine, a high-priority field for FDA in general and its Science Board Advisory Committee in particular (Also see ""Virtual Patients," Medical Countermeasures On FDA Regulatory Science Horizon" - Pink Sheet, 17 Aug, 2011.).

"His academic research has focused on human pharmacogenetics, mechanisms of idiosyncratic adverse drug reactions (intense clinical and genetic investigation), and on developmental pharmacology and pediatric clinical trials," according to a biography on Children's Mercy Hospital's website.

- Martin Berman-Gorvine ([email protected])