Monday, January 26, 2015

Duke's Dr. Califf To Lead FDA -- By Mid 2016? Hamburg Names A Potential Successor?

I believe Duke runs top flight programs. And I believe Dr. Califf is no small reason why. So it is gratifying to see him arrive at FDA. He has done a nice job of balancing the competing interests at the University -- so I expect he will do the same at FDA. And it won't hurt Kenilworth a bit that it has a nice relationship with him, of course.

Here is one of my backgrounders on Dr. Califf -- and his IMPROVE-IT work. I respect him immensely. And here is the FierceBiotech article of this morning:

. . . .FDA Commissioner Margaret Hamburg appointed a Duke cardiologist with ties to biopharma as the agency's deputy commissioner for medical products and tobacco, stoking speculation that she's lining up a successor.

Robert Califf will join the FDA next month, presiding over its separate drug, biologic, medical device and tobacco wings. Califf, now vice chancellor of clinical research at Duke, will oversee the agency's changing policies in personalized medicine, orphan drugs and pediatric science, the FDA said, and he'll play a role in the all-important advisory committee system. . . .

Califf also led the 6-year IMPROVE-IT study, in which Merck's Zetia had a [very slight] positive effect on cardiovascular outcomes, affirming the hopes of companies developing new cholesterol-lowering medicines. . . .

This is indeed good news, all the way 'round.

No comments: