NCI's Ned Sharp­less gets the nod to run the FDA in wake of Scott Got­tlieb’s sur­prise ex­it

The head of the Na­tion­al Can­cer In­sti­tute, UNC alum Nor­man “Ned” Sharp­less, has been tapped as the act­ing head of the FDA.

The news fol­lows a few dif­fer­ent sto­ries point­ing to Sharp­less as the like­ly next helms­man of the agency, where the pop­u­lar com­mis­sion­er Scott Got­tlieb an­nounced his sur­prise res­ig­na­tion less than 2 years af­ter tak­ing the post. And Got­tlieb was quick to of­fer a thumb’s up.

While not for­mal­ly nom­i­nat­ed, the move po­si­tions Sharp­less as Got­tlieb’s like­ly suc­ces­sor. If so, Sharp­less won’t en­counter much, if any, op­po­si­tion in the bio­phar­ma in­dus­try. But ex­ecs will be wait­ing to see if he can come close to match­ing Got­tlieb’s zeal for speed­ing up agency re­views and has­ten­ing ap­provals at a time of record new drug OKs — in­clud­ing the ini­tial launch­es for the first in a whole new gen­er­a­tion of cell and gene ther­a­pies.

Sharp­less has a sol­id re­sume that res­onates well with in­dus­try ex­ecs. He grad­u­at­ed from UNC School of Med­i­cine and did his res­i­den­cy at Mass Gen­er­al. Fol­low­ing a 2-year stint at Har­vard Med he went back to UNC, where he be­came the Well­come Pro­fes­sor of Can­cer Re­search in 2012. He was tapped to run the NCI in 2017.

That all trans­lates in­to in­stant re­spect in bio­phar­ma, but not nec­es­sar­i­ly un­bri­dled en­thu­si­asm.

Re­spect, though, will go a long way in set­ting the stage for Sharp­less, par­tic­u­lar­ly as ear­li­er can­di­dates pitched to Pres­i­dent Don­ald Trump in­cludes at least one with an odd lib­er­tar­i­an streak that didn’t sit well with drug de­vel­op­ers de­vot­ed to main­tain­ing a gold stan­dard for new drug ap­provals — even if that stan­dard has proven in­creas­ing­ly flex­i­ble.

Piper Jaf­fray’s Christo­pher Ray­mond put him­self down for an en­thu­si­as­tic en­dorse­ment.

Sharp­less was clear­ly Got­tlieb’s top choice, and in that he is a long time in­sid­er and physi­cian/sci­en­tist, we think in­vestors should ex­pect FDA to con­tin­ue on its cur­rent path of in­creased reg­u­la­to­ry ef­fi­cien­cy with an in­dus­try-friend­ly lean. We ex­pect the bio­phar­ma space to be up sharply on this news.

 


Im­age: Ned Sharp­less. AP IM­AGES

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

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