Sharpless' homecoming: the NCI chief's lessons from his time at FDA

NCI's Sharpless on personalized therapies, AI diagnostics, funding trends and what he learned at FDA

NCI Director Ned Sharpless has returned from his seven month stint as acting FDA Commissioner aiming to take on the regulatory hurdles that lie ahead for promising technologies, and seeking ways for NCI's grants to make the most of the flood of innovation in oncology.

In a conversation with BioCentury, Norman "Ned" Sharpless said his time at FDA made it clear that NIH’s National Cancer Institute (NCI) has a role to play in supporting regulatory innovations to facilitate the approval and reimbursement of key technologies that could transform cancer treatment.

He named personalized therapies and AI-driven diagnostics as two such technologies, and noted the latter includes the first glimmers of "strong AI," which can do things humans can't, as opposed to “weak AI,” which does human tasks more efficiently.

Sharpless thinks NCI could go beyond funding grant applications to bolster these new technologies by supporting regulatory filings, bespoke manufacturing and big data curation.

“The easy part is the NCI gives grants to support these activities, but maybe we do better than that.”

Ned Sharpless, NCI

Having led NCI since October 2017, Sharpless went on to hold the top job at FDA from April to November of 2019 in the wake of former FDA Commissioner Scott Gottlieb's resignation. He was then replaced on an interim basis by Assistant Secretary for Health Brett Giroir, with the role ultimately going to current FDA Commissioner Stephen Hahn.

Sharpless was previously a practicing oncologist and director of the Lineberger

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