How Ned Sharpless climbed to the top of the FDA

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WASHINGTON – Almost immediately after starting her daily work in Bethesda as a leading cancer researcher, Ned Sharpless has created a detour of about 7 miles into her weekly routine: a stay at the Food and Drug Administration's campus for a basketball game.

<p class = "canvas-atom-canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Whether networking is intentional or not, Sharpless will soon spend a lot more time with the FDA oncologists who once broke his finger. When Scott Gottlieb will retire after almost two years in office next month, Sharpless will take over, at least in the short term. "Data-reactid =" 23 "> Whether networking is intentional or not, Sharpless will do so much more time soon with FDA oncologists who once broke his finger. When Scott Gottlieb will retire after nearly two years in office next month, Sharpless will take over the reins of this agency, at least in the short term.

The Trump administration's announcement that Sharpless will become Acting Commissioner of the FDA has delighted his long-time colleagues and offered continuity, if not popularity, to the interests of tobacco and the pharmaceutical products it will regulate.

Sharpless, a cancer doctor and research veteran who founded two biotechnology companies, is seen as a potential candidate not only to lead the agency in Gottlieb's immediate wake, but also to lead it in the long run – giving the Trump administration a popular FDA and traditional chef. And in many interviews with STAT, current and former Sharpless associates have highlighted the breadth of his experience: from more than 150 published academic books bearing his name to the $ 105 million co-funded by G1 Therapeutics, a company created by Sharpless, in 2017 development of trilaciclib, a medicine for lung and breast cancer.

Together, they described Sharpless, 52, as an ideal candidate to lead one of the most stable federal agencies in the Trump administration, oversee the pharmaceutical industry with which he previously worked, and continue to strengthen regulatory compliance. combustible tobacco and electronic cigarettes.

Sharpless, said Karen Knudsen, director of the Sidney Kimmel Cancer Center at Jefferson University, is an "accessible, objective and multi-talented" personality.

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Read more: With the support of big names, a start-up launches to associate cancer patients with clinical trials"data-reactid =" 28 ">Read more: With the support of big names, a start-up launches to associate cancer patients with clinical trials

And even within the informal society of directors of cancer centers designated by the NCI – Sharpless had previously led the Lineberger Comprehensive Cancer Center of the University of North Carolina – Knudsen said his relationship in the industry distinguished him.

"His additional skills are his relationship with the pharmaceutical industry and his history of transporting compounds from bed to bed," she said. "It's actually unique. We all have considerable experience in the pharmaceutical industry in the management of compounds developed in our own centers and their approval. Not all directors have formed a corporation. "

Even less have founded two. Sapere Bio, also based in North Carolina, is the second company that science led by Sharpless has helped spawn. As part of its research on the relationship between aging and cancer, the company is developing a diagnostic test to measure a patient's "molecular age".

"One of the things that made me attractive in the White House was that in addition to working in research and as a director of cancer center, I had worked at marketing the drug." ideas, from a basic science laboratory to a phase 2 trial. "Sharpless said in an interview with STAT last year, referring to his appointment to the NCI.

According to public records, the creation of these companies may have paid off. Sharpless said it sold more than 400,000 shares of G1 Therapeutics in October 2017, which was worth more than $ 9 million. (Sharpless's precise capture is difficult to measure because the price he paid for these actions is not public.)

Sharpless recently helped NCI oversee the start of a $ 215 million, five-year partnership with 11 pharmaceutical manufacturers for the development of new cancer immunotherapies.

Most clinical trials for cancer treatment "are actually paid for by the industry," Sharpless recently said in the podcast of the American Society of Clinical Oncology.

"The pharmaceutical industry spends a lot of time on clinical trials and, from my point of view, it's great," he said. "The fact that the industry is funding trials to develop treatments for cancer patients is less money than the NCI has to spend on the same issues."

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "In the same interviewSharpless said he has witnessed the successes and failures of current cancer treatments in his personal and professional life. His father died of cancer; In the same interview, Sharpless stated that he has witnessed the successes and failures of current cancer treatments in his personal and professional life. His father died of cancer. her two sisters are both cancer survivors.

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Beyond its antecedents in biotechnology, Sharpless specified in many public statements claiming that he was participating in the FDA's mission – even beyond the weekly basketball games with the FDA's oncology staff, one of them having left Sharpless with a bulbous, violet ring, obliging him to wear his wedding ring in his right hand for some time afterwards (he tweeted "data-reactid =" 40 "> Beyond his antecedents in biotechnology, Sharpless has made it clear in many public statements that he was participating in the FDA's mission – even beyond – the weekly basketball games -ball pickup with the FDA's oncology staff, one of whom left Sharpless with a purple ring finger, forcing him to wear his wedding ring in his right hand for a while after (he tweeted that the injury has given a new meaning to the term "breakthrough designation".)

Gottlieb, at an event organized by the Washington Post with Sharpless last year, touted his partnership with Sharpless and pointed out that the FDA and the NCI were working together "probably more closely than we do." have never done.

Recalling the basketball incident, Gottlieb is excused for the broken bone. The replica of Sharpless: "Surprisingly aggressive, the FDA."

Beyond basketball, Sharpless is recognized for his ability to accelerate drug discovery, including streamlining clinical trials and improving patient care: in 2014, he proposed to Lineberger to be the # 1 39, one of the first cancer treatment centers to test IBM Watson. for genomics, the now controversial artificial intelligence system, designed to help doctors identify potentially cancer-causing mutations and suggest treatments. (The study was completed in early 2017, Lineberger has stopped using Watson and technology has never become an integral part of the clinic's clinical practice.)

"I would expect that he's working on the same issues at the FDA as [Gottlieb] especially vaping, "said Ronald DePinho, MD Anderson Cancer Center researcher in Houston and Sharpless postdoctoral supervisor at the Dana-Farber Cancer Institute. "Ned would carry this spear on the ground. I see him continue to do his best to ease the opioid crisis. I see him pushing to send new drugs to patients. "

The news that Sharpless would be acting director has sent shares to Altria, the parent company of the tobacco company Phillip Morris, 35% shareholder of the vape Juul manufacturing company.

Sharpless, in fact, has deep roots in this state that produces a lot more tobacco than any other. He holds a Bachelor of Mathematics from the University of North Carolina, Chapel Hill, where he attended a medical school and eventually became the director of the Lineberger Center.

<p class = "web-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "The Sharpless family presents three generations of doctors Tar Heel His parents both attended the UNC and, in one photo, her mother, Martha, stands out among only two women among the medical school students of 1959. Sharpless returned to campus for the white coat ceremony of his niece. in September. "data-reactid =" 49 "> The Sharpless family is made up of three generations of doctors from Tar Heel, his parents both attended the UNC and, in one photo, his mother, Martha, stands out among two women only in the class of 1959 from the medical school.Sharpless returned home.at the campus for the ceremony of the white coat of his niece in September.

Like her husband, Julie Sharpless is also a second-generation doctor. Both were in Boston for their residencies and scholarships; she completed endocrinology training after graduating from Harvard and Yale. The two were married in 1996, just as Ned was finishing her residency.

Sharpless is now an empty nest, known for its subway rides from tony Woodley Park in northwestern Washington DC to the NIH campus in Bethesda – and, in its free time, juggles along Washington's woodland trail system.

UNC colleagues describe Sharpless as a "Carolina from start to finish": loyal to her friends, modest and determined to make a difference in the world. Two weeks ago, he even returned to Chapel Hill to attend the defense of a student memoir. He and his wife still own their long-standing home a few miles from the university.

<p class = "canvas-atom text-canvas Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Even when publicly document In his last years of subsidy research, Kolsch style beer at his office was the product of a North Carolina brewery. (Two days later, when Sharpless returned to document his progress, the beer had been replaced for coffee and pretzels for a gigantic bag of cheddar goldfish.) "Data-reactid =" 53 "> Even when publicly document In his last years of subsidy research, Kolsch style beer at his office was the product of a North Carolina brewery. (Two days later, when Sharpless returned to document his progress, the beer had been replaced by coffee and pretzels, by a gigantic bag of goldfish with cheddar cheese.)

"One thing about Ned, is that he's an extremely optimistic and positive guy," said Candace Johnson, president and CEO of the Roswell Park Comprehensive Cancer Center in Buffalo, NY. Ned person knows him personally.This is a guy with whom you might want to have a beer, he is down to earth. "

Sharpless does not seem to fully share the political views of his future supervisor, Health Secretary Alex Azar, and President Trump, while he shows great confidence and confidence in leading an agency that less in theory, is apolitical. He has been donating to Democratic candidates for years: Barack Obama, long-time Democratic Senator Kay Hagan, and other Democratic nominees for government positions.

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Read more: Listen: Every imaginable aspect of the FDA's resignation from Scott Gottlieb"data-reactid =" 56 ">Read more: Listen: Every imaginable aspect of the FDA's resignation from Scott Gottlieb

Last May, Sharpless said he had not met with President Trump.

If Sharpless is appointed full-time FDA commissioner, he will have to be confirmed by a Republican-controlled Senate, a process not required for NCI directors that could be complicated by his seemingly democratic tendencies.

The most vociferously opposed senator to Gottlieb could be a problem: Richard Burr, a Republican from Sharpless's home state of North Carolina. Burr vocally opposed major elements of Gottlieb's nicotine repression, which is likely to continue in Sharpless.

Sharpless donated to one of Burr's challengers in the 2010 election, offering $ 250 to Cal Cunningham, a failed candidate in the Democratic primary.

If Sharpless was officially named – and if he managed to overcome the political obstacles that lie ahead – he would have the chance to become the next unifying personality of the Trump administration's health policy, a role Gottlieb quickly appreciated.

"We have big shoes to fill," said DePinho, former MD Anderson Cancer Center chairman, following Gottlieb's departure. "But Ned's pretty big."

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Sharon Begley and Adam Feuerstein contributed to the Boston report."data-reactid =" 63 "> Sharon Begley and Adam Feuerstein have written reports from Boston.