Stephen Hahn speaks at an FDA and AACR workshop, February 2018 [via the American Association for Cancer Research]

As clock ticks, Trump will nom­i­nate Stephen Hahn as FDA com­mis­sion­er next week — re­port

Stephen Hahn is set to be nom­i­nat­ed as the next FDA com­mis­sion­er next week, the Wall Street Jour­nal has re­port­ed.

With the clock tick­ing to­ward the No­vem­ber 1 dead­line, Pres­i­dent Don­ald Trump is cut­ting it close. But Hahn, the chief med­ical ex­ec­u­tive at Hous­ton’s MD An­der­son Can­cer Cen­ter, has emerged as the fron­trun­ner to fill Scott Got­tlieb’s seat — which Ned Sharp­less has been serv­ing in an in­ter­im ca­pac­i­ty — as ear­ly as Sep­tem­ber. From pre­vi­ous re­ports, it ap­peared that Hahn was just one FBI back­ground check away from the nom­i­na­tion.

In do­ing so Trump and his HHS sec­re­tary, Alex Azar, is go­ing against the opin­ion of sev­er­al pa­tient ad­vo­ca­cy groups, four oth­er for­mer agency lead­ers as well as Got­tlieb him­self, af­ter they came out in sup­port of Sharp­less in let­ters and tweets.

As act­ing com­mis­sion­er, the Na­tion­al Can­cer In­sti­tute di­rec­tor preached con­ti­nu­ity rather than change, vow­ing to up­hold the rig­or­ous reg­u­la­to­ry stan­dards he in­her­it­ed from Got­tlieb while step­ping the gas on as­sess­ments of new treat­ments.

In a speech to the NORD Con­fer­ence on Rare Dis­eases ear­li­er this week, Sharp­less said that his time in fed­er­al ser­vice, be that at the NCI or FDA, has taught him that these agen­cies “are not tasked with mak­ing life bet­ter for some Amer­i­cans, or most Amer­i­cans, but for ALL Amer­i­cans.”

“There­fore, we have the du­ty to find new and bet­ter ways of ap­proach­ing the chal­lenge of rare dis­eases,” he said. “We can­not leave any pa­tient be­hind, which means we can­not leave re­search in­to any dis­ease be­hind.”

The most high pro­file con­tro­ver­sy dur­ing his tenure has noth­ing to do with drugs, or food for that mat­ter. Rather, he presided over an erup­tion of scan­dals re­lat­ed to va­p­ing as politi­cians ques­tioned why the FDA didn’t start reg­u­lat­ing e-cig­a­rettes ear­li­er and deaths tied to THC con­t­a­m­i­nants in these prod­ucts trig­gered a na­tion­wide pan­ic.

Hahn will have to hit the ground run­ning on the is­sue — pend­ing a Sen­ate con­fir­ma­tion. De­spite not hav­ing any po­lit­i­cal back­ground (oth­er than be­ing a long­time Re­pub­li­can donor), he’s been cred­it­ed for lead­ing in­sti­tu­tions out of dif­fi­cult sit­u­a­tions. One of the most telling episodes took place just a few years ago at MD An­der­son, where sound­ed the alarm on steep fi­nan­cial loss­es at the can­cer cen­ter. Af­ter the then-pres­i­dent, Ron De­pin­ho, re­signed amid a di­vi­sive tenure, Hahn found him­self in the spot­light as the bridge be­tween ad­min­is­tra­tors, fac­ul­ty, and the out­side world look­ing on with great ex­pec­ta­tion. That was March 2017, and Hahn, who came to MD An­der­son orig­i­nal­ly to lead the ra­di­a­tion on­col­o­gy di­vi­sion, had just been tapped as COO a month pri­or.

At that point, two years in­to his MD An­der­son ca­reer, he had ap­par­ent­ly built up rap­port with staff. Julie Iz­zo, chair of the fac­ul­ty sen­ate, praised him for un­der­stand­ing what it’s like to be on the front lines and for walk­ing the walk: “If he says he’s go­ing to do some­thing, he does it,” she said to the Hous­ton Chron­i­cle.

Hahn over­saw day-to-day op­er­a­tions dur­ing the tran­si­tion and played a role in ul­ti­mate­ly turn­ing the fi­nances around be­fore cur­rent pres­i­dent Pe­ter Pis­ters took charge in De­cem­ber.

Be­fore that there’s the time when he re­built a qual­i­ty re­view process at the Uni­ver­si­ty of Penn­syl­va­nia’s ra­di­a­tion on­col­o­gy de­part­ment af­ter a doc­tor was al­leged­ly found to have im­prop­er­ly plant­ed ra­dioac­tive seeds in prostate can­cer pa­tients.

“Clear­ly, you don’t work in these dif­fi­cult aca­d­e­m­ic en­vi­ron­ments with­out hav­ing a lot of po­lit­i­cal savvy,” Karen Bird, the ex­ec­u­tive di­rec­tor of the Al­liance of Ded­i­cat­ed Can­cer Cen­ters, told STAT. “It’s not a straight­for­ward job at all. Aca­d­e­m­ic med­ical cen­ters have lots of stake­hold­ers with­in them, and you’ve got lots of peo­ple with very large egos.”

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Frank Zhang (AP Images)

Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Israel Lowy (Regeneron)

#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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