Af­ter jump­ing ship at Eli Lil­ly, Politi­co re­ports Alex Azar may soon land top HHS job

Back at the be­gin­ning of this year, Eli Lil­ly’s US chief Alex Azar left his post dur­ing the big ex­ec­u­tive shuf­fle as Dave Ricks re­placed John Lech­leit­er at the helm. But he may be about to line up a much bet­ter job than the one he ex­it­ed.

Politi­co re­ports that Azar is a fa­vorite in the race to re­place Tom Price, the ex­pe­ri­enced po­lit­i­cal hand who had a weak­ness for pri­vate jets. De­pend­ing on who the re­porters were talk­ing to in the ad­min­is­tra­tion, Azar had ei­ther been short­list­ed or was al­ready in­for­mal­ly tapped for the job.

The move would bring Azar back to Wash­ing­ton, where he did a stint as gen­er­al coun­sel and deputy sec­re­tary at HHS un­der George W Bush. Azar — a Yale Law School grad — was on one of my pan­els about 15 months ago and ably rep­re­sent­ed Lil­ly with a sharp and con­cise rep­re­sen­ta­tion of the kind of op­por­tu­ni­ties and pit­falls a Big Phar­ma like Lil­ly has to nav­i­gate every day.

Azar did not im­me­di­ate­ly jump to an­oth­er po­si­tion in the in­dus­try, up­ping the odds that he was pushed out rather than jumped as Ricks be­gan to re­struc­ture the com­pa­ny from top to bot­tom. Azar set up a con­sul­tan­cy called Seraphim Strate­gies in Feb­ru­ary as he “ex­plored lead­er­ship op­por­tu­ni­ties.”

What­ev­er Azar’s thoughts on Lil­ly, he’d be viewed as a de­pend­able and tal­ent­ed ad­vo­cate for the in­dus­try, some­one who isn’t like­ly to dis­com­fort the Big Phar­ma play­ers.

De­pend­ing on when he’s talk­ing, Pres­i­dent Don­ald Trump has been a caus­tic crit­ic of the bio­phar­ma in­dus­try’s drug pric­ing poli­cies. Just yes­ter­day he dou­bled down on his ear­li­er crit­i­cisms, not­ing that US drug prices are a mul­ti­ple of what they cost in oth­er coun­tries with a sin­gle-pay­er sys­tem — some­thing he would nev­er abide.

“Some­times it’s a frac­tion of what we pay in this coun­try,” Trump said in pre­pared re­marks. “The drug com­pa­nies frankly are get­ting away with mur­der and we want to bring our prices down to what oth­er coun­tries pay.”

We’ve been sub­si­diz­ing oth­er coun­tries, he added, “pay­ing dou­ble, triple, quadru­ple.”

But un­like his first slap­downs, this time Trump’s at­tack bare­ly caused a rip­ple in the in­dus­try, where top ex­ecs led by Mer­ck’s Ken Fra­zier ex­it­ed the pres­i­dent’s in­dus­try ad­vi­so­ry groups in the wake of the con­tro­ver­sy over the Char­lottesvil­lle, VA con­fronta­tion by ex­trem­ist or­ga­ni­za­tions.

One oth­er hot­ly ru­mored can­di­date for this job has been FDA com­mis­sion­er Scott Got­tlieb, who’s made an im­pres­sive en­try in­to a job that calls on the fed­er­al agency to bal­ance the gold stan­dard on ef­fi­ca­cy and safe­ty drug de­vel­op­ment with the man­date to speed new ap­provals. Got­tlieb re­cent­ly said he’d pre­fer to stay at the FDA, where his tal­ents lay, with­out ac­tu­al­ly rul­ing out a quick pro­mo­tion.

It ap­pears he may get his wish.

Deputy Health and Hu­man Ser­vices Sec­re­tary Alex Azar meets re­porters at de­part­ment head­quar­ters on June 8, 2006 to an­nounce the ap­proval of Gar­dasil, the first vac­cine de­vel­oped to pro­tect women against cer­vi­cal can­cer. AP Pho­to/Evan Vuc­ci

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

An un­ortho­dox pro­pos­al for Bio­gen's Medicare-man­dat­ed Aduhelm tri­al

Biogen has gone full blitz since Medicare announced it would only cover its new Alzheimer’s drug when used in clinical trials, accusing the agency of discriminating against Alzheimer’s patients and trying to get physicians to change regulators’ minds.  Critics, meanwhile, cheered what they see as a necessary wall protecting payers and patients from an unproven and unsafe drug.

Far less attention, though, has gone to what a Medicare-funded clinical trial would actually look like. Biogen has operated as if it would be a standard late-stage Alzheimer’s trial, enrolling a couple thousand patients and giving half placebo.

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