This is it? GSK rolls out a buzzy new R&D plan long on as­pi­ra­tions and short on per­for­mance goals

Glax­o­SmithK­line set out to kick­start some en­thu­si­asm for its pipeline this morn­ing. But CEO Em­ma Walm­s­ley and her new R&D chief Hal Bar­ron clear­ly have a lot more work cut out for them on that crit­i­cal point.

Its quar­ter­ly re­port high­lights a strat­e­gy in R&D that will be heav­i­ly fo­cused on the im­mune sys­tem and hu­man ge­net­ics — two well es­tab­lished fields that long ago at­tract­ed the at­ten­tion of just about every­one work­ing in drug de­vel­op­ment these days. And they signed up 23andMe — pay­ing $300 mil­lion to buy in and gain ex­clu­sive ac­cess to its da­ta base — to help ex­plore dis­ease rel­e­vant genes, herald­ing a “ma­jor ad­vance” while adding to a slate of al­liances on ge­net­ics the Lon­don-based gi­ant has al­ready com­plet­ed.

The phar­ma gi­ant says it will fo­cus more on CRISPR tech, with an em­pha­sis on ma­chine learn­ing and com­pu­ta­tion­al de­sign — a cou­ple of buzzy fea­tures that have al­so been mak­ing the rounds late­ly.

There’s a com­ment on cul­ture:

GSK al­so in­tends to pro­mote a cul­ture of in­creased ac­count­abil­i­ty and smart risk-tak­ing. This will in­clude re­defin­ing suc­cess and fos­ter­ing a cul­ture of truth-seek­ing ver­sus pro­gres­sion- seek­ing, and op­ti­mised port­fo­lio de­ci­sion-mak­ing, along­side im­ple­men­ta­tion of a new ro­bust gov­er­nance mod­el. Tar­get­ed busi­ness de­vel­op­ment to strength­en the Group’s pipeline and tech­nol­o­gy ca­pa­bil­i­ties will al­so be part of the new R&D ap­proach. 

And then there’s the po­ten­tial. Look­ing to make a come­back in phar­ma R&D, GSK tout­ed a BC­MA ther­a­py in de­vel­op­ment — hard­ly the first. HIV al­so war­rants a men­tion, though that will be cen­tered in its ma­jor­i­ty-owned sub­sidiary Vi­iV,  which has been mak­ing sig­nif­i­cant ad­vances along­side the vac­cines group.

With lit­tle in the way of specifics to of­fer from the phar­ma side in the near term, GSK is vague­ly promis­ing big things be­yond 2020.

In a con­fer­ence call with re­porters to­day — at least the ones that weren’t al­lowed a pre­view — Bar­ron and 23andMe chief Anne Wo­j­ci­c­ki hit the dis­cov­ery an­gle hard, high­light­ing what they see as an op­por­tu­ni­ty to find gene vari­ants for Parkin­son’s and can­cer and oth­er dis­eases that would make good new pro­grams.

I asked Bar­ron for his as­sess­ment of the R&D op­er­a­tion he had tak­en on. He em­pha­sized the pos­i­tive, but al­so ac­knowl­edged the weak­ness­es.

“I think it’s im­por­tant to look back at what GSK has done well,” he replied. There have been a num­ber of new ap­provals, he said, but with­out the kind of com­mer­cial im­pact that can gen­er­ate the num­bers the com­pa­ny needs. This new al­liance with 23andMe, he said, of­fered the chance to get at that — with new tar­gets that could be suit­able for mul­ti­ple ap­provals and bet­ter life cy­cle man­age­ment of im­por­tant new drugs.

I tried to fol­low up with a ques­tion on whether GSK had a dis­cov­ery or late-stage drug prob­lem, but got cut off on the call.

GSK brought in the leg­endary Genen­tech vet to turn around what is per­haps the slow­est, most woe­ful Big Phar­ma R&D group in the world. A ge­net­ics data­base deal with 23andMe will of­fer no short-term help, of­fer­ing a leg up for dis­cov­ery work that will be years in the mak­ing. And Bar­ron will try to or­ches­trate the turn­around from his base in the Bay Area, far from GSK’s cen­tral re­search op­er­a­tions around Philadel­phia and Steve­nage in the UK.

De­spite a bud­get of $6 bil­lion, Glax­o­SmithK­line has had lit­tle in the late-stage pipeline to boast about — and the late-stage pipeline is what is used to judge a com­pa­ny’s po­ten­tial in turn­ing out block­busters.

GSK’s phar­ma R&D group doesn’t make block­busters, though. Or hasn’t in years. And adopt­ing a strat­e­gy that any busi­ness school grad­u­ate could have whipped up one af­ter­noon won’t gin up miss­ing ex­cite­ment in the in­vest­ment com­mu­ni­ty.


Im­age: Hal Bar­ron. GSK

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Michel Vounatsos, Biogen CEO (Biogen via YouTube)

Damn the crit­ics, Bio­gen CEO Vounatsos or­ders full speed ahead on prep­ping a con­tro­ver­sial ad­u­canum­ab launch as FDA de­ci­sion looms

Right now one of the most interesting parlor games on Wall Street is offering odds on Biogen’s chances of getting an FDA OK on their controversial Alzheimer’s drug aducanumab.

For most objective players, it looks about like a coin toss, maybe a little worse than 50/50, as the Street balances the bull case of a full, mega blockbuster approval, a restricted approval or a disastrous order to go back to the clinic and mount a new Phase III. That last option was clearly the guidance most of the outside experts in the panel review offered the agency, as the industry is still puzzling out the question of whether or not the FDA is getting tougher in its oversight of drug development.

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