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

Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.

H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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Takeda's trans­la­tion­al cell ther­a­py group revs up for a race to the clin­ic with off-the-shelf CAR-T

Four years after Takeda launched a wide-ranging induced pluripotent stem cell project with the researchers at Nobel prize-winning Shinya Yamanaka’s lab at the University of Kyoto, the pharma company is taking delivery of the first of what it hopes will be a whole pipeline of iPS cell-derived therapies that can deliver on the promise of off-the-shelf CAR-T therapies.

From here, Stefan Wildt — the head of pharma sciences and translational cell therapy at Takeda — and his group of 100-plus scientists will be charged with steering their way to the clinic as they build out the manufacturing and support work for this pipeline-in-the-making. 

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SJ Lee [File photo]

Go­ing in­side cells, Sung Joo Lee has sketched some big goals for his small — but glob­al — team of drug hunters

For a small biotech based in South Korea with a research arm in Cambridge, MA, Orum Therapeutics has sketched out some big goals aimed at developing antibodies for intracellular targets. And now they have a new $30 million round to push the work forward, aiming at a slate of currently undruggable quests.

Orum has been working on a platform tech out of Ajou University that relies on endocytosis to smuggle antibodies and their cargo inside a cell. They’ve published work in Nature that illustrates its preclinical potential in RAS mutations, and KRAS is on their list of targets. 

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