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

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

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'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

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Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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