GSK déjà vu: Time for a top-down switch as new CEO tries to con­quer old R&D demons

Close to a decade ago, GSK CEO An­drew Wit­ty and R&D chief Mon­cef Slaoui de­cid­ed they need­ed to do some­thing new and dif­fer­ent to fire up a lack­lus­ter R&D group, look­ing to shock a sys­tem where re­searchers were far too fo­cused on hang­ing on to un­promis­ing drugs.

Now, new CEO Em­ma Walm­s­ley says she has in­her­it­ed the ex­act same prob­lem they vowed to fix.

Walm­s­ley notes the com­pa­ny needs new block­buster drugs that can bring in more than a bil­lion dol­lars each if she ex­pects to liv­en things up on the bot­tom line. An­a­lysts (hel­lo, GSK) have been say­ing the same thing for years, shak­ing their heads over the drug ap­provals that did come through with­out much chance of chang­ing the game in the dis­eases they ad­dressed.

The CEO im­me­di­ate­ly point­ed to the same source of the prob­lem as her pre­de­ces­sors: it’s the R&D group’s fault, where in­ves­ti­ga­tors are too en­trenched around the wrong as­sets.

“If you’ve been work­ing on an as­set for decades in R&D it’s very hard to de­cide it isn’t im­por­tant enough to take for­ward . . . so it’s not sur­pris­ing that peo­ple’s hu­man mo­ti­va­tion is to keep pro­gress­ing stuff,” the CEO said in an in­ter­view with the Fi­nan­cial Times.

Walm­s­ley’s de­ci­sion to shake things up comes with new au­thor­i­ty for her phar­ma chiefs — Jack Bai­ley and Luke Miels — to start call­ing the shots on what the pri­or­i­ties should be.  Wit­ty and Slaoui came up with DPUs, or Dis­cov­ery Per­for­mance Units, say­ing that each team had to jus­ti­fy their ex­is­tence at the end of the first three years, or else.

‘Or else’ turned out to be some new as­sign­ments, for a few re­searchers, though there was al­so plen­ty of dis­rup­tion with a ma­jor swap with No­var­tis or the US lay­offs that fol­lowed the R&D group’s poor per­for­mance.

Now, rather than look­ing for a bot­tom-up ap­proach to in­no­va­tion, GSK will go with a top-down stan­dard as Walm­s­ley kicks loose 30 pro­grams and adds new can­cer and im­muno-in­flam­ma­to­ry drugs as she shifts fo­cus to the key US mar­ket.

GSK al­so re­cent­ly de­cid­ed to shut­ter a neu­ro­sciences R&D group in Shang­hai, an­oth­er lega­cy of the Wit­ty/Slaoui regime. What comes next?

The big ques­tion for Walm­se­ly will be whether she can bring new life to a tor­pid and un­pro­duc­tive re­search arm that has been ham­mered by re­peat­ed cut­backs. For the rank and file, it’s time to face an old re­al­i­ty — again.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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