Hal Barron, GSK R&D chief

Build­ing up its AI op­er­a­tions, GSK opens a $13M Lon­don hub with plans to woo tal­ent now trekking to Sil­i­con Val­ley

Con­tin­u­ing its ef­forts to ramp up glob­al AI op­er­a­tions, Glax­o­SmithK­line has opened a £10 mil­lion ($13 mil­lion-plus) re­search base in Kings Cross, Lon­don.

The AI hotspot is al­ready home to Google’s Deep­Mind, and the Fran­cis Crick and Alan Tur­ing re­search in­sti­tutes. GSK said it hopes to “tap in­to the huge Lon­don tech tal­ent pool” and at­tract can­di­dates who might oth­er­wise head to Sil­i­con Val­ley.

“It’s a vi­brant ecosys­tem that has every­thing from out­stand­ing med­i­cine as well as al­so be­ing a big tech cor­ri­dor. Deep­Mind is there. Google is there. It’s near the Crick In­sti­tute, and of course mod­ern com­put­ing was born, ba­si­cal­ly, with Alan Tur­ing and the Tur­ing In­sti­tute,” GSK R&D pres­i­dent Hal Bar­ron said at a Lon­don Tech Week fire­side chat. “So we are quite con­vinced that both the tal­ent and the ecosys­tem will en­able us to build a very vi­brant hub in Lon­don, get­ting the top tal­ent, the best thinkers and peo­ple to be able to in­ter­act with us in GSK to take tech­nol­o­gy and help us turn it in­to med­i­cines.”

The com­pa­ny be­lieves AI has the pow­er to vast­ly im­prove its drug dis­cov­ery process. It claims that ge­net­i­cal­ly val­i­dat­ed drugs are twice as like­ly to be suc­cess­ful. And GSK has lots of ge­net­ic da­ta to work with. The new work­space, lo­cat­ed in the Stan­ley Build­ing, has al­ready lured in 30 sci­en­tists, 10 of whom are in the com­pa­ny’s AI fel­low pro­gram.

In fact, many biotechs are now turn­ing to AI, which they be­lieve can speed up suc­cess­ful de­vel­op­ment by an­a­lyz­ing hun­dreds of genes at once or rapid­ly screen­ing bil­lions of mol­e­cules.

“GSK is fo­cused on find­ing bet­ter med­i­cines and vac­cines — not just bet­ter prod­ucts, but find­ing them in bet­ter ways, so we are us­ing func­tion­al ge­nomics, hu­man ge­net­ics and ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing,” the com­pa­ny said in a state­ment.

Tony Wood

It al­so has AI re­searchers based in San Fran­cis­co and Boston, and aims to reach 100 AI-fo­cused em­ploy­ees by mid-2021. “Our goal is to have the best and bright­est peo­ple in the world to join us,” Bar­ron said.

“In AI, we are scour­ing the plan­et for the best peo­ple. These folks are very rare to find. Com­pe­ti­tion is high and there aren’t a large num­ber of them,” Tony Wood, GSK’s SVP of med­i­c­i­nal sci­ence and tech­nol­o­gy, told The Guardian in De­cem­ber.

The new Lon­don hub has the ca­pac­i­ty for 60 to 80 staff mem­bers. Now all that’s left to do is fill it.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.