No­var­tis teams up with Ox­ford re­searchers to crunch big da­ta in­to clin­i­cal in­sights

Since Vas Narasimhan’s Day 1 as CEO of No­var­tis, he has cham­pi­oned da­ta sci­ence and dig­i­tal tech­nolo­gies as a key pri­or­i­ty at the phar­ma gi­ant. Al­most a year in­to his tenure, in a re­cent con­ver­sa­tion with the tech VC firm An­dreessen Horowitz, he high­light­ed the abil­i­ties to an­a­lyze pathol­o­gy im­ages and cen­tral­ize clin­i­cal tri­al plan­ning as two promis­ing ap­pli­ca­tions of ma­chine learn­ing.

But, he ad­mit­ted, there are ar­eas where it’s “sim­ply not met up”:

Vas­ant Narasimhan

The Holy Grail of hav­ing un­struc­tured ma­chine learn­ing go in­to big clin­i­cal da­ta lakes and then sud­den­ly find­ing new in­sights, we’ve not been able to crack, most­ly be­cause the da­ta… to link it up… We are spend­ing a lot of our en­er­gy just try­ing to get all of our da­ta har­mo­nized, so that some al­go­rithm could maybe find any­thing of use.

It ap­pears that No­var­tis is now ready to dive in­to that lake with the help of an es­teemed aca­d­e­m­ic part­ner.

The Swiss drug­mak­er has two projects in mind to kick off the 5-year re­search al­liance with the Big Da­ta In­sti­tute at the Uni­ver­si­ty of Ox­ford. The first one will fo­cus on mul­ti­ple scle­ro­sis, lever­ag­ing clin­i­cal and mag­net­ic res­o­nance imag­ing, or MRI, da­ta of 35,000-plus pa­tients in hopes of un­der­stand­ing pat­terns and dis­ease pro­gres­sion. Ul­ti­mate­ly, the com­pa­ny says, the ex­er­cise should make clin­i­cal tri­als more ef­fi­cient and tar­get­ed.

For the sec­ond project, No­var­tis wants the BDI to de­ploy its deep learn­ing al­go­rithm across dif­fer­ent datasets — imag­ing, pro­teom­ic, ge­nom­ic, clin­i­cal — from more than 11,000 pa­tients who have tak­en its in­ter­leukin-17 in­hibitor, Cosen­tyx. The hope is to en­able quick­er di­ag­no­sis and ex­plore com­mon­al­i­ties be­tween dis­eases treat­ed by the drug, in­clud­ing pso­ri­a­sis, pso­ri­at­ic arthri­tis, anky­los­ing spondyli­tis and rheuma­toid arthri­tis.

These in­di­vid­u­als, though, on­ly rep­re­sent a frac­tion of the pool of pa­tients No­var­tis and BDI are pulling da­ta from. With ac­cess to da­ta from UK Biobank, Ge­nomics Eng­land and Chi­na Kadoorie Biobank, the al­liance will draw on a to­tal of 5 mil­lion pa­tients — a num­ber re­flec­tive of No­var­tis’ am­bi­tion to adopt da­ta sci­ence in clin­i­cal re­search at scale, spokesper­son Er­ic Al­thoff tells End­points News in an email.

We asked what the op­er­a­tion will look like on the ground, and here’s their re­sponse:

Ox­ford is build­ing an IT en­vi­ron­ment for the col­lab­o­ra­tion – they will host the en­vi­ron­ment and NVS is sup­port­ing the build.

To­day we have ap­prox 20 peo­ple from Ox­ford and 20 peo­ple from NVS in­volved – this in­cludes da­ta wran­gling ex­perts, da­ta sci­en­tists, sta­tis­ti­cians, IT ex­perts and clin­i­cal ex­perts.

No­var­tis added that oth­er part­ners like the Med­ical Re­search Coun­cil Har­well In­sti­tute and Ox­ford’s De­part­ment of Sta­tis­tics will al­so play a role.


Fea­tured im­age: Ox­ford’s Big Da­ta In­sti­tute. OX­FORD via YOUTUBE

An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Can an FDA hus­tle up on trastuzum­ab be far be­hind?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Mer­ck Serono’s Se­nior Vice Pres­i­dent and Glob­al Head of On­col­o­gy
EL­LIOTT LEVY — Am­gen’s Se­nior Vice Pres­i­dent of Glob­al De­vel­op­ment
CHRIS BOSHOFF — Pfiz­er On­col­o­gy’s Chief De­vel­op­ment Of­fi­cer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Ver­sant-backed Chi­nook gets a $65M launch round for its dis­cov­ery quest in a resur­gent kid­ney field

Versant is once again stepping off the beaten track in biotech to see if they can blaze a trail of their own in a field that has looked too thorny to many investors for years.

The venture group and their partners at Apple Tree are bringing their latest creation out of stealth mode today. Born in Versant’s Inception Sciences’ Chinook Therapeutics is betting that its preclinical take on kidney disease can get an early lead among the companies starting up in the field.

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

Using a laptop borrowed from his former employer, South London’s St George’s Hospital, Sir Andrew Dillon set about establishing NICE — launched by the then health secretary Frank Dobson — in 1999.  On Thursday, the UK cost-effectiveness watchdog said its first and only chief executive — Dillon — is stepping down in March 2020.

Back in the day, decisions about which drugs and interventions were funded by the National Health Service (NHS) were made at the local level, but this ‘postcode prescribing’ system was fraught with skewed healthcare deployment making the structure unsustainable. A national system was deemed necessary — and NICE was formed to bridge that gap.

Eight weeks be­tween each HIV treat­ment? GSK notch­es PhI­II win as it chas­es OK for long-act­ing reg­i­men

GSK has cleared another test in its grand plan to topple Gilead’s HIV dominance by offering alternative treatments that consist of fewer drugs and last longer. A year after scoring positive Phase III data on a four-week course of cabotegravir and rilpivirine, its ViiV subsidiary now says that an eight-week regimen seem to work just as well.

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Finch grabs a $53M round de­signed to take their ‘break­through’ mi­cro­bio­me treat­ment through a po­ten­tial­ly piv­otal tri­al

With a breakthrough designation in one hand and a fresh $53 million in venture backing in the other, Somerville, MA-based Finch Therapeutics is taking a shot at a one-trial pathway to a possible FDA OK for their new treatment for preventing recurrent C. difficile infections.

The funding brings their total raise for the microbiome company to $130 million, CEO Mark Smith tells me — enough money to pave a runway past the FDA approval they’ve sketched into the most optimistic version for their near-term future. 

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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