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

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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