'Site-less' tri­als in mind, No­var­tis launch­es an app for oph­thal­mol­o­gy re­search

In the lat­est com­pa­ny move to em­brace all things dig­i­tal, No­var­tis has launched an app that it hopes will boost par­tic­i­pa­tion in its oph­thal­mol­o­gy tri­als.

The phar­ma gi­ant is call­ing the tech Fo­calView, and it’ll be used by re­searchers to track dis­ease pro­gres­sion in pa­tients with oph­thalmic dis­ease re­al-time. Pa­tients will self-re­port da­ta through the app that will guide clin­i­cal re­search, start­ing by tak­ing as­sess­ments like vi­su­al acu­ity and con­trast sen­si­tiv­i­ty tests.

Right now, da­ta col­lect­ed for these tri­als most­ly comes from clin­ics, and its first gath­ered by physi­cians through in­ter­ac­tions with pa­tients. By bring­ing the clin­ic in­to peo­ple’s homes via the app, No­var­tis is bank­ing on the idea that mak­ing tri­al par­tic­i­pa­tion easy will boost its da­ta stash

“Op­ti­miz­ing dig­i­tal tech­nol­o­gy in re­search and de­vel­op­ment, par­tic­u­lar­ly in oph­thalmic dis­ease, could have a marked im­pact on the qual­i­ty of the da­ta we cap­ture,” said Bertrand Bod­son, No­var­tis Chief Dig­i­tal Of­fi­cer in a state­ment.

A No­var­tis spokesper­son tells me the app is be­ing test­ed in a prospec­tive, non-in­ter­ven­tion­al study to check on its ef­fi­ca­cy.

“Re­searchers will as­sess ease of use, lev­el of en­roll­ments and the abil­i­ty to ob­tain im­por­tant doc­u­men­ta­tion for fu­ture clin­i­cal tri­al re­search. In the next phase, the app will be val­i­dat­ed against tra­di­tion­al vi­su­al test­ing that takes place with­in con­ven­tion­al clin­i­cal set­tings.”

Fo­calView, which was built on Ap­ple’s soft­ware Re­searchK­it, is live on the App Store in the U.S. No­var­tis is plan­ning to launch in ad­di­tion­al mar­kets in the fu­ture, ac­cord­ing to a com­pa­ny state­ment.

This new app is the lat­est in No­var­tis’ push to mod­ern­ize the phar­ma gi­ant by em­brac­ing tech where ever it can, the com­pa­ny said. The spokesper­son went as far as to say No­var­tis imag­ines it­self a “med­i­cines and da­ta sci­ence com­pa­ny” now.

“Dig­i­tal tech­nolo­gies and da­ta sci­ence have in­cred­i­ble po­ten­tial to un­lock the next chap­ter of med­ical in­no­va­tion and at No­var­tis we think that go­ing big on da­ta and dig­i­tal are key to No­var­tis’ fu­ture. No­var­tis is unique­ly po­si­tioned to lead the dig­i­tal rev­o­lu­tion in phar­ma by in­te­grat­ing tech­nolo­gies in­to every as­pect of No­var­tis’ ap­proach across R&D, reimag­in­ing No­var­tis as a ‘med­i­cines and da­ta sci­ence’ com­pa­ny.”

The lat­est ex­am­ple of the ef­fort is the com­pa­ny’s new part­ner­ship with Pear Ther­a­peu­tics, one of the pi­o­neers in dig­i­tal med­i­cine, to de­vel­op new mo­bile apps for pa­tients with schiz­o­phre­nia and mul­ti­ple scle­ro­sis. No­var­tis al­so re­cent­ly an­nounced an ex­pand­ed part­ner­ship with Sci­ence 37 to launch up to 10 col­lab­o­ra­tive re­search stud­ies over the next three years that blend vir­tu­al and tra­di­tion­al mod­els. The idea is to em­brace more “site-less” tri­als in the fu­ture.

The com­pa­ny says its al­so gone live with a da­ta sci­ence pro­gram it calls Nerve, which us­es pre­dic­tive an­a­lyt­ics to de­sign, mon­i­tor, and cull in­sights from the com­pa­ny’s hun­dreds of clin­i­cal tri­als around the world. That pro­gram is al­ready de­liv­er­ing a 10-15% re­duc­tion in pa­tient en­roll­ment times in pi­lot tri­als, a No­var­tis spokesper­son said.

Im­age: Shut­ter­stock

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



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Lynn Baxter, Viiv Healthcare's head of North America

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

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Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

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The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

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