'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

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September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

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Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

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New York governor Andrew Cuomo (AP Images)

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