'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: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

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The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Pascal Soriot, AstraZeneca CEO (AP Images)

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While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

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“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

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Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.