Bur­dened with for­mi­da­ble chal­lenges, such as in­con­sis­tent ac­cess and de­ploy­ment of care in ad­di­tion to the un­sus­tain­able cost of care, the US health­care sys­tem has laid the ground­work for the use of dig­i­tal tools to re­fresh the prac­tice of med­i­cine. In re­cent years, in ad­di­tion to the pen­e­tra­tion of tech gi­ants in­to the realm of health­care (cue Google, Ap­ple), ma­jor drug­mak­ers have al­so em­braced the sig­nif­i­cance of these tech­nolo­gies, hir­ing chief dig­i­tal/tech­nol­o­gy of­fi­cers to ush­er in the era of telemed­i­cine, wear­ables, cloud com­put­ing, ma­chine learn­ing and ar­ti­fi­cial in­tel­li­gence. On Tues­day, France’s Sanofi said its chief med­ical of­fi­cer Ameet Nath­wani would al­so serve as the com­pa­ny’s first chief dig­i­tal of­fi­cer (CDO).

Sanofi fol­lows its peers in mak­ing the move. Last year, Pfiz­er and Mer­ck named their CDOs, while No­var­tis and GSK an­nounced sim­i­lar ap­point­ments in 2017.

Nath­wani, who was hired by Sanofi as chief med­ical of­fi­cer in 2016, is now al­so charged with in­te­grat­ing Sanofi’s ar­se­nal of med­i­cines with dig­i­tal tech­nolo­gies and ink­ing dig­i­tal part­ner­ships.

The promise of dig­i­tal tech­nol­o­gy to po­ten­tial­ly de­moc­ra­tize med­i­cine, en­abling in­di­vid­u­als and re­searchers to gen­er­ate re­al-world da­ta, is an­oth­er rea­son dig­i­tal health tech­nolo­gies are so com­pelling. In the UK, for­mer health sec­re­tary Je­re­my Hunt com­mis­sioned Cal­i­for­nia-based Er­ic Topol, a car­di­ol­o­gist, au­thor and dig­i­tal med­i­cine re­searcher, to car­ry out an in­de­pen­dent re­view in­to the dig­i­tal train­ing needs of NHS staff. The re­port was re­leased on Mon­day, de­tail­ing the promise of ge­nomics, AI, ro­bot­ics and dig­i­tal med­i­cine in the pre­ven­tion, man­age­ment and treat­ment of dis­ease, and high­light­ed the im­por­tance of ed­u­cat­ing the NHS work­force of these ad­vances.

To­day, here in Lon­don, a thrill to fi­nal­ly hold our new re­port for @NHSEn­g­land @MattHancock @DHSC­govuk. As far as I know, the 1st coun­try to plan #health­care w/ #AI, #ge­nomics, dig­i­tal (and to 2040!). On­line, #OA to­mor­row, thanks to the great work @NHS_HealthE­dEng pic.twit­ter.com/HjxH4naY­GR

— Er­ic Topol (@Er­ic­Topol) Feb­ru­ary 10, 2019

Na­ture too has rec­og­nized the trans­for­ma­tive po­ten­tial of dig­i­tal med­i­cine. In an ar­ti­cle en­ti­tled “Dig­i­tal med­i­cine, on its way to be­ing just plain med­i­cine,” the jour­nal sig­nalled the launch of its peer-re­viewed jour­nal fo­cused specif­i­cal­ly on the dig­i­ti­za­tion of med­i­cine last year.

Pho­to: Ameet Nath­wani. SANOFI

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”