Tech gi­ants have pen­e­trat­ed the realm of health­care. Mean­while, the bio­phar­ma­ceu­ti­cal in­dus­try has em­braced the promise of dig­i­tal drug de­vel­op­ment and med­i­cine as it ush­ers in the era of telemed­i­cine, wear­ables, cloud com­put­ing, ma­chine learn­ing and ar­ti­fi­cial in­tel­li­gence. No­var­tis, which was one of the pi­o­neer­ing large drug­mak­ers to hire a chief dig­i­tal/tech­nol­o­gy of­fi­cer in 2017, has now tied up with the wide­ly used cloud plat­form Ama­zon Web Ser­vices to stream­line its man­u­fac­tur­ing, sup­ply chain, and de­liv­ery op­er­a­tions.

The tech­nol­o­gy will be used to give No­var­tis sci­en­tists and re­searchers re­al-time vis­i­bil­i­ty in­to the Swiss drug­mak­er’s man­u­fac­tur­ing and dis­tri­b­u­tion ap­pa­ra­tus, en­abling teams to track pro­duc­tion lines, di­ag­nose po­ten­tial bot­tle­necks, de­tect risks to man­u­fac­tur­ing and ramp up pro­duc­tion of per­son­al­ized treat­ments.

No­var­tis’ for­ay in­to cell ther­a­pies — as the man­u­fac­tur­er of Kym­ri­ah, one of two FDA ap­proved CAR-T ther­a­pies — was cloud­ed by ini­tial­ly un­der­whelm­ing sales, as its ex­pen­sive price tag and slow, com­plex au­tol­o­gous man­u­fac­tur­ing process (marred by hic­cups) slowed adop­tion. Even­tu­al­ly, the drug­mak­er swal­lowed a cell and gene ther­a­py man­u­fac­tur­er in an at­tempt to un­clog the com­mer­cial roll­out. Mean­while, No­var­tis al­so scored the land­mark US ap­proval for its gene ther­a­py, Zol­gens­ma, which costs a hefty $2 mil­lion per pa­tient.

Vas Narasimhan

In a third-quar­ter earn­ings con­fer­ence call in Oc­to­ber, No­var­tis ex­ec­u­tives un­der­scored their com­mit­ment to im­prov­ing their man­u­fac­tur­ing prowess in re­la­tion to cell and gene ther­a­pies. The com­pa­ny’s ca­pac­i­ty to man­u­fac­ture has gone up by 60% be­tween the first and third quar­ters, it said.

“(W)e have with the cell and gene tech­nol­o­gy had to take some hit on our gross mar­gins, par­tic­u­lar­ly in on­col­o­gy with CART ther­a­py. Our as­pi­ra­tion is now to start to im­prove that and get that back up now in the com­ing year,” chief Vas Narasimhan said.

Late last month, No­var­tis told Reuters it had set aside $500 mil­lion to scale up its gene ther­a­py man­u­fac­tur­ing ef­forts.

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.