Top No­var­tis man­u­fac­tur­ing ex­ec jumps ship, takes charge of in­dus­tri­al­iz­ing Mod­er­na’s mR­NA tech

A lit­tle over a year ago No­var­tis’ CEO Joe Jimenez put Juan An­dres in charge of a move to slice a bil­lion dol­lars out of the glob­al man­u­fac­tur­ing bud­get through a cen­tral­ized ser­vices project. It was a clas­sic No­var­tis move, win­kling out costs in its nev­er-end­ing stream­lin­ing ef­fort that had al­ready seen it re­vamp man­u­fac­tur­ing, with 25 fa­cil­i­ties re­struc­tured or di­vest­ed over a 6-year pe­ri­od.

Now An­dres is tak­ing his Big Man­u­fac­tur­ing skills gained in Big Phar­ma — in­clud­ing the pi­o­neer­ing work done on CAR-T man­u­fac­tur­ing — and putting it to work for Mod­er­na as the biotech preps its own cen­tral man­u­fac­tur­ing site for its mR­NA plat­form. Of­fi­cial­ly, he’s hand­ing in his ti­tle as glob­al head tech­ni­cal op­er­a­tions (man­u­fac­tur­ing and sup­ply) at No­var­tis for se­nior vice pres­i­dent of
late stage tech­ni­cal de­vel­op­ment and man­u­fac­tur­ing (be­yond hu­man proof of con­cept) for Mod­er­na.

With An­dres’ ar­rival, Steve Harbin, who had been SVP for man­u­fac­tur­ing, is tran­si­tion­ing to new roles as chief of staff and chief sus­tain­abil­i­ty of­fi­cer.

“That was a big move and a big change,” An­dres tells me about his work for No­var­tis, which al­so in­volved spin­ning off fa­cil­i­ties to GSK and Eli Lil­ly in an in­te­gra­tion ef­fort that in­volved 30,000 staffers.

Stephane Ban­cel, Mod­er­na CEO

The key part of his job now is col­lect­ing the pieces of man­u­fac­tur­ing that Mod­er­na as­sem­bled for its pre­clin­i­cal and ear­ly-stage re­search ef­forts and ramp­ing up a new fa­cil­i­ty in Nor­wood, MA that will be staffed by about 200 em­ploy­ees, with a high lev­el of au­toma­tion built in.

“I’m just try­ing to get my hands around it,” An­dres tells me, about 48 hours af­ter he of­fi­cial­ly be­gan his new job. Strate­gi­cal­ly, it’s An­dres’ job “to start the in­dus­tri­al­iza­tion of the plat­form, which is re­al­ly, re­al­ly im­por­tant as the pro­grams ad­vance.”

His job at No­var­tis gave him a bird’s eye view of the CAR-T man­u­fac­tur­ing that No­var­tis set up for its per­son­al­ized can­cer cell ther­a­py, which is like­ly go­ing to be the first such ther­a­py ap­proved. And both Mod­er­na CEO Stephane Ban­cel and An­dres be­lieve that one-on-one man­u­fac­tur­ing ex­pe­ri­ence will be key to scal­ing up pro­duc­tion of mR­NA prod­ucts ap­proved for use around the world.

For No­var­tis, it’s the lat­est ex­am­ple of a top ex­ec jump­ing ship for an­oth­er job in biotech. For Mod­er­na, it’s an­oth­er ex­am­ple of the biotech’s zeal for re­cruit­ing high pro­file ex­ecs for its se­nior staff and board, where Flag­ship chief and Mod­er­na co-founder Noubar Afeyan is chair­man.

Flag­ship founder and CEO Noubar Afeyan

Mod­er­na isn’t just try­ing to pi­o­neer a new tech­nol­o­gy. It in­tends to forge a whole new com­pa­ny-build­ing mod­el for biotech, start­ing with rais­ing close to $2 bil­lion as it was prepar­ing a leap in­to the clin­ic. That process in­volved mul­ti­ple part­ners like Mer­ck and As­traZeneca — with Alex­ion drop­ping out re­cent­ly — as the grow­ing crew of more than 400 staffers tar­get­ed the first dozen clin­i­cal pro­grams.  The new man­u­fac­tur­ing site will em­ploy 200, and stay­ing true to its big am­bi­tions, Mod­er­na has al­ready blue­print­ed plant num­ber two.

Win­ning here would be huge. Los­ing would be a colos­sal cat­a­stro­phe. And An­dres knows what he’s get­ting in­to.

“Mak­ing a move like this is very risky,” he tells me frankly. But at the same time he’s known Ban­cel for 15 years, and he’s ea­ger to trans­late the sci­en­tif­ic work they’ve been do­ing to the CMC work he spe­cial­izes in, at an in­dus­tri­al scale.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

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