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.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.