Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Mod­er­na CEO Stéphane Ban­cel made clear on the last quar­ter­ly call that “now is not the time to slow down.” On Thurs­day, he made a bit more room in the cock­pit.

Juan An­dres

The com­pa­ny un­veiled a new ex­ec­u­tive role on Thurs­day, pro­mot­ing for­mer chief tech­ni­cal op­er­a­tions and qual­i­ty of­fi­cer Juan An­dres to pres­i­dent of strate­gic part­ner­ships and en­ter­prise ex­pan­sion, and poach­ing a for­mer No­var­tis ex­ec to take his place.

Jerh Collins, who was most re­cent­ly chief cul­ture of­fi­cer at No­var­tis, will join Mod­er­na on Oct. 3 and as­sume the CTO po­si­tion on Jan. 1 as An­dres makes his tran­si­tion. Both ex­ecs will re­port di­rect­ly to Ban­cel.

It’s all part of what Ban­cel calls Mod­er­na’s “next phase of growth,” as he at­tempts to push be­yond the com­pa­ny’s rep­u­ta­tion as a Covid vac­cine com­pa­ny and build up the broad­er mR­NA plat­form. The team has a few late-stage projects wait­ing in the wings, in­clud­ing a res­pi­ra­to­ry syn­cy­tial virus (RSV) vac­cine pro­gram that’s head­ed for a read­out in the next year or so, and a flu pro­gram that Ban­cel is po­si­tion­ing for a po­ten­tial ac­cel­er­at­ed ap­proval next year.

Jerh Collins

Ban­cel said the new hires come as the com­pa­ny preps for “sev­er­al up­com­ing new prod­uct launch­es.”

Collins brings near­ly 30 years of No­var­tis ex­pe­ri­ence to the ta­ble, where he served a va­ri­ety of lead pro­duc­tion and man­u­fac­tur­ing roles. He not­ed that he’s worked with An­dres “for many years,” as the two both held long tenures at No­var­tis.

“I’m con­fi­dent that Jerh pos­sess­es the mind­set and ex­pe­ri­ence to ex­pand our pro­duc­tion foot­print as we grow glob­al­ly and in­ter­nal­ize more of our pro­duc­tion ca­pa­bil­i­ties,” he said in a news re­lease. The com­pa­ny was not im­me­di­ate­ly avail­able for an in­ter­view.

The news comes as the fed­er­al gov­ern­ment grap­ples with short­ages of the com­pa­ny’s re­cent­ly au­tho­rized bi­va­lent Covid boost­er shot caused by man­u­fac­tur­ing de­lays over a safe­ty in­spec­tion at Catal­ent’s In­di­ana plant. The FDA cleared an ad­di­tion­al five batch­es from the plant on Mon­day af­ter de­cid­ing they’re safe for use.

Mod­er­na’s first-gen vac­cine, Spike­vax, earned the com­pa­ny $17.7 bil­lion last year alone. How­ev­er, in an ef­fort to raise aware­ness for the rest of the pipeline, the com­pa­ny un­der­took a ma­jor re­brand in Ju­ly.

​​“We’re proud of be­ing a Covid com­pa­ny — that was the proof point of our tech­nol­o­gy,” chief brand of­fi­cer Kate Cronin told End­points News at the time. “But now we have 40-plus pro­grams that we’re study­ing, and we want the world to know we be­lieve in this tech­nol­o­gy, and there’s a fu­ture be­yond Covid.”

That in­cludes a cy­tomegalovirus (CMV) pro­gram, which was among the com­pa­ny’s lead pro­grams be­fore Covid-19 came around. CMV is a type of la­tent her­pes virus, and the most com­mon cause of in­fec­tion be­fore birth, ac­cord­ing to Mod­er­na. The com­pa­ny’s can­di­date, mR­NA-1647, is in Phase III tri­al to eval­u­ate con­gen­i­tal in­fec­tion, which is cur­rent­ly en­rolling.

Fur­ther along is the com­pa­ny’s sea­son­al flu vac­cine, mR­NA-1010, which is in a ful­ly en­rolled study in the south and is slat­ed for an ac­cel­er­at­ed ap­proval ap­pli­ca­tion next year.

As for RSV, a Phase III tri­al is “rapid­ly ad­vanc­ing to­ward com­ple­tion,” with a read­out ex­pect­ed in the 2022-2023 win­ter sea­son. Mod­er­na’s al­so ex­pect­ing a Phase II read­out from its pre­ci­sion can­cer vac­cine, mR­NA-4157, in com­bi­na­tion with Keytru­da in the fourth quar­ter of this year.

Com­bi­na­tion vac­cine tri­als cov­er­ing the flu, Covid and RSV should be launched this year as well, Mod­er­na said at a re­cent in­vestor event. And on the Q2 call, pres­i­dent Stephen Hoge re­vealed that the com­pa­ny’s been look­ing in­to a pre­clin­i­cal mon­key­pox pro­gram which could po­ten­tial­ly be ramped up “very quick­ly.”

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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