Ver­tex COO Ian Smith oust­ed due to 'per­son­al be­hav­ior'; CFO Mats Blom ex­its Zealand Phar­ma; Ka­trine Bosley abrupt­ly ends Ed­i­tas reign

Ver­tex has oust­ed com­pa­ny COO and in­ter­im CFO Ian Smiththeir $6 mil­lion man — for per­son­al con­duct un­be­com­ing an ex­ec­u­tive at the com­pa­ny. The cys­tic fi­bro­sis drug de­vel­op­er says Smith’s ter­mi­na­tion “is the re­sult of per­son­al be­hav­ior that vi­o­lat­ed Ver­tex’s Code of Con­duct and val­ues and is un­re­lat­ed to the Com­pa­ny’s fi­nan­cial and busi­ness per­for­mance.” Chief ac­count­ing of­fi­cer Paul Sil­va will now step in as in­ter­im CFO while Ver­tex looks for a re­place­ment.

→ The cross pol­li­na­tion of ex­ec­u­tives be­tween Roche and its big biotech sub­sidiary Genen­tech is con­tin­u­ing to­day with news that the South San Fran­cis­co branch of the fam­i­ly is reel­ing back one of its for­mer ex­ecs in Basel to take the top job. Alexan­der Hardy, who start­ed at Genen­tech way back in 2005, will be tak­ing the helm March 1. He’s cur­rent­ly the head of glob­al prod­uct strat­e­gy at the big HQ base in Switzer­land, a job he land­ed af­ter a 2-year stint as head of Asia Pa­cif­ic. Hardy is tak­ing the place of Bill An­der­son, who moved to Switzer­land to be­come CEO of Roche Phar­ma­ceu­ti­cals Jan­u­ary 1 as Daniel O’Day made his move to Gilead.

Ka­trine Bosley

→ For close to 5 years now Ka­trine Bosley has led Ed­i­tas Med­i­cine $ED­IT through good times and bad, right to the thresh­old of dos­ing its first pa­tient in the pre­mier clin­i­cal study for its ground­break­ing gene-edit­ing tech. But the high-pro­file biotech CEO is un­ex­pect­ed­ly re­sign­ing from the com­pa­ny and abrupt­ly sev­er­ing her ties with the board as well. Ed­i­tas board mem­ber Cyn­thia Collins — the for­mer CEO at Hu­man Longevi­ty — is step­ping up to hold the post on an in­ter­im ba­sis, while the biotech looks for a re­place­ment.

→ Al­most two months af­ter Zealand Phar­ma an­nounced Britt Meel­by Jensen’s de­par­ture from the helm, the Copen­hagen-based com­pa­ny is see­ing off its CFO as well. Mats Blom’s re­main­ing tenure will over­lap briefly with that of new­ly ap­point­ed in­ter­im CEO Adam Steens­berg, who’s been serv­ing as EVP and chief med­ical and de­vel­op­ment of­fi­cer.

→ Days af­ter bag­ging a $100 mil­lion Se­ries B, Or­biMed-backed Apol­lomics has brought in two ex­ecs to prep for a year to be marked by a move from Hangzhou, Chi­na to Fos­ter City, CA and con­tin­ued ac­tiv­i­ties in its im­muno-on­col­o­gy pipeline. Wil­son Che­ung, for­mer­ly of KBP Bio­Sciences, is join­ing as CFO while biotech vet­er­an De­bra Thoma Vall­ner was named SVP, de­vel­op­ment op­er­a­tions. Most re­cent­ly at eF­FEC­TOR Ther­a­peu­tics, Vall­ner will now play a role in de­vel­op­ment strat­e­gy, pro­to­col de­sign, and the clin­i­cal tri­al port­fo­lio.

Anup Mar­da

Anup Mar­da has left a 17-year ca­reer at Bris­tol-My­ers Squibb to be­come CFO of Ca­balet­ta Bio, a Penn spin­out look­ing to jump­start hu­man stud­ies of a new-mod­el CAAR T cell ther­a­py aimed at au­toim­mune dis­eases

→ New York-based Neu­ro­gene has con­vinced Uni­ver­si­ty of Ed­in­burgh re­searcher Stu­art Cobb to spend half of his time lead­ing re­search for its nascent gene ther­a­py pipeline. He will help deep­en “ex­ist­ing aca­d­e­m­ic col­lab­o­ra­tions, es­tab­lish ad­di­tion­al part­ner­ships and pro­vide strate­gic guid­ance on nov­el tech­nolo­gies,” said CEO Rachel McMinn.

→ Hav­ing served as a “trust­ed ad­vi­sor” to the ex­ec­u­tive team at Flex­ion Ther­a­peu­tics $FLXN for the past nine years through a drug ap­proval and some buy­out buzz, Christi­na Will­w­erth has earned a spot in the C-suite. As chief strat­e­gy of­fi­cer, she will con­tin­ue some of the plan­ning and pri­or­i­ty set­ting work she took up as SVP of pro­gram man­age­ment and strat­e­gy, with ad­di­tion­al re­spon­si­bil­i­ties for port­fo­lio and hu­man re­sources.

Sanofi may have walked away from their re­search pact, but MyoKar­dia $MYOK is forg­ing ahead with com­mer­cial­iza­tion plans for its heart drug, ap­point­ing William Fairey as chief com­mer­cial of­fi­cer. An alum­ni of Acte­lion, Fairey was most re­cent­ly COO at Chemo­Cen­tryx. He will now plot the po­ten­tial launch mava­camten, which tar­gets the so-far un­tapped con­di­tion of ob­struc­tive hy­per­trophic car­diomy­opa­thy.

Jo­han Luth­man

→ With some pos­i­tive Phase II da­ta on its PTSD drug in hand, Lund­beck has re­cruit­ed Jo­han Luth­man to car­ry it — as well as the rest of the pipeline — for­ward as EVP and head of R&D. The ap­point­ment trig­gers a re­lo­ca­tion to Den­mark for Luth­man, a Swede who’s been liv­ing the in the US fol­low­ing a string of neu­rol­o­gy R&D roles at Ei­sai, Mer­ck, As­traZeneca and oth­ers.

→ As Sang­amo Ther­a­peu­tics $SG­MO braces for a “sig­nif­i­cant flow of clin­i­cal da­ta” from its gene edit­ing pro­grams, the Rich­mond, CA-based com­pa­ny has tapped Adri­an Woolf­son for the EVP of R&D po­si­tion. Woolf­son brings a back­ground in im­muno-on­col­o­gy, with a re­sume span­ning ge­net­ic can­cer vac­cine biotech Nous­com and Pfiz­er.

New boards have been es­tab­lished for Iron­wood and its biotech spin­out Cy­cle­ri­on. In­dus­try vet Julie McHugh will chair the Iron­wood board while Cy­cle­ri­on named Mar­sha Fanuc­ci — an ex-Gen­zyme/Mil­len­ni­um ex­ec — to the head of their new board.

Liz Bar­rett

Liz Bar­rett and George Golumbes­ki has joined the board of Sage Ther­a­peu­tics, lend­ing some heavy­weight sup­port for its cen­tral ner­vous sys­tem fo­cused pipeline, led by a post­par­tum de­pres­sion drug. While both Bar­rett and Golumbes­ki are work­ing in the can­cer field — Bar­rett as CEO of Uro­Gen af­ter a high-pro­file ex­it from No­var­tis and Golumbes­ki as pres­i­dent of can­cer de­tec­tion start­up Grail Cel­gene vet Golumbes­ki notes that his ca­reer start­ed in the CNS space.

→ As In­tel­lia Ther­a­peu­tics $NT­LA con­tin­ues down a path to first-in-hu­man stud­ies of its gene edit­ing tech, it will be get­ting ad­vice from Vi­da Ven­tures founder Fred Co­hen, its lat­est board di­rec­tor.

→ Hav­ing re­cent­ly closed an $85 mil­lion raise backed in part by GV, Schrödinger is ap­point­ing one of its ven­ture part­ners — and a fa­mil­iar face — to its board. Be­fore join­ing the fund for­mer­ly known as Google Ven­tures, Rosana Kapeller was found­ing CSO at Nim­bus, which ap­plied Schrödinger’s com­pu­ta­tion­al tech­nolo­gies in drug dis­cov­ery.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of 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.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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