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.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US, UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal a Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as “Cozy Bear,” that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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