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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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