Elizabeth Nabel (Elise Amendola/AP Images)

Eliz­a­beth Nabel steps down as pres­i­dent of Brigham and Wom­en's Hos­pi­tal to team up with hus­band's biotech joint — re­port

The pres­i­dent of Brigham and Women’s Hos­pi­tal, a renowned non­prof­it med­ical cen­ter in Boston, is re­port­ed­ly step­ping down from her po­si­tion to join her hus­band — Sanofi’s for­mer CSO — in the biotech sec­tor.

Eliz­a­beth Nabel and BWH an­nounced she would de­part as pres­i­dent on March 1 af­ter spend­ing 11 years at the hos­pi­tal. She will team up with her hus­band, Gary Nabel, who left the top R&D job at Sanofi in Oc­to­ber to launch his own biotech de­vel­op­ing im­mune ther­a­pies for can­cer and in­fec­tious dis­eases, ac­cord­ing to the Boston Globe

“I re­al­ly want to spend time dri­ving biotech in­no­va­tion by ad­vis­ing com­pa­nies and serv­ing on boards,” she told the Globe. “This is where I be­lieve I can have the great­est im­pact.”

It’s not im­me­di­ate­ly clear how far off the ground the Nabels’ new biotech is. BWH de­clined to com­ment to End­points News on Eliz­a­beth Nabel’s be­half.

Nabel has served as the pres­i­dent of BWH for the last 11 years, and told the Globe she had planned to step down af­ter a decade at the helm. But the Covid-19 pan­dem­ic com­pli­cat­ed mat­ters and she de­cid­ed to stay on un­til the first vac­cines had been au­tho­rized.

Her run at BWH has been high­ly suc­cess­ful for the hos­pi­tal, as she led fundrais­ing ef­forts since 2010 that have brought in $1.75 bil­lion, rough­ly half of which went to re­search. She al­so helped grow the hos­pi­tal’s rev­enue to $5 bil­lion per year.

Nabel’s role as pres­i­dent hasn’t been her on­ly job over that time pe­ri­od, how­ev­er, as she was a board mem­ber for Mod­er­na from 2015 un­til this past Ju­ly. She re­signed from that po­si­tion, fol­low­ing OWS chief Mon­cef Slaoui out the door, af­ter in­creas­ing scruti­ny in­to the tim­ing of Mod­er­na ex­ec­u­tives’ stock trans­ac­tions.

Specif­i­cal­ly with re­gards to Nabel, con­cerns arose over the op­tics of Nabel run­ning a hos­pi­tal where Mod­er­na test­ed its Covid-19 vac­cines. At the time, Flag­ship chief and Mod­er­na chair Noubar Afeyan said the move was made out of “an abun­dance of cau­tion” to avoid the ap­pear­ance of a con­flict of in­ter­est.

BWH had not be­gun re­cruit­ing par­tic­i­pants for Mod­er­na’s Phase III study when Nabel re­signed, and was one of 87 sites na­tion­wide where vol­un­teers re­ceived dos­es of the now-au­tho­rized vac­cine.

On Ju­ly 15, Nabel re­deemed about 60,000 of an avail­able 168,868 Mod­er­na stock op­tions, and sub­se­quent­ly sold 73,975 shares as part of a trad­ing plan re­vised in late May. The sale net­ted Nabel $6.5 mil­lion.

Sim­i­lar trad­ing plans en­act­ed by Mod­er­na ex­ecs Stéphane Ban­cel, Stephen Hoge and Tal Zaks drew heavy me­dia at­ten­tion last year, as Zaks’ plan was amend­ed in March and Hoge’s in June. Ban­cel’s had been in place since 2018.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.