For­mer J&J VP sues phar­ma gi­ant for discim­i­na­tion and ha­rass­ment, ac­cus­es top ex­ecs — in­clud­ing Alex Gorsky — of re­tal­i­at­ing against her

A for­mer J&J ex­ec has filed a law­suit against the phar­ma gi­ant for gen­der dis­crim­i­na­tion, un­equal pay and re­tal­i­a­tion lead­ing to what she al­leges is an abrupt and wrong­ful ter­mi­na­tion to her 25-year ca­reer at the com­pa­ny.

Gi­na Bilot­ti — who ex­it­ed J&J in May af­ter climb­ing the ranks through sup­ply chain, com­mer­cial, and R&D to vice pres­i­dent roles — named and ac­cused three top ex­ecs of ha­rass­ing, “os­tra­ciz­ing and mar­gin­al­iz­ing” her. And when she tried to raise the is­sue, the high­est lev­els of man­age­ment al­leged­ly “par­tic­i­pat­ed in and con­doned the re­tal­i­a­tion” against her.

Over two years of com­plain­ing with­in the com­pa­ny, Bilot­ti claimed the “re­tal­ia­to­ry abuse and be­tray­al” has left her ill both phys­i­cal­ly and emo­tion­al­ly.

De­fen­dant J&J and its CEO Alex Gorsky pub­licly claim to pro­mote di­ver­si­ty and in­clu­sion. J&J con­sis­tent­ly tells its em­ploy­ees that it is com­mit­ted to a ha­rass­ment and re­tal­i­a­tion-free work­place and en­cour­ages em­ploy­ees to feel safe to raise their con­cerns. These words are be­lied by J&J’s deeds. Just as J&J has lied for decades about the as­bestos in its ba­by pow­der, which it pro­mot­ed to women as a fem­i­nine hy­giene prod­uct know­ing that it caused ovar­i­an can­cer, J&J’s ac­tu­al em­ploy­ment prac­tices are the op­po­site of its claims of valu­ing, re­spect­ing, and lis­ten­ing to women and mi­nor­i­ty em­ploy­ees. These lies have im­pact­ed all fe­male em­ploy­ees of J&J.

The ac­cu­sa­tions of dis­crim­i­na­tion cen­tered around three men. Bilot­ti al­leged that Janssen CFO Dar­ren Snell­grove ig­nored her re­quests for meet­ings, talked to her in de­mean­ing ways (telling her to “shut up”) and, when she protest­ed a mis­rep­re­sen­ta­tion of her per­for­mance, threat­ened to cut her bud­get.

She ac­cused Math­ai Mam­men, glob­al head of R&D, of ma­nip­u­lat­ing and ex­ploit­ing their friend­ship as he was set­tling in­to the job, pres­sur­ing her in­to giv­ing him ac­cess to her per­son­al Face­book page, and then chang­ing his at­ti­tude to­ward her up­on learn­ing that she iden­ti­fies as gay.

To­geth­er with Troy Sarich — who at the time was head of strat­e­gy un­der Mam­men — Snell­grove and Mam­men al­leged­ly ex­clud­ed Bilot­ti from im­por­tant con­ver­sa­tions, even sidelin­ing her and mock­ing her when she was present.

Af­ter bring­ing the is­sues up to HR and sub­se­quent­ly re­ceiv­ing the “worst mid-year per­for­mance re­view” in 2018, Bilot­ti ap­pealed to both J&J CSO Paul Stof­fels and Gorsky that Oc­to­ber in an at­tempt to sal­vage her ca­reer, ac­cord­ing to the law­suit. De­spite al­leged ac­knowl­edg­ment of a “big, big prob­lem” and promis­es to fol­low up, though, they didn’t give her the pro­tec­tion she sought. Rather, as soon as she met with them, she was al­leged­ly re­moved from high-lev­el roles, sub­ject­ed to an ex­pens­es au­dit and forced in­to a $90,000 pay cut.

Im­me­di­ate­ly af­ter seek­ing help from CEO Gorsky, Plain­tiff ex­pe­ri­enced an es­ca­la­tion in the dis­man­tling of her re­spon­si­bil­i­ties and, in the end, her ca­reer. Gorsky clear­ly par­tic­i­pat­ed in in­creas­ing the re­tal­i­a­tion against Plain­tiff for her com­plaints about dis­crim­i­na­tion, ha­rass­ment and re­tal­i­a­tion against her per­son­al­ly – and against women, gays and mi­nori­ties in gen­er­al.

In re­sponse to an in­quiry, J&J said in a state­ment: “We take any claims about em­ploy­ee con­duct se­ri­ous­ly. We have in­ves­ti­gat­ed and can con­firm that the al­le­ga­tions of dis­crim­i­na­tion and re­tal­i­a­tion have no mer­it.”

The com­pa­ny, how­ev­er, de­clined to pro­vide de­tails on the na­ture and tim­ing of the in­ves­ti­ga­tion.

Bilot­ti not­ed in her law­suit, filed in the state court of New Jer­sey, that she was in­formed by J&J in May 2019 that her ac­cu­sa­tions were not “found cred­i­ble.” On that same day, she was al­leged­ly told by the le­gal coun­sel her fi­nan­cial au­dit “did not look good” and ad­vised to sign off on an ex­it arrange­ment in or­der to keep her pen­sion and med­ical ben­e­fits — which to her amount­ed to a threat.

Of­fered a project-based role in Au­gust with a con­tract that would end in Feb­ru­ary 2020 and un­der stress, Bilot­ti took a dis­abil­i­ty leave in No­vem­ber. She re­turned this May — and was then ter­mi­nat­ed.

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.