Jeannie Lee explains her epigenetic research after she was selected as the 2016 winner of the Lurie Prize in Biomedical Sciences. (Foundation for the National Institutes of Health via YouTube)

HH­MI dis­crim­i­nat­ed against two Asian Amer­i­can women in­ves­ti­ga­tors, law­suits al­lege

Howard Hugh­es Med­ical In­sti­tute — the not­ed non­prof­it known for dol­ing out gen­er­ous in­ves­ti­ga­tor awards to re­searchers all around the US — is fac­ing law­suits by two Asian Amer­i­can bi­ol­o­gists who al­lege they were un­fair­ly de­nied re­new­al of grants be­cause of their sex, age, na­tion­al ori­gin or dis­abil­i­ty.

Vi­vian Che­ung

Mered­ith Wad­man of Sci­ence first re­port­ed the law­suits, which ac­cord­ing to le­gal ex­perts and sev­er­al oth­er Asian Amer­i­can women who were dis­con­tin­ued as HH­MI in­ves­ti­ga­tors re­flect a pat­tern of prej­u­dice at the or­ga­ni­za­tion. They al­so come amid a gen­er­al in­crease in aware­ness about the ob­sta­cles women in life sci­ences face in their ca­reers. Ear­li­er this year, the Salk In­sti­tute in San Diego came un­der fire af­ter in which fe­male fac­ul­ty mem­bers claim an “old boys’ club” of se­niors re­strict­ed their ac­cess to funds, re­sources and net­works.

But the law­suit brought by Jean­nie Lee — and the one to be filed by Vi­vian Che­ung — might be the first high pro­file cas­es to ad­dress age, na­tion­al ori­gin and dis­abil­i­ty.

Lee, an epi­ge­neti­cist at Har­vard Med­ical School and Mass­a­chu­setts Gen­er­al Hos­pi­tal, sued in Au­gust 2016, two months af­ter the HH­MI re­fused to re­new her for a fourth five-year term. In ad­di­tion to dis­put­ing the re­new­al, she as­sert­ed in the law­suit that the HH­MI un­der­paid her com­pared to male col­leagues at Mass Gen­er­al, where her lab is based, de­spite rec­om­men­da­tions from the hos­pi­tal. The 55-year-old is a nat­u­ral­ized US cit­i­zen of Tai­wanese ori­gin.

The in­equal­i­ty that Lee was sub­ject­ed to, ac­cord­ing to the com­plaint, was ob­vi­ous if you com­pare the treat­ment she re­ceived to an­oth­er, white male in­ves­ti­ga­tor: No­bel lau­re­ate and for­mer HH­MI pres­i­dent Thomas Cech.

A sci­en­tif­ic dis­agree­ment be­tween Lee and Cech emerged in 2013, dur­ing Lee’s 2011-2016 term as an HH­MI in­ves­ti­ga­tor, cen­tered around the role of a type of pro­tein dubbed poly­comb re­pres­sive com­plex 2, or PRC2. Back in 2008, Lee’s lab pro­posed that PRC2 binds to RNA in a spe­cif­ic man­ner. But in 2013, Cech dis­put­ed that well-ac­cept­ed “speci­fici­ty” mod­el, claim­ing in a pa­per that he’s found ev­i­dence that PRC2 bind­ing is “promis­cu­ous” with­out well-de­fined mo­tifs.

Dur­ing his own HH­MI re­new­al re­view on Sep­tem­ber 13, 2016 — hours be­fore Lee’s — Cech, 72, cit­ed that pa­per as one of his top achieve­ments in the past five years as it had “com­plete­ly changed the di­rec­tion of an en­tire field.”

Ex­cept that it didn’t, Lee’s com­plaint stat­ed.

In fact, Dr. Cech had sub­mit­ted a man­u­script in Au­gust 2016, be­fore his HH­MI re­view, to the jour­nal Mol­e­c­u­lar Cell, in which he di­rect­ly con­tra­dict­ed his state­ments to HH­MI that Dr. Lee’s mod­el was wrong. […] Up­on in­for­ma­tion and be­lief, Dr. Cech dis­missed Dr. Lee’s Speci­fici­ty Mod­el in the sub­mis­sion and Pow­er­Point he pre­pared for his Sep­tem­ber 2016 HH­MI re­view, de­spite know­ing that re­sults from his lab had con­firmed the Speci­fici­ty Mod­el, and de­spite hav­ing sub­mit­ted an ar­ti­cle to a schol­ar­ly jour­nal re­port­ing those find­ings, in or­der to en­hance his own sci­en­tif­ic rep­u­ta­tion and achieve­ments at the ex­pense of Dr. Lee.

HH­MI re­newed Cech’s in­ves­ti­ga­tor award but ter­mi­nat­ed Lee’s, giv­ing her un­til Sep­tem­ber 2018 to find an al­ter­na­tive source of fund­ing.

In their eval­u­a­tion, the in­sti­tute fault­ed Lee for “view[ing] some top­ics dog­mat­i­cal­ly even when pre­sent­ed with new or con­flict­ing da­ta” and fail­ing to “deeply con­sid­er con­flict­ing da­ta from oth­er labs.”

From the com­plaint:

In ef­fect, HH­MI ap­plied a dif­fer­ent stan­dard to Dr. Cech than to Dr. Lee, choos­ing to cred­it, re­ward and re­new a white man, and to dis­cred­it, crit­i­cize and not re­new an Asian woman, where both had strong­ly held sci­en­tif­ic views on a com­mon sub­ject, which, in Dr. Lee’s case, had been con­firmed by mul­ti­ple oth­er labs (in­clud­ing, as it turns out, Dr. Cech’s lab).

To fur­ther un­der­stand Lee’s shock, one needn’t go fur­ther than HH­MI’s own words from 2011, her last re­new­al. Writ­ing in a cov­er let­ter for her eval­u­a­tion, then-CSO Jack Dixon not­ed: “Dr. Lee re­mains the sin­gle most in­flu­en­tial leader in the field of X-in­ac­ti­va­tion and one of half dozen or so in the broad­er field of mam­malian epi­ge­net­ics.”

Af­ter ini­tial­ly fil­ing her case with the Suf­folk Su­pe­ri­or Court, Lee has now tak­en it to the U.S. Dis­trict Court in Mass­a­chu­setts, where the two sides are still de­bat­ing HH­MI’s mo­tion to dis­miss parts of Lee’s claim.

For Che­ung, a 52-year-old RNA bi­ol­o­gist at the Uni­ver­si­ty of Michi­gan in Ann Ar­bor, there was no per­son to com­pare to. Rather, she claimed that her re­la­tion­ship with HH­MI (be­gin­ning in 2008) turned sour when she in­formed them that she was di­ag­nosed with a rare ge­net­ic dis­or­der caus­ing pro­gres­sive vi­sion loss. HH­MI re­spond­ed by turn­ing down her re­quests for ac­com­mo­da­tions and threat­ened to ter­mi­nate her con­tract.

HH­MI of­fi­cials then pres­sured her to ac­cept a 5-year phase­out award, she told Sci­ence. She re­fused, and in 2018 she too was de­nied a re­new­al.

Af­ter re­ceiv­ing a no­tice from the Equal Em­ploy­ment Op­por­tu­ni­ty Com­mis­sion giv­ing her the right to sue for dis­crim­i­na­tion based on sex, age and dis­abil­i­ty this month, Che­ung plans to press her case in court soon.

HH­MI Pres­i­dent Erin O’Shea, who was pro­mot­ed to the top in Sep­tem­ber 2016, wrote to Sci­ence that they are “ful­ly con­fi­dent in the in­tegri­ty of our re­view process.”

“We re­spect Drs. Lee and Che­ung and val­ue their con­tri­bu­tions dur­ing their tenures as HH­MI In­ves­ti­ga­tors,” she added. “While we can­not pro­vide de­tails of per­son­nel mat­ters, par­tic­u­lar­ly in cas­es of lit­i­ga­tion, we have in­ves­ti­gat­ed these claims and be­lieve they have no mer­it.”

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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