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.”

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.