Af­ter dis­miss­ing CFO over 'i­nap­pro­pri­ate mes­sages,' Eli Lil­ly faces new ac­cu­sa­tions of sex­u­al dis­crim­i­na­tion and ha­rass­ment

A month af­ter oust­ing CFO Josh Smi­ley for send­ing “in­ap­pro­pri­ate mes­sages” to em­ploy­ees, Eli Lil­ly is fac­ing new al­le­ga­tions that an ex­ec­u­tive and a se­nior man­ag­er at its Wash­ing­ton, DC of­fice sex­u­al­ly dis­crim­i­nat­ed against and ha­rassed mul­ti­ple women.

Sonya Elling, a for­mer Lil­ly lob­by­ist of about 16 years, filed a law­suit in fed­er­al court last Fri­day ac­cus­ing her sec­ond-lev­el su­per­vi­sor Leigh Ann Pusey of mak­ing sex­ist re­marks about her, un­der­min­ing her au­thor­i­ty, and sub­ject­ing her to a “sex­u­al­ly hos­tile work en­vi­ron­ment,” even­tu­al­ly forc­ing her to re­sign.

Leigh Ann Pusey

The com­plaint states that Pusey “reg­u­lar­ly mocked and be­lit­tled” Elling and oth­er fe­male em­ploy­ees, re­fer­ring to them as “nasty,” “mean,” and a “bitch.” And that an­oth­er su­per­vi­sor Shawn O’Neail, who Pusey hired in 2019, made “sex­u­al­ly ag­gres­sive ges­tures” to­ward the em­ploy­ees.

Lil­ly de­nied the al­le­ga­tions in a state­ment to End­points News. 

“Lil­ly is com­mit­ted to fos­ter­ing and pro­mot­ing a cul­ture of di­ver­si­ty and re­spect, and a work en­vi­ron­ment free of dis­crim­i­na­tion, ha­rass­ment or re­tal­i­a­tion of any kind,” spokesper­son Kathryn Beis­er said in an email. “We hold all em­ploy­ees ac­count­able to our core val­ues and be­lieve our ex­ec­u­tives car­ry an even high­er bur­den in en­sur­ing those val­ues are up­held.”

Pusey was tapped as se­nior vice pres­i­dent of cor­po­rate af­fairs and com­mu­ni­ca­tions in May 2017, months af­ter CEO Dave Ricks took the helm.

Among the ac­cu­sa­tions is that Pusey told Elling, who was 49 at the time, that her age would keep her from suc­cess­ful­ly en­gag­ing with mem­bers of Con­gress be­cause she wasn’t a “pret­ty young thing.” And she no­tice­ably pre­ferred male col­leagues, ac­cord­ing to Elling, of­ten flirt­ing and call­ing them names like “young buck.”

In May 2018, a col­league re­ferred to as “Em­ploy­ee Y” re­port­ed “sex­ist com­ments” that Pusey al­leged­ly made about Elling and oth­er fe­male em­ploy­ees. In a re­port to Joseph Kel­ley, Lil­ly’s for­mer vice pres­i­dent of glob­al gov­ern­ment and in­ter­na­tion­al cor­po­rate af­fairs, the em­ploy­ee wrote:

I gen­uine­ly be­lieve that Pusey has cre­at­ed a hos­tile work­place en­vi­ron­ment, and that in many ways, she tru­ly is a work­place bul­ly. Frankly, I have con­cerns about my po­si­tion, and be­cause Pusey has shown lim­it­ed com­pe­tence in terms of ex­hibit­ing the Lil­ly val­ues – Re­spect for Peo­ple, In­tegri­ty and Ex­cel­lence – I am gen­uine­ly con­cerned that she may take re­tal­ia­to­ry ac­tion against my­self or my team.

Elling ac­cus­es Pusey of re­tal­i­at­ing af­ter that, ex­clud­ing her and an­oth­er col­league from im­por­tant projects, meet­ings and com­mu­ni­ca­tions that were part of their job re­spon­si­bil­i­ties.

Shawn O’Neail

Af­ter Kel­ley re­tired in 2019, Pusey hired O’Neail as a re­place­ment, who was on a mis­sion to “clean house,” the com­plaint states. Elling ac­cused O’Neail of en­gag­ing in “in­ap­pro­pri­ate sex­u­al self-grop­ing in her of­fice, at her eye lev­el and in vi­o­la­tion of her per­son­al space.”

The No­var­tis vet al­leged­ly has a his­to­ry of “misog­y­nis­tic, as well as racist, be­hav­ior,” ac­cord­ing to the com­plaint, which ac­cus­es O’Neail of us­ing the “n” word to re­fer to a Pfiz­er lob­by­ist. It al­so ac­cus­es him of chang­ing his clothes in an all-glass con­fer­ence room “in full view of fe­male staff mem­bers” while work­ing at No­var­tis.

It isn’t clear how Elling’s coun­sel knows of these past ac­cu­sa­tions. End­points reached out to No­var­tis to ver­i­fy the claims, but a com­pa­ny spokesper­son would on­ly con­firm that O’Neail worked there, and that he left two years ago. End­points al­so reached out to Elling’s at­tor­ney, and has not re­ceived a re­sponse.

In a meet­ing with HR, O’Neail false­ly ac­cused Elling of mak­ing dis­parag­ing com­ments about Lil­ly to con­gres­sion­al staff, that law­suit states. He even­tu­al­ly put Elling on a per­for­mance im­prove­ment plan, which was “rid­dled with mis­rep­re­sen­ta­tions, as well as neg­a­tive stereo­types of women,” ac­cord­ing to the com­plaint.

Josh Smi­ley

On Dec. 1, 2019, Elling sent in her res­ig­na­tion, ex­plain­ing that she was forced to leave due to Pusey and O’Neail’s “dis­crim­i­na­tion and re­tal­i­a­tion” against her, the suit states.

That was just a cou­ple months be­fore Smi­ley the com­pa­ny’s fi­nance chief, was dis­missed over an “in­ap­pro­pri­ate per­son­al re­la­tion­ship” with an em­ploy­ee. The CFO was cit­ed for send­ing “con­sen­su­al but in­ap­pro­pri­ate per­son­al com­mu­ni­ca­tions” to mul­ti­ple team mem­bers, Lil­ly said. The drug­mak­er didn’t spec­i­fy the con­tent of those mes­sages or whether they were ex­plic­it­ly sex­u­al in na­ture.

Ac­cord­ing to an SEC fil­ing, Smi­ley was forced to for­feit $24 mil­lion in com­pen­sa­tion as he walked out the door.

A pre­vi­ous ver­sion of this ar­ti­cle stat­ed that Pusey and O’Neail were ac­cused of sex­u­al ha­rass­ment. The sto­ry has been up­dat­ed to re­flect that they were ac­cused of sex­u­al dis­crim­i­na­tion, and ha­rass­ment. 

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, 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.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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As­traZeneca-Alex­ion merg­er slides through FTC re­view af­ter sup­posed M&A crack­down pos­es no bar­ri­ers

The AstraZeneca-Alexion megamerger received a good sign Friday, despite warning signs of the tides turning against large M&A pharma deals.

US regulators at the FTC have cleared the acquisition for approval, AstraZeneca announced, all but signing off on the deal to go through once it officially closes in the third quarter. AstraZeneca originally said it was planning to buy out Alexion back in December for $39 billion.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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David Stack, Pacira Biosciences CEO

In high­ly un­usu­al move, Paci­ra sues med­ical jour­nal for li­bel over its non-opi­oid painkiller

A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug.

Pacira Biosciences filed the complaint against the American Society of Anesthesiologists in the US District Court for New Jersey on Wednesday afternoon. A February issue of the group’s journal Anesthesiology printed three articles and other content full of “bias” that “seriously disparaged” the drug Exparel, Pacira claimed.