Eric Lander (Matt Slocum/AP Images)

Er­ic Lan­der 'bul­lied and de­meaned' staff at White House sci­ence of­fice — in­ves­ti­ga­tion

A re­cent White House in­ves­ti­ga­tion con­clud­ed that Er­ic Lan­der, Pres­i­dent Biden’s top sci­ence ad­vi­sor, bul­lied and de­meaned his sub­or­di­nates, Politi­co re­port­ed.

The news dropped just hours af­ter Politi­co re­port­ed that Lan­der, the famed but of­ten con­tro­ver­sial ge­neti­cist who served as found­ing di­rec­tor of the Broad In­sti­tute be­fore get­ting tapped to lead the White House’s Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy, emailed all his staff to apol­o­gize for speak­ing to col­leagues in a “dis­re­spect­ful and de­mean­ing way.”

“The in­ves­ti­ga­tion found cred­i­ble ev­i­dence of in­stances of mul­ti­ple women hav­ing com­plained to oth­er staff about neg­a­tive in­ter­ac­tions with Dr. Lan­der, where he spoke to them in a de­mean­ing or abra­sive way in front of oth­er staff,” Chris­t­ian Peele, the White House’s deputy di­rec­tor of man­age­ment and ad­min­is­tra­tion for per­son­nel, said in a brief­ing — a record­ing of which was ob­tained by Politi­co.

Four­teen cur­rent and for­mer staffers of the OSTP — which has a head­count of about 140 — shared with Politi­co “sim­i­lar de­scrip­tions of a tox­ic work en­vi­ron­ment where they say Lan­der fre­quent­ly bul­lied, cut off and dis­missed sub­or­di­nates,” some­times yelling at peo­ple and mak­ing them feel hu­mil­i­at­ed in front of peers.

While most re­mained anony­mous, Rachel Wal­lace — a long­time civ­il ser­vant and the OSTP’s chief op­er­at­ing of­fi­cer, who first filed a com­plaint against Lan­der and OSTP lead­er­ship — went on the record say­ing that Lan­der “re­tal­i­at­ed against staff for speak­ing out and ask­ing ques­tions by call­ing them names, dis­parag­ing them, em­bar­rass­ing them in front of their peers, laugh­ing at them, shun­ning them, tak­ing away their du­ties, and re­plac­ing them or dri­ving them out of the agency. Nu­mer­ous women have been left in tears, trau­ma­tized, and feel­ing vul­ner­a­ble and iso­lat­ed.”

None of the de­tails were men­tioned in Lan­der’s vague­ly-word­ed apol­o­gy email.

“It’s my re­spon­si­bil­i­ty to set a re­spect­ful tone for our com­mu­ni­ty. It’s clear that I have not lived up to this re­spon­si­bil­i­ty,” reads an email ob­tained by Politi­co. “This is not on­ly wrong, but al­so in­con­sis­tent with our Safe and Re­spect­ful Work­place Pol­i­cy. It is nev­er ac­cept­able for me to speak that way. I am deeply sor­ry for my con­duct. I es­pe­cial­ly want to apol­o­gize to those of you who I treat­ed poor­ly or were present at the time.”

Wal­lace told Politi­co the apol­o­gy “did not come close to ad­dress­ing” the full ex­tent of his of­fense. Oth­er staffers ar­gue he should be fired, or at least face a sus­pen­sion, with one call­ing him an ag­gres­sor who “open­ly tar­gets women” and an­oth­er high­light­ing the “open and brazen way he con­ducts his abuse.”

“He did so much more than speak to staff in a ‘dis­re­spect­ful or de­mean­ing way,'” Wal­lace said, adding: “Lan­der’s apol­o­gy was not on­ly disin­gen­u­ous. It com­pound­ed the deep hurt and dam­age he has caused by ig­nor­ing these oth­er acts of ag­gres­sion, ha­rass­ment and re­tal­i­a­tion.”

Biden el­e­vat­ed the sci­ence of­fice to Cab­i­net lev­el in an at­tempt to sig­nal his gov­ern­ment’s fo­cus on sci­ence.

But his se­lec­tion of Lan­der as the leader of the of­fice and his sci­ence ad­vi­sor wasn’t with­out fric­tion, with crit­ics slam­ming what they see as over-the-top ar­ro­gance that con­sumes sci­en­tif­ic ac­co­lades at the ex­pense of oth­ers, es­pe­cial­ly women and peo­ple of col­or.

Dur­ing his in­au­gu­ra­tion, Biden al­so pledged a ze­ro-tol­er­ance pol­i­cy on im­prop­er con­duct: “If you are ever work­ing with me and I hear you treat an­oth­er col­league with dis­re­spect, talk down to some­one, I promise you I will fire you on the spot. On the spot. No ifs, ands or buts.”

It re­mains to be seen what con­se­quences Lan­der, who has al­so been tapped to head the re­cent­ly re­launched Can­cer Moon­shot ini­tia­tive — a project close to Biden’s heart — will face.

White House lead­er­ship has met with Lan­der to dis­cuss the “se­ri­ous­ness of the mat­ter,” ac­cord­ing to a spokesper­son. An OSTP spokesper­son said that “cor­rec­tive ac­tion was tak­en con­sis­tent with those find­ings.”

Lan­der, who ap­par­ent­ly got wind of the in­ves­ti­ga­tion and loom­ing Politi­co re­port, ref­er­enced it in his email.

“I un­der­stand that some of you have been asked about this, and I thought it was im­por­tant to write di­rect­ly to you,” he wrote. “I al­so re­al­ize that my con­duct re­flects poor­ly on this Ad­min­is­tra­tion, and in­ter­feres with our work. I deeply re­gret that.”

He promised to “take con­crete steps to pro­mote a bet­ter work­place,” in­clud­ing reg­u­lar fo­rums to check in with staff and train­ings to en­sure they know how to re­port con­cern­ing con­duct. In the record­ed brief­ing, Peele talked about re­quir­ing Lan­der to hold more col­lab­o­ra­tive meet­ings such as “brown bag ses­sions,” and men­tioned there would be a check-in with staff af­ter 30 and 45 days.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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David Hallal (L) and George Daley (Hallal photo: Bertrand Guay/AFP via Getty Images)

David Hal­lal's El­e­vate­Bio launch­es new com­pa­ny to 'dis­rup­t' off-the-shelf cell ther­a­py, but pro­vides few oth­er de­tails

David Hallal’s ElevateBio is launching a new company Thursday as it looks to continue making its mark in the cell and gene therapy spaces. But Hallal is also keeping his cards close to the vest, preferring to toe the line between bombast and mystique rather than going all-in in one direction.

The new company comes out of a partnership with Boston Children’s Hospital and research from George Daley, the dean of Harvard Medical School. The triumvirate claims to have found a way to design better off-the-shelf cell therapies using new methods discovered in Daley’s Boston Children’s Hospital lab (Harvard is not involved in the collaboration).

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.