Out­side re­view con­firms top Memo­r­i­al Sloan Ket­ter­ing ex­ec­u­tives flout­ed con­flicts-of-in­ter­est poli­cies — re­port

The up­per ech­e­lons of the Memo­r­i­al Sloan Ket­ter­ing (MSK) Can­cer Cen­ter have been charged with cul­ti­vat­ing a cul­ture of putting prof­its be­fore re­search and pa­tients by per­sis­tent­ly breach­ing con­flict-of-in­ter­est poli­cies in a re­view con­duct­ed by an in­de­pen­dent body.

The re­sults of the re­view — re­port­ed by the New York Times and ProP­ub­li­ca — so­lid­i­fies a sweep­ing in­ves­ti­ga­tion by the two me­dia or­ga­ni­za­tions last year that found var­i­ous top ex­ec­u­tives and board mem­bers from the lead­ing New York-based can­cer re­search and treat­ment cen­ter had prof­it­ed from re­la­tion­ships with drug­mak­ers, oth­er re­search out­fits and cor­po­rate board mem­ber­ships.

In re­sponse to the in­de­pen­dent re­view, MSK on Thurs­day al­so broad­ened its con­flicts-of-in­ter­est pol­i­cy over­haul, in­clud­ing pub­lic dis­clo­sure of physi­cian ties to cor­po­ra­tions and lim­its on work out­side of MSK.

The con­tro­ver­sial rev­e­la­tions com­ing out of Memo­r­i­al Sloan Ket­ter­ing have al­so had an im­pact on oth­er high pro­file can­cer in­sti­tu­tions, in­clud­ing the Boston-based Dana-Far­ber Can­cer In­sti­tute and Seat­tle-based Fred Hutchin­son Can­cer Re­search Cen­ter — both of whose ex­ec­u­tives sit on cor­po­rate boards — and are re­assess­ing their norms re­lat­ed to fi­nan­cial ties, ac­cord­ing to NYT/ProP­ub­li­ca.

José Basel­ga

The NYT/ProP­ub­li­ca re­ports trig­gered the Sep­tem­ber ex­it of MSK chief med­ical of­fi­cer, José Basel­ga, who failed to dis­close the re­mu­ner­a­tions he re­ceived from a spate of bio­phar­ma firms he as­sist­ed — in terms of ar­ti­cles in med­ical jour­nals as well as or­ga­ni­za­tions like AS­CO, where he head­lined ma­jor pre­sen­ta­tions. Basel­ga al­so stepped down from the boards of Bris­tol-My­ers Squibb and Var­i­an Med­ical Sys­tems, on­ly to be hired by As­traZeneca to run the British drug­mak­er’s on­col­o­gy di­vi­sion this Jan­u­ary.

Craig Thomp­son

The re­portage al­so sparked the dis­en­tan­gle­ment of oth­er MSK re­la­tion­ships. MSK CEO Craig Thomp­son in Oc­to­ber re­signed from the boards of Charles Riv­er Lab­o­ra­to­ries and Mer­ck. In Jan­u­ary, the non­prof­it re­search in­sti­tute re­formed its con­flicts-of-in­ter­est pol­i­cy, by ban­ning its top ex­ec­u­tives from serv­ing on cor­po­rate boards of bio­phar­ma com­pa­nies.

The out­side in­ves­ti­ga­tion — con­duct­ed by the law firm De­bevoise & Plimp­ton — found that MSK of­fi­cials  “fre­quent­ly vi­o­lat­ed or skirt­ed their own poli­cies; that hos­pi­tal lead­ers’ ties to com­pa­nies were like­ly con­sid­ered on an ad hoc ba­sis rather than through rig­or­ous vet­ting; and that re­searchers were of­ten un­aware that some se­nior ex­ec­u­tives had fi­nan­cial stakes in the out­comes of their stud­ies,” the NYT/ProP­ub­li­ca re­port pub­lished on Thurs­day said.

Nev­er­the­less, the vi­o­la­tions were not the re­sult of “in­ten­tion­al mis­con­duct” but due to “in­ad­e­quate over­sight and a lack of es­tab­lished pro­to­cols for ex­am­in­ing whether em­ploy­ees’ and ex­ec­u­tives’ af­fil­i­a­tions with cor­po­ra­tions could re­sult in bi­ased re­sults that fa­vored a com­pa­ny’s prod­ucts,” the ar­ti­cle high­light­ed, cit­ing an MSK staff meet­ing held on Thurs­day.

Im­age: Memo­r­i­al Sloan Ket­ter­ing (MSK) Can­cer Cen­ter

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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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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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Alan List, new Precision BioSciences CMO, in 2019 (Diane Bondareff/AP Images for Moffitt Cancer Center)

Eli Lil­ly-part­nered biotech taps star in­ves­ti­ga­tor Alan List as CMO — a year af­ter he re­signed from Mof­fitt over Chi­na scan­dal

After laying low for more than a year following a scandal that led to his ouster, former Moffitt Cancer Center CEO Alan List has emerged in the frontlines of biotech.

An expert in hematology and oncology drug development known as a lead investigator for Celgene’s blockbuster Revlimid, List is swapping “clinical trials consultant” for the chief medical officer title at Precision BioSciences — a Eli Lilly-partnered biotech boasting a new gene editing approach to cell and gene correction therapies.