John Martin in 2012 (Paul Sakuma/AP Images)

UP­DAT­ED: Biotech pi­o­neer and start­up in­vestor John Mar­tin, who built Gilead in­to a pow­er­house play­er, has died

John C. Mar­tin, who led Gilead to great­ness in de­vel­op­ing a huge­ly prof­itable HIV drug fran­chise, has died.

His death at the age of 69 was flagged by the com­pa­ny he built, though a spokesper­son for Gilead said the com­pa­ny didn’t know the cause of death.

“John’s lega­cy will be felt for gen­er­a­tions to come, liv­ing on through the sci­en­tif­ic progress made un­der his lead­er­ship and the pro­grams he cham­pi­oned that ex­pand­ed ac­cess to med­ica­tions for peo­ple around the world,” said Daniel O’Day, who took over as CEO af­ter Mar­tin and his close col­league John Mil­li­gan left Gilead a cou­ple of years ago. “On be­half of all of us at Gilead, I ex­tend our deep­est con­do­lences to John’s fam­i­ly.”

Mar­tin start­ed at Gilead as a VP of R&D back in 1990, mov­ing up to CEO on­ly 6 years lat­er as he helmed the com­pa­ny for a 20-year stretch be­fore hand­ing the reins to Mil­li­gan and stick­ing with the chair­man’s post un­til 2019. Dur­ing that time the com­pa­ny built a rep as a fear­some com­peti­tor in HIV, field­ing drug cock­tails that kept the dead­ly AIDS at bay for mil­lions — while al­so be­ing tar­get­ed by crit­ics for be­ing tone deaf on pric­ing con­tro­ver­sies.

It was Gilead that would be the first to win the race to de­vel­op a large­ly pain­less com­bo cure for he­pati­tis C, and it was Gilead that rocked the in­dus­try with an $84,000 price tag that threat­ened a wide swathe of pay­ers, cre­at­ing a con­tro­ver­sy that set the stage for a years-long pub­lic bat­tle over pric­ing that con­tin­ues to sim­mer in Wash­ing­ton, DC.

In the in­dus­try, how­ev­er, Mar­tin was wide­ly loved. And he con­tin­ued to play an ac­tive role as a biotech in­vestor and en­thu­si­ast back­ing a num­ber of fledg­ling star­tups, in­clud­ing the Kro­nos start­up led by ex-Gilead R&D chief Nor­bert Bischof­berg­er, where he joined the board and the in­vestor syn­di­cate. Kite founder and long­time biotech en­tre­pre­neur Arie Bellde­grun, who worked with Mar­tin on Kro­nos, sent this to End­points News:

John was a bril­liant life sci­ence leader and trust­ed ad­vi­sor to many, my­self in­clud­ed. Our bond was formed through a shared pas­sion for sci­ence, but it grew even deep­er as our fam­i­lies grew to­geth­er in friend­ship. The hole that now ex­ists by his ab­sence, not just in our fam­i­ly, but by all of us in the in­dus­try, is im­mea­sur­able. We will seek to fill it with grat­i­tude for his re­mark­able life and work to hon­or him in all we do. On be­half of my wife Re­bec­ka, my­self, our en­tire Bellde­grun/Funt fam­i­ly and our ex­tend­ed fam­i­ly of col­leagues across com­pa­nies, we ex­tend our deep­est sym­pa­thies to John’s fam­i­ly and every­one who was for­tu­nate enough to know him. He will be great­ly missed.

Bischof­berg­er of­fered this trib­ute:

On be­half of the em­ploy­ees and Board of Di­rec­tors at Kro­nos Bio, I am deeply sad­dened by John’s pass­ing. An ex­cep­tion­al sci­en­tist and busi­ness leader, John has made im­mea­sur­able con­tri­bu­tions to the life sci­ences com­mu­ni­ty, our com­pa­ny and nu­mer­ous oth­er or­ga­ni­za­tions. Most im­por­tant­ly, he has helped mil­lions of peo­ple around the world through the med­i­cines we de­vel­oped through­out our near­ly three decades as col­leagues. He leaves a last­ing lega­cy that will ben­e­fit pa­tients around the world for years to come. John was one of my dear­est friends and a great men­tor, and I will miss him ter­ri­bly. We ex­tend our deep­est sym­pa­thies to John’s fam­i­ly and every­one who was for­tu­nate to have known him.

Oth­ers took to Twit­ter to say good­bye.

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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Image: Shutterstock

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.