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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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