BD chief George Golumbes­ki is the lat­est top ex­ec to ex­it Cel­gene dur­ing man­age­ment over­haul

George Golumbes­ki (SO­TIO)

Over the past decade, George Golumbes­ki rose to be­come an ex­ec­u­tive vice pres­i­dent at Cel­gene, fre­quent­ly laud­ed for his high-pro­file role in lead­ing one of the most ag­gres­sive BD teams in biotech. 

But Golumbes­ki has qui­et­ly slipped out the back door at Cel­gene at a time CEO Mark Alles has been ex­e­cut­ing a se­ries of man­age­ment changes af­ter a string of prat­falls has been rais­ing ques­tions about the com­pa­ny’s com­pe­tence on ex­e­cut­ing on a longterm strat­e­gy.

Ac­cord­ing to a note on Golumbes­ki’s re­sume post­ed at Mor­phoSys AG, which just ap­point­ed him as a new su­per­vi­so­ry board mem­ber, the BD ex­ec of­fi­cial­ly left Cel­gene April 16, tran­si­tion­ing to a new role as an in­de­pen­dent con­sul­tant af­ter gath­er­ing a slate of new roles for his post-Cel­gene life. He’s al­so a sci­en­tif­ic ad­vis­er at new­ly launched KSQ, the start­up run by ex-Gen­zyme chief David Meek­er, and is list­ed as a ven­ture part­ner at ARCH.

In­vestors didn’t like the sound of it. Cel­gene’s stock plunged 5% af­ter the sto­ry came out.

The tran­si­tion last month, though, has been in the works for close to two and a half years, Golumbes­ki tells me to­day. That’s when he sat down with Bob Hug­in and Alles and some oth­ers to say that af­ter some 20 years on the deal side of the busi­ness, with more than 9 years at Cel­gene, he was ready to do some­thing new and dif­fer­ent.

“I com­mu­ni­cat­ed I was very hap­py to stay on,” he adds, “but in­tend­ed to leave in Q1 or Q2 2017.” For a va­ri­ety of rea­sons, his stay last­ed un­til April. And he em­pha­sizes his de­par­ture was com­plete­ly am­i­ca­ble all around.

Now Golumbes­ki has a va­ri­ety of new gigs, most­ly cen­tered on up and com­ing biotech com­pa­nies, where he plans to play a role in re­cruit­ing top ex­ecs, rais­ing mon­ey and fo­cus­ing on some game-chang­ing med­i­cines. And this way he al­so gets to spend more time with the fam­i­ly.

“I’m in a good place,” he adds. “I want to help to the ex­tent I can these young com­pa­nies.”

Cel­gene me­dia con­tacts nev­er re­spond­ed di­rect­ly to ques­tions abut Golumbes­ki’s de­par­ture.

Mark Alles

Work­ing un­der ex-Cel­gene CEO Bob Hug­in and in close part­ner­ship with ex-R&D chief Tom Daniel, Golumbes­ki was the chief ar­chi­tect of a strat­e­gy to snag a mul­ti­tude of drug rights in an ef­fort to ex­pand be­yond their block­buster Revlim­id. Cel­gene bought in­to Juno sev­er­al years ago, then fol­lowed up with a $9 bil­lion buy­out. Over­all, the com­pa­ny liked do­ing deals that left the part­ners in charge of the re­search, as they did suc­cess­ful­ly with Agios and oth­ers.

“We do a bet­ter job lis­ten­ing to what a part­ner has to say,” Golumbes­ki told me sev­er­al years ago, when he was in the midst of a deal fren­zy worth bil­lions in up­fronts and mile­stones.

Sev­er­al of his high-pro­file pacts, though, have been un­rav­el­ing or hit with se­vere set­backs. Right on the heels of the im­plo­sion of its $710 mil­lion cash roll of the dice on the in­flam­ma­to­ry bow­el dis­ease drug mon­gersen (GED-301), the FDA hit the com­pa­ny with a refuse-to-file for its would-be MS block­buster ozan­i­mod.

Scott Smith

In re­sponse, Alles has en­gi­neered some big changes at Cel­gene. Just days be­fore Golumbes­ki’s of­fi­cial de­par­ture, COO Scott Smith head­ed out the ex­its, leav­ing Alles in charge of every­thing from clin­i­cal de­vel­op­ment to reg­u­la­to­ry, the all-im­por­tant hema­tol­ogy and on­col­o­gy fran­chise as well as in­flam­ma­tion and im­munol­o­gy.


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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