Jay Brad­ner’s NI­BR ex­it sets off a suc­ces­sion plan at Mer­ck; Dyne and Mor­phoSys fill ma­jor R&D roles

Jay Brad­ner

→ In the Big Phar­ma world, com­pa­nies like J&J and Mer­ck have ex­pe­ri­enced a pro­nounced sea change in lead­er­ship over a two-year pe­ri­od, and you can be­gin to say the same at No­var­tis, which dis­missed head of de­vel­op­ment John Tsai and head of on­col­o­gy Su­sanne Schaf­fert as part of CEO Vas Narasimhan’s wide-rang­ing re­struc­tur­ing plan. The next shoe to drop is Jay Brad­ner, the pres­i­dent of the No­var­tis In­sti­tutes for Bio­Med­ical Re­search, who is leav­ing his post on Hal­loween and pass­ing the ba­ton to Fiona Mar­shall, Mer­ck’s SVP and glob­al head of dis­cov­ery sci­ences, pre­clin­i­cal de­vel­op­ment and trans­la­tion­al med­i­cine.

Fiona Mar­shall

In a LinkedIn post that made the rounds on Thurs­day, Brad­ner said, “I can­not prop­er­ly ex­press my grat­i­tude to all of my 5,600 in­cred­i­ble NI­BR col­leagues. In the dark­est and most iso­lat­ing mo­ments of the pan­dem­ic, we leaned on each oth­er and flour­ished per­son­al­ly and sci­en­tif­i­cal­ly, with grace and of­ten good hu­mor. Thank you, NI­BR, for the gift of your warm con­fi­dence, gen­er­ous ad­vices and to­tal com­mit­ment to our re­search; it has been hum­bling and in­spir­ing to be your leader.”

As Mar­shall ven­tures off to NI­BR, Mer­ck has her suc­ces­sor all fig­ured out. George Ad­dona joined the phar­ma gi­ant — from NI­BR, co­in­ci­den­tal­ly — in 2008 and has in­cre­men­tal­ly tak­en on big­ger roles ever since: For al­most three years, Ad­dona has been Mer­ck’s VP of quan­ti­ta­tive bio­sciences. You can read more of our cov­er­age about each of these ap­point­ments here and here.

Francesco Bib­biani

→ Now that the clin­i­cal hold has been lift­ed on its ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy — a field that has seen its share of sim­i­lar ac­tions from the FDA — Dyne Ther­a­peu­tics has tapped Francesco Bib­biani as SVP, head of de­vel­op­ment. Bib­biani had led glob­al clin­i­cal de­vel­op­ment at Ul­tragenyx, which just bought its An­gel­man syn­drome part­ner GeneTx in Ju­ly, since Feb­ru­ary 2021 and has held oth­er lead­er­ship po­si­tions in clin­i­cal de­vel­op­ment at PTC Ther­a­peu­tics and Ei­sai.

Tim De­muth

Mor­phoSys has a po­ten­tial block­buster on its hands with the myelofi­bro­sis drug pelabre­sib from its Con­stel­la­tion Phar­ma­ceu­ti­cals buy­out, but the Ger­man biotech will push for­ward with­out Malte Pe­ters, who will re­tire as chief R&D of­fi­cer at the end of the year. Schooled in Ger­many with a four-year run as Mer­ck KGaA’s head of glob­al clin­i­cal de­vel­op­ment on­col­o­gy, Tim De­muth will take over for Pe­ters at the Mon­ju­vi mak­er. Peer Re­view told you about where De­muth land­ed af­ter he left the Ger­man phar­ma, tak­ing the CMO job at Pieris Phar­ma­ceu­ti­cals in Au­gust 2021. This planned tran­si­tion comes af­ter Mor­phoSys struck a deal to ship off two an­ti­body pro­grams to ARCH’s Hu­man Im­munol­o­gy Bio­sciences in June.

Al­ix Hart

Pfiz­er has poached Drew Panayiotou from Al­pha­bet’s Ver­i­ly, nam­ing him bio­phar­ma glob­al chief mar­ket­ing of­fi­cer while Ver­i­ly pro­motes Al­ix Hart to his pre­vi­ous post. Panayiotou, the chief mar­ket­ing of­fi­cer at Ver­i­ly since late 2020, had been pres­i­dent of Chick-Fil-A sub­sidiary Red Wag­on Ven­tures and was al­so the US chief mar­ket­ing of­fi­cer for Best Buy from 2009-13. Hart is a for­mer Best Buy ex­ec in her own right who be­came Ver­i­ly’s head of con­tent and dig­i­tal strat­e­gy last year af­ter serv­ing as Nvidia’s glob­al head of dig­i­tal mar­ket­ing from 2016-21. Beth Bu­lik has more on both ap­point­ments.

Cigall Kadoch

→ With Cigall Kadoch div­ing in­to her new job as an in­ves­ti­ga­tor with the Howard Hugh­es Med­ical In­sti­tute on Sept. 6, she has re­signed as a board mem­ber at the biotech she co-found­ed, Foghorn Ther­a­peu­tics. She’ll still be on the SAB at Foghorn, which has sus­tained a reg­u­la­to­ry dou­ble wham­my with a par­tial clin­i­cal hold in May that grad­u­at­ed to a full clin­i­cal hold last week with its blood can­cer drug FHD-286.

Ker­ry Blan­chard

→ Putting a bow on a cou­ple of CEO de­par­tures End­points News re­port­ed on last Fri­day, Ker­ry Blan­chard walked away from Ever­est Med­i­cines short­ly af­ter hit­ting the moun­tain­top in Chi­na with Gilead-part­nered Trodelvy, gain­ing an ap­proval in the coun­try for un­re­sectable lo­cal­ly ad­vanced or metasta­t­ic triple-neg­a­tive breast can­cer. Ever­est pres­i­dent and CFO Ian Woo will be in­ter­im chief un­til the Shang­hai biotech finds a per­ma­nent suc­ces­sor.

Austin, TX-based Ae­glea Bio­Ther­a­peu­tics is trim­ming its staff by 25%, while chief ex­ec­u­tive An­tho­ny Quinn scales back to an ad­vi­so­ry role and gen­er­al coun­sel Jim Kas­ten­may­er takes charge as in­ter­im pres­i­dent and CEO. The FDA threw down the stop sticks with a re­fusal-to-file let­ter for Ae­glea’s arginase 1 de­fi­cien­cy drug pegzi­larginase in June.

And then there’s Nordic Nanovec­tor, try­ing to keep its head above wa­ter af­ter wav­ing the white flag with the PAR­A­DIGME study of its lead as­set Be­talutin in ear­ly Ju­ly. CEO Erik Skullerud is out, and Ma­lene Brond­berg will step in tem­porar­i­ly as she con­tin­ues her CFO du­ties — and as the Oslo biotech hud­dles up with Carnegie In­vest­ment Bank to “ex­plore strate­gic op­tions.”

Jeff Cis­li­ni

→ You say you want a Rev­o­lu­tion: Weeks re­moved from an up­sized pub­lic of­fer­ing to­tal­ing $230 mil­lion, RAS-mu­tat­ed can­cer biotech Rev­o­lu­tion Med­i­cines out of the Bay Area has se­lect­ed Daniel Si­mon as CBO while pro­mot­ing Jack An­ders to CFO and Jeff Cis­li­ni to gen­er­al coun­sel. Dur­ing Si­mon’s sev­en years with Guardant Health, he was SVP, bio­phar­ma busi­ness de­vel­op­ment and has worked in cor­po­rate de­vel­op­ment at Onyx Phar­ma­ceu­ti­cals. For­mer­ly SVP, fi­nance and the prin­ci­pal fi­nan­cial and ac­count­ing of­fi­cer for CEO Mark Gold­smith, An­ders logged 12 years at De­pomed be­fore piv­ot­ing to Rev­o­lu­tion Med­i­cines in 2018. Cis­li­ni, the deputy gen­er­al coun­sel since 2020, is a one-time le­gal ex­ec at Atara Bio­ther­a­peu­tics.

Arun Upad­hyay

Ocu­gen wasn’t in the FDA’s good graces when they faced a $10,000 fine for not un­veil­ing tri­al re­sults, but now that the clin­i­cal hold has been lift­ed on its Covid-19 vac­cine can­di­date Co­v­ax­in, the Malvern, PA biotech has ush­ered in Robert Hop­kins as CMO and pro­mot­ed Arun Upad­hyay to CSO. Hop­kins has been around the block with Mer­ck Re­search Lab­o­ra­to­ries and Emer­gent BioSo­lu­tions, among oth­er com­pa­nies, and in Au­gust 2021 he was el­e­vat­ed to med­ical chief at Adap­tive Phage Ther­a­peu­tics. Upad­hyay joined Shankar Musunuri’s squad in 2017 and had been run­ning R&D at Ocu­gen since De­cem­ber.

Eu­gene Kennedy

→ With its stock price $GRTX lan­guish­ing in the pen­ny stock range af­ter a Phase III prat­fall with its lead drug ava­sopasem last Oc­to­ber, Penn­syl­va­nia’s Galera Ther­a­peu­tics has ap­point­ed Eu­gene Kennedy as CMO. Jon Holm­lund, Galera’s med­ical chief since 2012, is re­tir­ing as the year comes to a close. Kennedy, the med­ical chief for the last year and a half at In­no­v­a­tive Cel­lu­lar Ther­a­peu­tics, tack­led the same role at Lu­mos Phar­ma.

→ Re­gen­er­a­tive med­i­cine com­pa­ny Ser­ax­is has reeled in Paul Strumph as CMO. Strumph brings ex­pe­ri­ence from his times at Meta­vant Sci­ences (CMO), Lex­i­con Phar­ma­ceu­ti­cals (VP, clin­i­cal de­vel­op­ment), Quin­tiles (North Amer­i­cal re­gion­al CMO), and Ju­ve­niles Di­a­betes Re­search Foun­da­tion (CMO). Strumph jump­start­ed his ca­reer at GSK, Mer­ck KGaA/EMD Serono and Bris­tol My­ers Squibb.

Jean-François Fournier

→ Que­bec-based Va­leo Phar­ma has re­cruit­ed Kyle Steiger as chief com­mer­cial of­fi­cer and Jean-François Fournier as busi­ness unit head — oph­thal­mol­o­gy. Both are No­var­tis Cana­da alums: Steiger was VP of oph­thal­mol­o­gy to cap off 19 years with the Big Phar­ma, and Fournier had spent the last three years as com­mer­cial di­rec­tor, mar­ket­ing & sales. Be­fore his time with No­var­tis Cana­da, Steiger was briefly the na­tion­al sales di­rec­tor for Ipsen’s on­col­o­gy port­fo­lio.

Ray Sta­ple­ton

→ Af­ter ap­point­ing In­hibitor Ther­a­peu­tics chair­man Mark Wat­son to the board of di­rec­tors in ear­ly Au­gust, Vaxart has wel­comed Ray Sta­ple­ton as chief tech­nol­o­gy of­fi­cer. Sta­ple­ton comes to the South San Fran­cis­co vac­cine mak­er from Geno­cea Bio­sciences, where he held the same ti­tle and was EVP. He al­so rose through the ranks in 15 years at Mer­ck, be­com­ing ex­ec­u­tive di­rec­tor, glob­al vac­cines tech­nol­o­gy and en­gi­neer­ing un­til he left the phar­ma gi­ant in 2015.

Rob Quinn

→ Ad­vanc­ing its lead as­set — a drug for Char­cot-Marie-Tooth dis­ease type 1A named PXT3003 — in­to Phase III, French neu­ro biotech Pharnext has in­stalled GSK fi­nan­cial vet Rob Quinn as CFO, while Valérie Wor­rall has moved on “to pur­sue oth­er in­ter­ests” af­ter more than six months on the job. Quinn’s most re­cent gig as fi­nance chief was with Benev­o­len­tAI, and he’s al­so been CFO for Si­lence Ther­a­peu­tics.

Be­hzad Mah­davi

Gink­go Bioworks has lined up Be­hzad Mah­davi as SVP of bio­phar­ma man­u­fac­tur­ing & life sci­ence tools af­ter raid­ing the bar­gain bin and buy­ing out Zymer­genwhich had en­dured a dis­as­trous ride on the strug­gle bus — for $300 mil­lion in Ju­ly. Mah­davi makes the leap to Gink­go from Catal­ent, where the 13-year Lon­za vet served as VP, glob­al open in­no­va­tion.

Scott Dixon

→ Not to be con­fused with the In­dy­Car su­per­star, Scott Dixon has reached the check­ered flag as chief com­mer­cial of­fi­cer of dig­i­tal clin­i­cal tri­al out­fit Ob­vio­Health. Dixon, who has worked at such com­pa­nies as Or­a­cle, Web­MD and Parex­el, spent the last year as chief rev­enue of­fi­cer of Fly­wheel.io.

→ Texas-based Biote has las­soed in Samar Kam­dar as CFO. Kam­dar hops aboard af­ter a stint as CFO of Slync.io and Tax­Act. Pri­or to that, Kam­dar had gigs at CROSS­MARK, Avail­i­ty, and Pep­si­Co.

Bar­ry Le­d­er­man

World­wide Clin­i­cal Tri­als has brought aboard Bar­ry Le­d­er­man as CFO. This isn’t Le­d­er­man’s first time don­ning the CFO hat, hav­ing served in the role at Perime­ter So­lu­tions and Ha­lo Phar­ma­ceu­ti­cals. Ear­li­er in his ca­reer, Le­d­er­man had gigs at Ei­sai and Ny­comed and a 10-year run at Roche.

Kim Bo­er­icke

→ Clin­i­cal tri­al ser­vice provider THREAD is weav­ing in Kim Bo­er­icke to its lead­er­ship team as chief de­liv­ery of­fi­cer. Bo­er­icke joins with ex­pe­ri­ence from her times at Icon (pres­i­dent, Icon com­mer­cial­iza­tion and out­comes), Quin­tiles (VP and man­ag­ing di­rec­tor) and i3 Re­search (glob­al VP).

→ Get­ting this year off to an aus­pi­cious start with a $100 mil­lion Se­ries B round, UK cell and gene ther­a­py man­u­fac­tur­er Ori Biotech has made a bevy of moves, start­ing with Kale Feeter and Lind­sey Clarke as di­rec­tors of busi­ness de­vel­op­ment.

Lind­sey Clarke

Feeter comes to Ori from Cy­ti­va, where he was en­ter­prise busi­ness de­vel­op­ment leader, cell & gene ther­a­py, while Clarke was Bio-Techne’s se­nior man­ag­er, glob­al prod­uct mar­ket­ing, cell & gene ther­a­py. Ori has al­so en­list­ed Sar­to­rius alum Quentin Vic­ard as di­rec­tor of prod­uct man­age­ment, Bri­an Macauley as cloud plat­form lead, and ex-Au­to­lus se­nior sci­en­tist Claire Hor­lock as prin­ci­pal sci­en­tist. Fi­nal­ly, Is­abelle Riv­ière and Ja­son Bock are now mem­bers of the sci­en­tif­ic ad­vi­so­ry board.

ProKid­ney is bring­ing in a pro it­self in the likes of Glenn Schul­man as SVP of in­vestor re­la­tions. Schul­man pre­vi­ous­ly served as VP of in­vestor re­la­tions at X4 Phar­ma­ceu­ti­cals and was SVP, in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions at Au­rinia Phar­ma­ceu­ti­cals. Schul­man has al­so held roles at Achillion Phar­ma­ceu­ti­cals and Cura­Gen.

Avid Bioser­vices has re­cruit­ed Pramthesh Pa­tel as VP, process de­vel­op­ment. Pa­tel, a 23-year vet from GSK, most re­cent­ly served as se­nior di­rec­tor. Pri­or to that, Pa­tel had a decade-long stint at Bris­tol My­ers.

Na­tal­ie Mount

→ Gate­way to a new chair­per­son: 16-year Pfiz­er vet Na­tal­ie Mount has been named to the po­si­tion at St. Louis cell ther­a­py out­fit Wu­gen, re­plac­ing John McK­earn, who will stay on the board. The ex-CSO of Gam­maDelta Ther­a­peu­tics, Mount was al­so CEO of Gam­maDelta spin­out Adap­tate Bio­ther­a­peu­ticstwo com­pa­nies that have been sold to Take­da in the last year.

Taiyin Yang has joined the board of di­rec­tors at Brii Bio­sciences af­ter re­tir­ing from a ca­reer at Gilead that be­gan in 1993. For­mer Sana ex­ec Stacey Ma suc­ceed­ed Yang as Gilead’s EVP of phar­ma­ceu­ti­cal de­vel­op­ment and man­u­fac­tur­ing on Ju­ly 18.

He­len Kim

→ Irish biotech Prothena has re­served space for He­len Kim — the for­mer EVP of busi­ness de­vel­op­ment at Kite — on the board of di­rec­tors. Since 2019, the ex-NGM Bio­phar­ma­ceu­ti­cals CBO has been a se­nior di­rec­tor at Arie Bellde­grun’s Vi­da Ven­tures. No­vo Nordisk forked over $100 mil­lion up­front for Prothena’s AT­TR amy­loi­do­sis drugs last sum­mer.

→ Ex-Fer­ring US chief Paul Navarre has clinched a spot on the board of di­rec­tors at Dan­ish biotech Leo Phar­ma dur­ing a pe­ri­od of job cuts — up to 150 on the R&D team alone — and re­struc­tur­ing. Af­ter his 15 years at Proc­ter & Gam­ble, Navarre held a string of lead­er­ship roles for a decade at Al­ler­gan and has been a strate­gic ad­vi­so­ry board mem­ber at Flag­ship Pi­o­neer­ing.

→ Speak­ing of Flag­ship, the epi­ge­net­ics-fo­cused Omega Ther­a­peu­tics has elect­ed Rain­er Boehm to the board of di­rec­tors. Boehm fin­ished up a long ca­reer at No­var­tis as chief com­mer­cial & med­ical af­fairs of­fi­cer in 2017 and is a board mem­ber at Cel­lec­tis and Hu­mani­gen.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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