George Golumbeski's first stop out of Cel­gene: Grail; Roivant taps Genen­tech vet Myr­tle Pot­ter for op­er­a­tions role

→ Three months af­ter qui­et­ly slip­ping out the back door at Cel­gene, George Golumbes­ki has tak­en up the pres­i­dent role at the can­cer de­tec­tion start­up Grail in a sim­i­lar­ly dis­creet man­ner. The for­mer BD chief — not­ed for his cen­tral role in a se­ries of deals for the big biotech — re­places Ken Drazan, who has been in the role for a year af­ter serv­ing as chief busi­ness of­fi­cer. Golumbes­ki joins at a time Grail is shak­ing up its C-suite un­der CEO Jen­nifer Cook: On­aiza Cadoret-Manier, who used to man­age Genen­tech’s res­pi­ra­to­ry fran­chise, joins as chief com­mer­cial of­fi­cer; Roche vet Fred Kohler will be­come VP of peo­ple; and ex-Googler An­gela Lai will rise from the VP rank to chief tech­nol­o­gy of­fi­cer.

→ An­oth­er ex­ec has ex­it­ed what has be­gun to look like a set of re­volv­ing doors at Hu­man Longevi­ty (HLI). For­mer CFO and COO Ni­no Fan­lo has been lot go, Fierce­Biotech first not­ed, af­ter be­ing em­broiled in a scan­dal in­volv­ing be­hav­ioral is­sues and sex­u­al ha­rass­ment at his pri­or com­pa­ny. He is no longer list­ed on the com­pa­ny web­site, with CTO Scott Sorensen now dou­bling as COO (though there’s no men­tion of a CFO). Such ad hoc arrange­ments have be­come com­mon at the an­ti-ag­ing com­pa­ny ever since Cyn­thia Collins un­ex­pect­ed­ly stepped down from the helm af­ter on­ly a year; founder J. Craig Ven­ter quick­ly grabbed back the reins, on­ly to re­sign sev­er­al months lat­er. Sev­er­al oth­er ex­ecs re­signed dur­ing that time.

Myr­tle Pot­ter (via YouTube)

→ The tal­ent mag­net that is Vivek Ra­maswamy’s Roivant Sci­ences has at­tract­ed a biotech vet­er­an to over­see op­er­a­tions of the ever-grow­ing Vant king­dom. Myr­tle Pot­ter, a for­mer pres­i­dent and COO of Genen­tech, has been named Vant op­er­at­ing chair. The role grants her an au­to­mat­ic board mem­ber­ship at each of Roivant’s 12 biotech sub­sidiaries, where she is ex­pect­ed to as­sist the (of­ten high-pro­file) CEOs and “en­sure op­er­a­tional ex­cel­lence.”Pot­ter had a sto­ried run in Big Phar­ma that be­gan with 14 years at Mer­ck, help­ing cre­ate the busi­ness that would lat­er be­come As­traZeneca. She lat­er moved to Bris­tol-My­ers Squibb, even­tu­al­ly helm­ing its car­dio­vas­cu­lar and meta­bol­ic busi­ness and over­see­ing sev­er­al cru­cial drug launch­es — a skill she con­tin­ued to hone at Genen­tech, where un­der her watch block­buster drugs like Avastin and Xo­lair came to be known.

PCI Phar­ma Ser­vices has in­stalled Sal­im Haf­far as CEO to lead its out­sourc­ing op­er­a­tions, which span drug man­u­fac­tur­ing, clin­i­cal tri­al ser­vices, and com­mer­cial pack­ag­ing. His pre­de­ces­sor, Bill Mitchell, will con­tin­ue guid­ing the com­pa­ny he’s led for six years in the po­si­tion of ex­ec­u­tive co-chair­man. Cur­rent­ly the pres­i­dent of drug de­liv­ery sys­tems com­pa­ny Ap­tar Phar­ma, Haf­far comes to the job with more than two decades of ex­pe­ri­ence in the phar­ma-ad­ja­cent space.

→ As Re­cur­sion marks the clear­ance of the first IND for a drug de­vel­oped us­ing their AI-based plat­form, the biotech has poached a tech­ni­cal ex­pert from Achao­gen to head up its op­er­a­tions. Tech­ni­cal op­er­a­tions will be at the core of Tina Lar­son’s job as COO — es­pe­cial­ly its au­to­mat­ed screen­ing plat­form — but she will al­so over­see more ad­min­is­tra­tive tasks such as hir­ing and hu­man re­sources, in ad­di­tion to “over­all op­er­a­tional ma­tu­ri­ty.” Ex­ecs of the young com­pa­ny are think­ing long-term, point­ing to her all-round­ed skill set in ex­pand­ing R&D ca­pa­bil­i­ties, ex­e­cut­ing clin­i­cal pro­grams, and launch­ing com­mer­cial prod­ucts de­vel­oped dur­ing her long tenure at Roche.

Syn­tim­mune’s long search for a per­ma­nent CMO has led them to Mario Saltarel­li, a sea­soned de­vel­op­ment ex­ec most re­cent­ly in charge of ear­ly de­vel­op­ment and neu­rol­o­gy in Ver­tex. Hav­ing han­dled port­fo­lios of dif­fer­ent shapes and sizes — he worked at Pfiz­er and Shire be­fore mov­ing to more se­nior roles at An­nex­on Bio­sciences and Mallinck­rodt Phar­ma — he is now tasked with steer­ing Syn­tim­mune’s pipeline of ear­ly-stage drugs, fo­cused on the neona­tal Fc re­cep­tor, through clin­i­cal de­vel­op­ment. He re­places Don­ald Johns, the Bio­gen vet who will now be­come EVP of med­ical and sci­en­tif­ic af­fairs.

No­var­tis vet Christi­na Cough­lin is the new CMO at Penn spin­out Tmu­ni­ty, where she will rekin­dle a work­ing re­la­tion­ship with Carl June, the famed CAR-T pi­o­neer be­hind the mega-start­up. A for­mer physi­cian-sci­en­tist at the Uni­ver­si­ty of Penn­syl­va­nia, Cough­lin stud­ied pa­tient re­spons­es to tu­mor anti­gens un­der June be­fore jump­ing in­to med­ical po­si­tions at Pfiz­er, Mor­photek (Ei­sai), No­var­tis and most re­cent­ly, Im­muno­core. It’s still ear­ly days at Tmu­ni­ty, now fo­cused on two sol­id tu­mor pro­grams in Phase I and sev­er­al more of its next-gen T cell im­munother­a­pies in pre­clin­i­cal mode — per­fect for Cough­lin to flex her re­search and trans­la­tion­al mus­cles. She will al­so be re­spon­si­ble for reg­u­la­to­ry af­fairs.

→ Ben­e­fit­ting from the stream of ex-staffers out of a post-ac­qui­si­tion Juno Ther­a­peu­tics, Seat­tle’s Im­mu­soft has scooped up Ja­son Fontenot to be their CSO. Fontenot spent two years run­ning ex­plorato­ry re­search and man­ag­ing ear­ly-stage col­lab­o­ra­tions at the CAR-T biotech af­ter leav­ing his long­time role in im­munol­o­gy dis­cov­ery at Bio­gen. His back­ground in im­munol­o­gy will still play a promi­nent role in this new ap­point­ment giv­en Im­mu­soft’s fo­cus on the im­mune sys­tem and mod­i­fied B cell ther­a­py. “We ex­pect his con­tri­bu­tions to help us rapid­ly ad­vance our cur­rent pro­grams and ex­tend our plat­form,” said CEO Sean Ainsworth.

→ Em­ma Walm­s­ley’s re­make of the ex­ec­u­tive round­table at GSK is near­ing com­ple­tion. To­day the phar­ma gi­ant not­ed that gen­er­al coun­sel Dan Troy is leav­ing the com­pa­ny af­ter 10 years. He’s be­ing re­placed by James Ford, cur­rent­ly SVP and gen­er­al coun­sel for Glob­al Phar­ma.

G1 Ther­a­peu­tics $GTHX may be nowhere near com­mer­cial­iza­tion yet, but that doesn’t stop them from plan­ning for it. The on­col­o­gy biotech has re­cruit­ed chief com­mer­cial of­fi­cer John De­ma­ree and gen­er­al coun­sel Still­man Han­son to their of­fice at Re­search Tri­an­gle Park, NC. Hav­ing helped launch a slate of can­cer drugs and led busi­ness de­vel­op­ment at the likes of No­var­tis and Ab­bott, De­ma­ree has re­cent­ly built a mar­ket­ing team from the ground up as a VP at Astel­las Phar­ma — some­thing he’s ex­pect­ed to repli­cate here. Han­son had a sim­i­lar test run as as­so­ciate gen­er­al coun­sel at IQVIA, which he joined back when it was still known as Quin­tiles­IMS (start­ing on the Quin­tiles side to be ex­act). Like De­ma­ree, he is fill­ing a new­ly cre­at­ed role.

→ As Mitchel Sa­yare claims a more ac­tive role at Al­tim­mune $ALT as ex­ec­u­tive chair­man, the com­pa­ny has brought on José Ochoa to aid him in one of his three fo­cus ar­eas. As CBO, Ochoa is ex­pect­ed to play a key role in get­ting the word out for the Phase II an­thrax and in­fluen­za pro­grams. Sa­yare, who came on the board through Al­tim­mune’s merg­er with Phar­mA­th­ene last year, will al­so re­vamp the strate­gic fo­cus and fi­nanc­ing ef­forts.

→ Bone dis­or­der drug­mak­er Clemen­tia Phar­ma­ceu­ti­cals $CM­TA has hired Steve Forte, for­mer­ly of Ap­tal­is Phar­ma, as CFO, re­plac­ing Michael Singer.

Lau­ra Shawver is build­ing out the lead­er­ship team at Syn­thorx, the syn­thet­ic bi­ol­o­gy up­start she took over a few months ago: Enoch Kar­iu­ki, an in­vestor and banker by train­ing, joins as SVP, cor­po­rate de­vel­op­ment; Ex-Igny­ta ex­ec Chris­t­ian Kuhlen will be the gen­er­al coun­sel;  and Charles Win­ter will take charge of all things chem­istry, man­u­fac­tur­ing and con­trols re­lat­ed, lever­ag­ing his streak of sim­i­lar jobs at Gilead, JHL Biotech and then De­nali.

→ What­ev­er Scott Drey­er been do­ing as Col­legium Phar­ma’s SVP of sales, mar­ket­ing and train­ing, the pain man­age­ment com­pa­ny must be lov­ing it — as he’s get­ting pro­mot­ed to the C-suite af­ter just six months in the job. It marks his first ap­point­ment as CCO, adding to a slate of se­nior roles at The Med­i­cines Com­pa­ny, Bio­gen and Mer­ck. Can­ton, MA-based Col­legium cur­rent­ly mar­kets two ex­tend­ed re­lease drugs, Xtam­pza (oxy­codone) and Nucyn­ta (tapen­ta­dol).

Gilead’s Kite Phar­ma has poached Michael Amoroso from Ei­sai to be its head of world­wide com­mer­cial, cell ther­a­py. Re­port­ing di­rect­ly to Gilead chief John Mil­li­gan, Amoroso has a broad man­date to run the whole com­mer­cial show rang­ing from sales, mar­ket­ing, mar­ket ac­cess, to health­care provider and pa­tient ser­vices. He ar­rives at a time Gilead is in­creas­ing­ly loud about its am­bi­tions in cell ther­a­py, pour­ing mon­ey in­to R&D and man­u­fac­tur­ing fa­cil­i­ties around the globe to sup­port the de­vel­op­ment of new treat­ments to fol­low its pi­o­neer­ing CAR-T Yescar­ta.

→ Hav­ing just moved out of a shared JLabs fa­cil­i­ty and in­to its new digs in South San Fran­cis­co, Nkar­ta Ther­a­peu­tics is fol­low­ing up the mo­men­tum by an­nounc­ing two new hires: Nadir Mah­mood as SVP of cor­po­rate de­vel­op­ment, and Ralph Bran­den­berg­er as head of process de­vel­op­ment and man­u­fac­tur­ing. That’s a move in­tend­ed to bol­ster Nkar­ta’s busi­ness and tech­ni­cal pow­ers while grow­ing its nat­ur­al killer cell-based can­cer R&D op­er­a­tions. Mah­mood moves from Sec­ond Genome, his sec­ond job in the front­lines of biotech af­ter some stints as a con­sul­tant and an­a­lyst. Bran­den­berg­er most re­cent­ly held a sim­i­lar tech­ni­cal role at Neu­rona Ther­a­peu­tics.

→ Prep­ping sev­er­al Phase III tri­als on its drugs for my­opia and chron­ic an­gle-clo­sure glau­co­ma, Eye­n­ovia $EYEN has named Michael Rowe its VP of mar­ket­ing. The plan is to com­mer­cial­ize two prod­ucts in the next 18 months and po­si­tion the com­pa­ny for the late-stage tri­als sched­uled for mid-2019. None of this will be new for Rowe, who dur­ing his long tenure at Al­ler­gan drew up strate­gies for its glau­co­ma fran­chise be­fore tak­ing up a top oph­thal­mol­o­gy role at Aerie Phar­ma.

→ Af­ter a ca­reer in Big Phar­ma, Tim­o­thy Cook is cross­ing over to biotech to play a big role at Athenex’s $AT­NX young and grow­ing com­mer­cial team. His of­fi­cial ti­tle will be SVP of glob­al com­mer­cial on­col­o­gy — but his du­ties will be some­what sim­i­lar to what he did as VP and COO of Lil­ly On­col­o­gy (a po­si­tion he re­tired from in 2017), build­ing out an on­col­o­gy busi­ness be­tween the US and Chi­na. Pro­vid­ed Athenex suc­ceeds in mak­ing IV chemother­a­pies in­to ap­prov­able oral drugs that can be more ef­fec­tive in treat­ing can­cer, of course.  

→ Look­ing to give its de­vel­op­ment pro­grams a boost, Sune­sis Phar­ma­ceu­ti­cals $SNSS has ap­point­ed three ex­ecs to its man­age­ment. Deepali Suri, who pre­vi­ous­ly ran clin­i­cal op­er­a­tions for Phar­ma­cyclics (now an Ab­b­Vie sub­sidiary), will as­sume a sim­i­lar role; Sean Gharpurey will join as ex­ec­u­tive di­rec­tor, project man­age­ment; and VP of qual­i­ty as­sur­ance and com­pli­ance Stephen Na­va is of­fi­cial­ly adding “reg­u­la­to­ry af­fairs” to his ti­tle. In­ter­est­ing­ly, Gharpurey — whose ca­reer has brought him to Roche, Genen­tech, J&J and Scher­ing — jumps from Jazz Phar­ma, where he briefly worked un­der Daniel Swish­er, the long­time Sune­sis chief who de­part­ed late last year.

→ Nim­bus, a small start­up in Cam­bridge, Mass­a­chu­setts, has re­cruit­ed Gilead’s se­nior di­rec­tor of clin­i­cal re­search — Adri­an Ray — to serve as the com­pa­ny’s se­nior vice pres­i­dent of dis­cov­ery bi­ol­o­gy. You might re­mem­ber Nim­bus for the mas­sive NASH deal it inked with Gilead a cou­ple years back — earn­ing a re­mark­able $400 mil­lion up­front. Now, it’s snag­ging Ray, who’s worked at Gilead for the past 15 years, to help lead its own R&D. “Adri­an is an out­stand­ing ad­di­tion to our al­ready world-class team, who will strength­en our ca­pa­bil­i­ties in dis­cov­ery sci­ence root­ed in cut­ting-edge bi­ol­o­gy and hu­man ge­net­ics,” said Don Nichol­son, CEO at Nim­bus, in a state­ment. “Adri­an is a ca­pa­ble leader in tar­get dis­cov­ery through­out the meta­bol­ic-on­col­o­gy-im­munol­o­gy tar­get space, and in the trans­la­tion of these dis­cov­er­ies in­to ef­fec­tive clin­i­cal de­vel­op­ment strate­gies. We’re thrilled to have him.”

Grant Blouse is re­turn­ing to Cat­a­lyst Bio­sciences $CBIO af­ter a six-year run at No­vo Nordisk, back at the trans­la­tion­al re­search work that laid the foun­da­tion for Cat­a­lyst’s he­mo­phil­ia pipeline. “He will be sup­port­ing the de­vel­op­ment of our he­mo­phil­ia pro­grams and our re­search pipeline” CEO Nas­sim Us­man ex­plained in a state­ment. “We are con­fi­dent in his abil­i­ty to im­me­di­ate­ly con­tribute to our Fac­tor IX CB 2679d/ISU304 and Fac­tor VI­Ia marzep­tacog al­fa clin­i­cal pro­grams.” At No­vo, where he was prin­ci­pal sci­en­tist and project man­ag­er of the he­mo­phil­ia en­zy­mol­o­gy unit, Blouse gained ex­pe­ri­ence lead­ing both ear­ly and late stage projects.

→ Equipped with PhI­II mac­u­lar ede­ma tri­al re­sults that sent its stock fly­ing in March, Clear­side Bio­med­ical $CLSD has just re­cruit­ed Car­ol Hoang to sup­port its po­ten­tial piv­ot in­to com­mer­cial stage. Part of the team that launched Lu­cen­tis at Genen­tech, Hoang lat­er moved to No­var­tis co­or­di­nat­ing the med­ical strate­gies that go in­to drug brands. The com­pa­ny plans to sub­mit an NDA for its treat­ment, dubbed supra­choroidal CLS-TA, dur­ing the fourth quar­ter of this year.

X4 Phar­ma­ceu­ti­cals has wooed Gen­zyme vet Mike Wyz­ga to chair its board of di­rec­tors. A one-time CEO — at Ra­dius Health — Wyz­ga will work with chief ex­ec­u­tive Paula Ra­gan (al­so a for­mer Gen­zyme staffer) in mat­ters of cor­po­rate gov­er­nance and man­age­ment as the com­pa­ny con­tin­ues to pur­sue its im­mune cell traf­fick­ing plat­form.

→ Still on sab­bat­i­cal af­ter an 8-year run as found­ing CSO of Nim­bus Ther­a­peu­tics, promi­nent biotech ex­ec Rosana Kapeller is spar­ing some time for board du­ties at Cedil­la Ther­a­peu­tics, an up­start found­ed by her for­mer col­leagues at Third Rock Ven­tures that lever­ages pro­tein sta­bil­i­ty mech­a­nisms for drug de­vel­op­ment.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.