Shinichi Tamu­ra re­claims the throne at So­sei; Jeff Abbey ex­its Ar­gos for No­vadip; Frank Cz­er­wiec is the new CMO at Goldfinch

Jeff Abbey is jump­ing to the helm of Bel­gium’s No­vadip Bio­sciences af­ter lead­ing Ar­gos Ther­a­peu­tics as pres­i­dent and CEO for the past eight years. Hav­ing led No­vadip’s au­tol­o­gous cell ther­a­py through a Phase I/IIa tri­al in spinal fu­sion pa­tients, found­ing CEO Jean-François Pol­let de­cid­ed it’s time to pass the reins to a more ex­pe­ri­enced chief ex­ec­u­tive. And Abbey — whose ex­pe­ri­ence in­cludes over­see­ing a Phase III tri­al, rais­ing over $250 mil­lion in pri­vate fi­nanc­ings and an IPO, and seal­ing sev­er­al part­ner­ships — fits the bill.

Daniel O’Day

→ The sus­pense over who will suc­ceed John Mil­li­gan at Gilead has fi­nal­ly end­ed. Daniel O’Day, cur­rent CEO of Roche’s phar­ma di­vi­sion, has been tapped for the top job, Gilead an­nounced days be­fore Mil­li­gan is set to de­part from his cor­ner of­fice. O’Day’s ap­point­ment ush­ers in a new era for the Fos­ter City, CA-based big biotech, which Mil­li­gan and his pre­de­ces­sor, John Mar­tin, ran for near­ly three decades, cre­at­ing an HIV pow­er­house and an in­dus­try-dom­i­nat­ing he­pati­tis C fran­chise.

Be­fore O’Day as­sumes his role on March 1, 2019, Gregg Al­ton — a 20-year vet­er­an of the com­pa­ny who’s served as gen­er­al coun­sel and, most re­cent­ly, chief pa­tient of­fi­cer — will man the fort as in­ter­im CEO.

Shinichi Tamu­ra’s ex­per­i­ment with putting a West­ern­er at the helm of So­sei in a bid to make the Japan­ese phar­ma com­pa­ny a more glob­al op­er­a­tion has come to a close. Tamu­ra — who found­ed the com­pa­ny — is now re­claim­ing the helm he hand­ed to Pe­ter Bains af­ter lim­it­ing him­self to the chair­man’s po­si­tion.

So­sei, which ac­quired UK-based Hep­tares’ GPCR plat­form in a $400 mil­lion deal back in 2015, isn’t back­ing away from the move to go glob­al. Tamu­ra says he is still in­tent on that strat­e­gy, with new in­vest­ments be­ing planned in R&D.

Jeff Jonker — an ex-lawyer who was part of the ex­ec­u­tive team at NGM Bio that inked a $450 mil­lion re­search deal with Mer­ck in 2015 — has risen to the ranks of CEO, at Third Rock-backed Am­bys Med­i­cines. The an­nounce­ment comes months af­ter the com­pa­ny — named af­ter the Mex­i­can sala­man­der famed for re­gen­er­at­ing limbs — se­cured $140 mil­lion in launch mon­ey and an elu­sive deal with Japan’s Take­da. The Red­wood City, Cal­i­for­nia-based com­pa­ny is tar­get­ing liv­er dis­ease on three fronts: cell ther­a­py for liv­er re­gen­er­a­tion; gene ther­a­py for liv­er restora­tion; and small mol­e­cule ther­a­py to re­place lost pro­tein func­tion.

Jonker takes over the reins from Third Rock’s ven­ture part­ner Jeff Tong, who was brought in to serve as in­ter­im CEO un­til a per­ma­nent ex­ec­u­tive was found. Tong will now move to the role of chair­man.

Tiffany Burt

→ En­ter­ing a sea­son of change, RNA biotech Pro­QR $PRQR has ap­point­ed four new ex­ecs as it pre­pares for two re­tire­ments. Aniz Girach, CMO, jumps from the same role at Night­star Ther­a­peu­tics to lead the reti­nal dis­ease pro­gram; No­var­tis vet Tiffany Burt will be VP, head of com­mer­cial; Cel­gene’s Lisa Hayes has been hired as VP of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions; CFO Smi­tal Shah will add chief busi­ness of­fi­cer to her ti­tle. Mean­while chief cor­po­rate de­vel­op­ment of­fi­cer and gen­er­al coun­sel René Beuke­ma and Robert Cor­nelisse — chief of peo­ple and or­ga­ni­za­tion — will re­tire at year-end 2018.

→ With an IND in sight for its lead pro­gram, Goldfinch Bio has scooped Frank Cz­er­wiec from Ot­su­ka Phar­ma, where he’s worked for 20 years end­ing in VP, glob­al clin­i­cal de­vel­op­ment role. As CMO, Cz­er­wiec will have over­sight on the en­tire kid­ney dis­ease pipeline with a keen eye on the lat­est break­throughs in the ge­net­ics of what trig­gers the ail­ments.

→ More than a year in­to Geno­cea’s $GN­CA quest to re­make it­self in­to a play­er in per­son­al­ized ther­a­pies, the com­pa­ny is ready to scout some deals. En­ter Girish Aakalu, the new chief busi­ness of­fi­cer with stints at Ipsen, Pfiz­er and Genen­tech. “(W)e be­lieve that Girish will help us max­i­mize our pipeline op­por­tu­ni­ties and cap­i­tal­ize on the myr­i­ad of pos­si­ble ap­pli­ca­tions of our AT­LAS plat­form, which us­es each pa­tient’s im­mune re­sponse ma­chin­ery to iden­ti­fy and char­ac­ter­ize anti­gens, rather than re­ly­ing on pre­dic­tive ap­proach­es,” said Chip Clark, pres­i­dent and CEO.

→ As Adap­ti­m­mune $ADAP tran­si­tions in­to the clin­i­cal stage, chief tech­nol­o­gy of­fi­cer Gwen Binder is sign­ing off her his­toric role at the com­pa­ny to pur­sue oth­er op­por­tu­ni­ties in ear­ly de­vel­op­ment and tech­ni­cal in­no­va­tion. Binder first joined the biotech’s US of­fice in 2011, man­ag­ing what be­gan as a one-woman trans­la­tion­al col­lab­o­ra­tion with the Uni­ver­si­ty of Penn­syl­va­nia. She will de­part in Jan­u­ary 2019.

Adam Schechter is step­ping down as pres­i­dent of glob­al hu­man health at Mer­ck, trig­ger­ing a re­or­ga­ni­za­tion of the phar­ma gi­ant’s com­mer­cial or­ga­ni­za­tion. Frank Clyburn has been pro­mot­ed to chief com­mer­cial of­fi­cer while Micheal Nal­ly as­sumes the chief mar­ket­ing of­fi­cer post.

Saila­ja Put­ta­gun­ta has joined Is­raeli biotech Bio­mX as CMO, tasked with steer­ing its mi­cro­bio­me pro­grams in ac­ne and ir­ri­ta­ble bow­el dis­ease to the clin­ic — with tri­als slat­ed for mid 2019 and 2020 re­spec­tive­ly. An an­ti-in­fec­tive ex­pert for­mer­ly of Pfiz­er and Al­ler­gan, Put­ta­gun­ta most re­cent­ly served as VP of de­vel­op­ment at Iterum Ther­a­peu­tics.

→ Can­cer de­tec­tion com­pa­ny Grail has ap­point­ed ex-Mor­gan Stan­ley man­ag­ing di­rec­tor Cather­ine Fried­man to the head of its board, re­plac­ing Bill Rastet­ter. Con­cur­rent­ly Alex Ar­a­va­nis, a co-founder, is get­ting pro­mot­ed to the CSO and head of R&D role.

→ Push­ing a plan to es­tab­lish com­mer­cial man­u­fac­tur­ing ca­pa­bil­i­ties in the US, Cel­lec­tis has tapped Den­dreon vet William Mon­tei­th to over­see the cell man­u­fac­tur­ing plant it’s build­ing to sup­port its off-the-shelf CAR-T ther­a­pies.

→ Fol­low­ing a cou­ple of deals to beef up its im­muno-on­col­o­gy pipeline, CStone Phar­ma has hired Archie Tse to fill the new­ly cre­at­ed role of SVP and chief trans­la­tion­al med­i­cine of­fi­cer, re­spon­si­ble for ear­ly-stage as­sets up to proof-of-con­cept. Trained at Memo­r­i­al Sloan Ket­ter­ing, Tse has pre­vi­ous­ly led on­col­o­gy pro­grams at Mer­ck and Dai­ichi Sankyo.

Nkar­ta Ther­a­peu­tics has hired Matthew Plun­kett to be CFO and SVP, cit­ing his mix of man­age­ment — at the likes of Mede­or Ther­a­peu­tics and CTI Bio­Phar­ma — and in­vest­ment bank­ing ex­pe­ri­ence.

En­zy­vant, a mem­ber of the Roivant fam­i­ly fo­cused on rare dis­eases, has ap­point­ed bio­phar­ma vet George El­ston as CFO and head of cor­po­rate de­vel­op­ment. El­ston was most re­cent­ly pres­i­dent and CEO of 2X On­col­o­gy.

Chris­t­ian Jones is the first chief com­mer­cial of­fi­cer at Nanoform, join­ing the drug par­ti­cle en­gi­neer­ing com­pa­ny with a back­ground in API de­vel­op­ment and man­u­fac­tur­ing.

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.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

Scott Gottlieb has another position to add to his lengthy roster of boards and advisory roles in the wake of his departure from the helm of the FDA.

He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.

Af­ter a run of CT­LA-4 com­bo fail­ures, sci­en­tists spot­light a way to make it work — in se­lect pa­tients

CTLA-4/PD-(L)1 combinations have been one of the El Dorados of oncology, its promise forever behind that next hill but apparently unattainable after a series of pivotal clinical failures. But researchers at New York’s Memorial Sloan Kettering Cancer Center and the Technical University of Munich think they may know how to fix what’s wrong and boost the drive to next-gen cancer combos.

In a preclinical animal research program, researchers found that within a cell, checkpoints rely on a specific molecule — RNA-sensing molecule RIG-I — to work. If that sounds familiar, it’s because it has already been identified as a target for boosting immune responses and was subject to at least one Phase I/II trial. Pfizer in December allied itself with Kineta with $15 million upfront and $505 million in potential milestones to develop RIG-I immunotherapies, and three years ago Merck purchased German upstart Rigontec for $137 million upfront and over $400 million in potential milestones for the same purpose.

Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.

Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.