EpimAb nabs Bin Peng from NI­BR; Jef­frey Chodake­witz ex­its Ver­tex; Chris­tiana Sta­moulis is pres­i­dent at Unum

Chris­tiana Sta­moulis

Chris­tiana Sta­moulis is get­ting busier at Unum Ther­a­peu­tics as she adds the role of pres­i­dent to her CFO and head of cor­po­rate de­vel­op­ment du­ties. She will now be re­spon­si­ble for many of the im­munother­a­py com­pa­ny’s func­tions, in­clud­ing cor­po­rate strat­e­gy, le­gal, in­vestor re­la­tions and com­mu­ni­ca­tions. A for­mer in­vest­ment banker and Ver­tex ex­ec, Sta­moulis was cred­it­ed for head­ing Unum’s $65 mil­lion se­ries B and its part­ner­ship with Seat­tle Ge­net­ics.

→ Chi­na up­start EpimAb Bio­ther­a­peu­tics has wooed in a top re­searcher from No­var­tis as its first chief med­ical of­fi­cer. Bin Peng, who had been glob­al chief of on­col­o­gy trans­la­tion­al med­i­cine at NI­BR’s Shang­hai group, is jump­ing to the start­up, which grabbed a $25 mil­lion launch round last April and is al­lied with not­ed UK an­ti­body de­sign shop Kymab. They have a lead drug — EMB01 — now head­ed in­to the clin­ic. He’s join­ing a glob­al team of de­vel­op­ers as­sem­bled by CEO Cheng­bin Wu, a Har­vard post­doc who had worked at Ab­bott be­fore be­ing named CSO at Shang­hai CP Guo­jian Phar­ma­ceu­ti­cal. Peng is al­so among a long line­up of ex­ecs in­side No­var­tis who are launch­ing new chap­ters of their ca­reers in biotech. “Dr. Peng’s suc­cess­ful glob­al lead­er­ship and ex­per­tise will be ex­treme­ly ben­e­fi­cial to EpimAb’s port­fo­lio of pre­clin­i­cal can­di­dates, which have been de­vel­oped with­in just two years us­ing our pro­pri­etary bis­pe­cif­ic an­ti­body plat­form FIT-Ig,” says the CEO.

Jef­frey Chodake­witz is hit­ting the ex­it doors. Just days af­ter the launch of Ver­tex’s big Phase III study of its lead cys­tic fi­bro­sis triple ther­a­py, the big biotech is bid­ding farewell to its high pro­file chief med­ical of­fi­cer. The CMO has been with Ver­tex for four years, jump­ing ship from phar­ma gi­ant Mer­ck, where he held a top R&D po­si­tion. Chodake­witz is stay­ing on for a pe­ri­od as an ad­vis­er. He’s be­ing re­placed by Resh­ma Ke­wal­ra­mani, who’s been hold­ing the ti­tle for SVP of clin­i­cal de­vel­op­ment and med­ical af­fairs at Ver­tex. There’s no im­me­di­ate word for Chodake­witz’s next steps — on­ly the usu­al an­nounce­ment that he’s re­tir­ing, which could mean any­thing — who with his ex­pe­ri­ence would find it easy to take the helm of one of the biotech star­tups be­ing launched.

Ab­der­rahim Fan­di

Ox­ford Bio­Ther­a­peu­tics, a play­er at the in­ter­sec­tion of im­muno-on­col­o­gy and an­ti­body-drug con­ju­gates, has re­cruit­ed Ab­der­rahim Fan­di as its first CMO. The new­ly cre­at­ed po­si­tion re­flects OBT’s move to ad­vance its lead ADC ther­a­py, MEN1309, in the US in par­al­lel with clin­i­cal test­ing in Eu­rope. This al­so rep­re­sents a shift for Fan­di, who spent time at As­traZeneca, Bris­tol My­ers, No­var­tis and ul­ti­mate­ly Cel­gene. He will now over­see the de­vel­op­ment of OBT’s pre­clin­i­cal as­sets, some of which Boehringer In­gel­heim is part­nered on.

→ As CEO William Mann heads out the door, the Helsinn Group has tapped Paul Rittman as his suc­ces­sor at Helsinn Ther­a­peu­tics, the Swiss com­pa­ny’s US sub­sidiary. A Te­va vet, Rittman now joins an ex­o­dus of se­nior ex­ec­u­tives from the strug­gling gener­ics gi­ant. His most re­cent role fo­cused on on­col­o­gy, fit­ting well with the can­cer care busi­ness of his new em­ploy­er. “Giv­en the fo­cus of Helsinn Ther­a­peu­tics on both on­col­o­gy ther­a­peu­tics and sup­port­ive care, one of my first pri­or­i­ties will be to fur­ther ex­pand the com­mer­cial pres­ence of Helsinn in the US,” Rittman said in a state­ment.

→ An­tibi­ot­ic de­vel­op­er Tetraphase Phar­ma­ceu­ti­cals $TTPH has pro­mot­ed its chief com­mer­cial of­fi­cer Lar­ry Ed­wards to the COO po­si­tion, ex­pand­ing his man­date in op­er­a­tions be­yond pre-com­mer­cial­iza­tion ac­tiv­i­ties. When he joined the in 2015, Ed­wards had built up some ex­pe­ri­ence with pre- and post-launch mar­ket­ing at Cu­bist Phar­ma and Mer­ck. The Wa­ter­town, MA-based biotech re­mains con­fi­dent in its lead drug er­ava­cy­cline for com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions, even as it kept run­ning in­to the wall in com­pli­cat­ed uri­nary tract in­fec­tions tri­als.

→ As Blade Ther­a­peu­tics read­ies its en­trance in­to the clin­ic in a few months, it is count­ing on Ryan May­nard to pro­vide fi­nan­cial lead­er­ship from here on out. May­nard was re­cruit­ed from fel­low South San Fran­cis­co biotech Rigel Phar­ma­ceu­ti­cals, where he helped raise over $700 mil­lion as CFO. Out­side of fi­nance and ac­count­ing, his new po­si­tion al­so in­volves in­vestor and pub­lic re­la­tions — com­mu­ni­cat­ing about Blade’s in­tra­cel­lu­lar cys­teine pro­tease in­hibitor which holds po­ten­tial for a num­ber of fi­bro­sis in­di­ca­tions.

→ Con­tin­u­ing a trek on biotech land, Mark Ger­gen has land­ed a new gig as CBO and CFO of Po­sei­da Ther­a­peu­tics. Be­tween Halozyme, Mi­rati and Amylin (now part of Bris­tol My­ers), Ger­gen has jug­gled fi­nan­cial, busi­ness and op­er­a­tion roles. San Diego-based Po­sei­da is de­vel­op­ing au­tol­o­gous T cell and NK cell ther­a­pies.

Gi­ga­Gen is step­ping up its game in im­mune dys­reg­u­la­tion by ap­point­ing a se­nior di­rec­tor of tech­nol­o­gy, Jan Fredrik, to cre­ate next-gen se­quenc­ing de­vices to an­a­lyze im­mune sys­tems and of­fer in­sight for the an­ti­body ther­a­peu­tics it’s de­vel­op­ing. The South San Fran­cis­co-based up­start’s claim to fame is its re­com­bi­nant in­tra­venous im­munoglob­u­lin (IVIG) for pa­tients with im­mune de­fi­cien­cy, but its new tar­get is to ap­ply the tech in im­muno-on­col­o­gy. Si­mons, who jumps from a se­nior R&D po­si­tion at DNA se­quenc­ing com­pa­ny Quan­ta­pore, has spent much of his ca­reer work­ing with se­quenc­ing tech­nolo­gies in mul­ti­ple fields.

→ Ly­on, France-based Enyo Phar­ma has brought on Raphaël Darteil as a VP of non-clin­i­cal de­vel­op­ment and prod­uct pro­fil­ing to help op­ti­mize de­vel­op­ment plans. The hope is that as the biotech ex­plores NASH as a sec­ond in­di­ca­tion for its FXR ag­o­nist EYP001, Darteil can guide the path with his NASH ex­per­tise. The drug’s PhIb tri­al among chron­ic HBV in­fect­ed pa­tients doesn’t read out un­til Q2, but the ex­ecs say it’s proven to be safe enough to start plan­ning two PhI­Ia stud­ies.

→ As Dart Neu­ro­science closed its doors per­ma­nent­ly, Kim Al­biza­ti — se­nior di­rec­tor of chem­istry, man­u­fac­tur­ing and con­trols — has found his next op­por­tu­ni­ty at Mol­e­c­u­lar As­sem­blies. As VP of chem­istry and bio­chem­istry, Al­biza­ti will lead a team of sci­en­tists striv­ing to per­fect DNA syn­the­sis us­ing Mol­e­c­u­lar As­sem­blies’ en­zy­mat­ic tech­nol­o­gy. The ap­pli­ca­tion ranges from health care and chem­i­cals to elec­tron­ics and bio­fu­els. Al­so a lec­tur­er at UC San Diego, Al­biza­ti was an R&D di­rec­tor at Pfiz­er for 12 years.

→ De­gen­er­a­tive dis­ease spe­cial­ist Bi­o­Time has cre­at­ed a new po­si­tion called SVP of clin­i­cal and med­ical af­fairs, and Gary Hogge is fill­ing it. Hogge’s re­sume con­sists of a slate of med­ical af­fairs and clin­i­cal de­vel­op­ment roles, the most re­cent be­ing Quest­cor Phar­ma (lat­er ac­quired by Mallinck­rodt). Add those to the bio­med­ical con­sult­ing prac­tice he runs on the side, and Bi­o­Time ex­ecs are con­vinced that he can help lead their cell re­place­ment and de­liv­ery plat­forms in­to new clin­i­cal pro­grams.

→ Fol­low­ing a short fam­i­ly leave, Gilead’s James Mey­ers has de­cid­ed to re­tire from his po­si­tion of EVP, com­mer­cial op­er­a­tions en­tire­ly. While Mey­ers had been in the role for less than two years, his ca­reer at Gilead dates back to 1996 when he first joined as a re­gion­al sales di­rec­tor. He will stay with the Fos­ter City, CA com­pa­ny as an ad­vis­er while it search­es for his suc­ces­sor.

Fed­eri­co Pol­lano is the new SVP of busi­ness de­vel­op­ment at Rentschler Bio­phar­ma, a Ger­man de­vel­op­er and man­u­fac­tur­er of bi­o­log­ics, suc­ceed­ing Christoph Win­ter­hal­ter. A long­time bio­phar­ma ex­ec who cut his teeth at Glaxo Well­come, Pol­lano com­bined his pre­vi­ous ex­pe­ri­ence to es­tab­lish a CD­MO busi­ness in his re­cent job at Pol­phar­ma Bi­o­log­ics.

→ Am­gen re­tiree William Ash­ton has tak­en a board seat at Hen­der­son, NV-based Spec­trum Phar­ma­ceu­ti­cals, which is look­ing hard at the com­mer­cial po­ten­tial of its late-stage as­sets snagged in deals. At Am­gen, Ash­ton had head­ed sales and busi­ness ef­forts, li­ais­ing with health sys­tems, pri­vate pay­ers and dis­tri­b­u­tion chan­nels, among oth­ers.

Ac­celeron co-founder and Keros Phar­ma CEO Jas­bir Seehra has joined the board of Eloxx Phar­ma­ceu­ti­cals to of­fer ad­vice on its rare dis­ease pipeline of read-through drug can­di­dates de­signed to treat pre­ma­ture stop codon dis­eases.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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Maze in­ter­im chief Charles Hom­cy pass­es ba­ton to Ja­son Colo­ma; William Col­lier tapped as CEO of Ar­bu­tus

→ Four months in­to Maze Ther­a­peu­tics’ launch, Charles Hom­cy is pass­ing the start­up’s reins to an­oth­er Third Rock col­league. Ja­son Colo­ma, the cur­rent COO, is leav­ing his role at the VC firm to be­come full-time CEO on a mis­sion to trans­late ge­net­ic in­sights in­to new med­i­cines. Equipped with a whop­ping $191 mil­lion with sup­port from Arch, Maze’s big idea is to find and tar­get ge­net­ic mod­i­fiers that play a role in Mendelian dis­eases caused by an­oth­er gene. Colo­ma, a Roche/Genen­tech vet sea­soned in busi­ness de­vel­op­ment, was CBO at Corvus Phar­ma­ceu­ti­cals be­fore join­ing Third Rock in 2017.

Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Re­gen­eron/Sanofi's an­ti­body un­der­whelms in asth­ma study — shares of ri­val Anap­tys­Bio pay the price

Al­though ex­pec­ta­tions were mut­ed, Re­gen­eron $REGN and Sanofi’s $SNY ex­per­i­men­tal IL-33 an­ti­body has un­der­whelmed in a proof-of-con­cept mid-stage asth­ma tri­al. Al­though the drug sig­nif­i­cant­ly im­proved the loss of asth­ma con­trol and lung func­tion as a monother­a­py com­pared to a place­bo, its ef­fect was nei­ther su­pe­ri­or to the es­tab­lished Dupix­ent, nor of val­ue when com­bined with the IL-4/IL-13 treat­ment.