John Robin­son re­cruits a small band of Ar­ray vets to kick­start dis­cov­ery at Co­gent; Syn­tim­mune co-founder takes charge at Arch On­col­o­gy

John Robin­son

Biotech is a small world — and all the more so in a tight-knit com­mu­ni­ty like Boul­der, CO.

A serendip­i­tous re­union with An­drew Rob­bins, a for­mer col­league at Ar­ray, was what sparked John Robin­son’s jump to his new gig as CSO of Co­gent Bio­sciences.

He had start­ed fol­low­ing the com­pa­ny, a rein­car­na­tion of the trou­bled cell ther­a­py biotech Unum Ther­a­peu­tics, af­ter it tapped Rob­bins as CEO. The two had worked on mul­ti­ple projects to­geth­er at Ar­ray — as Robin­son shep­herd­ed to the clin­ic what even­tu­al­ly be­came Mek­tovi, Tukysa, Vi­t­rakvi, Retev­mo and Kosel­u­go — but part­ed ways af­ter Pfiz­er bought it for $11.4 bil­lion. Robin­son stayed on at the phar­ma gi­ant, most re­cent­ly get­ting el­e­vat­ed to VP of med­i­c­i­nal chem­istry.

Rob­bins, who’s tasked with re­build­ing Co­gent with a new fo­cus on pre­ci­sion med­i­cines, was in­ter­est­ed in set­ting up an in-house dis­cov­ery unit that could keep feed­ing in­to the pipeline. Those con­ver­sa­tions turned in­to a plan to gath­er some Ar­ray vet­er­ans and launch the Co­gent Re­search Team. There are 8 of them now, with plans to slow­ly grow to 50 over the next 3 to 4 years as Co­gent scales the phys­i­cal re­search fa­cil­i­ty.

“There are many many biotech op­por­tu­ni­ties right now,” Robin­son ad­mit­ted.

Two things about Co­gent, though, drew him in: the first is CGT9486, the KIT D816V ki­nase in­hibitor that Unum got by ac­quir­ing Kiq be­fore the brand re­fresh, which he can an­chor the dis­cov­ery group around. The oth­er? He was itch­ing to roll up his sleeves to start a re­search or­ga­ni­za­tion and ready to “build some­thing great.”

Part of the ear­ly work will in­volve team­ing up with CMO Jes­si­ca Sachs to so­lid­i­fy the da­ta around PLX9486, a key re­la­tion­ship to nav­i­gate.

“I’ve seen it op­er­ate in a cou­ple of dif­fer­ent ways,” he said. “One is sort of a siloed or­ga­ni­za­tion where you toss an as­set over the wall. I think a re­al­ly great or­ga­ni­za­tion is one in which the de­vel­op­ment or­ga­ni­za­tion and re­search or­ga­ni­za­tion has a com­mon vi­sion for which pa­tients we’re go­ing af­ter, how we’re gonna se­lect those pa­tients, and there’s no sur­pris­es.”

The mantra he will be tak­ing in­to the job echoes what many sea­soned drug hunters say: Short-term, ear­ly and fre­quent fail­ures dri­ve long-term suc­cess.

“If you think about the fastest way to de­rail or kill a com­pound or a project and you do that as ear­ly as you can in a project and you’re not emo­tion­al­ly wed­ded to that project, you can make a re­al­ly — I think a much bet­ter de­ci­sion,” he said. “It’s un­com­fort­able, though, be­cause you re­al­ly pres­sure test the sys­tem ear­ly.” — Am­ber Tong


→ An­ti-CD47 out­fit Arch On­col­o­gy has named Lau­rence Blum­berg pres­i­dent and CEO as board mem­ber af­ter ex-Ideaya Bio­sciences CMO Julie Ham­ble­ton had been lead­ing the biotech on an in­ter­im ba­sis. Blum­berg co-found­ed and was the found­ing CEO of Syn­tim­mune, which Alex­ion nabbed in Sep­tem­ber 2018 for $1.2 bil­lion. In ad­di­tion, Blum­berg co-found­ed Syn­tonix Phar­ma­ceu­ti­cals (bought by Bio­gen in 2007) and was Kad­mon’s SVP, project man­age­ment. Ham­ble­ton was cho­sen as in­ter­im CEO af­ter Julie Cher­ring­ton helmed Arch On­col­o­gy from 2017-20.

John O’Brien

→ The search is over for a new leader at the Na­tion­al Phar­ma­ceu­ti­cal Coun­cil, with John O’Brien tak­ing on the roles of pres­i­dent and CEO at the or­ga­ni­za­tion ef­fec­tive June 1. Robert Dubois had held those ti­tles on an in­ter­im ba­sis when Dan Leonard stepped aside last Sep­tem­ber af­ter a 12-year run, and Dubois will ease back in­to his du­ties as EVP and CSO. O’Brien was se­nior ad­vi­sor to for­mer HHS Sec­re­tary Alex Azar and deputy as­sis­tant sec­re­tary of plan­ning and eval­u­a­tion (health pol­i­cy). He’s al­so been VP of pub­lic pol­i­cy for Care­First Blue­Cross BlueShield.

Er­ic Koo

Hill­house-backed Over­land AD­CT Bio­Phar­ma, which bands to­geth­er Over­land Phar­ma­ceu­ti­cals and ADC Ther­a­peu­tics in a new kind of in-li­cens­ing mod­el that our Am­ber Tong re­port­ed on in De­cem­ber, has brought on Er­ic Koo as CEO. Koo pre­vi­ous­ly led the on­col­o­gy busi­ness unit at Take­da Chi­na and di­rect­ed both the on­col­o­gy busi­ness unit and mar­ket ac­cess, ex­ter­nal af­fairs & key ac­count man­age­ment at Mer­ck Sharp and Dohme in Tai­wan. He al­so de­vot­ed 16 years to Pfiz­er in an as­sort­ment of ca­pac­i­ties rang­ing from prod­uct man­age­ment to mar­ket­ing.

Yan Zhang

Char­lie Sil­ver will no longer be CEO of Mis­sion Bio, the com­pa­ny he co-found­ed in 2014, mov­ing in­to an ad­vi­so­ry role as Yan Zhang steps in to pro­pel the biotech’s sin­gle-cell se­quenc­ing plat­form for­ward. Over a 10-year pe­ri­od at Ther­mo Fish­er, Zhang was gen­er­al man­ag­er of the re­pro­duc­tive health and mi­croar­ray busi­ness­es, and in Chi­na she led the ge­net­ic sci­ences and clin­i­cal next-gen­er­a­tion se­quenc­ing di­vi­sions. She’s al­so had mar­ket­ing stints at Affymetrix and Nu­GEN Tech­nolo­gies.

David David­son

Ge­off von Maltzahn’s gene writ­ing biotech Tessera made a loud state­ment with a hefty $230 mil­lion Se­ries B, and that same splashi­ness is car­ry­ing over as he builds his C-suite. Tessera has plucked David David­son from blue­bird bio as chief med­ical and de­vel­op­ment of­fi­cer while mak­ing Hari Pu­jar COO and Lin Guey SVP of rare dis­eases pro­gram strat­e­gy and op­er­a­tions. David­son’s de­par­ture from Nick Leschly’s crew was an­nounced the same week that Be Bio turned to ex-blue­bird COO Joanne Smith-Far­rell to fill the CEO slot. Pu­jar, an 18-year Mer­ck vet who re­cent­ly be­came an op­er­at­ing part­ner at Flag­ship Pi­o­neer­ing, is the for­mer CTO at Spark and was Mod­er­na’s head of tech­ni­cal de­vel­op­ment and man­u­fac­tur­ing. Guey al­so spent time at Mod­er­na (se­nior di­rec­tor, rare dis­eases) and makes the leap from Xilio, where she was VP, pro­gram and port­fo­lio strat­e­gy.

Cyril Kon­to has left Al­lo­gene to be CMO at Glen­mark spin­off Ich­nos Sci­ences, which launched in Oc­to­ber 2019 and is de­vel­op­ing drugs for can­cer, au­to-im­mune dis­or­ders and pain. Kon­to has Big Phar­ma roots from Pfiz­er, where he was glob­al head of ear­ly im­muno-on­col­o­gy clin­i­cal de­vel­op­ment, and from Bris­tol My­ers Squibb. Not long af­ter Al­lo­gene snapped up Pfiz­er’s al­lo­gene­ic CAR-T port­fo­lio in 2018, Kon­to be­came Al­lo­gene’s VP of clin­i­cal de­vel­op­ment, but now he’s ready for a change as David Chang los­es a key staffer to Ich­nos, helmed by Gilead alum Alessan­dro Ri­va.

Hide­ki Gar­ren

Res­ur­rect­ing bir­tamimab af­ter it went bust in a Phase IIb tri­al, Prothena has giv­en Hide­ki Gar­ren the nod as CMO. Gar­ren, who co-found­ed Bay­hill Ther­a­peu­tics, pi­lot­ed the Phase III pro­grams for Ocre­vus and En­spryng dur­ing his tenure as Genen­tech’s glob­al head of mul­ti­ple scle­ro­sis and neu­roim­munol­o­gy. Our Nicole De­Feud­is has more on Gar­ren’s ap­point­ment here.

Lau­ren Merendi­no

→ With its June 1 PDU­FA date loom­ing and more Phase III da­ta to comb through with re­l­u­golix, My­ovant has made its biggest staff change since CEO David Marek took the ba­ton from Lynn Seely, as long­time Roche and Genen­tech vet Lau­ren Merendi­no be­comes chief com­mer­cial of­fi­cer. Merendi­no had been Genen­tech’s VP, neu­ro­log­i­cal rare dis­eases, end­ing an as­so­ci­a­tion with Roche and its sub­sidiary that be­gan in the 1990s. Adele Gul­fo had been serv­ing as My­ovant’s in­ter­im CCO for the past year.

→ Like Gar­ren and Merendi­no, Howard Stern has Genen­tech ex­pe­ri­ence of his own; in his case, he was a sci­en­tist/pathol­o­gist for sev­en years there. His lat­est chap­ter is with Ram Ai­yar and At­las up­start Ko­r­ro Bio, the RNA edit­ing biotech which launched in Oc­to­ber 2019, as their CSO af­ter near­ly two years as chief sci­en­tist at Fog­Phar­ma. Stern al­so worked in trans­la­tion­al sci­ence at Juno Ther­a­peu­tics and In­fin­i­ty Phar­ma­ceu­ti­cals.

Fred­er­ic Pla

Fred­er­ic Pla led off Peer Re­view ex­act­ly one year ago when he signed on to be­come COO at the Park­er In­sti­tute for Can­cer Im­munother­a­py. But for Pla, an­oth­er op­por­tu­ni­ty awaits as he takes on the COO post at spa­tial bi­ol­o­gy play­er Akoya Bio­sciences out of Marl­bor­ough, MA. Pri­or to his time at the Park­er In­sti­tute, Pla was Ge­nom­ic Health’s chief busi­ness and prod­uct de­vel­op­ment of­fi­cer and lat­er its COO up through the com­pa­ny’s 2019 sale to Ex­act Sci­ences for $2.8 bil­lion.

→ End­points got more ac­quaint­ed a year ago with Howard Federoff when he cap­tained the ship at As­pen Neu­ro­science dur­ing its $70 mil­lion Se­ries A raise. He has since de­cid­ed to sign on as CEO of Brook­lyn Im­munoTher­a­peu­tics, which put the fin­ish­ing touch­es on a re­verse merg­er with NTN Buz­ztime a cou­ple weeks ago. Federoff has been a neu­rol­o­gy pro­fes­sor at UC-Irvine and is the ex-CEO of UCI Health. Brook­lyn is shoot­ing for topline re­sults of a Phase IIb tri­al of its cy­tokine-based IRX-2 for squa­mous cell can­cer of the head and neck in 2022 af­ter the suc­cess of the Phase IIa study.

An­nal­isa D’An­drea

→ Rough­ly a cou­ple months af­ter an­nounc­ing its launch, Long­wood Fund im­munol­o­gy com­pa­ny and Stephen Elledge spin­out Im­muneID has named An­nal­isa D’An­drea its pres­i­dent and CSO. D’An­drea heads to Im­muneID af­ter more than a year and a half as chief sci­en­tist at Kiniksa, and be­fore that, she was Roche’s VP and glob­al head of dis­cov­ery for im­munol­o­gy and in­flam­ma­tion. Elledge and Im­muneID’s found­ing CEO Lea Hachi­gian al­so helped launch TScan.

→ Sin­gin’ in the Rain: Richard Bryce has got­ten the call to be CMO at Rain Ther­a­peu­tics the same week that the Cal­i­for­nia on­col­o­gy play­er filed for a $100 mil­lion IPO. Pri­or to this lat­est CMO gig with Rain co-founders Robert Doe­bele and Avan­ish Vel­lan­ki, Bryce was chief med­ical and sci­en­tif­ic of­fi­cer at Puma Biotech­nol­o­gy the last four years, spend­ing nine years to­tal at the biotech. From 2008-12, Bryce was with Onyx Phar­ma­ceu­ti­cals as se­nior med­ical di­rec­tor of clin­i­cal sci­ence.

Véronique Ri­ethuisen

→ Sur­pass­ing its Se­ries A with a $57.6 mil­lion Se­ries B last fall, San­dra Glucks­mann-led can­cer biotech Cedil­la Ther­a­peu­tics has wel­comed Véronique Ri­ethuisen as CBO and head of fi­nance. Ri­ethuisen hails from Ipsen, serv­ing as SVP, glob­al busi­ness de­vel­op­ment and strate­gic al­liance man­age­ment. She al­so led glob­al trans­ac­tions for a year at Take­da and has al­so tak­en on M&A, BD and al­liance man­age­ment posts at Pfiz­er, Te­va, Bris­tol My­ers and Mon­san­to.

Nush­mia Khokhar

Janssen vet Nush­mia Khokhar has been se­lect­ed as CMO of Seat­tle in vi­vo im­munother­a­py up­start Umo­ja Bio­phar­ma, which popped the Se­ries A cham­pagne bot­tle with $53 mil­lion in fi­nanc­ing back in No­vem­ber. Khokhar, the for­mer glob­al clin­i­cal leader for Darza­lex at Janssen, had pre­vi­ous­ly been SVP, head of clin­i­cal de­vel­op­ment at Au­to­lus, where she had served the past four years.

→ Speak­ing of Au­to­lus vets, Do­minic More­land has jumped on board at Oslo-based GE Health­care spin­out Ex­act Ther­a­peu­tics, the artists for­mer­ly known as Phoenix So­lu­tions, as CFO. As Au­to­lus’ VP of fi­nance, More­land guid­ed the biotech through its IPO in the sum­mer of 2018. Else­where, he found­ed and was CEO of Care­ol­o­gy — once Gen­zyme’s home­care busi­ness — and it was lat­er sold in 2010 to Med­co Health So­lu­tions.

Am­ryt — fo­cused on the treat­ment of rare and or­phan dis­eases — has signed on Sheila Frame as pres­i­dent Amer­i­c­as. Frame brings to the ta­ble ex­pe­ri­ence from her times at No­var­tis, Bris­tol My­ers, UCB and As­traZeneca.

Michael Faerm

→ Sev­er­al weeks re­moved from a meaty $120 mil­lion Se­ries B that fol­lowed its pact with Mer­ck and now with an S-1 filed, San Diego NK cell ther­a­py play­er Arti­va Bio­ther­a­peu­tics has re­cruit­ed Michael Faerm as CFO. Faerm’s pre­vi­ous stops have ranged from Wells Far­go (se­nior phar­ma­ceu­ti­cals eq­ui­ty re­search an­a­lyst) to Ther­a­vance (CBO). Most re­cent­ly he had his own en­ter­prise, MEF Con­sult­ing, and was in­ter­im CFO and CBO for bio­phar­ma star­tups at Burk­land As­so­ci­ates.

Jonathan Wang’s new im­munol­o­gy biotech, In­ma­gene, has ap­point­ed two ex­ecs with An­bo Xi­ang and Qian Xu join­ing the team. Xi­ang, In­ma­gene’s CMO (Chi­na) and SVP, op­er­a­tions, makes the move af­ter be­ing CMO (non-on­col­o­gy) for Qilu Phar­ma­ceu­ti­cal Group. She spent 14 years in phar­ma­ceu­ti­cal R&D at GSK Japan and was a se­nior med­ical di­rec­tor for Hen­grui. Xu, him­self a for­mer se­nior med­ical di­rec­tor at Hen­grui, has Big Phar­ma cre­den­tials from Roche, Eli Lil­ly and No­var­tis.

Don­ald Wuchterl

Don­ald Wuchterl is on board as SVP and chief man­u­fac­tur­ing of­fi­cer at T cell re­cep­tor biotech T-knife Ther­a­peu­tics, backed by Ver­sant and RA Cap­i­tal in its $78+ mil­lion Se­ries A round. Wuchterl piv­ots to T-knife from his role as SVP, tech­ni­cal op­er­a­tions & qual­i­ty for Au­dentes, where he spent five years. He’s al­so been COO at Cy­to­vance, the di­rec­tor of man­u­fac­tur­ing at Den­dreon and Shire, and the se­nior man­ag­er of man­u­fac­tur­ing at Am­gen. Wuchterl’s ap­point­ment comes af­ter the ad­di­tions of CEO Thomas Soloway and CBO / CFO Camille Lan­dis in Jan­u­ary.

→ Nat­ur­al killer-fo­cused NKGen Biotech out of San­ta Ana, CA has ush­ered in Philip Moody as CFO. Moody moved through the ranks at Ch­i­ron Cor­po­ra­tion for 11 years, even­tu­al­ly serv­ing as CFO and SVP of fi­nance and op­er­a­tions, bio­phar­ma­ceu­ti­cals be­fore No­var­tis bought the com­pa­ny in 2006. He was al­so CFO at Pax­Vax be­fore it was pur­chased in 2018 by the now-em­bat­tled Emer­gent BioSo­lu­tions.

→ Can­cer me­tab­o­lism-based ther­a­py de­vel­op­er Tyme Tech­nolo­gieshelmed by ex-NFL kick­er Richie Cun­ning­hamhas tapped Jan Van Tornout as act­ing CMO, suc­ceed­ing Giuseppe Del Pri­ore. Be­fore found­ing B.IO.Phar­ma eCon­sult­ing, Van Tornout had brief stays as head of on­col­o­gy at Nat­era and VP of on­col­o­gy de­vel­op­ment at In­ovio. He was al­so an on­col­o­gy di­rec­tor at Bris­tol My­ers Squibb and Astel­las.

Mike Spi­garel­li

Psy­Bio Ther­a­peu­tics has pulled in Mike Spi­garel­li as CMO. Spi­garel­li is mak­ing a quick piv­ot to Psy­Bio af­ter tak­ing the CMO gig at Lu­men Bio­science sev­en months ago. In ad­di­tion, Spi­garel­li has served at Im­mu­cor and was chair of the Amer­i­can Board of Clin­i­cal Phar­ma­col­o­gy.

Click Ther­a­peu­tics has made a new round of hires with the ap­point­ments of Ran­dall Stan­icky as CFO, Lee Shapiro as a board mem­ber and Muza­m­mil Mansuri as board chair. Stan­icky is a Wall Street vet­er­an, bring­ing with him ex­pe­ri­ence from RBC Cap­i­tal Mar­kets and Gold­man Sachs.

Shapiro is man­ag­ing part­ner and co-founder at in­vest­ment firm 7wireVen­tures. His pre­vi­ous work in­cludes stints at Livon­go and Allscripts. Mean­while, Mansuri serves as a part­ner at F-Prime Cap­i­tal. Pri­or to F-Prime, Mansuri was EVP, strat­e­gy, busi­ness de­vel­op­ment, and li­cens­ing at Sanofi. In ad­di­tion, he was SVP re­search and de­vel­op­ment strat­e­gy and busi­ness de­vel­op­ment at Gilead.

Amie Krause

Amie Krause was el­e­vat­ed to SVP and chief peo­ple of­fi­cer at Atara Bio­ther­a­peu­tics ef­fec­tive April 2, as re­flect­ed on Atara’s so­cial me­dia and web­site. An 11-year Am­gen alum in tal­ent ac­qui­si­tion and hu­man re­sources, Krause has held a se­ries of posts since she joined Atara in 2016 as se­nior di­rec­tor of hu­man re­sources. In De­cem­ber, Bay­er made a move to get a win­ning hand in the CAR-T game by ink­ing a $610 mil­lion deal ($60 mil­lion of that up­front) for Atara’s as­sets that tar­get mesothe­lin.

→ Seat­tle-based Nau­tilus Biotech­nol­o­gy, which took a dip in the SPAC pool by re­verse merg­ing with Arya Sci­ences Ac­qui­si­tion Corp III in Feb­ru­ary, has cor­ralled Matt Mur­phy as gen­er­al coun­sel. Mur­phy has most no­tably served as VP, gen­er­al coun­sel at 10x Ge­nomics and as VP of in­tel­lec­tu­al prop­er­ty and gen­er­al coun­sel with Pa­cif­ic Bio­sciences.

→ Durham, NC-based BioSkryb has brought on Sean Keo­hane as SVP of com­mer­cial op­er­a­tions. Keo­hane comes from nu­mares AG, where he served as VP of US mar­ket­ing and sales. Pri­or to that, Keo­hane held roles at Mol­e­c­u­lar De­vices, Ther­mo Fish­er, Qi­a­gen and Roche among oth­ers.

Lib­bie Mansell

Lex­eo Ther­a­peu­tics is bring­ing in Paul Mc­Cor­mac as SVP, tech­ni­cal op­er­a­tions and Lib­bie Mansell as SVP and head of reg­u­la­to­ry af­fairs. Mc­Cor­mac comes to the New York-based com­pa­ny from Pfiz­er Rare Dis­ease, where he served as med­i­c­i­nal sci­ences cat­e­go­ry lead. Pri­or to Pfiz­er, Mc­Cor­mac was with Ave­cia. As for Mansell, she joins from AskBio, where she served as SVP, reg­u­la­to­ry af­fairs. Pri­or to AskBio, Mansell was with Curis, Gen­zyme and Mil­len­ni­um Phar­ma­ceu­ti­cals among oth­ers.

Can­del Ther­a­peu­tics has bagged Chris Ma­th­e­ny as VP, de­vel­op­ment leader. Ma­th­e­ny brings to the ta­ble near­ly two decades worth of ex­pe­ri­ence from GSK — most re­cent­ly serv­ing as as­set de­vel­op­ment leader on four sep­a­rate im­muno-on­col­o­gy pro­grams.

→ In­vest­ment firm MPM Cap­i­tal has en­list­ed David Bredt to its team of ex­ec­u­tive part­ners. Pri­or to his new role at MPM, Bredt was site head for John­son & John­son’s R&D cam­pus in La Jol­la and was al­so glob­al head of neu­ro­science dis­cov­ery at J&J. Pri­or to that, Bredt was with Eli Lil­ly as VP of in­te­gra­tive bi­ol­o­gy and, lat­er on, VP of neu­ro­science dis­cov­ery and ear­ly de­vel­op­ment.

Tom Wig­gans

→ One of sev­er­al biotechs that have braced them­selves from the fe­ro­cious NASH head­winds, CymaBay has brought on Tom Wig­gans and Janet Dor­ling to serve on the board of di­rec­tors. Wig­gans, the for­mer chair­man and CEO at Der­mi­ra, was re­cent­ly named chair­man of An­nex­on. Mean­while, Dor­ling had a fleet­ing tenure as CymaBay’s CCO and then be­came Gilead’s SVP, glob­al com­mer­cial prod­uct strat­e­gy in May 2020. Al­so, Paul Truex re­signed from the CymaBay board to take on CEO du­ties at LQT Ther­a­peu­tics.

→ A rough 2020 start­ed out as an equal­ly rough 2021 for DBV Tech­nolo­gies af­ter the peanut patch biotech sent 200 staffers pack­ing at the start of the year. DBV has nonethe­less elect­ed Tim­o­thy Mor­ris to the board of di­rec­tors as it picks up the pieces from the FDA re­jec­tion. Mor­ris, the COO and CFO for Cameron Dur­rant at Hu­mani­gen, has al­so been CFO at Io­vance and Acel­Rx.

Yi Lar­son

→ With such lu­mi­nar­ies as San­dra Horn­ing and Ian Clark al­ready on the board, Sean Bo­hen-led Ole­ma On­col­o­gy has made room for Yi Lar­son on the board of di­rec­tors as well. Lar­son just made a Peer Re­view ap­pear­ance a month ago when she ac­cept­ed the CFO post at Lian­Bio.

→ For­mer Bay­er Phar­ma CEO Di­eter Weinand has added a new board seat to his ré­sumé with his ap­point­ment to Robert Mill­manfound­ed Vesi­gen Ther­a­peu­tics. Weinand pre­vi­ous­ly served in roles at Sanofi, Pfiz­er, Bris­tol My­ers and Ot­su­ka. Weinand al­so par­tic­i­pates on the boards of Ziel­Bio and Replimune.

→ Dry eye dis­ease biotech Oys­ter Point Phar­ma has named George Eli­ades to the board of di­rec­tors. The ex-Bain part­ner has been SVP, cor­po­rate de­vel­op­ment and chief trans­for­ma­tion of­fi­cer at Jazz Phar­ma­ceu­ti­cals since De­cem­ber.

Ju­lia Owens

→ Liv­er and gas­troin­testi­nal dis­ease-fo­cused Metacrine has pulled in ex-Mil­len­do CEO Ju­lia Owens to its board of di­rec­tors. Cur­rent­ly, Owens serves as ex­ec­u­tive chair­per­son for the be­lea­guered biotech she co-found­ed, which merged with Tem­pest Ther­a­peu­tics in late March. Owens al­so sits on the boards of BIO and Michi­gan Bio­med­ical Ven­ture Fund.

→ Sweep­ing the leg with a nine-fig­ure IPO to fight can­cer through its Im­munoPhage plat­form, Sen­sei Bio­ther­a­peu­tics has made Jessie Eng­lish a mem­ber of the board of di­rec­tors. An ex-staffer with Pfiz­er, Mer­ck and EMD Serono, Eng­lish is cur­rent­ly CSO at Bakx Ther­a­peu­tics.

Pan­thera Biopart­ners has reeled in Chris Steed as non-ex­ec­u­tive di­rec­tor. Steed is the founder and man­ag­ing part­ner at Ar­gyll Part­ners and has gained ex­pe­ri­ence from his time at Arthur An­der­sen and De­loitte.

BioRestora­tive Ther­a­pies — fo­cused on stem cell-based ther­a­pies — has ap­point­ed Nick­o­lay Kukekov to its board of di­rec­tors. Cur­rent­ly, Kukekov is a se­nior man­ag­ing di­rec­tor at Paul­son In­vest­ment Com­pa­ny and has pre­vi­ous­ly served at High­line Re­search Ad­vi­sors, Para­mount Bio­Cap­i­tal and Rod­man and Ren­shaw.

→ Ad­vanced can­cers-fo­cused Pen­rose Ther­a­peuTx has added Mircea Ivan, David Ru­bin and Patrick Farmer to its sci­en­tif­ic ad­vi­so­ry board. Ivan is an as­so­ciate pro­fes­sor of med­i­cine at the Uni­ver­si­ty of In­di­ana School of Med­i­cine. His re­search con­tributed to the 2019 No­bel Prize in Med­i­cine or Phys­i­ol­o­gy. Ru­bin is the Joseph B. Kirsner pro­fes­sor chair, chief of the sec­tion of gas­troen­terol­o­gy, he­pa­tol­ogy and nu­tri­tion and the co-di­rec­tor of the Di­ges­tive Dis­eases Cen­ter at UChica­go Med­i­cine. Farmer is a pro­fes­sor and chair of the de­part­ment of chem­istry and bio­chem­istry at Bay­lor Uni­ver­si­ty.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.

Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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