As Co­di­ak en­ters 'next phase of growth,' Jen­nifer Whel­er steps in­to CMO role; Mark Tim­ney lines up his sec­ond CEO op­por­tu­ni­ty af­ter Pur­due Phar­ma reign

Most CMOs don’t start out as art stu­dents. But af­ter get­ting her bach­e­lor’s in art his­to­ry from Prince­ton Uni­ver­si­ty, Jen­nifer Whel­er de­cid­ed to go af­ter an MD from Cor­nell, kick­ing off a decades-long ca­reer in bio­phar­ma. Her next move? Lead­ing the team at Co­di­ak Bio­Sciences to de­liv­er ther­a­peu­tics us­ing a form of cel­lu­lar postal ser­vice called ex­o­somes.

“I was cap­ti­vat­ed by the sci­ence and the po­ten­tial for ex­o­somes to have trans­for­ma­tion­al im­pact in can­cer and oth­er dis­ease ar­eas,” the in­com­ing CMO told End­points News via email. “Co­di­ak has a po­tent com­bi­na­tion of great sci­ence and won­der­ful­ly ex­pe­ri­enced and kind peo­ple — it doesn’t get much bet­ter.”

Jen­nifer Whel­er

Ex­o­somes are lipid vesi­cles that shut­tle mol­e­c­u­lar mail be­tween cells. A se­ries of com­pa­nies — in­clud­ing Co­di­ak and Mantra Bio — is try­ing to un­der­stand this nat­ur­al mes­sag­ing sys­tem, and copy it to build couri­ers that can slide drugs in­to hard-to-reach places. Us­ing its en­gEx plat­form to de­sign and en­gi­neer ex­o­somes, Co­di­ak put two can­di­dates in the clin­ic in the last year.

“My im­me­di­ate goals are to sup­port the team in achiev­ing the mile­stones for our two cur­rent clin­i­cal pro­grams, ex­oIL-12 and ex­oST­ING, and ush­er a third pro­gram, exoA­SO-STAT6, in­to the clin­ic,” Whel­er said. “We’re look­ing for­ward to im­por­tant da­ta-read­outs for our two lead pro­grams this year.”

Whel­er was in­tro­duced to Co­di­ak through a “serendip­i­tous con­nec­tion from a friend.” Be­fore this, she was CMO at bis­pe­cif­ic an­ti­body play­er Bicara Ther­a­peu­tics. She pre­vi­ous­ly led first-in-hu­man stud­ies in im­muno-on­col­o­gy at the No­var­tis In­sti­tutes for Bio­Med­ical Re­search, and served near­ly a decade in the De­part­ment of In­ves­ti­ga­tion­al Can­cer Ther­a­peu­tics at the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter.

While at MD An­der­son, she found­ed Col­lage — a non­prof­it that brings art pro­grams to can­cer pa­tients — as a way of con­nect­ing her pas­sions in art and med­i­cine.

“Pa­tients ben­e­fit from their work with artists in di­verse ways — from find­ing wel­come di­ver­sion while await­ing a doc­tor’s vis­it to be­ing able to find peace through artis­tic ex­pres­sion at the end of their lives — this is un­de­ni­ably im­por­tant work,” she said.

Ben­ny Sorensen, who’s been lead­ing pre­clin­i­cal to clin­i­cal trans­la­tion­al work and clin­i­cal strat­e­gy for Co­di­ak, is step­ping in­to a new role as se­nior VP of strate­gic projects.

“With the an­tic­i­pat­ed ad­vance­ment and in­ten­si­fied fo­cus in on­col­o­gy, we be­lieve it is an ide­al time for us to ex­pand our team for the next phase of growth,” CEO Doug Williams said in a state­ment. — Nicole De­Feud­is


→ The same week that Alex Gib­ney’s HBO doc­u­men­tary The Crime of the Cen­tu­ry on the opi­oid cri­sis pre­miered, Mark Tim­ney has been named CEO of sys­temic amy­loi­do­sis biotech At­tralus Ther­a­peu­tics out of South San Fran­cis­co. With his name in a bevy of law­suits, his time as CEO of Oxy­Con­tin mak­er Pur­due Phar­ma earned but a fleet­ing men­tion in the re­lease, but it did talk up Tim­ney’s re­cent run at the helm of The Med­i­cines Com­pa­ny. He’s al­so the chair­man at Blade Ther­a­peu­tics.

Oth­er ex­ecs who have joined the At­tralus fray are Gre­go­ry Bell (CMO), Glen Fire­stone (CBO), Kr­ish­na Gor­ti (head of cor­po­rate de­vel­op­ment) and Michael Klein (head of CMC). Co-founder Spencer Guthrie stays on as COO, while Rahul Kakkar — the CEO of Pan­dion be­fore Mer­ck pur­chased it for $1.85 bil­lion — is now a mem­ber of the board.

Luisa Salter-Cid

→ We had Luisa Salter-Cid’s de­par­ture from Gos­samer Bio in Peer Re­view less than a month ago, and this week Flag­ship Pi­o­neer­ing has giv­en her an­oth­er op­por­tu­ni­ty to be chief sci­en­tist, this time at Pi­o­neer­ing Med­i­cines. When she left for Gos­samer af­ter 13 years at Bris­tol My­ers Squibb, she was the Big Phar­ma’s VP and head of im­munol­o­gy, small mol­e­cule im­muno-on­col­o­gy, and ge­nomics dis­cov­ery. She joins a team at Pi­o­neer­ing Med­i­cines that’s head­lined by pres­i­dent Paul Bion­di — a fa­mil­iar face from Bris­tol My­ers — and CMO Lu­ciano Ros­set­ti from Mer­ck KGaA. Lau­ra Carter suc­ceed­ed Salter-Cid as Gos­samer’s CSO on April 30.

→ Quick­ly lin­ing up an IPO af­ter mak­ing a splash with its Feb­ru­ary de­but, Saurabh Sa­ha-led Centes­sa added more grav­i­tas to its lead­er­ship with An­toine Yver as CMO. Head­ing to Centes­sa af­ter some time as Dai­ichi Sankyo’s glob­al head of on­col­o­gy R&D, Yver was a key cog in the ap­provals of Tagris­so, Lyn­parza and En­her­tu — climb­ing his way to SVP, glob­al med­i­cine head, on­col­o­gy, and glob­al med­i­cines de­vel­op­ment Chi­na lead. One of the big names as­so­ci­at­ed with Centes­sa’s first few weeks in ex­is­tence, ex-Op­er­a­tion Warp Speed chief Mon­cef Slaoui, re­signed his CSO and ad­vi­sor po­si­tions in the wake of sub­stan­ti­at­ed sex­u­al ha­rass­ment al­le­ga­tions while with Glax­o­SmithK­line.

Yizhe Wang

Yizhe Wang has suc­ceed­ed Bing Li as CEO of Lian­Bio, chaired by Per­cep­tive’s Kon­stan­tin Poukalov and awash in cash af­ter a $310 mil­lion raise. Wang makes the jump to lead­ing a com­pa­ny af­ter three years at Eli Lil­ly that cul­mi­nat­ed in be­ing the point man for bam­lanivimab as glob­al plat­form lead for an­ti-Covid ther­a­py at Lil­ly Re­search Lab. He al­so made his mark in the US, UK and Chi­na dur­ing 15 years at Glax­o­SmithK­line, lead­ing GSK Chi­na Phar­ma­ceu­ti­cals’ res­pi­ra­to­ry busi­ness unit be­fore set­ting off for Lil­ly.

→ A for­mer Ab­b­Vie ex­ec is hit­ting the trail to­wards a mid-sized biotech as its new­ly-mint­ed CMO. Thorsten Graef makes the leap to NK cell play­er Ace­po­dia af­ter serv­ing as head of ear­ly on­col­o­gy de­vel­op­ment at Ab­b­Vie. Pri­or to his role at Ab­b­Vie, Graef had a stint at Phar­ma­cyclics — the mak­er of blood can­cer med Im­bru­vi­ca.

Swati Tole

→ Backed by Ver­sant and West­lake Vil­lage BioPart­ners (Beth Sei­den­berg is on the board), Bob Cud­di­hy’s new gene ther­a­py play Cap­si­da has hand­ed the CMO reins to Swati Tole. She comes to Cap­si­da fol­low­ing al­most 13 years work­ing in gas­troen­terol­o­gy and he­pa­tol­ogy at Genen­tech, tak­ing on an as­sort­ment of job ti­tles in that time and mov­ing up to VP, clin­i­cal de­vel­op­ment. Ad­di­tion­al­ly, Mu­na Ther­a­peu­tics CSO Ri­ta Bal­ice-Gor­don has joined Cap­si­da’s board of di­rec­tors.

Marc Sta­p­ley

→ Start­ing June 1, Marc Sta­p­ley will take over as CEO of South San Fran­cis­co ge­nom­ic di­ag­nos­tics play­er Ve­r­a­cyte, as Bon­nie An­der­son piv­ots to ex­ec­u­tive chair and an ad­vi­sor to Sta­p­ley. An­der­son, who of­fi­cial­ly steps down June 1, co-found­ed Ve­r­a­cyte in 2008 and was CEO from the be­gin­ning, guid­ing the com­pa­ny to its IPO in Fall 2013. Sta­p­ley will move to Ve­r­a­cyte from He­lix af­ter two years as chair­man and CEO, and from 2012-19, the Pfiz­er fi­nan­cial vet was EVP, CFO and chief ad­min­is­tra­tive of­fi­cer for Il­lu­mi­na.

Michael Stocum is set­tling in as pres­i­dent and CEO at New York-based Ban­tam Phar­ma­ceu­ti­cal. The found­ing CEO of Ini­va­ta from 2014-18, Slocum has Big Phar­ma ties at GSK as di­rec­tor, busi­ness de­vel­op­ment & al­liance man­age­ment. Ban­tam has sharp­ened its fo­cus on dif­fuse large B-cell lym­phoma with BTM-3566, a se­lec­tive mod­u­la­tor of mi­to­chon­dr­i­al dy­nam­ics.

Mary New­man

Taysha Gene Ther­a­pies has been mo­tor­ing along at a break­neck pace since launch­ing in April 2020, with an­oth­er fund­ing round, an IPO that closed in Sep­tem­ber and a deal made in April for the gene ther­a­py TSHA-120 to treat gi­ant ax­on­al neu­ropa­thy. The biotech has as­sem­bled an im­pres­sive staff  in a sim­i­lar­ly speedy fash­ion, with Mary New­man sign­ing on as chief de­vel­op­ment of­fi­cer. New­man had been SVP of reg­u­la­to­ry af­fairs for Astel­las Gene Ther­a­pies (once known as Au­dentes) and has al­so held reg­u­la­to­ry man­age­ment roles at Bio­Marin.

Pritesh Gand­hi

On­ly time will tell: Bev­er­ly, MA-based Tell­Bio took the wraps off its liq­uid biop­sy plat­form with a mod­est $5 mil­lion Se­ries A, nam­ing Pritesh Gand­hi CEO and An­nie Par­ti­sano SVP and head of op­er­a­tions in the process. With roles at Alex­ion, Mil­len­ni­um and Sanofi Gen­zyme un­der his belt, Gand­hi came to Al­ny­lam in 2014 as VP, med­ical af­fairs and had been gen­er­al man­ag­er for John Maraganore’s squad since 2018. Mov­ing on from Kiniksa af­ter her time as VP, med­ical op­er­a­tions, Par­ti­sano al­so brings ex­pe­ri­ence as Gand­hi does from Al­ny­lam and Sanofi Gen­zyme.

Mat­i­ca Biotech­nol­o­gy — pro­vid­ing vi­ral vec­tor GMP man­u­fac­tur­ing ser­vices for cell and gene ther­a­pies — has reeled in Yun Jeong Song to sail at the helm of the ship as CEO, suc­ceed­ing Byung Se So. Pri­or to her new role, Song was the CEO of Im­mu­neOn­cia Ther­a­peu­tics. Pri­or to that, Song was with the NIH, Sam­sung and Sanofi.

In­trance Med­ical Sys­tems has tapped Patrick Shea as CEO and mem­ber of the board. Shea comes from Antares Phar­ma­ceu­ti­cals, where he served as SVP, com­mer­cial. Pri­or to that role, he was CCO at Ea­glet Cor­po­ra­tion and Clarus Ther­a­peu­tics. Ad­di­tion­al­ly, Shea held roles at CSL Behring, Astel­las, Lig­and Phar­ma­ceu­ti­cal and Boehringer In­gel­heim.

Kyle Chi­ang

Kyle Chi­ang is leav­ing Log­icBio af­ter just get­ting pro­mot­ed to COO sev­en months ago. Chi­ang, who joined the biotech in 2016, “will pur­sue an op­por­tu­ni­ty at a ven­ture cap­i­tal firm fo­cus­ing on ear­ly-stage sus­tain­abil­i­ty and life sci­ences fo­cused ven­tures,” ac­cord­ing to a re­lease.

Start­ing Mon­day, An­drea Paul will be gen­er­al coun­sel and cor­po­rate sec­re­tary at Log­icBio, while fur­ther down the line, the gene ther­a­py and gene edit­ing biotech will roll out the wel­come mat for SVP of strat­e­gy and port­fo­lio man­age­ment Jan­ice Ol­son on June 7. Paul comes to Log­icBio from Ake­bia, where she was VP, le­gal, and she’s the ex-se­nior cor­po­rate coun­sel at Mo­men­ta. Ol­son spent more than a quar­ter cen­tu­ry with Sanofi Gen­zyme, cap­ping that run as head of glob­al med­ical af­fairs op­er­a­tions.

→ Pfiz­er spin­out Spring­Works Ther­a­peu­tics has tapped Mike Burgess as head of R&D, re­plac­ing act­ing head of R&D Stephen Squin­to, who will now con­cen­trate on his CEO du­ties at Gen­nao Bio. Burgess has a deep Big Phar­ma back­ground, start­ing at Eli Lil­ly, then at Roche, and lat­er at Bris­tol My­ers, where he was SVP, car­dio­vas­cu­lar, fi­bro­sis and im­muno­science de­vel­op­ment. He then turned away from Bris­tol My­ers to be­come pres­i­dent of R&D at Turn­stone Bi­o­log­ics in 2017.

Jen­ny Ni

→ Pfiz­er vet Jen­ny Ni has moved on to Shang­hai-based CAR-T play­er Gra­cell Biotech­nolo­gies as chief tech­nol­o­gy of­fi­cer. Ni takes com­mand of CAR-T prod­uct de­vel­op­ment, sup­ply chain and CMC at Gra­cell, which rang in 2021 as one of the year’s first IPOs. She’s led process de­vel­op­ment at both Pfiz­er and most re­cent­ly at Al­lo­gene, where she had served since Arie Bellde­grun and David Chang start­ed the com­pa­ny in 2018.

→ You could say that there are a pletho­ra of new staffers team­ing up with Diem Nguyen at IL-10 gene ther­a­py biotech Xalud Ther­a­peu­tics, so we’ll run through them quick­ly: First, chief de­vel­op­ment of­fi­cer Howard Rut­man makes his way to Xalud af­ter his tenure as VP of med­ical af­fairs for the US busi­ness di­vi­sion at Dai­ichi Sankyo. COO Bren­dan O’Leary has logged 17 years at Pfiz­er and was gen­er­al man­ag­er of its gener­ics sub­sidiary Green­stone. Pfiz­er and Shire alum Kristin Mur­ray, Xalud’s chief reg­u­la­to­ry of­fi­cer, just had a brief stay at Ul­tragenyx as head of reg­u­la­to­ry CMC, gene ther­a­py. Good on you for spot­ting the trend, as the Pfiz­er theme re­curs with new chief tech­nol­o­gy of­fi­cer Steve Vi­cik, who brings a wealth of sup­ply chain and prod­uct de­vel­op­ment ex­pe­ri­ence with him from his years with the phar­ma gi­ant. Fi­nal­ly, the Pfiz­er theme re­solves with SVP of com­mer­cial de­vel­op­ment Kris­ten Al­bright, for­mer­ly the US team leader for Zoloft (among oth­er drugs) who rose to VP, women’s health mar­ket­ing and sales.

Cokey Nguyen

→ Fol­low­ing the ar­rival of chief peo­ple of­fi­cer Amie Krause, Cokey Nguyen has been named CSO of Atara Bio­ther­a­peu­tics, which has a new best friend in Bay­er with a $610 mil­lion deal aimed at cell ther­a­pies for mesothe­lin. Nguyen, the ex-se­nior di­rec­tor of on­col­o­gy R&D at Pfiz­er who al­so as­sist­ed with the J&J/Leg­end union while with Janssen, has most re­cent­ly been VP, R&D in­no­va­tion at Fate Ther­a­peu­tics. Af­ter his time at Pfiz­er, Fate came call­ing for Nguyen in the fall of 2019, serv­ing as VP, sol­id tu­mor bi­ol­o­gy un­til his pro­mo­tion.

Chris Mora­bito

Chris Mora­bito has left af­ter less than a year as CMO at Car­du­ri­on Ther­a­peu­tics to take the same po­si­tion at Ful­crum. Mora­bito has made the Big Phar­ma rounds at Mer­ck and Sanofi, but most no­tably at Take­da as SVP and head of R&D for plas­ma-de­rived pro­tein ther­a­pies. Back in Au­gust, Ful­crum’s stock took a nose dive af­ter losmapi­mod — a drug that had been gath­er­ing dust at GSK un­til it was snapped up a cou­ple years ago — flopped in a Phase II study.

→ One of sev­er­al biotechs that can tell you all about trudg­ing through the un­for­giv­ing NASH field, CymaBay has brought on Lewis Stu­art as chief com­mer­cial of­fi­cer af­ter a short pe­ri­od of time lead­ing the prostate can­cer fran­chise at My­ovant, where he start­ed as VP of on­col­o­gy sales and mar­ket­ing in 2019. Stu­art has tak­en a spin around the CCO block be­fore at Nov­aBay and CV Ther­a­peu­tics, and he spent four years as VP, US on­col­o­gy for Ge­nom­ic Health.

Tanya Lewis

→ Af­ter poach­ing CCO Sushil Pa­tel from Genen­tech, Woburn, MA can­cer biotech Replimune isn’t done break­ing in new ex­ecs, ap­point­ing Tanya Lewis as chief de­vel­op­ment op­er­a­tions of­fi­cer. Lewis was pre­vi­ous­ly chief reg­u­la­to­ry strat­e­gy and strate­gic op­er­a­tions of­fi­cer at Karyopharm, now led by Richard Paul­son. A reg­u­la­to­ry VP at such biotechs as Tesaro, Idera and Sy­ros, Lewis re­signed from Replimune’s board a week ago be­fore vault­ing in­to this po­si­tion.

Chris Heberlig has been named CFO at KSQ Ther­a­peu­tics, the biotech join­ing forces with Take­da on a $100 mil­lion part­ner­ship to de­vel­op im­muno-on­col­o­gy ther­a­pies us­ing KSQ’s CRISPRomics dis­cov­ery en­gine. Heberlig makes the jump af­ter serv­ing as CFO at Kiniksa from 2015-20, and pri­or to that he was a fi­nan­cial ex­ec at Synage­va un­til Alex­ion’s 2015 ac­qui­si­tion.

Map­Light Ther­a­peu­tics — fo­cused on treat­ing CNS dis­or­ders — has pulled in Erin Pen­nock Foff as CMO. Foff comes aboard from Aca­dia Phar­ma­ceu­ti­cals, where she served as ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment. Pri­or to that, she was an as­sis­tant pro­fes­sor at the Uni­ver­si­ty of Vir­ginia, where she was an in­ves­ti­ga­tor in nu­mer­ous in­ter­ven­tion­al clin­i­cal tri­als in neu­rode­gen­er­a­tive and neu­rovas­cu­lar dis­ease.

Chris­tine Coyne

→ As the June 1 PDU­FA date nears for oral an­ti­fun­gal ibrex­a­fungerp — show­ing “sta­tis­ti­cal­ly su­pe­ri­or ef­fi­ca­cy” to treat vagi­nal yeast in­fec­tion — Scynex­is has se­lect­ed Chris­tine Coyne as chief com­mer­cial of­fi­cer. Once the di­rec­tor of Latin Amer­i­ca com­mer­cial op­er­a­tions dur­ing a long run at Pfiz­er, Coyne had been SVP, com­mer­cial with Paratek Phar­ma­ceu­ti­cals be­fore her move to Scynex­is.

→ UK im­muno-on­col­o­gy biotech Crescen­do Bi­o­log­ics is turn­ing up the vol­ume with Michael Booth as CFO. Booth de­vot­ed al­most sev­en years to In­cyte, be­com­ing di­vi­sion VP, in­vestor re­la­tions & cor­po­rate re­spon­si­bil­i­ty at the tail end of his tenure. Else­where, he was Al­ge­ta’s SVP, com­mu­ni­ca­tions & cor­po­rate af­fairs un­til Bay­er ponied up $2.6 bil­lion to buy the com­pa­ny.

Vi­neet Agar­w­al

→ Af­ter Howard Stern (the oth­er one) took on the CSO job with RNA edit­ing up­start Ko­r­ro Bio a month ago, the C-suite has ex­pand­ed with Vi­neet Agar­w­al be­com­ing Ko­r­ro’s first CFO. Agar­w­al had been se­nior ex­ec­u­tive di­rec­tor in the health­care in­vest­ment bank­ing group at JP Mor­gan Chase, where he had spent the past 14 years. Ko­r­ro made its de­but in Oc­to­ber 2019 and is chaired by co-founder Ness Berming­ham.

→ Can­cer me­tab­o­lism-based ther­a­py (CMBT) de­vel­op­er Tyme Tech­nolo­gies out of New Jer­sey has re­cruit­ed No­var­tis vet Frank Por­fi­do as CFO. Por­fi­do left No­var­tis in 2019 af­ter more than 15 years, round­ing out his ca­reer at the phar­ma gi­ant as head of glob­al fi­nance and op­er­a­tions for the on­col­o­gy busi­ness unit, and since then he had been Uro­Gen’s VP, fi­nance.

→ Al­most ex­act­ly a year af­ter Matt David be­gan as CFO, Thomas Nus­bick­el has got­ten the call to be the first CCO at in­fec­tious and in­flam­ma­to­ry dis­ease-fo­cused CorMedix. Nus­bick­el makes the tran­si­tion to CorMedix from Co­herus Bio­sciences, where he was VP of mar­ket ac­cess and gov­ern­ment af­fairs. He al­so de­vot­ed more than two decades to Am­gen, with 10 of those years cen­tered on the launch of Sen­si­par as ex­ec­u­tive di­rec­tor, glob­al mar­ket­ing and lat­er as ex­ec­u­tive di­rec­tor, val­ue ac­cess & ad­vo­ca­cy.

Andy Hur­witz

Mana Ther­a­peu­tics is mak­ing way for the pro­mo­tions of Andy Hur­witz as CSO and Michael Kuo as SVP of tech­ni­cal op­er­a­tions. Hur­witz moved his way up the ranks from his for­mer po­si­tion as SVP and head of re­search at Mana. Pri­or to his gig at MANA, Hur­witz was with Agen­Tus Ther­a­peu­tics and the NIH. Mean­while, Kuo was pro­mot­ed from his po­si­tion as VP of qual­i­ty and sup­ply chain. Be­fore Mana, Kuo was at Max­Cyte, Mesoblast and Am­gen, among oth­ers.

→ Equipped with $80 mil­lion in Se­ries C fund­ing to chal­lenge the big boys from Take­da and CSL Behring in hered­i­tary an­gioede­ma (HAE), Swiss-based Phar­varis has locked in Wim Sou­ver­i­jns as chief com­mu­ni­ty en­gage­ment & com­mer­cial of­fi­cer. Sou­ver­i­jns had been Ob­sE­va’s CCO since 2018, pre­ced­ed by a se­ries of roles over 11 years at Cel­gene, capped by his two years as cor­po­rate VP, glob­al mar­ket­ing hema­tol­ogy & on­col­o­gy.

Bal­tazar Gomez-Man­cil­la

→ Swiss-based Stal­i­cla has snagged Bal­tazar Gomez-Man­cil­la as CMO. Gomez-Man­cil­la brings with him ex­pe­ri­ence from his times at Phar­ma­cia-Up­John as se­nior di­rec­tor of clin­i­cal ge­nomics and No­var­tis In­sti­tutes for Bio­med­ical Re­search — where he served as ex­ec­u­tive di­rec­tor neu­ro­science, trans­la­tion­al med­i­cine.

→ At the same time as en­rolling pa­tients for its PhI­II clin­i­cal tri­al, Prile­nia Ther­a­peu­tics is pick­ing up Paul Gold­berg as CSO and head of ear­ly clin­i­cal de­vel­op­ment. Gold­berg joins the com­pa­ny from Io­n­is Phar­ma­ceu­ti­cals, where he served as VP of clin­i­cal de­vel­op­ment. Pri­or to that, Gold­berg was with Xenon Phar­ma­ceu­ti­cals.

Chris Rus­sell

→ Af­ter serv­ing as a fi­nan­cial ad­vi­sor for the com­pa­ny, Seat­tle-based On­coRe­sponse has locked in Chris Rus­sell as CFO. Rus­sell comes from Or­a­cle Corp, where he served as pres­i­dent. Pri­or to that, he was with Arc­Sight, Wage­Works and TrustArc.

Syn­thekine has named Naiy­er Rizvi as CMO. Rizvi joins the com­pa­ny af­ter his most re­cent stint as the Price Fam­i­ly pro­fes­sor of med­i­cine, di­rec­tor of tho­racic on­col­o­gy and co-di­rec­tor of can­cer im­munother­a­py at Co­lum­bia Uni­ver­si­ty Med­ical Cen­ter. In ad­di­tion, he was the co-founder of Grit­stone On­col­o­gy.

→ Mere weeks af­ter Re­lay Ther­a­peu­tics ac­quired the Google-part­nered ma­chine learn­ing com­pa­ny Ze­bi­AI for $85 mil­lion in up­front cash, who bet­ter to bring in than some­one from the tech gi­ant? Re­lay — which al­so raked in a mon­ster IPO last sum­mer — has pegged Patrick Ri­ley as SVP of ar­ti­fi­cial in­tel­li­gence af­ter more than 15 years with Google, work­ing his way up to prin­ci­pal en­gi­neer and se­nior re­searcher with Google Ac­cel­er­at­ed Sci­ence.

→ Se­quenc­ing com­pa­ny DNAe has en­list­ed Richard Ham­mond as VP of tech­nol­o­gy. Ham­mond comes aboard from Cam­bridge Con­sul­tants, where he was tech­nol­o­gy di­rec­tor and head of bioin­no­va­tion. Pri­or to that, he served at Alere (now Ab­bott Rapid Di­ag­nos­tics).

John Chimin­s­ki

Corza Health CEO Gre­go­ry Luci­er has been named chair­man of the board at Berke­ley Lights, while Catal­ent CEO John Chimin­s­ki al­so nabs a seat on the board of di­rec­tors. The dig­i­tal cell bi­ol­o­gy out­fit’s up­sized IPO ex­ceed­ed $200 mil­lion at its close in Ju­ly 2020.

→ Launched by Fra­zier Health­care Part­ners a year ago this week with a $15 mil­lion Se­ries A, San Diego-based on­col­o­gy drug de­vel­op­er Lengo Ther­a­peu­tics has made Dave John­son chair­man of the board. John­son, the CEO of Velos­Bio, al­so helmed Ac­er­ta Phar­ma from 2013-16.

Cia­ra Kennedy

Ang­ie You’s im­muno-on­col­o­gy biotech Amu­nix, bol­stered by $117 mil­lion in Se­ries B cash for AMX-818 — a masked pro­tease-ac­ti­vat­ed T cell en­gager for HER2 ex­press­ing tu­mors — has re­served a seat for Cia­ra Kennedy on the board of di­rec­tors. Kennedy was pres­i­dent and CEO of Am­plyx un­til Pfiz­er bought it out in April for an undis­closed amount.

Bruce Booth-chaired Nim­bus Ther­a­peu­tics has elect­ed Anne Mc­Ge­orge to the board of di­rec­tors. Mc­Ge­orge, the for­mer man­ag­ing part­ner of the glob­al health care and life sci­ences prac­tices at Grant Thorn­ton, is al­so on the board at Ma­gen­ta Ther­a­peu­tics, among oth­ers.

→ Af­ter en­list­ing Robert Scan­nevin as CSO last week, drug dis­cov­ery com­pa­ny Verge Ge­nomics is bring­ing on Mario Saltarel­li to its sci­en­tif­ic ad­vi­so­ry board. Saltarel­li is the CEO of US Green Val­ley Phar­ma­ceu­ti­cals. Ad­di­tion­al­ly, over his ca­reer, Saltarel­li has held po­si­tions at such com­pa­nies as Neu­ron23, En­tra­da, Syn­tim­mune, Pfiz­er, Ab­bott, Shire and Ver­tex.

Vic­ki Seyfert-Mar­go­lis has stepped in­to her new role at the sci­en­tif­ic ad­vi­so­ry board of Pen­rose Ther­a­peuTx. Seyfert-Mar­go­lis is the CEO and founder of My Own Med. Seyfert-Mar­go­lis comes with over 20 years of ex­pe­ri­ence from her roles at the FDA, NI­AID, ITN and NIH.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.