As­traZeneca pro­motes on­col­o­gy ex­ec to CMO; Pfiz­er re­places re­tir­ing chief deal­mak­er as war chest ex­pands

Cris­t­ian Mas­sace­si

The biggest bright spot for As­traZeneca over the last few years has been its work in on­col­o­gy, as CEO Pas­cal So­ri­ot has helped shep­herd block­busters Imfinzi, Lyn­parza, and Calquence, among oth­er can­cer med­i­cines.

One of the top ex­ec­u­tives from the can­cer di­vi­sion is now mak­ing the leap to the larg­er C-suite. The Swedish-British phar­ma named its on­col­o­gy chief de­vel­op­ment of­fi­cer Cris­t­ian Mas­sace­si as the new CMO.

Mas­sace­si, who will con­tin­ue his role in on­col­o­gy along­side CMO du­ties, re­places Ann Tay­lor, who re­tired this sum­mer af­ter two years as CMO and two decades at Pfiz­er, No­var­tis, As­traZeneca sub­sidiary Med­Im­mune and ul­ti­mate­ly As­traZeneca.

Mas­sace­si is a Pfiz­er and No­var­tis vet­er­an him­self, com­ing to As­traZeneca in 2017 af­ter lead­ing an im­muno-on­col­o­gy team at Pfiz­er. Be­fore join­ing Pfiz­er, he led clin­i­cal de­vel­op­ment for P13K and ALK mol­e­cules at No­var­tis. While he was there, the com­pa­ny got the ALK drug Zyka­dia ap­proved for cer­tain lung can­cer pa­tients and, in 2017, the P13K breast can­cer drug Piqray fol­lowed.

The on­col­o­gist will take over med­ical du­ties as As­traZeneca con­tin­ues to try to push its Covid-19 an­ti­bod­ies across the fin­ish line, while de­vel­op­ing its next gen­er­a­tion of can­cer med­i­cines, in­clud­ing fol­low-on AD­Cs to their fast-sell­ing breast can­cer drug En­her­tu along­side Dai­ichi Sankyo. — Ja­son Mast


Aamir Ma­lik

Three days af­ter Pfiz­er inked its lat­est bil­lion-dol­lar buy­out, the New York phar­ma gi­ant an­nounced a suc­ces­sor for their chief deal­mak­er, CBO John Young, who re­tires af­ter two years in the role and 34 years at the com­pa­ny. He will be re­placed by Aamir Ma­lik, a 24-year vet­er­an of the “Big Three” con­sult­ing firm McK­in­sey, whose phar­ma di­vi­sion is most fa­mous for hav­ing ad­vised Pur­due Phar­ma on how to in­crease opi­oid sales.

Ma­lik’s of­fi­cial ti­tle will be chief busi­ness in­no­va­tion of­fi­cer. Al­though Ma­lik is not men­tioned in court doc­u­ments re­lat­ed to McK­in­sey’s work with Pur­due, he served as head of the phar­ma di­vi­sion as far back as 2014. McK­in­sey ad­vised Pur­due from 2009 to 2019.

At Pfiz­er, Ma­lik will have big shoes to fill, and a lot of mon­ey to do it. Al­though Young was not CBO when Pfiz­er orig­i­nal­ly signed an mR­NA vac­cine col­lab­o­ra­tion with BioN­Tech back in 2018, he helped bro­ker the ex­pand­ed deal in win­ter of 2020 that led to their de­vel­op­ment of the first Covid-19 vac­cine, as well as the var­i­ous sub-deals and part­ner­ships that helped them ex­pand pro­duc­tion to up to 3 bil­lion dos­es per year.

Of course, all that Covid work has now giv­en Pfiz­er a siz­able war chest to con­tin­ue its ex­pan­sion. Ma­lik will have plen­ty of vac­cine rev­enues to spend as he looks to con­tin­ue the vi­sion from CEO Al­bert Bourla, who has promised in­vestors would “see a lot of Phase II, Phase III busi­ness de­vel­op­ment deals that will al­low us to bring in-house a lot of po­ten­tial med­i­cines that could be­come med­i­cines in this time frame.”

Ma­lik is co-man­ag­ing part­ner of McK­in­sey’s US of­fice and pre­vi­ous­ly led its phar­ma­ceu­ti­cals and med­ical prod­ucts di­vi­sion. McK­in­sey’s phar­ma­ceu­ti­cal di­vi­sion is most well-known for its role in ad­vis­ing Pur­due Phar­ma on how best to sell the Oxy­con­tin. Pur­due’s ag­gres­sive mar­ket­ing of the opi­oid painkiller, be­gin­ning in the 1990s, is wide­ly cred­it­ed with help­ing start the opi­oid epi­dem­ic in the US.

McK­in­sey apol­o­gized for its work with Pur­due and set­tled law­suits for near­ly $600 mil­lion, al­though it de­nied wrong­do­ing. Pfiz­er de­ferred ques­tions about Ma­lik’s work at McK­in­sey to the firm. End­points News has reached out and will up­date ac­cord­ing­ly.

While at McK­in­sey, Ma­lik was al­so men­tioned in a law­suit over Valeant Phara­maceu­ti­cals, the small phar­ma that made head­lines in 2016 af­ter rais­ing the price of two heart drugs 310% and 720% re­spec­tive­ly. A Flori­da law­suit quot­ed an email from Ma­lik to the CEO in Valeant in De­cem­ber, 2014 say­ing those drugs and oth­ers “have ma­te­r­i­al pric­ing po­ten­tial.” — Ja­son Mast 


Jim DeTore

→ Run­ning along­side yes­ter­day’s news of its $60 mil­lion Se­ries B round led by Vi­vo Cap­i­tal, Boston GI biotech Neu­ro­gas­trx and CEO Jim O’Hara have wel­comed three C-suit­ers: Jim DeTore (CFO), Christophe Ar­bet-En­gels (CMO) and Paul Rogers (CCO). DeTore has pre­vi­ous CFO ex­pe­ri­ence at blue­bird bio and Pro­teo­sta­tis Ther­a­peu­tics with eight ad­di­tion­al years un­der his belt as a fi­nance ex­ec at Iron­wood. With plen­ty of Big Phar­ma gigs to his cred­it (Mer­ck, Roche and Sanofi among them), Ar­bet-En­gels has al­so filled the CMO post at Mil­len­do and Pox­el. Fi­nal­ly, Rogers is an Iron­wood vet in his own right who was VP of mar­ket­ing strat­e­gy dur­ing a por­tion of his 10-year run at As­traZeneca.

Jonathan Yu

→ A quar­tet of lead­er­ship changes has hit the stage at hema­to­log­ic dis­ease-fo­cused Disc Med­i­cine — a Cam­bridge, MA biotech that launched with a $50 mil­lion Se­ries A backed by At­las Ven­ture and No­vo Hold­ings in Oc­to­ber 2019 — start­ing with the pro­mo­tions of Will Sav­age to CMO and Jonathan Yu to CBO. Sav­age first rolled in­to Disc Med­i­cine a year ago as head of clin­i­cal de­vel­op­ment af­ter a stint as se­nior med­ical di­rec­tor at Ma­gen­ta, while Yu al­so ar­rived last sum­mer as SVP, cor­po­rate de­vel­op­ment.

The new­com­ers to Disc Med­i­cine are Hua Yang (VP of non-clin­i­cal de­vel­op­ment) and Sarah Tuller (VP of reg­u­la­to­ry af­fairs). A Mil­len­ni­um and Bris­tol My­ers Squibb alum, Yang spent a decade at Agios and from 2016-20 was head of DMPK and clin­i­cal phar­ma­col­o­gy. Tuller moves on from Astel­las, where she was se­nior di­rec­tor of reg­u­la­to­ry af­fairs and med­ical spe­cial­ties team lead for the cell ther­a­py/re­gen­er­a­tive med­i­cine and mi­to­chon­dr­i­al dys­func­tion port­fo­lios.

An­drea Pirzkall

→ Last year’s “con­grat­u­la­tions” have turned in­to “sor­ry, we don’t need you any­more” for CMO An­drea Pirzkall at Replimune. An SEC fil­ing in­di­cates that Pirzkall has been “ter­mi­nat­ed, with­out cause” on Wednes­day, stat­ing that any­one who had re­port­ed to her will now re­port to pres­i­dent Robert Cof­fin or chief de­vel­op­ment op­er­a­tions of­fi­cer Tanya Lewis, who was just hired in May. Peer Re­view read­ers may re­mem­ber that Pirzkall left her role as BeiGene’s ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment to join Replimune on Aug. 31, 2020.

→ As Robert Hop­kins steps down as CFO at Adamis, David Bene­dic­to — who first joined Adamis in 2014 and has served as con­troller and chief ac­count­ing of­fi­cer dur­ing his tenure with the com­pa­ny — will take over that va­cant seat. Bene­dic­to looks to bring a mea­sure of sta­bil­i­ty to the fi­nan­cial op­er­a­tions at Adamis, which al­so an­nounced that it hadn’t filed its Form 10-Q to the SEC for the last two quar­ters. Back in No­vem­ber, the San Diego biotech was hit with a CRL for its high-dose nalox­one in­jec­tion that ham­mered the stock.

Matt Killeen

Ren­o­va­cor, one of the En­er­giz­er bun­nies of Peer Re­view this sum­mer, keeps go­ing and go­ing and go­ing in this space af­ter its SPAC deal with Chardan Health­care Ac­qui­si­tion 2 Corp by lock­ing in Matt Killeen as CSO. A Bio­gen vet in the mul­ti­ple scle­ro­sis fran­chise, Killeen spent six years with Bio­Marin and mere months ago was el­e­vat­ed to head of ther­a­peu­tic re­search, found­ing the car­dio­vas­cu­lar ther­a­peu­tic area. Oth­er re­cent ap­pointees you may re­call from Ren­o­va­cor in­clude CMO Marc Sem­i­gran, CBO and SVP of op­er­a­tions Eliz­a­beth White, and SVP of reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance Ji­wen Zhang.

→ Farm­ing­dale, NY-based biotech Coda­genix, which net­ted a mod­est $20 mil­lion Se­ries B round in Jan­u­ary 2020 for its soft­ware-de­rived vac­cine plat­form, has re­cruit­ed Tyler Cook as CFO. Cook piv­ots to Coda­genix af­ter four years at Samus Ther­a­peu­tics, where he earned a pro­mo­tion to CFO, and he’s al­so been Zio­pharm On­col­o­gy’s SVP of fi­nance, ad­min­is­tra­tion and in­for­ma­tion tech­nol­o­gy.

Kia Bengts­son

→ Ef­fec­tive Oct. 1, Swedish on­col­o­gy play­er Oas­mia Phar­ma­ceu­ti­cal has called up­on Kia Bengts­son to lead clin­i­cal de­vel­op­ment and Jo­han­na Röstin to be in charge of reg­u­la­to­ry af­fairs. Bengts­son, who worked in drug de­vel­op­ment and clin­i­cal op­er­a­tions at Ipsen from 2006-14 and then briefly at As­traZeneca, will make the tran­si­tion to Oas­mia af­ter two years as CMO of Nanolog­i­ca. A long­time staffer at So­bi, Röstin is fin­ish­ing her time as di­rec­tor of CMC, pro­gram man­age­ment and reg­u­la­to­ry at Ox­Thera.

→ Big Phar­ma alum Jean Fan has been pro­mot­ed to the new­ly-cre­at­ed role of chief clin­i­cal of­fi­cer at T cell play­er NeoIm­muneTech out of Rockville, MD. Fan, who left her VP of clin­i­cal de­vel­op­ment post at Blue­print Med­i­cines last year to lead clin­i­cal de­vel­op­ment at NeoIm­muneTech, is the ex-glob­al clin­i­cal lead of As­traZeneca’s late-stage im­muno-on­col­o­gy R&D di­vi­sion. Ear­li­er, Fan served as se­nior glob­al clin­i­cal pro­gram leader for NSCLC drug Gilotrif at Boehringer In­gel­heim.

Christo­pher Ken­ney

→ No­var­tis and EMD Serono vet Christo­pher Ken­ney has ven­tured off to Xenon Phar­ma­ceu­ti­cals to be­come CMO at the neu­ro­log­i­cal dis­or­der biotech. From 2016-19, Ken­ney was SVP, clin­i­cal de­vel­op­ment and lat­er SVP, med­ical af­fairs at Acor­da Ther­a­peu­tics be­fore he moved on to No­var­tis part­ner Ca­dent Ther­a­peu­tics as CMO. In De­cem­ber, No­var­tis forked over $216 mil­lion up­front to pur­chase Ca­dent and boost its neu­ro pipeline, name­ly NM­DA re­cep­tor mod­u­la­tor MIJ-821.

End­point Health has wel­comed for­mer Take­da ex­ec Kirsten De­t­rick as CCO. Dur­ing her time at Take­da, De­t­rick served in a va­ri­ety of roles, in­clud­ing as VP and ther­a­py area com­mer­cial leader for the glob­al gas­troin­testi­nal fran­chise, gen­er­al man­ag­er of Aus­tria and head of the com­pa­ny’s mul­ti-coun­try or­ga­ni­za­tion in cen­tral and East­ern Eu­rope. Pri­or to that, De­t­rick was with Am­gen and Bris­tol My­ers.

Mer­dad Parsey

In ad­di­tion to De­t­rick’s ap­point­ment, the Pa­lo Al­to, CA-based com­pa­ny has pulled in some renowned in­dus­try vet­er­ans as strate­gic ad­vi­sors of the com­pa­ny: Paul Brown (for­mer CEO, pres­i­dent and glob­al head of Roche Mol­e­c­u­lar So­lu­tion); Javier San Mar­tin (CMO of Ar­row­head Phar­ma­ceu­ti­cals and a for­mer Ul­tragenyx ex­ec); Mer­dad Parsey (CMO of Gilead); and Mike Var­ney (Eras­ca‘s R&D chair and for­mer head of Genen­tech‘s re­search and ear­ly de­vel­op­ment).

→  San Diego-based Aris­tea Ther­a­peu­tics has tapped Justin Thack­er as CFO. Thack­er for­mer­ly served as VP, fi­nance at De­sign Ther­a­peu­tics and al­so served in the same role at Syn­thorx. Ad­di­tion­al­ly, Thack­er has held po­si­tions at Aca­dia Phar­ma­ceu­ti­cals, Aus­pex Phar­ma­ceu­ti­cals and Ca­dence Phar­ma­ceu­ti­cals.

William Lud­lam

→ Recor­dati Rare Dis­eases, part of the Mi­lan-based Recor­dati Group, has waved in William Lud­lam as CMO and VP, clin­i­cal de­vel­op­ment. Lud­lam has spent the last six years as a clin­i­cal de­vel­op­ment ex­ec at Chi­as­ma, and while he was with No­var­tis from 2012-15, he brought his ex­per­tise in pi­tu­itary dis­or­ders to the rare dis­ease fran­chise as se­nior med­ical di­rec­tor in US clin­i­cal de­vel­op­ment and med­ical af­fairs.

Jiang Bian has signed on to be gen­er­al coun­sel and chief com­pli­ance of­fi­cer for Con­nect Bio­phar­ma, fur­ther fill­ing out the C-suite al­most ex­act­ly a year af­ter a $115 mil­lion Se­ries C round. Bian hails from Guardant Health, where he was se­nior coun­sel, and he al­so held that ti­tle at Pieris Phar­ma­ceu­ti­cals. Mean­while, Jean LiuSeagen’s EVP, le­gal af­fairs, gen­er­al coun­sel and sec­re­tary — has been giv­en a seat on the board of di­rec­tors at Con­nect, which al­so ap­point­ed CBO Sel­wyn Ho back in Jan­u­ary.

Chuck Ryan

→ The Prostate Can­cer Foun­da­tion has tagged gen­i­touri­nary on­col­o­gist Chuck Ryan to be its pres­i­dent and CEO. Ryan, who has ex­per­tise in the bi­ol­o­gy and treat­ment of ad­vanced prostate can­cer, comes to the foun­da­tion from the Uni­ver­si­ty of Min­neso­ta, where he served as di­rec­tor of the hema­tol­ogy, on­col­o­gy and trans­plan­ta­tion di­vi­sion in the de­part­ment of med­i­cine. Ryan al­so brings to the ta­ble ex­pe­ri­ence from his time at the Ma­son­ic Can­cer Cen­ter, Uni­ver­si­ty of Wis­con­sin Hos­pi­tal and Clin­ics, Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter and the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co.

→  Fac­ing sub­poe­nas from the DOJ and SEC, trou­bled Cy­to­Dyn has pulled in Seenu Srini­vasan as ex­ec­u­tive di­rec­tor-CMC reg­u­la­to­ry af­fairs. Pre­vi­ous­ly, Srini­vasan served as di­rec­tor of CMC reg­u­la­to­ry af­fairs at Re­gen­eron and he was glob­al VP/CSO, CMC phar­ma­ceu­ti­cal de­vel­op­ment ser­vices for Co­v­ance. Cy­to­Dyn dis­closed the sub­poe­nas ear­li­er this month af­ter flood­ing the zone with press re­leas­es tout­ing the suc­cess of its Covid-19 drug that failed to show any ben­e­fit.

Jeff Dou­glas

Jeff Dou­glas has an­swered the call to be VP, clin­i­cal op­er­a­tions at Es­ker Ther­a­peu­tics, the sec­ond biotech hatched from Vik Ba­jaj‘s in­cu­ba­tor at Fore­site Labs. Dou­glas is part­ing ways with MyoKar­dia — which was re­cent­ly bought out by Bris­tol My­ers for $13 bil­lion — where he served as head of clin­i­cal op­er­a­tions for the last three years. Dou­glas has al­so di­rect­ed pro­grams fo­cused on can­cer im­munother­a­py and hema­to­log­ic ma­lig­nan­cies at Genen­tech. Es­ker, which launched in May with $70 mil­lion in Se­ries A fi­nanc­ing, cou­ples this an­nounce­ment with the open­ing of their new 14,000-square foot of­fice space in South San Fran­cis­co.

Ad­verum is in a pre­car­i­ous po­si­tion af­ter safe­ty is­sues shut­tered its study of AD­VM-022 for di­a­bet­ic mac­u­lar ede­ma. Hop­ing to sal­vage the drug for those with wet AMD, the biotech has ap­point­ed Jim Wang as SVP, head of reg­u­la­to­ry af­fairs. Wang, who has vast reg­u­la­to­ry ex­pe­ri­ence at Sanofi, Bris­tol My­ers, No­vo Nordisk, Shire and Spark, was re­cent­ly with PTC Ther­a­peu­tics as VP, glob­al head of reg­u­la­to­ry strat­e­gy.

Provenge mak­er Den­dreon Phar­ma­ceu­ti­cals, which just un­veiled a con­tract man­u­fac­tur­ing and ser­vices di­vi­sion un­der sec­ond-year CEO Ja­son O’Neill, has en­list­ed Sher­ry Sauri­ni as VP of qual­i­ty. Sauri­ni had held the same post at Tis­sueTech and Cry­oLife be­fore head­ing to Den­dreon.

Bruce Binkowitz

→ Skin dis­ease biotech Ar­cutis has opened up its doors to new ex­ecs in man­u­fac­tur­ing, in­vestor re­la­tions and com­mu­ni­ca­tions in the last cou­ple months, and there’s no off switch on the hir­ing spree with Bruce Binkowitz as VP of bio­met­rics. Binkowitz had been VP of bio­met­rics at Sh­iono­gi ever since he com­plet­ed his 32-year tenure at Mer­ck in 2017.

→ Lo­cat­ed near the heart of Penn State Uni­ver­si­ty, NeuEx­cell Ther­a­peu­tics has tapped Russ Ad­dis as VP, re­search, stay­ing in Penn­syl­va­nia af­ter join­ing Sue Dil­lon’s crew at Aro Bio­ther­a­peu­tics around the time of its 2018 launch. Ad­dis was pro­mot­ed to se­nior di­rec­tor of bi­ol­o­gy in Jan­u­ary at Aro be­fore piv­ot­ing to the CNS and neu­rode­gen­er­a­tive dis­ease-fo­cused biotech.

Tarif Awad

→ San­ta Clara, CA-based Re­bus Biosys­tems has plucked Tarif Awad as VP sci­en­tif­ic af­fairs. Awad comes to the com­pa­ny from Ther­mo Fish­er Sci­en­tif­ic, where he di­rect­ed the re­pro­duc­tive health pro­gram. In ad­di­tion to Awad’s ap­point­ment, Re­bus has brought on bio­chemist Glo­ria Chui and Si­mone Codelup­pi (as­sis­tant pro­fes­sor at Karolin­s­ka In­sti­tute in Stock­holm) as prin­ci­pal sci­en­tists.

Dot­mat­ics — a cloud-based sci­en­tif­ic R&D da­ta man­age­ment plat­form that was ac­quired in March by In­sight­ful Sci­encehas re­cruit­ed Michael Swartz as SVP en­ter­prise prod­uct. Pri­or to his new role, Swartz was VP of soft­ware so­lu­tions and strat­e­gy at PerkinElmer In­for­mat­ics.

Nan­cy Whit­ing

→ Long­time Seagen ex­ec Nan­cy Whit­ing has joined the board of di­rec­tors at Jen­nifer Doud­na’s Cari­bou Bio­sciences, which has en­joyed an event­ful sum­mer with its $300 mil­lion-plus IPO and the start of its al­lo­gene­ic CAR-T tri­al. Cari­bou’s board al­so in­cludes CEO Rachel Hau­r­witz, Mar­i­nus CEO Scott Braun­stein and Vax­cyte CFO An­drew Guggen­hime.

→ Ex-Wyeth (now Pfiz­er) pres­i­dent of R&D Robert Ruf­fo­lo has been elect­ed to the board of di­rec­tors at Fort Worth-based Nacu­ity Phar­ma­ceu­ti­cals, which aims to treat eye dis­eases that in­volve ox­ida­tive stress like re­tini­tis pig­men­tosa and cataracts. The chief in­no­va­tion of­fi­cer at Ver­si­col­or Tech­nolo­gies, Ruf­fo­lo is al­so on the board at OcuTer­ra, which is chaired by Brent Saun­ders.

Nisha Nan­da

→ Cham­pi­oned by Ab­b­Vie in a fi­bro­sis part­ner­ship and gal­va­nized by IBD da­ta that sent its stock soar­ing to its high­est lev­el of the year in March, Mor­phic Ther­a­peu­tic has ap­point­ed Nisha Nan­da to the board of di­rec­tors. Since Jan­u­ary 2019, Nan­da has been chief de­vel­op­ment of­fi­cer of Loxo On­col­o­gy at Lil­ly.

Yu­jiro Ha­ta

→ De­vel­op­ing drug can­di­dates in such dis­eases as RSV, HBV and NASH, Enan­ta Phar­ma­ceu­ti­cals has space avail­able on the board of di­rec­tors for Yu­jiro Ha­ta. The founder and CEO of Ideaya Bio­sciences al­so oc­cu­pies board seats at Xen­cor and Ex­pan­sion Ther­a­peu­tics.

Di­ane Parks is adding an­oth­er board seat to her ré­sumé with her new ap­point­ment at CTI Bio­Phar­ma. Parks has held a va­ri­ety of roles across the in­dus­try, in­clud­ing as SVP, head of US com­mer­cial at Kite, where she led the launch and strate­gic plan­ning for Yescar­ta. Ad­di­tion­al­ly, Parks has served at Phar­ma­cyclics, Genen­tech and Am­gen. Parks cur­rent­ly sits on the boards of Cal­lid­i­tas, Soli­genix and Ku­ra On­col­o­gy, among oth­ers.

Hol­ly Schachn­er

→ Myokar­dia vet Hol­ly Schachn­er just got start­ed as CMO at Dou­ble Rain­bow, and she’s picked up a board ap­point­ment to boot at Ap­plied Mol­e­c­u­lar Trans­port. Late last spring, AMT watched its IPO steam­roll past the $100 mil­lion it pen­ciled in, tal­ly­ing a $177.1 mil­lion raise.

→ Woburn, MA-based Re­Form Bi­o­log­ics has giv­en So­bi North Amer­i­ca CMO John Yee a seat on the board of di­rec­tors. Yee, a for­mer di­a­betes ex­ec at As­traZeneca, has al­so been glob­al head of med­ical af­fairs at Ver­tex.

Pri­ti Hegde

→ Cam­bridge, MA-based TCR2 Ther­a­peu­tics — spe­cial­iz­ing in T cell ther­a­pies for on­col­o­gy — has brought on Pri­ti Hegde to its board of di­rec­tors. Cur­rent­ly, Hegde serves as CSO of Foun­da­tion Med­i­cine, and pre­vi­ous­ly worked at Glax­o­SmithK­line along with a 12-year stint at Genen­tech.

BioCryst — which bagged $250 mil­lion in a debt and roy­al­ty deal last year — has pulled out a seat on its board of di­rec­tors for Steven Gal­son, a for­mer di­rec­tor of the FDA’s CDER. Most re­cent­ly, Gal­son served as SVP, re­search and de­vel­op­ment at Am­gen.

Chip Clark

Geno­cea Bio­sciences pres­i­dent and CEO Chip Clark is hop­ping on­to the board of di­rec­tors of iBio. Pri­or to his cur­rent stint at Geno­cea, Clark was CBO of Van­da Phar­ma­ceu­ti­cals — a com­pa­ny he co-found­ed in 2004 — and served in roles at Care Cap­i­tal and SmithK­line Beecham.

→ Af­ter reel­ing in a $210 mil­lion Se­ries B in June, Umo­ja Bio­phar­ma has en­list­ed Greg Sar­gen to its board of di­rec­tors. Sar­gen joins the Seat­tle-based com­pa­ny af­ter his most re­cent stint as CFO and EVP of cor­po­rate de­vel­op­ment and strat­e­gy at Cam­brex Cor­po­ra­tion. Pri­or to that, he served at Ex­panets, Mer­ck and Fish­er Sci­en­tif­ic, among oth­ers.

Phar­ma Two B has se­lect­ed Jef­frey Berkowitz as chair­man of its board of di­rec­tors. Berkowitz is cur­rent­ly CEO of Re­al End­points and, in the past, has held po­si­tions at Mer­ck, Scher­ing-Plough, Unit­ed­Health Group/Op­tum and Wal­greens Boots Al­liance.

→ Seat­tle-based Vi­s­us Ther­a­peu­tics has brought on two new faces to its board of di­rec­tors with the ap­point­ments of Tracey Val­o­rie (for­mer SVP and gen­er­al man­ag­er, US oph­thal­mol­o­gy RX and sur­gi­cal at Bausch + Lomb) and Dwight Mox­ie (SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary at Re­vance Ther­a­peu­tics).

→ One-time pen­ny stock play­er Vaxart has cre­at­ed an eight-mem­ber sci­en­tif­ic and clin­i­cal ad­vi­so­ry board which in­cludes: Ralph Bar­ic (pro­fes­sor, de­part­ment of epi­demi­ol­o­gy, mi­cro­bi­ol­o­gy, and im­munol­o­gy at UNC-Chapel Hill); Robert Belshe (pro­fes­sor emer­i­tus, di­vi­sion of in­fec­tious dis­eases, al­ler­gy and im­munol­o­gy at St Louis Uni­ver­si­ty); Ste­fan Graven­stein (pro­fes­sor of med­i­cine at Brown Uni­ver­si­ty); Gre­go­ry Gray (pro­fes­sor of med­i­cine, di­vi­sion of in­fec­tious dis­eases at Duke Uni­ver­si­ty School of Med­i­cine); Har­ry Green­berg (pro­fes­sor in the school of med­i­cine at Stan­ford Uni­ver­si­ty); Mar­i­on Pep­per (as­so­ciate pro­fes­sor, im­munol­o­gy at the Uni­ver­si­ty of Wash­ing­ton); Stan­ley Plotkin (emer­i­tus pro­fes­sor at the Uni­ver­si­ty of Penn­syl­va­nia); and George Siber (for­mer CSO of Wyeth Vac­cines Re­search).

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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