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).

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.