Flag­ship turns to No­var­tis HR gu­ru in lat­est ad­di­tion; David Grainger sad­dles up to new po­si­tion at Centes­sa while Pfiz­er's Rod MacKen­zie pre­pares to ride in­to the sun­set

David Grainger

→ In a de­vel­op­ment that just seemed to add up neat­ly giv­en Medicxi’s in­volve­ment with Centes­sa, the brain­child of Francesco de Ru­ber­tis has named fel­low Medicxi co-founder David Grainger as chief in­no­va­tion of­fi­cer. Div­ing in here at Centes­sa means that Grainger will cede his pre­vi­ous Medicxi re­spon­si­bil­i­ties but he will “con­tin­ue in a con­sult­ing ca­pac­i­ty,” as con­firmed by our Am­ber Tong on Tues­day.

“By jump­ing in­to a full-time op­er­a­tions role I feel I can have the biggest im­pact, bring­ing in­no­v­a­tive med­i­cines to pa­tients as quick­ly as pos­si­ble, while cre­at­ing sig­nif­i­cant val­ue for Centes­sa share­hold­ers,” Grainger told End­points News.

Rod MacKen­zie

Pfiz­er CEO Al­bert Bourla tweet­ed out plau­dits for Rod MacKen­zie when he an­nounced the chief de­vel­op­ment of­fi­cer’s re­tire­ment on Wednes­day. Macken­zie be­gan at Pfiz­er 35 years ago as a med­i­c­i­nal chemist and has per­formed a cav­al­cade of roles ever since, get­ting the nod as de­vel­op­ment chief in 2016. This marks the third ma­jor re­tire­ment in the last year at the drug gi­ant, with Ai­da Habtezion tak­ing over for CMO Mace Rothen­berg, who stepped aside to kick off 2021, and CBO John Young leav­ing af­ter 34 years. (Pfiz­er al­ready has named Aamir Ma­lik as Young’s re­place­ment.) And like Young, MacKen­zie is set to re­tire in ear­ly 2022.

Steven Baert

Flag­ship Pi­o­neer­ing has poached Steven Baert from No­var­tis, mak­ing him chief hu­man cap­i­tal of­fi­cer. It’s a huge task in front of him, but 15 years at the Swiss phar­ma equipped him for it: He will be in charge of piec­ing to­geth­er lead­er­ship teams for the 6-8 com­pa­nies that Flag­ship forms an­nu­al­ly. Baert had steadi­ly climbed through the ranks in hu­man re­sources at No­var­tis, even­tu­al­ly be­com­ing glob­al head of HR and then chief peo­ple of­fi­cer, a po­si­tion he had held since 2014.

Va­le­ria Fan­tin

→ One year won­der: Va­le­ria Fan­tin has changed Big Phar­ma al­le­giances from Gilead to Sanofi, be­com­ing the glob­al head of on­col­o­gy re­search at the French multi­na­tion­al af­ter just a year lead­ing on­col­o­gy re­search at Gilead. Sanofi CEO Paul Hud­son has made sev­er­al on­col­o­gy plays re­cent­ly, scoop­ing up a check­point in­hibitor from Biond Bi­o­log­ics for $125 mil­lion up­front in Jan­u­ary and ac­quir­ing Kiadis and its NK cell plat­form in No­vem­ber 2020. Fan­tin, the ex-CSO at Zai Lab, will be over­see­ing im­muno-on­col­o­gy and mol­e­c­u­lar on­col­o­gy re­search.

→ Still smart­ing from the FDA re­jec­tion of its he­mo­phil­ia A gene ther­a­py — with dura­bil­i­ty ques­tions that con­tin­ue to linger af­ter pre­sent­ing more da­ta this sum­mer — Bio­Marin has turned to for­mer Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co pro­fes­sor Harold Bern­stein to be CMO and head of clin­i­cal de­vel­op­ment, and Ganesh Vedan­tham is now part of JJ Bi­en­aimé’s team as SVP, tech­ni­cal de­vel­op­ment. Dur­ing al­most four years at Ver­tex, Bern­stein was head of trans­la­tion­al med­i­cine and VP of glob­al med­i­cines de­vel­op­ment. Vedan­tham spent al­most 20 years at Am­gen, and in his last role there, he led process de­vel­op­ment or­ga­ni­za­tion at the phar­ma gi­ant’s man­u­fac­tur­ing fa­cil­i­ty in Sin­ga­pore.

Mor­gan Mol­loy

Launched in Jan­u­ary with sup­port from Bio­gen and Genen­tech, Boston neu­ro biotech Ata­lan­ta Ther­a­peu­tics has ush­ered in three new staffers, start­ing with chief cor­po­rate de­vel­op­ment of­fi­cer Mor­gan Mol­loy, who re­cent­ly held the same ti­tle at Ak­ou­os. Mol­loy, the ex-CCO at En­zy­vant, is for­mer­ly the head of US com­mer­cial for Spark. Join­ing Mol­loy is head of neu­ro­science Ste­fan Mc­Do­nough, a 12-year Am­gen vet who was re­cent­ly the head of hu­man ge­net­ics at Pfiz­er. Fi­nal­ly, VP of chem­istry and Io­n­is alum Garth Kin­berg­er strides to the plate for Ata­lan­ta af­ter five years at Reg­u­lus Ther­a­peu­tics, clos­ing out his time there as ex­ec­u­tive di­rec­tor of chem­istry, CMC and phar­ma­ceu­ti­cal de­vel­op­ment.

There­sa Heg­gie

There­sa Heg­gie starts anew af­ter on­ly a year as CEO of Free­line Ther­a­peu­tics, join­ing Dutch rare dis­ease play­er Pro­QR as chief com­mer­cial of­fi­cer. Heg­gie bid adieu to Free­line in Au­gust while pres­i­dent and COO Michael Pari­ni — who just ar­rived from Ver­tex in Feb­ru­ary — stepped in as her suc­ces­sor. Around that time, CMC is­sues forced a two-year de­lay on Free­line’s gene ther­a­py tri­al for he­mo­phil­ia B can­di­date FLT180a. Things are get­ting se­ri­ous at Pro­QR with Eli Lil­ly’s $1 bil­lion part­ner­ship for five RNA edit­ing tar­gets in a space that al­ready saw sig­nif­i­cant Big Phar­ma trac­tion from Roche’s $3 bil­lion bet with Shape Ther­a­peu­tics.

→ One of the stars from Con­stel­la­tion Phar­ma­ceu­ti­cals is shin­ing else­where. CMO Jef­frey Humphrey has land­ed at Ma­gen­ta Ther­a­peu­tics in the same po­si­tion, fill­ing a va­cant space that was once held by John Davis. Be­fore tak­ing over for Adri­an Senderow­icz as CMO of Con­stel­la­tion, Humphrey was pres­i­dent, CMO and then chief de­vel­op­ment of­fi­cer at Ky­owa Kirin, and he owns Big Phar­ma lead­er­ship ex­pe­ri­ence at Pfiz­er, Bris­tol My­ers Squibb and Bay­er. Davis, who was al­so R&D chief at Ma­gen­ta, cit­ed fam­i­ly rea­sons for his May de­par­ture.

Den­ny Kim

No­vavax al­ways likes to keep us busy here at Peer Re­view, and so it is this week with the se­lec­tion of Den­ny Kim as chief safe­ty of­fi­cer & head of glob­al vac­cine safe­ty and the pro­mo­tions of Raburn Mal­lo­ry to SVP, head of clin­i­cal de­vel­op­ment and Mar­co Cac­ci­ut­to­lo to SVP, process and an­a­lyt­i­cal de­vel­op­ment. Kim heads to No­vavax from the of­fice of the chief med­ical of­fi­cer at J&J, no­tably over­see­ing safe­ty strate­gies for Janssen’s Covid-19 vac­cine, and for a short time he was Hori­zon’s VP of pa­tient safe­ty and phar­ma­covig­i­lance. Mal­lo­ry had been VP of clin­i­cal de­vel­op­ment at As­traZeneca and the glob­al clin­i­cal lead for its Covid-19 and in­fluen­za vac­cines be­fore jump­ing to No­vavax in 2020. And as for Cac­ci­ut­to­lo, the Med­Im­mune vet in cell cul­ture de­vel­op­ment and man­u­fac­tur­ing gets the SVP bump af­ter he too came on board in 2020. The ex-COO at Patho­Vax, Cac­ci­ut­to­lo was head of man­u­fac­tur­ing for Noso­co­mi­al Vac­cine Cor­po­ra­tion.

Mit­tie Doyle

→ In Au­gust, Philly biotech Aro Bio­ther­a­peu­tics wel­comed three ex­ecs, in­clud­ing COO Scott Green­berg. This time around, Sue Dil­lon has hand­ed CMO du­ties to Mit­tie Doyle af­ter her four years at CSL Behring, where she held the role of VP, glob­al ther­a­peu­tic area head, R&D, im­munol­o­gy. Along the way, Doyle has been a se­nior med­ical di­rec­tor at Alex­ion, VP of clin­i­cal re­search at Flex­ion, and be­fore join­ing CSL Behring, the VP, glob­al de­vel­op­ment team leader in im­munol­o­gy at Shire. Cen­tyrin-fo­cused Aro bulked up its fi­nanc­ing with an $88 mil­lion round in Jan­u­ary.

Ted Yed­nock

Ted Yed­nock is slid­ing in­to the role of chief in­no­va­tion of­fi­cer at An­nex­on af­ter eight years as CSO, while Lar­ry Mattheakis is al­ready in place as the new chief sci­en­tist for CEO Doug Love. Once the CSO at Prothena, Yed­nock piv­ot­ed to An­nex­on in 2013 af­ter his time as head of re­search with Elan Phar­ma­ceu­ti­cals. Mean­while, Mattheakis comes to An­nex­on af­ter spend­ing al­most a decade at Pro­tag­o­nist Ther­a­peu­tics and was SVP, dis­cov­ery bi­ol­o­gy and trans­la­tion­al re­search. Ear­li­er, he led clin­i­cal de­vel­op­ment for PI3Kẟ in­hibitor XL499 at Ex­elix­is. The drug that’s fur­thest along in An­nex­on’s pipeline is ANX005, a mon­o­clon­al an­ti­body in Phase II/III for Guil­lain-Bar­ré syn­drome.

Tran Nguyen

→ While we have Prothena in mind from the pre­vi­ous en­try, the Irish biotech has cre­at­ed the chief strat­e­gy of­fi­cer post for Tran Nguyen, who will con­tin­ue as CFO in ad­di­tion to the new du­ties, while Bran­don Smith gets bumped up to COO. Nguyen had served as COO since 2018 and he’s been with the com­pa­ny since his CFO stint at So­max­on Phar­ma­ceu­ti­cals end­ed in 2013. Smith joined Prothena as CBO in March 2020 and left Am­gen in 2012 as head of strat­e­gy for the phar­ma gi­ant’s biosim­i­lars busi­ness unit. Prothena’s lead drug NEOD001 (bir­tamimab) now has a sec­ond wind in AL amy­loi­do­sis af­ter a re­sound­ing thud in a Phase IIb tri­al in 2018.

→ Let’s stay in Ire­land with an­tibi­ot­ic de­vel­op­er Nabri­va Ther­a­peu­tics — head­quar­tered in Dublin — which has hand­ed the CMO job to Big Phar­ma vet Chris­tine Guico-Pabia. Af­ter 10 years at Mer­ck, Guico-Pabia then worked in clin­i­cal af­fairs at Wyeth (now Pfiz­er) and al­so led clin­i­cal de­vel­op­ment and med­ical af­fairs at Meta­gen­ics. Nabri­va has run in­to prob­lems with Con­tepo as the FDA is­sued its sec­ond CRL for the an­tibi­ot­ic in June 2020.

Louise Modis

→ Big Phar­ma alum Louise Modis has signed on to Mo­gri­fy — a start­up in Eng­land tak­ing aim at Lux­tur­na us­ing its in vi­vo cel­lu­lar re­pro­gram­ming ther­a­pies — as CSO. Be­fore the leap to Mo­gri­fy, which topped off its Se­ries A to bring its to­tal to $33 mil­lion in May, Modis was VP of im­munol­o­gy re­search as part of her sev­en years at Glax­o­SmithK­line. Be­fore that, she spent eight years as a sci­en­tist with Boehringer In­gel­heim.

Grab­bing $54 mil­lion in a sum­mer­time Se­ries B for its own spin on pro­tein de­graders called AnD­Cs (an­ti­body neode­grad­er con­ju­gates), Sung Joo Lee’s Orum Ther­a­peu­tics has picked up Olaf Chris­tensen as CMO. Af­ter a four-year stay at Bris­tol My­ers in the im­muno-on­col­o­gy clin­i­cal de­vel­op­ment group, Chris­tensen head­ed to EMD Serono in 2015, and be­fore this op­por­tu­ni­ty at Orum, he had been the US and Cana­di­an Mer­ck KGaA sub­sidiary’s head of on­col­o­gy glob­al clin­i­cal de­vel­op­ment for near­ly three years.

Robert Lyne

Robert Lyne has shed the in­ter­im la­bel and is now per­ma­nent CEO of Lon­don VC Ar­ix Bio­science. Lyne orig­i­nal­ly signed on to Ar­ix in 2017 as gen­er­al coun­sel and al­so spent some time as COO be­fore as­cend­ing to in­ter­im CEO in April. Else­where at Ar­ix, ex-Har­bour­Vest Glob­al Pri­vate Eq­ui­ty chair­man Sir Michael Bun­bury has been added to the board as se­nior in­de­pen­dent di­rec­tor, and on Oct. 15, for­mer Uni­ver­si­ty of Ox­ford CFO Giles Kerr makes his ex­it from the board.

Mike We­in­stein is locked in as CFO of Dal­las-area liq­uid biop­sy play­er Caris Life Sci­ences, which hauled in a gar­gan­tu­an $830 mil­lion megaround this spring. We­in­stein left JP Mor­gan af­ter 26 years in 2018, be­com­ing SVP, strat­e­gy and a mem­ber of the ex­ec­u­tive com­mit­tee at Medtron­ic. The in­flux of cash is noth­ing new at Caris: Since 2018, to­tal fi­nanc­ing has hit the $1.3 bil­lion mark.

Joanne Chang

→ Sev­er­al months re­moved from its Se­ries C round, Swiss oph­thalmic biotech Oculis has filled a key po­si­tion on its lead­er­ship ros­ter with Joanne Chang as CMO and head of port­fo­lio man­age­ment, con­clud­ing a run at No­var­tis that be­gan in 2008. Chang had spent the last three years lead­ing glob­al med­ical af­fairs for the Big Phar­ma’s oph­thal­mol­o­gy port­fo­lio. Oculis is us­ing its SNP (sol­u­bi­liz­ing nanopar­ti­cles) tech­nol­o­gy on lead can­di­date OCS-01, which is be­ing de­vel­oped as a top­i­cal al­ter­na­tive for eye in­jecta­bles.

→ New Jer­sey-based biosim­u­la­tion play­er Cer­tara has en­list­ed Dray­ton Virkler for the new­ly cre­at­ed CCO po­si­tion. Virkler spent the last decade at IQVIA, where he served as VP and glob­al head of sales. He has al­so held lead­er­ship roles at GSK and Tale­cris Plas­ma Re­sources.

Tom Height­man

→ GSK part­ner Adres­tia Ther­a­peu­tics, a “syn­thet­ic vi­a­bil­i­ty” biotech un­der the di­rec­tion of CEO Steve Jack­son, has tapped Tom Height­man as chief R&D of­fi­cer. Height­man, a GSK vet in his own right, just had a two-year run as VP, glob­al head on­col­o­gy chem­istry at As­traZeneca be­fore shift­ing gears at Adres­tia, which raised a Se­ries A in De­cem­ber 2020 co-led by GSK and Ahren In­no­va­tion Cap­i­tal.

→ Is there a Gala­pa­gos purge in the works af­ter the litany of fails and On­no van de Stolpe’s re­tire­ment? Mi­lan-based au­toim­mune dis­ease biotech En­thera Phar­ma­ceu­ti­cals has put out the wel­come mat for An­to­nio Speziale, who has been named CMO and was re­cent­ly the trans­la­tion­al med­i­cine leader for Gala­pa­gos. Speziale wrapped up his six-year tenure at No­var­tis in 2019 as glob­al pro­gram clin­i­cal head for au­toim­mu­ni­ty and skele­tal dis­eases.

Ahmed Mousa

→ Genen­tech res­pi­ra­to­ry part­ner Pieris Phar­ma­ceu­ti­cals has pro­mot­ed Thomas Bu­res to CFO and Ahmed Mousa to CBO. Bu­res com­plet­ed a two-year run at Geno­cea as VP, cor­po­rate con­troller in 2017 to take the VP of fi­nance post at Pieris. Mousa, who be­gan his time at Pieris in 2016 as se­nior coun­sel, will re­main gen­er­al coun­sel in ad­di­tion to his CBO du­ties. In Au­gust, Pieris el­e­vat­ed Shane Ol­will to de­vel­op­ment of­fi­cer and ap­point­ed Tim De­muth as its CMO.

Sam Back­en­roth

Sam Back­en­roth has tak­en over as CFO at Is­raeli-based VBL Ther­a­peu­tics. Most re­cent­ly, Back­en­roth held the same po­si­tion at NeuBase Ther­a­peu­tics and Ohr Phar­ma­ceu­ti­cal. Back in Au­gust, VBL an­nounced that they were restart­ing their Phase III tri­al of VB-111, an an­ti-can­cer gene ther­a­py, af­ter the study had been paused for FDA eval­u­a­tion.

Daniel Clark has stepped in as in­ter­im CFO at Kiromic Bio­Phar­ma. Clark re­places Tony Ton­tat, who held the po­si­tion since Oc­to­ber 2019 and re­signed last month. Clark is no stranger to fi­nan­cial lead­er­ship at Kiromic — he has served as both VP of fi­nance op­er­a­tions and cor­po­rate con­troller. Pri­or to join­ing Kiromic in Feb­ru­ary 2020, he worked at sev­er­al firms, in­clud­ing The Siegfried Group and FTI Con­sult­ing.

→ Re­cent­ly ac­quired by a group led by Gold­man Sachs for $8.5 bil­lion as a stand­out il­lus­tra­tion of 2021’s CRO ma­nia, Parex­el has re­cruit­ed Stephen Pyke as EVP, clin­i­cal da­ta and dig­i­tal ser­vices. Pyke held sev­er­al roles at GSK, fin­ish­ing up his 10-year run there as SVP & de­vel­op­ment head, dig­i­tal da­ta & an­a­lyt­ics.

Nazareth Mar­tinez Shed­den

→ When we last saw Third Rock’s MO­MA Ther­a­peu­tics here, the mol­e­c­u­lar ma­chine biotech had named Se­mi Trot­to as chief peo­ple and ex­pe­ri­ence of­fi­cer. More ex­ecs fol­low this week with Hans Bit­ter and Nazareth Mar­tinez Shed­den get­ting the call at MO­MA as SVP and head, da­ta sci­ence and VP, strate­gic fi­nance, re­spec­tive­ly. Bit­ter, who’s re­cent­ly been SVP of da­ta sci­ences and chief da­ta of­fi­cer for on­col­o­gy at blue­bird bio, has al­so tak­en on lead­er­ship roles at the No­var­tis In­sti­tutes of Bio­med­ical Re­search (glob­al head of on­col­o­gy bioin­for­mat­ics) and Roche (deputy glob­al head of bioin­for­mat­ics and sta­tis­tics). Mean­while, Shed­den led fi­nance in the neu­ro­science, gas­troin­testi­nal and on­col­o­gy busi­ness units at Take­da, where she spent 15 years over­all.

→ Gene ther­a­py-fo­cused Ren­o­va­cor is pick­ing up an­oth­er ex­ec with the ap­point­ment of Ku­mar Dhanasekha­ran as SVP of tech­ni­cal op­er­a­tions. Dhanasekha­ran joins the Philadel­phia-based com­pa­ny from Swan­Bio Ther­a­peu­tics, where he served as VP of tech­ni­cal op­er­a­tions. Pri­or to that role, Dhanasekha­ran was with Am­i­cus Ther­a­peu­tics, Cook Pharmi­ca, Lon­za and Sanofi Gen­zyme.

Julie Speed

→ She feels the need, the need for Speed: Is­raeli pres­by­opia biotech Ora­sis Phar­ma­ceu­ti­cals, which reeled in a $30 mil­lion Se­ries C round last Sep­tem­ber, has revved up the en­gine with Julie Speed as its head of strat­e­gy and mar­ket­ing. A 15-year Al­con vet, Speed had held the chief com­mer­cial of­fi­cer post at Eye­vance Phar­ma­ceu­ti­cals since Feb­ru­ary 2020 be­fore mo­tor­ing in­to Ora­sis. From 2018-20, she was se­nior di­rec­tor of mar­ket­ing, Amer­i­c­as for J&J Vi­sion Sur­gi­cal.

Heather Savelle

→ TCR biotech TScan Ther­a­peu­tics, the Har­vard spin­out which went pub­lic over the sum­mer with a nine-fig­ure IPO, has ap­point­ed Heather Savelle as VP, in­vestor re­la­tions. Savelle de­parts from Ar­got Part­ners, where she served as man­ag­ing di­rec­tor. Be­fore join­ing Ar­got, she was SVP at Mac­Dougall Bio­med­ical Com­mu­ni­ca­tions.

→ San Diego-based aTyr Phar­ma has in­stalled Robert Ash­worth as VP of reg­u­la­to­ry af­fairs. Ash­worth, who owned the same ti­tle the last three years at On­coSec, has bounced around a bit as a reg­u­la­to­ry ex­ec since his six-year tenure at For­est Labs, serv­ing as a VP at such com­pa­nies as Ot­su­ka, NPS Phar­ma and Ad­vax­is.

Michael Humphries

Per­cep­tive‘s Lian­Bio filed for the stan­dard $100 mil­lion IPO last week, and the US/Chi­na up­start has added Michael Humphries to the team this week as chief sci­en­tif­ic ad­vi­sor. Be­fore join­ing Lian­Bio, Humphries served as CMO and head of de­vel­op­ment strat­e­gy at Shang­hai-based Cel­lu­lar Bio­Med­i­cine Group (CB­MG). Pri­or to that, he was CSO at No­var­tis De­vel­op­ment Chi­na.

Heat Bi­o­log­ics has wel­comed aboard Paul Tebbey as SVP of prod­uct de­vel­op­ment and port­fo­lio strat­e­gy. Tebbey comes with ex­pe­ri­ence from his times at Ab­b­Vie, Bax­ter, Cen­to­cor/John­son & John­son and Wyeth/Pfiz­er.

Re­cro Phar­ma has tapped Tim Bourque as VP and head of op­er­a­tions for Re­cro San Diego. Bourque joins the PA-based com­pa­ny from Aji­nomo­to Bio-Phar­ma Ser­vices. Pri­or to that, Bourque had stints at Lon­za, Althea, Shire Hu­man Ge­net­ic Ther­a­pies and Ipsen.

Il­lu­mi­na Ven­tures-backed Re­bus Biosys­tems has named Dani­lo Tait as VP com­mer­cial op­er­a­tions, EMEA. Tait for­mer­ly served as busi­ness de­vel­op­ment man­ag­er, NGS/ge­nomics at PerkinElmer and has al­so held po­si­tions at Caliper Life Sci­ences, MGI and Ad­vanced An­a­lyt­i­cal.

Jeff Jonas

Jeff Jonas has been named chair­man of the board at Swiss based neu­ro start­up Noe­ma Phar­ma, which took psy­chi­a­try castoffs from Roche and col­lect­ed $59 mil­lion in a Se­ries A in De­cem­ber 2020. Jonas, who was CEO at Sage un­til Bar­ry Greene took over, is now the biotech’s chief in­no­va­tion of­fi­cer.

Ca­r­ole Faig

→ One of the biotechs hon­ored in the 2021 edi­tion of the End­points 11, Rick Mo­di’s folks at Affinia have a spot on the board of di­rec­tors for Ca­r­ole Faig. She re­cent­ly re­tired from Ernst & Young’s health­care busi­ness af­ter 25 years with the com­pa­ny.

Kevin Fitzger­ald has joined the board of di­rec­tors at Ovid, reel­ing from a Phase III An­gel­man syn­drome bust that prompt­ed a lead­er­ship makeover in Ju­ly. Fitzger­ald cur­rent­ly serves as CSO and head of re­search at Al­ny­lam, where he has been a key mem­ber of the drug de­vel­op­ment team since 2005.

Thomas El­dered

→ Lon­don-based mi­cro­bial im­munother­a­py play­er Prokar­i­um has made Thomas El­dered chair­man of the board as his pre­de­ces­sor, Steve Chat­field, will con­tin­ue as a board mem­ber. Don­ning an ever-present bow tie, El­dered co-found­ed and was the long­time CEO at Re­ci­pharm, a job that now be­longs to ex-Lon­za chief ex­ec­u­tive Marc Funk.

Gerd Zettlmeissl has a new gig as chair­man of the board at Min­er­vaX, a Dan­ish biotech backed by No­vo and Sanofi Ven­tures that’s work­ing on a Group B strep­to­coc­cus vac­cine to com­pete with Pfiz­er. Zettlmeissl was CEO of Val­ne­va (then known as In­ter­cell) from 2001 un­til his res­ig­na­tion in 2011.

→ Raleigh, NC-based 9 Me­ters Bio­phar­ma has elect­ed Saman­tha Ven­timiglia to the board of di­rec­tors. Ven­timiglia, the SVP, US pub­lic af­fairs for Ver­tex, was a gov­ern­ment af­fairs di­rec­tor at Astel­las be­fore her move to Ver­tex in 2010.

NextCure is adding some new faces to its board of di­rec­tors with the ap­point­ments of Ellen Fei­gal and Anne Borgman. Fei­gal cur­rent­ly serves as part­ner and head of the bi­o­log­ics prac­tice at NDA Part­ners and sits on the board of Xen­cor. Pre­vi­ous­ly, Fei­gal was ex­ec­u­tive med­ical di­rec­tor at Am­gen. Mean­while, Borgman is the cur­rent VP and glob­al ther­a­peu­tic area lead, hema­tol­ogy-on­col­o­gy at Jazz Phar­ma­ceu­ti­cals. Pri­or to those stints, Borgman was with Ex­elix­is, Hana Bio­sciences (now Talon Ther­a­peu­tics), Kalo­Bios Phar­ma­ceu­ti­cals and Ab­bott Phar­ma­ceu­ti­cals.

Jill Howe

Ad­ju­vant Cap­i­tal-backed syn­bio play­er Coda­genix out in Long Is­land has ap­point­ed Lori Rudolph-Owen and Jill Howe to the board of di­rec­tors. Since 2018, Rudolph-Owen has been chief de­vel­op­ment of­fi­cer at Goldfinch Bio, while Howe ap­peared in Peer Re­view a few months ago when she took the CFO job at DTx Phar­ma.

→ The afore­men­tioned Adri­an Senderow­icz is step­ping on­to the board of di­rec­tors at Step Phar­ma. Pri­or to his CMO role at Con­stel­la­tion, Senderow­icz was CMO at Cerulean Phar­ma and had served at Sanofi On­col­o­gy, Tokai Phar­ma­ceu­ti­cals and As­traZeneca.

Alan Ash­worth has se­cured a seat on the board of di­rec­tors at Cy­tomX. Ash­worth, the pres­i­dent of the He­len Diller Fam­i­ly Com­pre­hen­sive Can­cer Cen­ter at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, has been with the school since 2015.

Roswell Biotech­nolo­gies has ap­point­ed Mike Aich­er as chair­man of its board. Aich­er was pres­i­dent and founder of Alveo Tech­nolo­gies and was co-founder and CEO of the Na­tion­al Ge­net­ics In­sti­tute. Ad­di­tion­al­ly, Aich­er brings ex­pe­ri­ence from his times at Ge­net­ic Sig­na­tures and Cy­to­Bay.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.