Cure­Vac gains COO and hands Flo­ri­an von der Mülbe new as­sign­ment in the midst of Covid-19 vac­cine trou­bles; As Ken Fra­zier re­tires, Mer­ck hires chief strat­e­gy of­fi­cer

Malte Gre­une

→ Aim­ing to bounce back and try­ing to ac­cen­tu­ate the pos­i­tive af­ter its mR­NA Covid-19 vac­cine took a ma­jor prat­fall, Cure­Vac is shak­ing things up by bring­ing in Malte Gre­une as COO and giv­ing new re­spon­si­bil­i­ties to co-founder and chief pro­duc­tion of­fi­cer Flo­ri­an von der Mülbe. Gre­une jumps on board from Sanofi af­ter a near­ly 10-year run where he was sta­tioned in Ger­many and spent the last sev­er­al months as gen­er­al man­ag­er and VP, car­tridges, de­vices & in­sulin tech­nol­o­gy group in Frank­furt.

As for von der Mülbe, who was COO at Cure­Vac for 18 years be­fore his tenure as chief pro­duc­tion of­fi­cer, he will now de­vote his en­er­gy to de­vel­op­ing its man­u­fac­tur­ing tech known as The RNA Print­er.

De­spite what amounts to train wreck-lev­el da­ta in which Cure­Vac’s vac­cine post­ed an in­ter­im ef­fi­ca­cy of 47% — a pal­try fig­ure com­pared to mR­NA coun­ter­parts Mod­er­na and Pfiz­er/BioN­Tech — and re­sults that still failed to hit 50% ef­fi­ca­cy over­all in the fi­nal analy­sis, CEO Franz-Wern­er Haas vowed to push for­ward, em­pha­siz­ing the num­bers in those aged 18 to 60. “In the cur­rent con­text of an in­creas­ing­ly di­verse en­vi­ron­ment of COVID-19 vari­ants, and with very lit­tle resid­ual preva­lence of the orig­i­nal strain,” Haas said in a state­ment, “we are con­fi­dent that the HER­ALD study of­fers clin­i­cal­ly rel­e­vant da­ta re­gard­ing the ef­fect of emerg­ing vari­ants on vac­cine ef­fi­ca­cy.”

→ The Rob Davis era is of­fi­cial­ly up­on us at Mer­ck af­ter Ken Fra­zier’s re­tire­ment, and the phar­ma gi­ant ad­di­tion­al­ly has tapped Michael Klobuchar as chief strat­e­gy of­fi­cer ef­fec­tive Tues­day, a new­ly-cre­at­ed po­si­tion. Klobuchar’s Mer­ck ca­reer got un­der­way in 1998 as a syn­thet­ic process de­vel­op­ment en­gi­neer, and in the en­su­ing 23 years he’s made a steady as­cent up the lad­der in count­less roles, even­tu­al­ly be­com­ing SVP, Mer­ck Re­search Lab­o­ra­to­ries fi­nance and glob­al project and al­liance man­age­ment.

Enoch Kar­iu­ki

Dave John­son’s get­ting the band back to­geth­er: Lengo Ther­a­peu­tics, the San Diego on­col­o­gy biotech where John­son is chair­man, has se­lect­ed Enoch Kar­iu­ki as CEO. Just last sum­mer, while John­son was still CEO of Velos­Bio, he named Kar­iu­ki CFO — and then Mer­ck bought the com­pa­ny for $2.75 bil­lion in a No­vem­ber 2020 an­nounce­ment. Be­fore his short tenure at Velos­Bio, Kar­iu­ki was SVP, cor­po­rate de­vel­op­ment for Lau­ra Shawver at Syn­thorx, and then it too was bought out by a Big Phar­ma, this time for $2.5 bil­lion by Sanofi. Kar­iu­ki’s ap­point­ment at Lengo comes af­ter Di­ana Haus­man earned the CMO spot a few weeks ago.

JoAnne Mi­cale Foody

Es­pe­ri­on has been fight­ing such an up­hill sales bat­tle with its cho­les­terol drug Nexle­tol that CEO Tim Mayleben stepped down last month and was re­placed by Shel­don Koenig, with Covid-19 shoul­der­ing most of the blame. JoAnne Mi­cale Foody now steps in as CMO af­ter six years with J&J. Since Au­gust, Foody had served as Janssen’s VP and head of da­ta sci­ences in the fol­low­ing ther­a­peu­tic ar­eas: car­dio­vas­cu­lar, me­tab­o­lism, reti­nal and pul­monary hy­per­ten­sion. Pri­or to those re­spon­si­bil­i­ties, her en­er­gy was di­rect­ed to­ward Xarel­to as VP and com­pound de­vel­op­ment team leader.

Al­fred Bowie

→ Throw­ing the in­dus­try a bit of a curve­ball with this next step, ex-Mer­ck R&D lu­mi­nary Roger Perl­mut­ter leads the charge as CEO of drug dis­cov­ery biotech Eikon Ther­a­peu­tics and has ap­point­ed his first CFO. Al­fred Bowie heads to Hay­ward, CA-based Eikon af­ter two years as VP, cor­po­rate and busi­ness de­vel­op­ment at Ve­r­a­cyte, which has just un­der­gone a CEO tran­si­tion as Marc Sta­p­ley suc­ceeds Bon­nie An­der­son. Bowie has al­so been Roche sub­sidiary Foun­da­tion Med­i­cine’s se­nior di­rec­tor, cor­po­rate de­vel­op­ment & strat­e­gy.

Su­san Gal­braith is mov­ing up the ranks with her ap­point­ment as EVP of on­col­o­gy re­search at As­traZeneca’s new re­search and de­vel­op­ment home in Cam­bridge, UK. Her new po­si­tion comes months af­ter the trag­ic death of José Basel­ga from Creutzfeldt-Jakob dis­ease, af­ter the cel­e­brat­ed on­col­o­gist had been brought in to head can­cer R&D in an un­usu­al di­vi­sion of the lead R&D roles at the com­pa­ny. Gal­braith joined the can­cer R&D team at As­traZeneca in 2010 and most re­cent­ly served as the EVP and head of re­search and ear­ly de­vel­op­ment, on­col­o­gy R&D — which in­clud­ed ush­er­ing 7 can­cer drugs in­to Phase III stud­ies en­com­pass­ing Lyn­parza and Tagris­so.

Kate Cronin

Kate Cronin’s first day as chief brand of­fi­cer for Covid-19 vac­cine heavy­weight Mod­er­na will be Ju­ly 12. Be­fore this op­por­tu­ni­ty came along to build the brand of one of the hottest names in the in­dus­try, Cronin was a part of Ogilvy Health for 17 years and had been glob­al CEO there since Oc­to­ber 2020. “What Mod­er­na has achieved is tru­ly in­spi­ra­tional and I’m in­cred­i­bly ex­cit­ed to be join­ing a com­pa­ny that has such a tremen­dous im­pact on the world,” Cronin said in a state­ment. Our Nicole De­Feud­is has more here on Cronin’s ar­rival.

→ We’re not done with the Big Phar­ma fun. Awny Fara­jal­lah has left Ipsen to be Take­da’s head of glob­al med­ical af­fairs, on­col­o­gy busi­ness unit. Fara­jal­lah spent the last year at Ipsen as SVP, North Amer­i­ca med­ical af­fairs, pre­ced­ed by 15 years at Bris­tol My­ers Squibb where he even­tu­al­ly led the US med­ical af­fairs team and was al­so in­flu­en­tial in the launch­es of Op­di­vo and Yer­voy. In the last sev­er­al weeks the Japan­ese phar­ma gi­ant shared pos­i­tive piv­otal da­ta with the NSCLC can­di­date mobo­cer­tinib and notched a pri­or­i­ty re­view for its cy­tomegalovirus drug marib­avir.

An­dree Amels­berg

Bio­gen hit jack­pots on the reg­u­la­to­ry slot ma­chine through­out the month of June: first with the shock wave-in­duc­ing Aduhelm ap­proval that has been large­ly met with dis­be­lief and de­ri­sion, and then with a break­through ther­a­py des­ig­na­tion for Alzheimer’s drug lecanemab last week. Mean­while Bio­gen’s part­ner for lecanemab, Ei­sai, has locked in An­dree Amels­berg as VP US med­ical af­fairs, on­col­o­gy busi­ness group. Amels­berg has been an on­col­o­gy ex­ec at Boehringer In­gel­heim (14 years), Astel­las (three years) and Janssen (near­ly six years) and just had a snap-your-fin­ger-and-that’s-it tenure as SVP of med­ical af­fairs at Hutchmed, which is hop­ing for good news of its own from the FDA with its on­col­o­gy as­set su­r­u­fa­tinib.

Ste­fano Por­tolano is suc­ceed­ing Olivi­er Morand as CEO of Dutch biotech Aza­faros, launched in 2018 and tar­get­ing lyso­so­mal stor­age dis­eases with its lead can­di­date AZ-3102. Por­tolano takes the helm here af­ter five years as head of Eu­rope for Ul­tragenyx and an­oth­er 10 years wear­ing var­i­ous hats at Cel­gene, in­clud­ing VP, strat­e­gy & com­mer­cial op­er­a­tions. As AZ-3012 en­ters Phase I, For­bion in April con­tributed an ad­di­tion­al €2.75 mil­lion to the orig­i­nal Se­ries A, with to­tal fund­ing for Aza­faros sit­ting at €28.75 mil­lion.

Ma­lene Brond­berg

→ Af­ter tak­ing over as CEO near­ly 4 months ago, Pe­ter Braun is now leav­ing his post at Nordic Nanovec­tor for per­son­al rea­sons. In the mean­time, CFO Ma­lene Brond­berg is tak­ing over the reins as in­ter­im CEO as the board looks for a re­place­ment. Brond­berg came to Nordic as VP, in­vestor re­la­tions in Feb­ru­ary 2018.

EQRx, helmed by Blue­print co-founder Alex­is Borisy, has plucked up Car­los Gar­cia-Echev­er­ria as chief of Rx cre­ation. Gar­cia-Echev­er­ria is a Sanofi vet and served as COO of re­search and glob­al head of re­search plat­forms. Be­fore his gig at Sanofi, Gar­cia-Echev­er­ria held a va­ri­ety of po­si­tions at No­var­tis, re­spon­si­ble for man­ag­ing mul­ti­ple late-stage drug dis­cov­ery can­cer pro­grams.

Chao Zhang

→ Be­sides mov­ing its head­quar­ters from Berke­ley to South San Fran­cis­co, Plexxikon — a mem­ber of the Dai­ichi Sankyo Group — is mak­ing some changes to its C-suite with the pro­mo­tions of CSO Chao Zhang to CEO and Mar­guerite Hutchin­son to COO and gen­er­al coun­sel. Zhang is suc­ceed­ing Gideon Bol­lag, who will tran­si­tion to a part-time po­si­tion as chief bi­ol­o­gist.

Zhang has served as the com­pa­ny’s CSO since Au­gust 2018 and pre­vi­ous­ly held the role of SVP of re­search in his ear­ly days with the com­pa­ny in 2001. Mean­while, Hutchin­son joined Plexxikon in 2013.

Or­bit Dis­cov­ery has reeled in Neil Butt as CEO. Butt makes his way to Or­bit from ION­TAS, where he served as CBO. Be­fore that, he was part of the man­age­ment team at Abzena and An­ti­tope.

→ Ef­fec­tive June 25, a CEO change un­fold­ed at Ta­vo mak­er On­coSec as Bri­an Leuth­n­er was in­stalled on an in­ter­im ba­sis to re­place Dan O’Con­nor. A SPAC led by O’Con­nor, named Lark­spur Health Ac­qui­si­tion, filed for an IPO in mid-May. Leuth­n­er kicked off his ca­reer in the in­dus­try at Glax­o­SmithK­line as an HIV and on­col­o­gy prod­uct man­ag­er, and he has since been chief ex­ec­u­tive at sev­er­al com­pa­nies — in­clud­ing Edge Ther­a­peu­tics, which he co-found­ed and helped merge with PDS Biotech­nol­o­gy.

Su­san Blum

→ Else­where in In­ter­imville, the in­ter­im la­bel has been re­moved for Su­san Blum and she’s now CFO for Melin­ta Ther­a­peu­tics, which cap­tured an FDA ap­proval in March for its an­tibi­ot­ic Kimyr­sa to treat acute bac­te­r­i­al skin and skin struc­ture in­fec­tions. Blum, who had been in­ter­im CFO for Chris­tine Ann Miller’s team af­ter Pe­ter Mil­li­gan’s ex­it since March 31, was pre­vi­ous­ly VP of fi­nance & chief ac­count­ing of­fi­cer.

In­tel­lia is hav­ing it­self a week, start­ing with the mo­men­tous da­ta that showed CRISPR can be used to ed­it DNA di­rect­ly in hu­mans and let­ting the good times roll by pump­ing a whop­ping $600 mil­lion in­to its cof­fers. Run­ning along­side this news, In­tel­lia has named a Bio­gen vet as EVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. James Bas­ta held var­i­ous le­gal po­si­tions at Bio­gen from 2006-19, leav­ing as chief cor­po­ra­tion coun­sel and then sign­ing on with Troy Wil­son’s team at Ku­ra On­col­o­gy, where he was chief le­gal of­fi­cer, sec­re­tary and chief com­pli­ance of­fi­cer.

Amit Nath­wani

→ Close fol­low­ers of Peer Re­view know that Ro­muald Cor­bau was pro­mot­ed to CSO last fall at Free­line Ther­a­peu­tics. But Cor­bau is now leav­ing his post, and it’s Amit Nath­wani to the res­cue on an in­ter­im ba­sis. Nath­wani, who co-found­ed the AAV gene ther­a­py play­er out of the UK in 2015 and is a board mem­ber, re­turns to the job he’s held be­fore at Free­line, which is sad­dled with a tri­al de­lay for its he­mo­phil­ia B pro­gram as CDC is­sues are ad­dressed. Cor­bau will stay on as chief sci­en­tist un­til Aug. 20.

In oth­er Free­line de­vel­op­ments, James Bircher has been added to the ros­ter as chief tech­ni­cal op­er­a­tions of­fi­cer af­ter hold­ing the CTO job at Abeona.

Ellen Lefever

→ The mad dash from Gala­pa­gos has con­tin­ued apace af­ter the col­lapse of the Gilead part­ner­ship and CSO Piet Wiger­inck’s de­par­ture. Gala­pa­gos vets Ellen Lefever and Tim Van Kaem have turned up at AgomAb, which hauled in a $74 mil­lion Se­ries B in March for its lead can­di­date, an HGF-mimet­ic ag­o­nist of the MET re­cep­tor dubbed AGMB-101. Lefever (gen­er­al coun­sel) had held a hand­ful of le­gal roles at Gala­pa­gos since 2014, in­clud­ing deputy gen­er­al coun­sel, while Van Kaem (head of clin­i­cal op­er­a­tions) de­vot­ed nine years to the com­pa­ny in drug de­vel­op­ment and project man­age­ment. AgomAb CBO Paul van der Horst is al­so a Gala­pa­gos alum.

→ Med­ical de­vice com­pa­ny Pre­sidio Med­ical, which raised $30 mil­lion last sum­mer to ad­vance its neu­ro­mod­u­la­tion plat­form tech, has plucked Michael Onuscheck from Al­con to be CEO and chair­man ef­fec­tive Sept. 1. Onuscheck was pre­vi­ous­ly Al­con’s pres­i­dent, glob­al busi­ness­es and in­no­va­tion, and for three of his 10 years at Boston Sci­en­tif­ic, Onuscheck was pres­i­dent of the neu­ro­mod­u­la­tion di­vi­sion. Cred­it out­go­ing CEO Michael Ack­er­mann for es­chew­ing the usu­al mo­not­o­ny of press re­leas­es, say­ing, “Michael Onuscheck is the Le­Bron James of neu­ro­mod­u­la­tion and one of the world’s pre­mier lead­ers in med­ical tech­nol­o­gy … It feels great to pass the ball to an MVP.”

Leone Pat­ter­son

Leone Pat­ter­son re­signed as Ad­verum’s pres­i­dent and CFO last week, leav­ing CBO Chris DeRespino to slide in as act­ing CFO. We’ve learned about her land­ing spot as she be­comes chief fi­nan­cial and busi­ness of­fi­cer at Tenaya Ther­a­peu­tics, a biotech that scored $106 mil­lion worth of Se­ries C fund­ing for its heart dis­ease pro­grams in March. Pat­ter­son, whose five years at Ad­verum in­clud­ed a turn as CEO, was pre­vi­ous­ly a fi­nance ex­ec with such names as No­var­tis, Ex­elix­is and Di­adexus. That’s not the on­ly ap­point­ment at Tenaya: Matthew Poll­man has joined the fray as SVP, clin­i­cal de­vel­op­ment af­ter his time as EVP of Nav­i­Gate Car­diac Struc­tures. Poll­man is for­mer­ly the CMO of Ju­ven­tas Ther­a­peu­tics and di­rec­tor, car­dio­vas­cu­lar bi­ol­o­gy for Mil­len­ni­um Phar­ma­ceu­ti­cals.

Scripps spin­out Am­brx, shoot­ing for an IPO a sec­ond time af­ter the first at­tempt was with­drawn in 2014, has wel­comed Son­ja Nel­son as CFO. A new board ap­pointee at Mo­tus GI, Nel­son was Im­mu­ni­ty­Bio’s SVP of fi­nance af­ter the re­verse merg­er closed with Nan­tK­west in March. Be­fore the merg­er, she ini­tial­ly signed on to Patrick Soon-Sh­iong’s team in 2015 as chief ac­count­ing of­fi­cer and lat­er be­came CFO. Nel­son has al­so been VP, cor­po­rate con­troller at Alt­heaDx.

→ Stan the Man: Stan Mu­sial has been named CFO at Vivek Ra­maswamy’s Aru­vant, which re­cent­ly start­ed putting their heads to­geth­er with Jasper Ther­a­peu­tics to col­lab­o­rate on sick­le cell dis­ease treat­ments. Mu­sial hails from Dutch biotech Xenikos, where he was CFO and CBO. He’s al­so held the CFO ti­tle at Zy­la Life Sci­ences (then known as Egalet) and Ital­ian biotech Ery­Del.

Stew­art Ab­bot

→ New York-based can­cer biotech Turn­stone Bi­o­log­ics con­tin­ues to fill out its team of ex­ecs with CSO Stew­art Ab­bot. The for­mer chief sci­en­tif­ic and op­er­at­ing of­fi­cer at Adicet Bio, Ab­bot has al­so been chief de­vel­op­ment of­fi­cer at Fate as well as ex­ec­u­tive di­rec­tor of in­te­gra­tive re­search and se­nior di­rec­tor of re­search for Cel­gene. In May, Turn­stone pro­mot­ed José Manuel Otero to chief tech­nol­o­gy of­fi­cer and Saryah Az­mat to CBO, while Mike Burgess si­mul­ta­ne­ous­ly be­came Turn­stone’s ex­ec­u­tive chair­man of R&D and re­placed act­ing head of R&D Stephen Squin­to at Spring­Works.

OcuTer­ra, which made head­lines in May when ex-Al­ler­gan CEO Brent Saun­ders was named chair­man, is shoring up its lead­er­ship fur­ther with David Tanz­er as CMO. Tanz­er, who was in charge of the Navy Re­frac­tive Surgery Pro­gram, makes the move to OcuTer­ra af­ter his time with the No­var­tis oph­thal­mol­o­gy fran­chise as glob­al ex­ec­u­tive med­ical di­rec­tor. OcuTer­ra’s lead pro­gram, OTT166 for pa­tients with di­a­bet­ic retinopa­thy, is look­ing to start Phase II stud­ies this year.

Rahul Agraw­al

→ Ger­man heart dis­ease biotech Car­dior Phar­ma­ceu­ti­cals, tak­ing the non-cod­ing RNA (ncR­NA) route with its ther­a­pies, has called up­on Rahul Agraw­al to be CMO. At the tail end of his sev­en years at As­traZeneca, Agraw­al was VP and glob­al med­i­cines leader, car­dio­vas­cu­lar. Among oth­er po­si­tions at Bay­er from 2006-14, Agraw­al served as glob­al di­rec­tor of med­ical af­fairs and clin­i­cal, glob­al launch team, and pul­monary hy­per­ten­sion with Bay­er Health­Care.

→ With the PARP7 in­hibitor RBN-2397 top­ping its pipeline, Cam­bridge, MA-based Ri­bon Ther­a­peu­tics has tapped Paul Bran­nel­ly as CFO. Bran­nel­ly spent the last six years as CFO of Col­legium Phar­ma­ceu­ti­cal, pre­ced­ed by a brief stay at Karyopharm as SVP, fi­nance and ad­min­is­tra­tion. He’s al­so been Ve­rastem’s VP, fi­nance, trea­sur­er and sec­re­tary.

Mark Mul­vi­hill

→ Flush with $67.5 mil­lion from a Se­ries B raise, metasta­t­ic can­cer out­fit Hi­ber­Cell has pro­mot­ed Mark Mul­vi­hill to CSO. Mul­vi­hill, who ini­tial­ly punched his tick­et to Hi­ber­Cell in 2018, had served as SVP, chem­istry and drug dis­cov­ery. From 2001-13 he was with Astel­las sub­sidiary OSI Phar­ma­ceu­ti­cals, ris­ing to di­rec­tor of chem­istry & glob­al project leader.

BioSkryb has brought on Gary Har­ton as CSO. Pri­or to his new role, Har­ton was port­fo­lio di­rec­tor, preim­plan­ta­tion ge­net­ic test­ing at Perkin Elmer’s new preim­plan­ta­tion ge­net­ic test­ing prod­uct line. In ad­di­tion to Perkin Elmer, Har­ton has had stints at Igenomix US, Prog­y­ny, Il­lu­mi­na, BlueG­nome Lim­it­ed and Re­pro­g­e­net­ics.

Pe­tra Molan

→ As it’s tak­ing the leap in­to man­u­fac­tur­ing with the pur­chase of an Irish plant, Hori­zon Ther­a­peu­tics has brought on Pe­tra Molan as group VP, gen­er­al man­ag­er of Eu­rope, Mid­dle East and Africa (EMEA). Pe­tra makes her way to Hori­zon af­ter serv­ing as SVP, head of com­mer­cial op­er­a­tions at Arvelle Ther­a­peu­tics. Pri­or to that, Molan was with Take­da, Shire, Bay­er and Eli Lil­ly. In June, Hori­zon forked over $40 mil­lion up­front for the glob­al rights to Ar­row­head‘s RNAi drug ARO-XDH.

→ In­duced pluripo­tent stem cell play­er Shore­line Bio­sciences, which just inked a $45 mil­lion iP­SC deal with BeiGene a few short weeks ago, has named Mo­ham­mad El-Kalay SVP and head of CMC. Be­fore his tran­si­tion to the San Diego-based biotech, El-Kalay was VP, tech­ni­cal op­er­a­tions for Er­ic Os­tertag’s crew at Po­sei­da Ther­a­peu­tics. Ear­li­er, El-Kalay held ex­ec­u­tive roles in tech­ni­cal op­er­a­tions at San­Bio and Sang­amo.

Man­ju­nath Ra­ma­rao

Part­ner­ing with Genen­tech at the start of this year in a dis­cov­ery deal aimed at drug­ging RNA, Re­search Tri­an­gle biotech Ri­bometrix has ap­point­ed Man­ju­nath Ra­ma­rao SVP of re­search, leav­ing Bris­tol My­ers Squibb af­ter a dozen years. Based in Ban­ga­lore, In­dia, Ra­ma­rao was ex­ec­u­tive di­rec­tor, head of dis­cov­ery and trans­la­tion­al med­i­cine at the Bio­con-Bris­tol-My­ers Squibb R&D Cen­ter.

→ Next-gen­er­a­tion se­quenc­ing com­pa­ny DNAe has named Al­i­son Howie VP of com­mer­cial. Howie has spent the last decade at Ther­mo Fish­er Sci­en­tif­ic, where she was VP of mar­ket­ing & prod­uct de­vel­op­ment and VP of R&D and busi­ness de­vel­op­ment for the com­pa­ny’s mi­cro­bi­ol­o­gy busi­ness. Pri­or to that, she was CCO and chief prod­uct of­fi­cer at Ix­i­co.

Mary Beth Dorr

Mary Beth Dorr takes on a new role as VP, clin­i­cal sci­ence at Penn­syl­va­nia-based Ve­na­torx Phar­ma­ceu­ti­cals, which dosed its first pa­tient this week in a Phase I tri­al of its an­tivi­ral com­pound VN­RX-9945 for HBV. Dorr hails from Mer­ck, where she was prod­uct de­vel­op­ment team leader and clin­i­cal lead, in­fec­tious dis­eases, con­cen­trat­ing on be­zlo­tox­um­ab — a C. dif­fi­cile an­ti­body ap­proved by the FDA in 2016.

→ Ul­tragenyx has reeled a big fish on­to its board of di­rec­tors with the ap­point­ment of for­mer Cel­gene CMO Corsee Sanders. This will be yet an­oth­er ad­di­tion to Sanders’ long list of board seats — which in­cludes BeiGene, Mol­e­c­u­lar Tem­plates, Leg­end, Al­tru­Bio and the Fred Hutchin­son Can­cer Re­search Cen­ter.

Daphne Qui­mi

Joshua Co­hen and Justin Klee have swung the door open for Daphne Qui­mi as the next mem­ber of ALS-cen­tered Amy­lyx’s board of di­rec­tors. A J&J and Bris­tol My­ers vet, Qui­mi is the CFO at Am­i­cus and is in her 14th year with John Crow­ley’s bunch.

Kin­nate’s en­su­ing lead­er­ship move af­ter Ne­ha Kr­ish­namo­han took on the CFO job in ear­ly June is elect­ing He­len Sabze­vari to the board of di­rec­tors. Sabze­vari — the for­mer SVP of im­muno-on­col­o­gy at Mer­ck KGaA sub­sidiary EMD Serono — is now the pres­i­dent and CEO of Pre­ci­gen.

Greg Covi­no

→ Af­ter abrupt­ly walk­ing away from his CFO post at No­vavax — where he is still an ex­ec­u­tive ad­vi­sor — Greg Covi­no is resur­fac­ing as part of the board of di­rec­tors at Ren­o­va­cor once the $116 mil­lion SPAC deal clos­es with Chardan Health­care Ac­qui­si­tion 2 Corp. Covi­no will be joined on the board by Spirovant co-founder and CEO Joan Lau.

Tal­ly­ing a shade more than $40 mil­lion in a Se­ries B round in May, bac­te­rio­phage biotech Adap­tive Phage Ther­a­peu­tics has elect­ed three new board mem­bers. The tri­umvi­rate con­sists of Paratek CEO Evan Loh, Deer­field Man­age­ment part­ner and Deer­field In­sti­tute chair­man Jonathan Leff, and Deer­field Dis­cov­ery and De­vel­op­ment COO Jana Jensen.

Lau­ra Williams

→ Boston-based Imara has waved in Ab­bott/Ab­b­Vie vet Lau­ra Williams to its board of di­rec­tors. Williams served as SVP of glob­al ther­a­peu­tic strate­gies and pa­tient ad­vo­ca­cy at Arde­lyx. Pri­or to that, Williams was with AM­AG Phar­ma­ceu­ti­cals and My­ovant Sci­ences.

→ The ra­dio­phar­ma­ceu­ti­cals jew­el be­hind Pe­ter Kolchin­sky’s first SPAC, Point Bio­phar­ma has brought on Big Phar­ma alum Myra Rosario Her­rle as EVP of reg­u­la­to­ry af­fairs. Her­rle, who has held reg­u­la­to­ry posts at Ab­b­Vie and No­var­tis, spent the last year as VP of reg­u­la­to­ry af­fairs at Gly­coMimet­ics.

Mol­ly Harp­er

Mol­ly Harp­er ap­peared in Peer Re­view last May when she joined Rel­ma­da Ther­a­peu­tics as EVP of op­er­a­tions, and this week we find out she’s on the board of di­rec­tors at Cat­a­lyst Phar­ma­ceu­ti­cals. Be­fore Rel­ma­da, Harp­er was Akcea’s SVP and glob­al fran­chise gen­er­al man­ag­er.

→ CD47-fo­cused Tril­li­um Ther­a­peu­tics has made room for Cather­ine Mack­ey on its board of di­rec­tors. Mack­ey, the SVP, glob­al R&D and di­rec­tor of Pfiz­er’s La Jol­la Lab­o­ra­to­ries from 2001-10, has been a di­rec­tor be­fore at Po­sei­da, GW Phar­ma­ceu­ti­cals and YM Bio­sciences (bought by Gilead in 2012).

Ca­balet­ta Bio, fo­cus­ing on B cell-me­di­at­ed au­toim­mune dis­eases and col­lab­o­rat­ing with fel­low cell ther­a­py com­pa­ny Ar­ti­san Bio, has made Scott Brun a mem­ber of the board of di­rec­tors. The Ab­b­Vie and Ab­bott vet re­places Bri­an Daniels, who re­signed from his seat June 24.

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.

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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Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Break­ing: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more coverage, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. Biogen said on its earnings call that about 120 sites so far have infused at least one patient with Aduhelm, which is priced at $56,000 annually. Morgan Stanley previously predicted about 14,000 patients will access Aduhelm by the end of 2022.

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Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most popular targets in drug development, representing about a third of existing drugs, are G-protein coupled receptors — the tiny but integral membrane proteins responsible for recognizing things like light, taste, smell, hormones and pain.

But due to challenges in mapping their structure, the protein family remains largely unexplored.

A slate of companies has emerged over the last few years to change that. If one can figure out the structure of these elusive membrane receptors, it might be possible to create small molecule drugs that overcome the limitations of, say, biologic and peptide therapies. That promise is what gets serial entrepreneur Raymond Stevens out of bed in the morning.