Blue­print Med­i­cines gets more ducks in a row be­fore CEO tran­si­tion; Paul Stof­fels has his work cut out for him at Gilead’s crum­bling part­ner

Phili­na Lee

→ When Jeff Al­bers an­nounced he would no longer be CEO of Blue­print Med­i­cines, the lead­er­ship carousel at the Aykak­it mak­er had yet to wind down. Yes, Kate Hav­i­land is next in line to re­place Al­bers in April and Christi­na Rossi will suc­ceed Hav­i­land as COO, but who would fill Rossi’s po­si­tion? The an­swers lies with­in the com­pa­ny again, as Phili­na Lee has been pro­mot­ed to chief com­mer­cial of­fi­cer and He­len Ho takes over CBO re­spon­si­bil­i­ties.

In Au­gust 2014, Lee joined Blue­print as se­nior di­rec­tor, new prod­uct strat­e­gy and de­vel­op­ment, and she has since risen to SVP, head of port­fo­lio strat­e­gy and pro­gram man­age­ment. Ho, a vet­er­an of TCR² Ther­a­peu­tics and Agios Phar­ma­ceu­ti­cals, be­came VP of cor­po­rate de­vel­op­ment at Blue­print in 2018 and will han­dle Lee’s port­fo­lio strat­e­gy and pro­gram man­age­ment du­ties in ad­di­tion to cor­po­rate and busi­ness de­vel­op­ment.

Paul Stof­fels

→ If you didn’t have Paul Stof­fels to Gala­pa­gos on your bin­go card this week, we don’t blame you. On par with Hal Bar­ron’s de­ci­sion to leave Glax­o­SmithK­line and tack­le the CEO job at Al­tos Labs, the Bel­gian biotech pro­duced some shock waves on Wednes­day with the news that Stof­fels will take over as chief ex­ec­u­tive on April 1 af­ter his re­tire­ment from J&J. Stof­fels will try to ap­ply a de­fib­ril­la­tor to a com­pa­ny in des­per­ate need of re­sus­ci­ta­tion now that the part­ner­ship with Gilead has col­lapsed un­der the weight of the fil­go­tinib fail of 2020 and oth­er de­flat­ing read­outs from last year, mak­ing this a steep moun­tain to climb for the re­spect­ed ex­ec. Stof­fels re­places On­no van de Stolpe, who saw the writ­ing on the wall and an­nounced last Au­gust that he would re­tire as Gala­pa­gos CEO.

Bill Con­kling

→ Af­ter the Phase III study for metasta­t­ic pan­cre­at­ic can­cer at Rafael Hold­ings bel­lyflopped im­pres­sive­ly in Oc­to­ber 2021, CEO Ameet Mallik was ini­tial­ly sup­posed to cede the top spot to founder and chair­man Howard Jonas. In­stead, the CEO job will go to Bill Con­kling, one of sev­er­al ex­ecs on the chop­ping block in the first place. Con­kling, ex-VP of sales, mar­ket­ing, mar­ket ac­cess and com­mer­cial op­er­a­tions at Im­munomedics, had tak­en on the roles of chief com­mer­cial and busi­ness of­fi­cer last March and will take the helm on Feb. 1.

That’s not all from Rafael: Rick Ew­ing has stepped in to lead drug dis­cov­ery, and ef­fec­tive this com­ing Mon­day, CMO Mi­mi Huizin­ga will take the ex­it ramp. Ew­ing rides in­to Rafael af­ter a 21-year ca­reer at Bris­tol My­ers Squibb, where he was re­cent­ly se­nior di­rec­tor, small mol­e­cule drug dis­cov­ery.

Nad­er Pourhas­san

→ In a Hail Mary at­tempt to nurse the re­main­ing bits of its im­age back to health, Cy­to­Dyn has fired CEO Nad­er Pourhas­san — the ex­ec­u­tive re­spon­si­ble for guid­ing the dis­as­trous R&D ef­fort and PR cam­paign for leron­limab, an in­ves­ti­ga­tion­al drug the com­pa­ny has pitched as a po­ten­tial ther­a­py for can­cer, Covid-19 and HIV. In the in­ter­im, CFO An­to­nio Migliarese will be tak­ing up the man­tle, while the com­pa­ny search­es for a more per­ma­nent re­place­ment with the “req­ui­site phar­ma­ceu­ti­cal in­dus­try ex­pe­ri­ence to en­hance the Com­pa­ny’s ef­forts to achieve reg­u­la­to­ry ap­proval and com­mer­cial­iza­tion of leron­limab.” Leron­limab, once pitched as a po­ten­tial “pipeline-in-a-prod­uct” for Cy­to­Dyn, has land­ed the com­pa­ny in­to a lot of hot wa­ter with the DOJ and SEC as they are still in­ves­ti­gat­ing whether the biotech ac­tive­ly looked to fool in­vestors about the state of its drug’s chances.

Jo­han­na Rossell

→ Is there an on­go­ing purge at Bio­gen? There are signs point­ing in this di­rec­tion, with one source telling End­points News a cou­ple months ago “we are los­ing peo­ple left and right” at the com­pa­ny that’s be­come in­fa­mous for its Alzheimer’s drug Aduhelm. Case in point: Bio­gen’s glob­al Alzheimer’s lead Jo­han­na Rossell has bolt­ed to fill En­zy­vant’s chief com­mer­cial of­fi­cer post. Af­ter a decade at No­var­tis, Rossell was Mer­ck’s US biosim­i­lars head, im­munol­o­gy and then the VP of new prod­ucts at Mallinck­rodt be­fore join­ing Bio­gen in 2019. Rossell will steer com­mer­cial­iza­tion ef­forts for En­zy­vant’s con­gen­i­tal athymia drug Rethymic, which was ap­proved by the FDA in Oc­to­ber 2021.

Tri­cia Brooks

→ Bio­gen’s Alzheimer’s part­ner Ei­sai, which al­so teams up with Mer­ck on a Keytru­da/Lenvi­ma com­bo, has en­list­ed Tri­cia Brooks as VP & head of of­fice, gov­ern­ment af­fairs and pol­i­cy. Brooks, who spent near­ly nine years with No­vo Nordisk in pub­lic af­fairs, jumps to Ei­sai af­ter a fair­ly short stay as VP, gov­ern­ment af­fairs & pol­i­cy at Arde­lyx, a biotech try­ing to re­cov­er from last year’s CRL and two dras­tic re­duc­tions in its staff.

Brent Saun­ders

→ Time to play an­oth­er game of “What’s Brent Saun­ders Up To Now?” This week, Saun­ders has been added to the board of di­rec­tors at Os­mind, a San Fran­cis­co health­care com­pa­ny “build­ing the first dig­i­tal in­fra­struc­ture for neu­ropsy­chi­a­try” that scored a mod­est Se­ries A round in Ju­ly 2021. In one of his first post-Al­ler­gan moves, Saun­ders al­so joined the board of OcuTer­ra last May when few peo­ple knew any­thing at all about the oph­thalmic dis­ease biotech. His ap­point­ment fol­lows that of Os­mind’s chief growth of­fi­cer Adam Far­ren and two new mem­bers of the sci­en­tif­ic ad­vi­so­ry board, Mau­r­izio Fa­va and Boris Heifets.

Shan­non Camp­bell

→ Part­ner­ing with Eli Lil­ly on can­cer drug zeno­cu­tuzum­ab — which had a da­ta re­veal at AS­CO last sum­mer — Dutch biotech Merus has ap­point­ed Shan­non Camp­bell as chief com­mer­cial of­fi­cer to carve out zeno’s com­mer­cial­iza­tion strat­e­gy. Camp­bell shifts to Merus af­ter lead­ing the US sol­id tu­mor fran­chise at No­var­tis since 2017, and she was al­so head of the US on­col­o­gy busi­ness dur­ing her 12 years at Bay­er. Merus and Lil­ly’s T cell en­gager deal, inked in Jan­u­ary 2021, is worth up to $1.6 bil­lion.

Cin­tia Pic­ci­na had on­ly been with Nick Leschly’s blue­bird bio spin­off 2sev­en­ty for a cou­ple months be­fore piv­ot­ing to a chief com­mer­cial of­fi­cer gig at Adap­ti­m­mune, which plans to sub­mit a BLA some­time this year for afa­mi-cel. Be­fore she was head of com­mer­cial at 2sev­en­ty, Pic­ci­na was at the fore­front of the Abec­ma launch as blue­bird’s SVP, com­mer­cial on­col­o­gy and US gen­er­al man­ag­er, and to cap off a 23-year ca­reer with No­var­tis, she was VP, glob­al on­col­o­gy cell and gene strat­e­gy & pro­gram man­age­ment of­fice, for Kym­ri­ah and the rest of the Swiss phar­ma’s CAR-T pipeline.

Guy Braun­stein

They’ll be there for you: Hop­ing that new TV ads with Jen­nifer Anis­ton can boost sales of its new­ly-ap­proved in­som­nia drug Qu­viviq, Idor­sia has pro­mot­ed Guy Braun­stein to CMO and Al­ber­to Gi­mona to head of glob­al clin­i­cal de­vel­op­ment. Braun­stein had led glob­al clin­i­cal de­vel­op­ment from the be­gin­ning at Idor­sia and since the Acte­lion days, go­ing back to 2009. Gi­mona’s as­so­ci­a­tion with CEO Jean-Paul Clozel al­so dates back to Acte­lion, slid­ing in­to Braun­stein’s old job af­ter near­ly three years as head of ther­a­peu­tic area units.

Flo­rence Zhu

Ash­er Bio­ther­a­peu­tics, an IL-2 biotech backed by Third Rock and RA Cap­i­tal which lists the Nether­lands Can­cer In­sti­tute’s Ton Schu­mach­er as one of its sci­en­tif­ic founders, has a pa­rade of new ex­ecs, start­ing with CBO Don O’Sul­li­van. This is O’Sul­li­van’s first C-suite post af­ter more than 11 years at Roche/Genen­tech, where he was VP, glob­al head of on­col­o­gy part­ner­ing. Next, James Cross (VP, reg­u­la­to­ry af­fairs) had been run­ning his own con­sult­ing firm af­ter his year-long stints as ex­ec­u­tive di­rec­tor of reg­u­la­to­ry af­fairs for Halozyme and head of reg­u­la­to­ry af­fairs with Forty Sev­en. Fi­nal­ly, Flo­rence Zhu (VP, fi­nance) is an­oth­er Forty Sev­en alum who was VP of fi­nance and cor­po­rate con­troller at Ole­ma On­col­o­gy.

Flag­ship Pi­o­neer­ing has made Tom DiLenge se­nior part­ner, glob­al pub­lic pol­i­cy, reg­u­la­to­ry & gov­ern­men­tal strat­e­gy. DiLenge joins Noubar Afeyan’s troops af­ter more than 15 years at the Biotech­nol­o­gy In­no­va­tion Or­ga­ni­za­tion (BIO) that con­clud­ed in May 2021 as pres­i­dent of the Ad­vo­ca­cy, Law & Pub­lic Pol­i­cy Di­vi­sion.

David Thom­son

→ San Fran­cis­co AI play­er Atom­wise has a stacked slate of hires, and CSO David Thom­son bats lead­off. Thom­son — the ex-head of re­search and non­clin­i­cal de­vel­op­ment at Shire — has made the leap to Atom­wise from Pre­ci­sion Bio­Sciences, where he was chief de­vel­op­ment of­fi­cer and then COO dur­ing a four-year run. Next, CFO Jonathan Barr is a Juno vet who was re­cent­ly VP of fi­nance and op­er­a­tions at Bridge­Bio, while new gen­er­al coun­sel and cor­po­rate sec­re­tary Jef­frey Ce­rio just held the same posts at Triplet Ther­a­peu­tics and was Mod­er­na’s se­nior cor­po­rate coun­sel, se­cu­ri­ties. One oth­er note: Atom­wise has al­so made room for Lori Kunkel and Ron Dror on its board of di­rec­tors.

Ed­win Tuck­er

→ An­oth­er biotech with Third Rock ties, kid­ney dis­ease play­er Goldfinch Bio, has tapped Ed­win Tuck­er as CMO. Tuck­er, the med­ical chief at Mirum Phar­ma­ceu­ti­cals since Oc­to­ber 2019, has al­so played a cen­tral role in the US ap­proval of Calquence as COO at Ac­er­ta Phar­ma. Goldfinch Bio’s lead as­set GFB-887 tar­gets fo­cal seg­men­tal glomeru­loscle­ro­sis (FS­GS) and di­a­bet­ic nephropa­thy, and the biotech is shoot­ing to read out da­ta for the drug this year along with an­oth­er can­di­date, GFB-024.

Paul Rob­son

→ Cloud-based R&D start­up Bench­ling, which tacked on a $100 mil­lion Se­ries F round back in No­vem­ber, has snared Paul Rob­son as pres­i­dent of field op­er­a­tions. Rob­son had spent the last decade at Adobe and was pres­i­dent of the com­pa­ny’s in­ter­na­tion­al busi­ness since 2019. Al­so, Bench­ling has giv­en for­mer Ax­iom CEO Ele­na Do­nio a seat at the board of di­rec­tors.

Pe­ter Thielbacked pep­tide play­er Pep­ti­log­ics out of Pitts­burgh (say that five times fast) has pro­mot­ed Nicholas Ny­s­trom to chief tech­nol­o­gy of­fi­cer. Ny­s­trom be­came head of com­pu­ta­tion and da­ta at Pep­ti­log­ics in ear­ly 2021 af­ter he spent 28 years at the Pitts­burgh Su­per­com­put­ing Cen­ter, work­ing his way up to in­ter­im di­rec­tor and lat­er chief sci­en­tist.

Daniel Ca­mar­do

→ Re­gen­er­a­tive med­i­cine com­pa­ny Ather­sys has locked in Daniel Ca­mar­do as CEO — tak­ing over for in­ter­im CEO William Lehmann, who will con­tin­ue serv­ing as the com­pa­ny’s pres­i­dent and COO. Ca­mar­do comes to the Cleve­land-based com­pa­ny from Hori­zon Ther­a­peu­tics, where he cur­rent­ly serves as EVP and head of the rare dis­ease and in­flam­ma­tion busi­ness units. Ad­di­tion­al­ly, Ca­mar­do has served at Astel­las, where he helped dri­ve the com­mer­cial busi­ness from US mar­ket en­try to more than $3.5 bil­lion in an­nu­al net sales dri­ven by a port­fo­lio of spe­cial­ty and rare dis­ease med­i­cines.

Mar­tire Par­tic­co has be­come the new CMO at Napo Ther­a­peu­tics, a sub­sidiary of Jaguar Health. For the last five years, Par­tic­co served as VP, head of med­ical af­fairs for Eu­rope for Sh­iono­gi Eu­rope. Par­tic­co was se­nior med­ical di­rec­tor for biotech­nol­o­gy at the tail end of her time with Pfiz­er/Wyeth, and she’s al­so been di­rec­tor of glob­al phar­ma­covig­i­lance, med­ical & clin­i­cal af­fairs for Kedri­on Bio­phar­ma.

Mark Levine

Pe­te Salz­mann-led Im­muno­vant has pegged Mark Levine as chief le­gal of­fi­cer, sev­er­al months af­ter bring­ing CFO Re­nee Bar­nett in­to the fold. Levine has served as gen­er­al coun­sel and cor­po­rate sec­re­tary at Flex­ion Ther­a­peu­tics and Min­er­va Neu­ro­sciences be­fore head­ing to Im­muno­vant, which is poised to ini­ti­ate a Phase III tri­al in the first half of this year for its myas­the­nia gravis drug ba­to­climab.

Janelle An­der­son

→ Ac­cord­ing to its web­site, UK-Aus­tria an­ti­fun­gal biotech F2G has re­tooled its C-suite a bit with Mark Baglin as chief com­mer­cial of­fi­cer and Janelle An­der­son as CBO. Baglin was in charge of the hered­i­tary an­gioede­ma fran­chise at Shire be­fore kick­start­ing a four-year run at Al­ny­lam, where he got el­e­vat­ed to SVP, head of mar­ket­ed prod­ucts. An­der­son is the for­mer chief strat­e­gy of­fi­cer at Cen­tu­ry Ther­a­peu­tics, which made a $150 mil­lion cell ther­a­py deal with Bris­tol My­ers ear­li­er this month. In oth­er F2G news, Sylvie Gre­goire — the ex-pres­i­dent of Shire’s rare dis­ease di­vi­sion and the cur­rent ex­ec­u­tive chair of EIP Phar­ma — is now a mem­ber of the board of di­rec­tors.

→ Gala­pa­gos’ id­io­path­ic pul­monary fi­bro­sis part­ner On­coAren­di Ther­a­peu­tics has brought on Sam­son Fung as CMO. Af­ter a myr­i­ad of roles at such Big Phar­mas as Roche, No­var­tis and As­traZeneca, Fung has held lead­er­ship posts at ar­genx, Mi­cromet and Mor­phoSys. Rafal Kamin­s­ki just left On­coAren­di to be­come chief sci­en­tist at An­geli­ni Phar­ma.

Karen Neuen­dorff

→ Chi­nese biotech Brii Bio­sciences — which stood by its Covid-19 an­ti­body cock­tail’s abil­i­ty to fight against the Omi­cron vari­ant even though one of the an­ti­bod­ies showed a drop in ac­tiv­i­ty when it was test­ed alone — has reeled in Karen Neuen­dorff as chief peo­ple of­fi­cer and head of hu­man re­sources. Neuen­dorff joins the com­pa­ny from WeDriveU, where she served as SVP, hu­man re­sources. Pri­or to that, she had a 14-year stint as VP, glob­al hu­man re­sources at Nex­ant.

Stu­art Mil­stein

→ Flag­ship “in­ter­sys­tems” play­er Sen­da Bio­sciences, which en­joyed a $98 mil­lion Se­ries B haul last June, has re­cruit­ed Stu­art Mil­stein as SVP and head of plat­form bi­ol­o­gy. Mil­stein led the RNAi lead de­vel­op­ment group dur­ing his 11-year tenure at Al­ny­lam, and since 2019 he had served as VP of plat­form bi­ol­o­gy at the Nes­san Berming­ham RNA edit­ing start­up Ko­r­ro Bio.

Char­lotte Jones-Bur­ton

→ Seat­tle kid­ney dis­ease biotech Chi­nook Ther­a­peu­tics makes its first Peer Re­view ap­pear­ance since the ap­point­ment of CFO Er­ic Bjerk­holt, nam­ing Char­lotte Jones-Bur­ton SVP of prod­uct de­vel­op­ment and strat­e­gy. Be­fore her re­cent stint as VP of glob­al clin­i­cal de­vel­op­ment and head of nephrol­o­gy at Ot­su­ka, Jones-Bur­ton gained Big Phar­ma ex­pe­ri­ence at Mer­ck and as glob­al de­vel­op­ment team leader for the car­dio­vas­cu­lar area dur­ing her eight years at Bris­tol My­ers.

→ Next-gen can­cer im­munother­a­py play­er BioE­clipse Ther­a­peu­tics has brought on Stephen Ghiglieri, a man­ag­ing di­rec­tor for the West Coast Re­gion at Dan­forth Ad­vi­sors, as in­ter­im CFO. Ghilglieri has worn the CFO hat be­fore while run­ning stints at Oacis Health­care Sys­tems, Av­o­lent, Neu­ro­gesX, Med­Da­ta, Gale­na Bio­Phar­ma and Co­va­lent Health.

In ad­di­tion, the com­pa­ny has al­so wel­comed Mah­moud Mah­moudi­an to its board of di­rec­tors. Mah­moudi­an hails from Sum­it­o­mo On­col­o­gy, where he served as SVP and head of glob­al on­col­o­gy ex­ter­nal in­no­va­tion hub. Ear­li­er in his ca­reer, Mah­moudi­an had roles at Fer­ring Phar­ma­ceu­ti­cals, Mer­ck and GSK.

Brad Savall

Brad Savall has signed on to be VP and head of chem­istry at Herophilus, the Cal­i­for­nia neu­ro up­start that nabbed CSO Sharath Hegde from Re­cur­sion last May. Savall just had a light­ning-quick stay as di­rec­tor of med­i­c­i­nal chem­istry at Plex­i­um (now helmed by Astel­las vet Per­ci­val Bar­ret­to-Ko) and has al­so been a med­i­c­i­nal chem­istry leader at J&J’s Janssen.

Sud­hir Rao has joined Boston-based RNA play­er Ex­pan­sion Ther­a­peu­tics, which just wel­comed Gary Bridger to the board of di­rec­tors, as SVP of busi­ness de­vel­op­ment. Rao is the for­mer VP of busi­ness de­vel­op­ment for Geno­cea Bio­sciences, and he has al­so served as the di­rec­tor of R&D trans­ac­tions at Take­da.

Jim Ken­namer

→ The US-UK CD­MO Abzena has las­soed Jim Ken­namer as SVP and site head of North Car­oli­na, a fa­cil­i­ty we told you about in April 2021. Ken­namer just spent six years at Im­mu­cor as VP of glob­al man­u­fac­tur­ing op­er­a­tions, and ear­li­er he was VP of man­u­fac­tur­ing at Tale­cris Bio­ther­a­peu­tics, con­tin­u­ing in the role when Gri­fols bought the plas­ma com­pa­ny in 2010.

→ San Diego RNA edit­ing start­up ADARx Phar­ma­ceu­ti­cals fol­lows up the ap­point­ment of CMO Hu­bert Chen by wel­com­ing Christo­pher Clae­boe as VP, CMC and man­u­fac­tur­ing. Clae­boe filled mul­ti­ple roles in his four-plus years at Chemo­Cen­tryx, clos­ing out his time at the ava­co­pan de­vel­op­er as ex­ec­u­tive di­rec­tor, drug sub­stance & drug prod­uct.

Nir­dosh Jago­ta

Nir­dosh Jago­ta has been named SVP, reg­u­la­to­ry af­fairs, com­pli­ance & safe­ty at Ocu­gen, a gene ther­a­py biotech that’s al­so try­ing its hand at a Covid-19 vac­cine. Jago­ta’s time at Arc­turus was fleet­ing, last­ing on­ly a hand­ful of months as chief reg­u­la­to­ry of­fi­cer, and he’s al­so held reg­u­la­to­ry posts in the land of phar­ma gi­ants, in­clud­ing with Pfiz­er, Roche/Genen­tech and Mer­ck.

→ San Diego CD­MO Aji­nomo­to Bio-Phar­ma Ser­vices is bring­ing on Al­ler­gan vet Tony O’Neill as its VP of com­pli­ance, US op­er­a­tions. Dur­ing his quar­ter cen­tu­ry at Al­ler­gan, O’Neill’s roles in­clud­ed ex­ec­u­tive di­rec­tor, qual­i­ty op­er­a­tions and ex­ec­u­tive di­rec­tor, risk man­age­ment and com­pli­ance.

Michael Kauff­man

→ For­mer Karyopharm CEO Michael Kauff­man has tak­en a seat on the board of di­rec­tors at BiVic­triX Ther­a­peu­tics as an in­de­pen­dent non-ex­ec­u­tive di­rec­tor. Pri­or to run­ning the ship at Karyopharm, Kauff­man was CMO at Onyx Phar­ma­ceu­ti­cals and pres­i­dent and CEO of EPIX Phar­ma­ceu­ti­cals. Kauff­man’s oth­er stints in­clude roles at Mil­len­ni­um and Bio­gen.

Melanie Ivars­son

→ Mod­er­na’s chief de­vel­op­ment of­fi­cer Melanie Ivars­son is mak­ing her way on­to the board of di­rec­tors at UK-based Lo­Qus23 Ther­a­peu­tics as a non-ex­ec­u­tive di­rec­tor. Pri­or to her cur­rent role at Mod­er­na, Ivars­son has led a star-stud­ded ca­reer with stints at Eli Lil­ly, Pfiz­er, Shire and Take­da.

Paul Hoelsch­er

No­vo Ven­tures part­ner Ken­neth Har­ri­son has re­signed from the board of di­rec­tors at Re­neo Phar­ma­ceu­ti­cals, leav­ing a slot open for Paul Hoelsch­er. Re­neo ex­ec­u­tive chair­man Mike Grey and Hoelsch­er know each oth­er from Hori­zon; Hoelsch­er has been Tim Wal­bert’s CFO since 2014. In oth­er board news, Lon Car­don will serve out his term and then step down af­ter be­com­ing pres­i­dent and CEO of The Jack­son Lab­o­ra­to­ry.

→ Boston-based Ike­na On­col­o­gy, which struck while the IPO iron was still hot last year, has elect­ed Richard Woost­er to the board of di­rec­tors. The GSK on­col­o­gy vet was pre­vi­ous­ly the CSO of Trans­late Bio, which Sanofi pur­chased for $3.2 bil­lion back in Au­gust.

Curt Medeiros and Gregg Givens have joined the board of di­rec­tors at Kansas City, KS-based AD­HD biotech Cin­gu­late, a poster child for a flag­ging IPO land­scape. Medeiros is the CEO of Ova­tion.io, where he al­so serves on the board. Pri­or to that, he was pres­i­dent of both Op­tum An­a­lyt­ics and Op­tum Ad­vanced Da­ta & An­a­lyt­ics. Givens has held the po­si­tions of SVP, CFO, and trea­sur­er at DST Sys­tems.

→ San Fran­cis­co-based Con­cen­tric Anal­gesics has signed on two new mem­bers to its board of di­rec­tors with the ap­point­ments of for­mer Gilead EVP and CCO Paul Carter and Jonathan Lynch. This isn’t Carter’s first rodeo in a board seat. He cur­rent­ly sits on the boards of HutchMed PLC, Mallinck­rodt, Im­mat­ics, Vec­tivBio and Evox Ther­a­peu­tics. Mean­while, Lynch cur­rent­ly man­ages In­ci­sive Cap­i­tal.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.