No­vavax CFO Greg Covi­no makes a quick ex­it as lead­er­ship carousel keeps turn­ing; Kite ex­ecs fly away to a cell ther­a­py up­start team­ing up with Lyell

Greg Covi­no

→ If it seems like Covid-19 vac­cine brides­maid No­vavax is shut­tling staffers in and out, you’re not alone. This week, Greg Covi­no an­nounced he’s leav­ing the biotech af­ter hold­ing the CFO job for a blink-and-you-miss-it tenure. An ad­vi­so­ry role with­in the com­pa­ny awaits for Covi­no, who came to No­vavax just five months ago from Bris­tol My­ers Squibb, while CCO and CBO John Trizzi­no jug­gles even more ex­ec­u­tive re­spon­si­bil­i­ty by tak­ing on the in­ter­im CFO ti­tle.

Else­where, No­vavax has pro­mot­ed Gale Smith to SVP, dis­cov­ery and pre­clin­i­cal re­search and chief sci­en­tist, while Troy Mor­gan steps in as chief com­pli­ance of­fi­cer. No­vavax’s sci­en­tif­ic plat­form hinges on the in­sect-cell tech­nol­o­gy de­vel­oped by Smith, who has been with the biotech since 2004. Mor­gan has held com­pli­ance po­si­tions with Bio­gen, Biover­a­tiv and, more re­cent­ly, with EMD Serono as chief com­pli­ance of­fi­cer.

And so it goes with the dizzy­ing ar­ray of lead­er­ship changes at No­vavax, which in the last year alone has named Rick Crow­ley as COO, se­lect­ed Fil­ip Dubovsky for CMO and ap­point­ed Hen­ri­et­ta Uk­wu as chief reg­u­la­to­ry and qual­i­ty of­fi­cer, among many oth­ers. EVP of CMC Ben Machielse al­so joined in Ju­ly 2020, but Crow­ley took over CMC du­ties when he be­came COO in De­cem­ber.

→ Part­ner­ing with Lyell on cell ther­a­pies while net­ting $40 mil­lion in Se­ries A fi­nanc­ing last year, South San Fran­cis­co’s CERo Ther­a­peu­tics has bol­stered its staff with Re­mus Vezan as CMO and John Rossi as SVP and head of trans­la­tion­al med­i­cine. Both Vezan and Rossi hail from Kite: Vezan was ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment for such drugs as Yescar­ta and Tecar­tus, while Rossi was in charge of the cell ther­a­py clin­i­cal phar­ma­col­o­gy team. Pri­or to Kite, Vezan spent four years at Phar­ma­cyclics and Rossi had a 13-year stay at Am­gen.

Karim Mikhail

→ At a time when M&A prospects aren’t look­ing par­tic­u­lar­ly promis­ing for Amarin, John Thero is mov­ing on af­ter sev­en years as CEO and 12 years over­all. On Aug. 1, the re­tir­ing Thero will be re­placed by Karim Mikhail, who came on the scene at Amarin less than a year ago as com­mer­cial head of the com­pa­ny’s fish oil pill in Eu­rope, known as Vazkepa as it launch­es in that re­gion and Vas­cepa in the US. From 1996-2018, Mikhail took on nu­mer­ous roles at Mer­ck, the last four of those years as the glob­al com­mer­cial leader of the Big Phar­ma’s lipid fran­chise.

Dio­go Rau has cer­tain­ly left his mark af­ter 10 years as a se­nior di­rec­tor with Ap­ple, and he’s mak­ing the leap to Eli Lil­ly, be­com­ing the phar­ma gi­ant’s SVP, chief in­for­ma­tion and dig­i­tal of­fi­cer. The re­tire­ment of his pre­de­ces­sor, Aar­ti Shah, af­ter 27 years has been in the works at Lil­ly for some time. If you’re like most of the pop­u­la­tion and have ever vis­it­ed an Ap­ple Store, shopped at the Ap­ple On­line Store, or used the Ap­ple Store app, Rau was a guid­ing force be­hind de­vel­op­ing all the tech­nol­o­gy.

Daniel Kemp

→ Fo­cused on de­vel­op­ing off-the-shelf CAR-T ther­a­pies, Wu­gen has snagged Daniel Kemp to steer the ship as CEO. Kemp hails from Take­da, where he was re­spon­si­ble for trans­act­ing the com­pa­ny’s strate­gic part­ner­ships in the CAR-NK and CAR-T cell ther­a­py space — most no­tably spear­head­ing the in-li­cens­ing of Take­da’s flag­ship al­lo­gene­ic NK cell pro­gram from MD An­der­son Can­cer Cen­ter in 2019. Kemp al­so sat on the boards of Gam­maDelta Ther­a­peu­tics and Adap­tate Bio­ther­a­peu­tics. Ear­li­er in his ca­reer he had stints at Beryl­li­um, Mer­ck Re­search Labs and No­var­tis In­sti­tutes for Bio­med­ical Re­search.

→ Swiss-based Quer­cis Phar­ma is mak­ing a whole slew of changes to its lead­er­ship team with the ap­point­ments of John Boghoss­ian as CEO, Manon Ve­r­aart as CBO, Thomas Pfeif­fer as di­rec­tor of pipeline projects and the ad­di­tion of Lars Wilde to the board of di­rec­tors. Boghoss­ian is tak­ing over for Il­ias Läber, who will tran­si­tion to the role of chair­man of the board. Boghoss­ian pre­vi­ous­ly served as VP of op­er­a­tions at Com­pass Path­ways. Boghoss­ian’s fel­low col­league Ve­r­aart for­mer­ly served as VP of busi­ness de­vel­op­ment at Com­pass. Mean­while, Pfeif­fer comes aboard from the Uni­ver­si­ty Col­lege Lon­don, where he served as a se­nior re­searcher. Last, but not least, Wilde is the cur­rent co-founder, pres­i­dent and CBO of Com­pass and co-founder of Atai Life Sci­ences.

Rónán O’Ha­gan

→ Two weeks af­ter Sal­va­tore Giovine and Chris Franken­field joined the squad as CFO and gen­er­al coun­sel, re­spec­tive­ly, im­muno-on­col­o­gy biotech Xilio has made a trio of moves by pro­mot­ing Rónán O’Ha­gan to CSO while nam­ing Li Malm­berg chief tech­nol­o­gy and man­u­fac­tur­ing of­fi­cer and Uli Bialucha SVP of re­search. O’Ha­gan, who first ar­rived on the scene at Xilio in 2018 as SVP of re­search and trans­la­tion­al sci­ence, logged sev­en years at Mer­ck and round­ed out his ca­reer at the Big Phar­ma by helm­ing the on­col­o­gy dis­cov­ery pro­gram. Malm­berg, the ex-head of process sci­ences at Ab­b­Vie and a Cel­gene vet, makes the switch to Xilio from Ma­gen­ta Ther­a­peu­tics, where she was SVP head of CMC tech­ni­cal op­er­a­tions. And Bialucha spent nine years at the No­var­tis In­sti­tutes for Bio­med­ical Re­search be­fore his re­cent stint as VP of drug dis­cov­ery with Im­mu­ni­tas Ther­a­peu­tics.

Jen­nifer Yang

Backed by Hill­house and RA Cap­i­tal — and mak­ing a big $423 mil­lion splash in its Hong Kong de­but —Shang­hai-based Ever­est Med­i­cines has scaled to the top of the moun­tain to se­lect Jen­nifer Yang as CSO. Yang is no stranger to Big Phar­ma af­ter al­most eight years at J&J, in­clud­ing as VP of the phar­ma gi­ant’s Lung Can­cer Ini­tia­tive. She’s al­so been a se­nior re­search sci­en­tist at Eli Lil­ly and a se­nior sci­en­tist in Pfiz­er’s on­col­o­gy re­search unit. Trodelvy, Ever­est’s big-tick­et item with li­cens­ing part­ner Gilead, just won ac­cel­er­at­ed ap­proval for lo­cal­ly ad­vanced or metasta­t­ic urothe­lial can­cer this week.

→ Rad­nor, PA-based Mar­i­nus Phar­ma­ceu­ti­cals is fill­ing out its C-suite with Steven Pfanstiel as CFO while bring­ing on Lisa Lejuwaan for the new VP of sales po­si­tion. Pfanstiel de­vot­ed 16 years to J&J and was re­cent­ly VP, fi­nance at an­oth­er Penn­syl­va­nia com­pa­ny, LifeS­can. Lejuwaan was Alex­ion’s ex­ec­u­tive sales di­rec­tor, neu­rol­o­gy fran­chise and spent sev­en years there over­all. CEO Scott Braun­stein adds the two ex­ecs af­ter Christy Shafer hit the ground run­ning in No­vem­ber as chief com­mer­cial of­fi­cer and he heaped praise on Phase III da­ta for ganax­olone that could be con­sid­ered com­pa­ny-sav­ing: “We were close to go­ing un­der a year ago,” Braun­stein said in Sep­tem­ber.

Paul Herzich

Aa­van­tiBio has been a fre­quent fly­er on the Peer Re­view air­line, and this week is no dif­fer­ent at Bo Cum­bo’s gene ther­a­py play­er as Paul Herzich and Jared Si­mons jump on board as chief tech­nol­o­gy of­fi­cer and VP of man­u­fac­tur­ing, re­spec­tive­ly. Herzich has held lead­er­ship po­si­tions at No­var­tis Vac­cines and Pfiz­er, and he just com­plet­ed his time at Bridge­Bio as VP of CMC. Si­mons, mean­while, was se­nior di­rec­tor of man­u­fac­tur­ing sci­ences and tech­nol­o­gy for John Crow­ley at Am­i­cus Ther­a­peu­tics. Aa­van­tiBio has built the team rapid­ly af­ter its Oc­to­ber de­but, gain­ing a CFO, COO and CMO in the span of a month.

Lu­ca Sca­vo is mak­ing his way to Sim­ba Gill’s Evelo Bio­sciences as CFO, ef­fec­tive June 1. Sca­vo will round out his tenure as SVP and CFO of Roche Di­ag­nos­tics North Amer­i­ca be­fore mak­ing the switch to the Flag­ship-backed biotech, which is de­vel­op­ing drugs for in­flam­ma­to­ry dis­eases and can­cer. Sca­vo has al­so been VP, chief ac­count­ing of­fi­cer at Genen­tech and the CFO for As­traZeneca Spain. Evelo al­so an­nounced a new mem­ber of its board of di­rec­tors: ex-Cen­to­cor pres­i­dent and cur­rent Iron­wood chair Julie McHugh.

Ajay Ver­ma

→ Co-found­ed by Tony Coles, neu­rode­gen­er­a­tive dis­ease biotech Yu­man­i­ty — which re­verse merged with Pro­teosta­sis Ther­a­peu­tics last year — has ap­point­ed Ajay Ver­ma as EVP, head of R&D. Ver­ma was a Bio­gen ex­ec from 2010-16, ul­ti­mate­ly tak­ing on the role of VP, neu­rol­o­gy drug dis­cov­ery and de­vel­op­ment. His most re­cent chap­ter was with Co­di­ak Bio­Sciences, where he was EVP of re­search and ex­per­i­men­tal med­i­cine.

→ Co-found­ed and chaired by Corey Good­man, and with $62 mil­lion worth of Se­ries A fund­ing at its dis­pos­al, Bay Area can­cer biotech Tal­lac Ther­a­peu­tics has giv­en the CBO keys to Cur­tis Hecht. He hails from Calithera Bio­sciences, where he held the same ti­tle the last sev­en years, and he al­so took on var­i­ous busi­ness de­vel­op­ment re­spon­si­bil­i­ties at Roche and Genen­tech, name­ly as glob­al al­liance di­rec­tor.

→ Help­ing Dan O’Day re­dou­ble his on­col­o­gy ef­forts with Gilead in an $805 mil­lion deal for the an­ti-CCR8 drug JTX-1811, Jounce Ther­a­peu­tics has poached Dmitri Wieder­schain from Sanofi to be CSO. Wieder­schain, who al­so spent time at the No­var­tis In­sti­tutes for Bio­med­ical Re­search, had an 11-year run at Sanofi with du­ties rang­ing from sec­tion head of on­col­o­gy dis­cov­ery to glob­al head of the im­muno-on­col­o­gy re­search ther­a­peu­tic area.

Joan Con­nol­ly

→ With the FDA giv­ing a pri­or­i­ty re­view to lead drug ode­vix­i­bat — “We are over the moon,” CEO Ron Coop­er told End­points News in Jan­u­ary — Al­bireo has al­so turned its at­ten­tion to new ex­ecs, wel­com­ing Joan Con­nol­ly as chief tech­nol­o­gy of­fi­cer. Con­nol­ly pre­vi­ous­ly served as SVP, tech­ni­cal op­er­a­tions at Stem­line Ther­a­peu­tics and has al­so been di­rec­tor, strate­gic sourc­ing at Bris­tol My­ers.

→ Long­time Genen­tech alum George Gau­thi­er has signed on to be­come chief com­mer­cial of­fi­cer of Sil­i­con Val­ley-based IGM Bio­sciences. Gau­thi­er heads to the IgM an­ti­body biotech af­ter an 18-year as­so­ci­a­tion with Roche/Genen­tech, leav­ing as VP of glob­al prod­uct strat­e­gy for breast and gy­ne­co­log­i­cal can­cers. He was al­so mar­ket­ing di­rec­tor for Xo­lair and life cy­cle leader for Rozyl­trek and Kady­cla.

James Chung

→ Berke­ley cell ther­a­py play­er Kyver­na Ther­a­peu­tics, part­ner­ing with Gilead to tar­get au­toim­mune dis­eases and backed by Vi­da Ven­tures and West­lake Vil­lage, has made James Chung CMO. Chung spent al­most 17 years at Am­gen, start­ing in med­ical ser­vices/ear­ly de­vel­op­ment and climb­ing up to ex­ec­u­tive med­ical di­rec­tor, head of in­flam­ma­tion and neu­ro­science, glob­al med­ical or­ga­ni­za­tion, and glob­al de­vel­op­ment leader for En­brel.

Fore­site’s Jim Tanan­baum con­sid­ered Gem­i­ni Ther­a­peu­tics a per­fect SPAC match last fall, and the AMD play­er has hand­ed the CMO reins to Samuel Barone, two months af­ter Bri­an Piekos be­came Gem­i­ni’s CFO. Barone, an ex-med­ical of­fi­cer in the FDA’s Of­fice of Cel­lu­lar, Tis­sue and Gene Ther­a­pies, found­ed and was CMO of Halo­dine. He was al­so CMO of Avalanche Biotech­nolo­gies, and when the com­pa­ny lat­er be­came Ad­verum, Barone served as SVP of clin­i­cal de­vel­op­ment.

Tim­o­thy Reil­ly

→ Co-found­ed by Nim­bus vets Ger­ry Har­ri­man and Jonathan Mon­tagu and com­ing up on a year since their $65 mil­lion Se­ries B, al­losteric ther­a­py biotech HotSpot Ther­a­peu­tics has en­list­ed Tim­o­thy Reil­ly as chief de­vel­op­ment of­fi­cer. Reil­ly wore many hats in his 18 years with Bris­tol My­ers, start­ing out as a re­search in­ves­ti­ga­tor in im­muno­tox­i­col­o­gy and bid­ding farewell to the Big Phar­ma as SVP, ear­ly de­vel­op­ment pro­gram lead­er­ship.

Cory Hogaboam has been cho­sen as CSO of Austin, TX-based Lung Ther­a­peu­tics, which scored or­phan drug des­ig­na­tions in the US and EU as well as a fast track des­ig­na­tion with lead can­di­date LTI-01 for loc­u­lat­ed pleur­al ef­fu­sion. Hogaboam is a pro­fes­sor of med­i­cine at Cedars-Sinai and is al­so a re­search sci­en­tist at the Women’s Guild Lung In­sti­tute that’s lo­cat­ed at the hos­pi­tal.

Jo­han As­chan

Janssen vet Jo­han As­chan has joined the fray at Stock­holm-based nat­ur­al killer biotech XNK Ther­a­peu­tics as CMO. As­chan heads over to XNK af­ter a brief run as a glob­al clin­i­cal lead in clin­i­cal de­vel­op­ment for an­oth­er Swedish com­pa­ny, On­copep­tides, which named Mar­ty Du­vall as its CEO last sum­mer. As­chan served in sev­er­al ca­pac­i­ties dur­ing his time at Janssen, among them med­ical di­rec­tor or hema­tol­ogy in the EMEA re­gion.

Bri­an Les­ti­ni has an­swered the call to be­come CMO at Waltham, MA biotech Pyra­mid Bio­sciences, which has TRK in­hibitor PBI-200 in de­vel­op­ment for pri­ma­ry and metasta­t­ic brain can­cers. Les­ti­ni ex­its Bris­tol My­ers af­ter a nine-year tenure that saw him get el­e­vat­ed to VP and de­vel­op­ment leader for re­latlimab. Pyra­mid has al­so plucked Jef­frey Wasser­man from law firm Cur­cio Mirza­ian Sirot and he will take over as gen­er­al coun­sel.

Kipp Er­ick­son

→ Sioux Falls, SD-based SAB Bio­ther­a­peu­tics — which pulled in fund­ing from BAR­DA to de­vel­op a poly­clon­al an­ti­body drug to treat Covid-19 — has cor­ralled Kipp Er­ick­son as COO. Er­ick­son has a vet­eri­nary phar­ma­ceu­ti­cal dis­cov­ery back­ground with Pfiz­er An­i­mal Health and Zoetis, but al­so has hu­man drug dis­cov­ery ex­pe­ri­ence with Proc­ter and Gam­ble and Pfiz­er. He was re­cent­ly COO of RTI, a vet­eri­nary CRO out of near­by Brook­ings.

→ Sit­ryx has named Iain Kilty as their new CSO. Kilty joins the team from Quench Bio, where he al­so served as CSO. Pri­or to Quench, Kilty held a 22-year stint with Pfiz­er, most re­cent­ly serv­ing as VP, pre­clin­i­cal sci­ences in the In­flam­ma­tion and Im­munol­o­gy Re­search Unit. In ad­di­tion, Kilty is an en­tre­pre­neur in res­i­dence at At­las Ven­ture.

→ Tübin­gen, Ger­many-based Atri­va Ther­a­peu­tics has made some new ad­di­tions to its man­age­ment team with the ap­point­ments of Olaf Al­thaus as CFO and Stephan Sten­glein as CMO. Al­thaus brings to the ta­ble ex­pe­ri­ence from CellMed, where he was co-founder, CEO and CFO, as well as AEter­na Zen­taris. Mean­while, Sten­glein comes from As­traZeneca, where he was VP & head late-stage de­vel­op­ment res­pi­ra­to­ry. Be­fore that, he was with No­var­tis, Glen­mark and Shire.

En­ver­ic Bio­sciences has bagged Carter Ward as CFO. Ward suc­ceeds John Van Buiten, who will re­main in a con­sult­ing role with the com­pa­ny. Ward hops aboard from Elite Phar­ma­ceu­ti­cals, where he served as CFO. Pri­or to that, Ward was serv­ing at Ac­tavis, Cen­ten­ni­al Com­mu­ni­ca­tions, Cee­jay Health­care and Petro Phar­ma.

Med­van­tx has pro­mot­ed Mic­ah Ben­ford to the po­si­tion of chief phar­ma­cy of­fi­cer of Med­van­tx Phar­ma­cy Ser­vices. Ben­ford joined Med­van­tx last May as phar­ma­cy op­er­a­tions man­ag­er/PIC. Be­fore Med­van­tx, Ben­ford was with Knip­peRx.

Lin­da Mal­don­a­do

Coda­genix — which scored a $20 mil­lion Se­ries B round last year for its plat­form tech — has reeled in Lin­da Mal­don­a­do as VP, bi­o­log­ics chem­istry and man­u­fac­tur­ing con­trols. Mal­don­a­do joins the Farm­ing­dale, NY-based com­pa­ny from Catal­ent Cell and Gene Ther­a­py. Pri­or to that, she was with Phar­mA­th­ene, Hu­man Genome Sci­ences, Bax­ter Bio­science, Prog­en­ics and Sanofi Pas­teur.

→ Fo­cused on al­lo­gene­ic gam­ma delta T cell ther­a­pies, Adicet Bio has en­list­ed Blake Aftab as VP of re­search. Aftab leaves his role as VP and head of pre­clin­i­cal sci­ence and trans­la­tion­al med­i­cine at Atara Bio­ther­a­peu­tics, where he logged six years over­all. Aftab is the lat­est new ex­ec at Adicet af­ter the biotech named Nick Har­vey as CFO and Don Healey as CTO last fall.

Chase Leav­itt

→ San Diego can­cer biotech Onc­ter­nal Ther­a­peu­tics has brought on Chase Leav­itt to be its gen­er­al coun­sel. Leav­itt spent near­ly two years at Lin­eage Cell Ther­a­peu­tics as gen­er­al coun­sel and cor­po­rate sec­re­tary, and be­fore that he was VP, le­gal af­fairs at Tang Cap­i­tal Man­age­ment and Odonate (which just had a wreck­ing ball plow through the com­pa­ny af­ter the dis­con­tin­u­a­tion of tese­tax­el).

Ben­jamin Jack­son has tak­en on the role of gen­er­al coun­sel at Salt Lake City’s Sera Prog­nos­tics, a health di­ag­nos­tics com­pa­ny spe­cial­iz­ing in in­di­vid­u­al­ized pre­na­tal care. Jack­son just spent the last 15 years hold­ing a se­ries of le­gal ca­pac­i­ties at an­oth­er Salt Lake City out­fit, Myr­i­ad Ge­net­ics, be­com­ing gen­er­al coun­sel in 2019.

En­ter­ing a SPAC race that’s all the rage these days with Panacea Ac­qui­si­tion II a month ago, Oleg Nodel­man has been elect­ed to the board of di­rec­tors at Anap­tys­Bio, which saw its lead drug im­si­dolimab flop in a Phase II tri­al. Nodel­man is the man­ag­ing di­rec­tor at EcoR1 Cap­i­tal, which he found­ed in 2012.

Geor­gia Ker­esty

→ Af­ter a ker­fuf­fle in­volv­ing what was ar­gued as in­suf­fi­cient ci­ta­tion of David Liu’s work at a March pre­sen­ta­tion, CRISPR biotech In­tel­lia has made Geor­gia Ker­esty a mem­ber of the board of di­rec­tors. Ker­esty has decades of Big Phar­ma ex­pe­ri­ence and is now in an ad­vi­so­ry role with Take­da R&D af­ter be­ing its COO for three years.

→  Stan­ley Frankel has joined the board of di­rec­tors at Jim Wil­son col­lab­o­ra­tor Pre­ci­sion Bio­Sciences, along with ex-Mof­fitt Can­cer Center CEO Alan List‘s ar­rival as CMO. As Bris­tol My­ers’ SVP, cel­lu­lar ther­a­py de­vel­op­ment, Frankel was in charge of such drugs as Breyanzi and Abec­ma.

→ Af­ter prep­ping for a nine-fig­ure IPO back in Jan­u­ary, Lan­dos Bio­phar­ma, the lead com­pa­ny in the port­fo­lio of Chris Garabe­di­an‘s fund with Per­cep­tive, has cleared a seat for Tia­go Girão on its board of di­rec­tors. Cur­rent­ly, Girão is the CFO of Pro­teo­Vant Ther­a­peu­tics — a new­ly-launched de­vel­op­ment-stage biotech cre­at­ed by Roivant Sci­ences. Be­fore that, Girão was with Cy­tori Ther­a­peu­tics and Nu­Va­sive.

Hide­ki Gar­ren

Hide­ki Gar­ren just made a Peer Re­view ap­pear­ance last week by tak­ing the CMO gig at Prothena, and now he gets a seat at the board of di­rec­tors at Hous­ton-based neu­ro start­up Coya Ther­a­peu­tics, which launched with a mod­est $10 mil­lion Se­ries A in Feb­ru­ary. Join­ing Gar­ren on the board is In­dap­ta CFO and CBO Dov Gold­stein.

→ A cou­ple months re­moved from a $130 mil­lion Se­ries B round, South San Fran­cis­co’s Day One Bio­phar­ma­ceu­ti­cals has named Saira Ra­masas­try to the board of di­rec­tors. Ra­masas­try, a man­ag­ing part­ner with Life Sci­ences Ad­vi­so­ry, is al­so on the boards of Vir, Ak­ou­os, Glen­mark and Sang­amo.

Shamim Ruff

Bat­tling with the FDA over its Friedre­ich’s atax­ia drug omavelox­olone, Rea­ta is adding Christy Oliger and Shamim Ruff to the board of di­rec­tors. Oliger, a 20-year Genen­tech vet, is al­so on the board at Karyopharm, while Ruff is Stoke Ther­a­peu­tics’ chief reg­u­la­to­ry af­fairs of­fi­cer and SVP, head of qual­i­ty as­sur­ance.

Res­o­lu­tion Ther­a­peu­tics has re­cruit­ed Lisa Bright as non-ex­ec­u­tive di­rec­tor. Bright served as chief com­mer­cial and cor­po­rate af­fairs of­fi­cer and lat­er pres­i­dent in­ter­na­tion­al at In­ter­cept. In ad­di­tion, she held roles at Gilead, GSK and As­cendis Phar­ma among oth­ers.

Maria Koehler

→ Bris­tol My­ers part­ner Ike­na On­col­o­gy has made room for Maria Koehler on the board of di­rec­tors. Koehler, the CMO at Re­pare Ther­a­peu­tics, is the ex-CMO at Bi­cy­cle Ther­a­peu­tics and was a key ex­ec in Pfiz­er’s on­col­o­gy busi­ness unit.

→ Who’ll stop the Rain? No­body yet. Rain Ther­a­peu­tics has elect­ed Ste­fani Wolff to the board of di­rec­tors af­ter nab­bing a CMO last week. A Genen­tech alum, Wolff had been Prin­cip­ia Bio­phar­ma’s chief de­vel­op­ment of­fi­cer. Ad­di­tion­al­ly, Memo­r­i­al Sloan Ket­ter­ing’s Si­mon Pow­ell has been giv­en a place on Rain’s sci­en­tif­ic ad­vi­so­ry board.

→  San Diego-based Am­brx — the pro­tein en­gi­neers that inked a deal with BeiGene last year — has tapped Olivia Ware and Ka­trin Ru­pal­la to its board of di­rec­tors. Like Wolff, Ware was an ex­ec at Prin­cip­ia Bio­phar­ma, serv­ing as SVP, BTK fran­chise head. Be­fore that, she served in roles at CytRx and Genen­tech, among oth­ers. Mean­while, Ru­pal­la cur­rent­ly serves as SVP of reg­u­la­to­ry af­fairs, R&D qual­i­ty and med­ical in­for­ma­tion at Lund­beck. Pri­or to her role at Lund­beck, Ru­pal­la was with Bris­tol My­ers, Cel­gene, Roche and Mer­ck.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Susan Galbraith, AstraZeneca EVP, Oncology R&D

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

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

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

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

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

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

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

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

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

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