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.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

As Co­di­ak en­ters 'next phase of growth,' Jen­nifer Whel­er steps in­to CMO role; Mark Tim­ney lines up his sec­ond CEO op­por­tu­ni­ty af­ter Pur­due Phar­ma reign

Most CMOs don’t start out as art students. But after getting her bachelor’s in art history from Princeton University, Jennifer Wheler decided to go after an MD from Cornell, kicking off a decades-long career in biopharma. Her next move? Leading the team at Codiak BioSciences to deliver therapeutics using a form of cellular postal service called exosomes.

“I was captivated by the science and the potential for exosomes to have transformational impact in cancer and other disease areas,” the incoming CMO told Endpoints News via email. “Codiak has a potent combination of great science and wonderfully experienced and kind people — it doesn’t get much better.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).