A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

Jay Fein­gold

→ Last week we told you about the CMO re­volv­ing door at ADC Ther­a­peu­tics, as Joseph Ca­mar­do re­placed the de­part­ing Jay Fein­gold. The next op­por­tu­ni­ty for Fein­gold in the CMO slot has opened up at an­ti­body-drug con­ju­gate and mAb de­vel­op­er Pyx­is On­col­o­gy, which has added sev­er­al new ex­ecs and sci­en­tif­ic ad­vi­so­ry board mem­bers in re­cent months, in­clud­ing ex-Im­muno­vant CFO Pamela Yanchik Con­nealy. Be­fore his tenure at ADC, Fein­gold was Dai­ichi Sankyo’s VP of US med­ical af­fairs and chair­man of the Glob­al Med­ical Af­fairs Over­sight Com­mit­tee. With­in weeks in March, Pyx­is struck a li­cens­ing deal with Pfiz­er for two of its AD­Cs and raked in $152 mil­lion from a Se­ries B round.

Re­nee Bar­nett

→ Mean­while, Im­muno­vant has found Con­nealy’s re­place­ment, se­lect­ing Re­nee Bar­nett as fi­nance chief a month af­ter Roivant de­cid­ed to pump $200 mil­lion in­to a mem­ber of Vivek Ra­maswamy’s Vant fam­i­ly that has wres­tled with tri­al sus­pen­sions and freefalling stocks. Un­til now the chief in­te­gra­tion of­fi­cer at tele­men­tal health provider Able­To, Bar­nett has spent a large por­tion of her ca­reer at Eli Lil­ly, ris­ing to CFO of Aus­tria & Switzer­land and lat­er di­rec­tor of fi­nan­cial plan­ning & analy­sis. LDL lev­els (the bad cho­les­terol) shot up con­sid­er­ably in pa­tients on the high and low dos­es of Im­muno­vant’s an­ti­body IMVT-1401 for thy­roid eye dis­ease in Feb­ru­ary, and new da­ta in June did lit­tle to quell con­cerns even as Im­muno­vant al­so forges ahead with IMVT-1401 in myas­the­nia gravis and warm au­toim­mune he­molyt­ic ane­mia (WAI­HA).

An­drew Pec­o­ra

Robert Hariri has a new pres­i­dent work­ing along­side him at New Jer­sey-based Celu­lar­i­ty, an­oth­er biotech that chose the SPAC route to gal­lop in­to Nas­daq — do­ing so here with GX Ac­qui­si­tion Corp. A hema­tol­o­gist and on­col­o­gist, An­drew Pec­o­ra was pres­i­dent of the Physi­cian En­ter­prise and chief in­no­va­tion of­fi­cer at Hack­en­sack Merid­i­an Health, and he co-found­ed, chaired and helmed Prog­en­i­tor Cell Ther­a­py. When the merg­er closed in Ju­ly, Hariri told our Am­ber Tong that Celu­lar­i­ty had waved the white flag on its Covid-19 ef­forts with its NK cell ther­a­py ap­proach: “The change in man­age­ment of pa­tients at the hos­pi­tal set­ting made it very very dif­fi­cult to find pa­tients who met the in­clu­sion cri­te­ria,” he said.

Jesse Hall

→ One month sep­a­rates big hires at San Fran­cis­co’s Al­tru­Bio, with Jesse Hall join­ing Judy Chou’s squad as CMO fol­low­ing the in­tro­duc­tion of CFO Jeroen Gras­man in ear­ly Au­gust. Since 2018, Hall was CMO for Sub­lim­i­ty Ther­a­peu­tics be­fore tak­ing on the same role at Al­tru­Bio, which brought in a $63 mil­lion Se­ries A haul in the spring and has a Phase Ib study un­der­way for graft-ver­sus-host dis­ease with its lead drug nei­hulizum­ab. From 2009-13, Hall was a med­ical di­rec­tor at Am­gen be­fore be­com­ing an ex­ec­u­tive med­ical di­rec­tor at Ardea Bio­sciences.

In­grid Simms

→ San Diego pre­ci­sion on­col­o­gy biotech Lengo Ther­a­peu­tics — where Dave John­son and Enoch Kar­iu­ki have re­unit­ed as chair­man and CEO re­spec­tive­ly af­ter their Velos­Bio days — has three new ex­ecs on the ros­ter, in­clud­ing an­oth­er fa­mil­iar face. In­grid Simms (SVP and prin­ci­pal ac­count­ing of­fi­cer) held the same ti­tle at Velos­Bio and from 2013-20 was the VP of fi­nance for Alder Bio­Phar­ma­ceu­ti­cals. Paul Pear­son (chief of de­vel­op­ment) was ex­ec­u­tive di­rec­tor of pre­clin­i­cal drug me­tab­o­lism dur­ing his years at Mer­ck Re­search Lab­o­ra­to­ries, and lat­er be­came Am­gen’s glob­al head of phar­ma­co­ki­net­ics and drug me­tab­o­lism. And the 11 years at Pfiz­er’s La Jol­la Lab­o­ra­to­ries for Er­ic Gruff (SVP of CMC) cul­mi­nat­ed in his role as re­search team leader in de­vel­op­ment of di­a­betes and frailty (mus­cle wast­ing) ther­a­pies.

→ By rais­ing a sub­stan­tial chunk of change for its Se­ries B in Au­gust, Jef­frey Blue­stone’s Sono­ma Bio­ther­a­peu­tics has 265 mil­lion rea­sons to grab every­one’s at­ten­tion, and this week Sono­ma has pulled in Doug Shee­hy as chief le­gal of­fi­cer and sec­re­tary. The ex-gen­er­al coun­sel and sec­re­tary at Aim­mune, Shee­hy al­so de­vot­ed nine years to Codex­is, where he was EVP, chief ad­min­is­tra­tive of­fi­cer, gen­er­al coun­sel and sec­re­tary.

Gu­darz Davar

→ CNS dis­ease-fo­cused Au­to­bahn Ther­a­peu­tics out of San Diego, lift­ing the lid in June 2020 with a $76 mil­lion round head­lined by ARCH and Cowen, has tapped Gu­darz Davar as CMO and pro­mot­ed Chan Beals to SVP, chief of trans­la­tion­al med­i­cine. Davar — who can sing his own vers­es of John­ny Cash’s “I’ve Been Every­where” with stints at Am­gen, Al­ler­gan and Bio­gen un­der his belt — just led R&D for a year at Aca­dia Phar­ma­ceu­ti­cals af­ter he was in charge of glob­al neu­rol­o­gy clin­i­cal de­vel­op­ment at Eli Lil­ly. Beals sped in­to Au­to­bahn in Jan­u­ary 2020 as SVP of trans­la­tion­al med­i­cine, and ear­li­er he was CMO at Abide Ther­a­peu­tics, which Lund­beck bought to boost a scuf­fling pipeline in the spring of 2019.

Sun­jeet Sawh­ney

No­vo Seeds led a mod­est fi­nanc­ing round in Oc­to­ber 2020 for Finnish can­cer start­up Rapp­ta Ther­a­peu­tics, fo­cused on pro­tein phos­phatase 2 (PP2A) in­hibitors. Found­ing CEO Mikko Man­nerkos­ki is slid­ing in­to the CFO role at Rapp­ta as Sun­jeet Sawh­ney steps in­to the spot­light in his place, ef­fec­tive im­me­di­ate­ly. Sawh­ney hails from Ipsen, where the new chief ex­ec­u­tive was glob­al head of the on­col­o­gy fran­chise, and his Big Phar­ma ex­pe­ri­ence start­ed ear­ly at Roche and Sanofi be­fore ris­ing to on­col­o­gy head of mar­ket­ing & com­mer­cial ex­cel­lence, emerg­ing growth mar­kets to con­clude his nine years at No­var­tis On­col­o­gy.

→ Start­ing Mon­day, Erik Skullerud will be CEO at Oslo, Nor­way-based Nordic Nanovec­tor, which takes aim at hema­to­log­i­cal can­cers with its ra­dioim­muno­con­ju­gate (RIC) Be­talutin. Skullerud suc­ceeds Ma­lene Brond­berg af­ter she had held the top spot on an in­ter­im ba­sis since Ju­ly. From 2000-16, Skullerud scaled the sales and mar­ket­ing peaks at Am­gen, leav­ing as the Big Phar­ma’s mar­ket­ing di­rec­tor, Eu­rope, on­col­o­gy/hema­tol­ogy.

Lars Boes­gaard

→ Stay­ing in Eu­rope, Dutch biotech AM-Phar­ma has brought on Lars Boes­gaard to be its CFO. The first AM-Phar­ma ex­ec­u­tive to be based in the US, the No­vo Nordisk and Alex­ion vet joins the com­pa­ny from Co­lum­bia Care just a week af­ter Ky­owa Kirin paid the biotech more than $23 mil­lion up­front for de­vel­op­ment and com­mer­cial­iza­tion rights in Japan on kid­ney drug ilo­fo­tase al­fa.

Tim­o­thy Ki­ef­fer

→ Proof-of-con­cept da­ta from a sin­gle pa­tient were re­leased in June from Vi­a­Cyte’s stem cell treat­ment for type 1 di­a­betes, and CEO Michael Yang has found a new CSO with the req­ui­site stem cell back­ground in this in­di­ca­tion. Tim­o­thy Ki­ef­fer was in charge of the Lab­o­ra­to­ry of Mol­e­c­u­lar and Cel­lu­lar Med­i­cine at the Uni­ver­si­ty of British Co­lum­bia, where he was al­so part of the Di­a­betes Re­search Group at the school’s Life Sci­ences In­sti­tute. The en­Gene co-founder re­places Kevin D’Amour, now the chief sci­en­tist at Brook­lyn Im­munoTher­a­peu­tics.

Ian Clark

Kyver­na Ther­a­peu­tics has re­cruit­ed two new faces with the ap­point­ments of for­mer Genen­tech CEO Ian Clark as chair of its board of di­rec­tors and Karen Walk­er as chief tech­nol­o­gy of­fi­cer. Pri­or to his sev­en-year tenure at the helm of Genen­tech, Clark was serv­ing as the com­pa­ny’s EVP of com­mer­cial op­er­a­tions and SVP and gen­er­al man­ag­er of bio-on­col­o­gy. Ear­li­er in his ca­reer, Clark served in a va­ri­ety of roles at No­var­tis, Sanofi, Ivax and Sear­le. This is far from Clark’s first board seat; he cur­rent­ly sits on the boards of Take­da, Agios Phar­ma­ceu­ti­cals, Guardant Health, Ole­ma Phar­ma­ceu­ti­cals, Corvus Phar­ma­ceu­ti­cals and Avro­bio.

Mean­while, Walk­er comes to Kyver­na af­ter stints at Roche/Genen­tech, Seagen, No­var­tis, Am­gen, Bay­er and Bris­tol My­ers Squibb. Walk­er most re­cent­ly served as se­nior ad­vi­sor, cell and gene ther­a­py man­u­fac­tur­ing at Roche/Genen­tech.

Found­ed by Bob Langer and head­ing in­to Phase III with its lead drug for chron­ic rhi­nos­i­nusi­tis, Lyra Ther­a­peu­tics has locked in Ja­son Cav­a­lier as CFO. Af­ter stops at Bear Stearns, Bar­clays and RBC Cap­i­tal Mar­kets, Cav­a­lier was Can­tor Fitzger­ald’s man­ag­ing di­rec­tor, head of life sci­ences merg­ers & ac­qui­si­tions.

Han Lee

Han Lee will de­part from his CFO po­si­tion at Ar­cel­lx to per­form the same role at Neo­gene Ther­a­peu­tics. Pri­or to Ar­cel­lx, Lee served as se­nior di­rec­tor in the cor­po­rate de­vel­op­ment and ven­tures group at As­traZeneca. Over the sum­mer, the South­ern Cal­i­for­nia TCR biotech al­so added Brent Pfeif­f­en­berg­er as COO.

David Liebowitz is step­ping over to Hous­ton-based DNA­trix as CMO. Liebowitz most re­cent­ly served as VP of clin­i­cal on­col­o­gy at Xen­cor. Pri­or to that stint, Liebowitz was the CMO for Vaxart and CSO and CMO of Vi­val­di Bio­sciences. Ear­li­er in his ca­reer, Liebowitz was with Galileo Phar­ma­ceu­ti­cals, Am­gen and Im­munex.

Jaa Rober­son

→ The sun shone bright­ly over South San Fran­cis­co pe­di­atric can­cer play­er Day One Bio­phar­ma­ceu­ti­cals when it start­ed trad­ing on Nas­daq with the tick­er $DAWN af­ter an up­sized IPO hit $160 mil­lion in May. CEO Je­re­my Ben­der con­tin­ues to piece to­geth­er the C-suite with Jaa Rober­son climb­ing on board as chief peo­ple of­fi­cer, piv­ot­ing from her role as a hu­man re­sources ex­ec at Bel­licum. Af­ter six years at Genen­tech as an HR busi­ness part­ner, Rober­son spent a year lead­ing HR at Achao­gen.

John Limon­gel­li

→ Thomas Jef­fer­son Uni­ver­si­ty spin­out Im­vax, led by ex-Spark COO John Furey, has locked in John Limon­gel­li as chief le­gal of­fi­cer. Limon­gel­li was gen­er­al coun­sel at Neos Ther­a­peu­tics and then at Tra­ve­na, where he tacked on the chief ad­min­is­tra­tive of­fi­cer ti­tle. Im­vax re­vealed pos­i­tive Phase Ib da­ta on its glioblas­toma mul­ti­forme drug IGV-001 in Jan­u­ary and has brought COO Sean Hem­ing­way and CFO Josh Munt­ner in­to the fold this year.

→ Pitts­burgh’s Krys­tal Biotech has added Lau­rent Goux as their gen­er­al man­ag­er for Eu­rope. Goux comes from Swiss der­ma­to­log­i­cal phar­ma Gal­der­ma, where he was in charge of glob­al strate­gic mar­ket­ing and mar­ket ac­cess. Krys­tal Biotech is in the mid­dle of a Phase III tri­al for epi­der­mol­y­sis bul­losa.

NeuBase Ther­a­peu­tics resur­faces in Peer Re­view yet again, as the Pitts­burgh ge­net­ic med­i­cine biotech waves in An­tho­ny Rosso­man­do as chief tech­nol­o­gy of­fi­cer. A staff sci­en­tist at Bay­er in the 1990s, Rosso­man­do has roamed the land­scape ex­ten­sive­ly, from his nine years at Bio­gen to his three years at Al­ny­lam as se­nior di­rec­tor of siR­NA bio­pro­cess­ing. The Anokion and Alex­ion vet heads to NeuBase af­ter a brief stay as chief process de­vel­op­ment of­fi­cer at Pine­tree Ther­a­peu­tics. With­in a year’s time, NeuBase has al­so bol­stered its C-suite with a new COO, CSO, CMO and chief busi­ness and strat­e­gy of­fi­cer.

Neal Mu­ni

→ Just a week af­ter tap­ping Jeff Hack­man as pres­i­dent and CEO, Re­Form Bi­o­log­ics is bring­ing in Neal Mu­ni as EVP and COO. Pri­or to join­ing Re­Form, Mu­ni most re­cent­ly served as the CEO of Azu­ri­ty, which is­sued a na­tion­al re­call of one lot of Fir­vanq last week.

→ Vi­va LaFrance: Part­ner­ing with Ra­dioMedix on the pro­duc­tion of its ra­dio­phar­ma­ceu­ti­cals, Plus Ther­a­peu­tics out of Austin, TX has ap­point­ed Nor­man LaFrance as CMO ef­fec­tive “on or around” Dec. 8. Be­fore join­ing the ra­dio­ther­a­peu­tic de­vel­op­er, LaFrance was SVP and CMO of Ju­bi­lant Phar­ma, and in the mid 2000s the for­mer mem­ber of the Johns Hop­kins med­ical fac­ul­ty was Bausch + Lomb’s VP, glob­al phar­ma­ceu­ti­cal de­vel­op­ment.

Gus­ta­vo Stolovitzky

Se­ma4, the J&J and Sanofi-part­nered pa­tient da­ta, test­ing and ge­nomics plat­form that merged with Eli Cas­din’s $450 mil­lion SPAC, has pulled in Gus­ta­vo Stolovitzky as CSO. Stolovitzky has spent the last two decades at IBM Re­search, where he was ap­point­ed IBM fel­low. Pri­or to his ap­point­ment as fel­low, Stolovitzky was the di­rec­tor of the trans­la­tion­al sys­tems bi­ol­o­gy and nanobiotech­nol­o­gy pro­gram.

Re­solve Bio­sciences has named Erik Wiberg as CFO. Wiberg comes aboard from RE­VA Med­ical, where he al­so served as CFO. Pri­or to his stint at RE­VA, Wiberg served at Gy­ros Pro­tein Tech­nolo­gies, Ther­mo Fish­er Sci­en­tif­ic, Al­liedSig­nal and the Cham­ber­lain Group.

Wendy Dwyer

San­iona has brought on Wendy Dwyer as CBO. Dwyer joins the com­pa­ny from Sur­face On­col­o­gy, where she served in the same role as CBO. Dwyer brings with her ex­pe­ri­ence from her time at Por­tal In­stru­ments, Ipsen Bio­science, As­traZeneca, Anti­gen­ics (now Agenus), En­do Phar­ma­ceu­ti­cals and In­de­vus Phar­ma­ceu­ti­cals.

In ad­di­tion, the San­iona has giv­en a seat to Robert Hoff­man on its board of di­rec­tors. This isn’t Hoff­man’s first board ap­point­ment, he cur­rent­ly sits on the boards of ASLAN Phar­ma­ceu­ti­cals, Kin­tara Ther­a­peu­tics and An­tibe Ther­a­peu­tics. Most re­cent­ly, Hoff­man served as CFO of Heron Phar­ma­ceu­ti­cals. Hoff­man jump­start­ed his ca­reer at Are­na Phar­ma­ceu­ti­cals.

Xen­ter has wel­comed Mark Tur­co aboard as pres­i­dent of its Xen­ter Med­ical Tech­nolo­gies busi­ness unit. Tur­co hails from Sir­tex Med­ical, where he served as EVP of re­search & de­vel­op­ment and glob­al CMO. In ad­di­tion, Tur­co pre­vi­ous­ly served as CMO of Co­vi­di­en and lat­er VP and CMO of Medtron­ic’s aor­tic, pe­riph­er­al and vas­cu­lar di­vi­sions.

Marni Kot­tle

Nor­bert Bischof­berg­er at Kro­nos Bio has looked to his old stomp­ing grounds at Gilead to wel­come Marni Kot­tle as SVP of cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions. Kot­tle joined Gilead in 2013, over­lap­ping with Bischof­berg­er’s 28-year run with the Cal­i­for­nia phar­ma, and was VP of cor­po­rate com­mu­ni­ca­tions af­ter a ca­reer in me­dia where she was a re­porter for the San Fran­cis­co Chron­i­cle, Bloomberg and the Seat­tle Post-In­tel­li­gencer. Kro­nos got in on the 2020 IPO craze last fall, top­ping $250 mil­lion in an up­sized of­fer­ing.

Nicole Chi­ef­fo

→ It’s been a steady stream of new hires and pro­mo­tions at South San Fran­cis­co-based Sutro Bio­phar­ma, and this week is no dif­fer­ent with the in­tro­duc­tions of Nicole Chi­ef­fo (VP of clin­i­cal op­er­a­tions) and Wern­er Rubas (VP of pre­clin­i­cal de­vel­op­ment). Sutro poach­es Chi­ef­fo from Janssen, hold­ing such posts as se­nior di­rec­tor, on­col­o­gy glob­al op­er­a­tions head and lead on­col­o­gy clin­i­cal sci­en­tist. Rubas spent the last nine years at Nek­tar and was ex­ec­u­tive di­rec­tor in non-clin­i­cal phar­ma­co­ki­net­ics and phar­ma­co­dy­nam­ics. Along with Trevor Hal­lam’s pro­mo­tion to pres­i­dent of re­search and CSO, Sutro’s oth­er lead­er­ship moves in 2021 in­clude ap­point­ing CCO Jane Chung, pro­mot­ing David Paul­ing to gen­er­al coun­sel and el­e­vat­ing Robert Kiss to SVP of process and an­a­lyt­i­cal de­vel­op­ment.

jCyte just keeps on grow­ing too — its lat­est new­com­er is Vic­tor Chao as the Cal­i­for­nia biotech’s first VP of CMC op­er­a­tions, ap­point­ed late last week. Chao ar­rived at jCyte af­ter leav­ing San­ten Phar­ma­ceu­ti­cals as its head of com­mer­cial op­er­a­tions in North and Latin Amer­i­ca. The new jCyte staffers un­der first-year CEO Shan­non Blalock run the gamut from CFO Adam Walsh to gen­er­al coun­sel John Shol­ar, among sev­er­al oth­ers.

Tim Largen

→ Af­ter adding Daniela Dra­go from Bio­gen as chief reg­u­la­to­ry of­fi­cer last month, Au­ri­on Biotech ap­points Tim Largen as VP of man­u­fac­tur­ing. Largen over­saw man­u­fac­tur­ing at Lykan Bio­science af­ter spend­ing near­ly a decade climb­ing the ranks at Den­dreon. Au­ri­on, which has head­quar­ters in the US and Japan, is fo­cused on push­ing for­ward its first can­di­date, a cell ther­a­py to treat corneal en­dothe­lial dys­func­tion.

Ae­tion, the New York health tech start­up that has for­mer FDA com­mis­sion­er Scott Got­tlieb sit­ting on its board of di­rec­tors, has named Mar­la Kessler its first chief cus­tomer of­fi­cer. Kessler comes to the com­pa­ny from IQVIA, where she served as SVP, strat­e­gy, mar­ket­ing and com­mu­ni­ca­tion. In ad­di­tion to her role at IQVIA, Kessler has served at Pfiz­er and McK­in­sey. Kessler cur­rent­ly sits on the board of Iron­wood Phar­ma­ceu­ti­cals.

Ra­tio­nal Vac­cines, fo­cused on the treat­ment and pre­ven­tion of her­pes, has wel­comed Ker­stin Westritschnig as CMO. Westritschnig hails from Ape­iron Bi­o­log­ics, where she al­so served in the role of CMO. Pri­or to that, she was SVP and mem­ber of the ex­ec­u­tive com­mit­tee of Val­ne­va.

Christi­na Isac­son

→ Run­ning in par­al­lel with the news of a third and largest ven­ture fund — $375 mil­lion, to be ex­act — Light­stone Ven­tures has al­so named Christi­na Isac­son as part­ner and Young Kwon as op­er­at­ing part­ner. The ex-Third Rock prin­ci­pal and in­ter­im head of busi­ness de­vel­op­ment and strat­e­gy at Deci­bel, Isac­son had been CBO at Ma­gen­ta Ther­a­peu­tics un­til this March. Kwon spent a decade with Mo­men­ta, ini­tial­ly as VP of busi­ness de­vel­op­ment and then work­ing his way up to chief fi­nan­cial and busi­ness of­fi­cer.

→ Lon­don-based VC Abing­worth has named Jay Cui and Lu­cille Con­roy prin­ci­pals, while Diya Mal­ho­tra jumps ship from LEK Con­sult­ing to be an in­vest­ment man­ag­er. Cui was most re­cent­ly a di­rec­tor at Ab­b­Vie Ven­tures, while Con­roy was a se­nior as­so­ciate at F-Prime Cap­i­tal af­ter al­most two years at McK­in­sey.

Kathy Biber­stein

→ Churn­ing out biotechs at its usu­al steady clip, Flag­ship Pi­o­neer­ing has brought on Kathy Biber­stein as gen­er­al coun­sel and will of­fi­cial­ly join the team on Mon­day. In 2018 Biber­stein wrapped up a 15-year as­so­ci­a­tion with Alk­er­mes in which she wore a num­ber of ex­ec­u­tive hats — EVP, chief ad­min­is­tra­tive of­fi­cer, chief com­pli­ance of­fi­cer, chief risk of­fi­cer, and chief le­gal of­fi­cer. She’s al­so left the board of Nes­san Berming­ham-chaired Triplet Ther­a­peu­tics af­ter on­ly serv­ing less than a year in that ca­pac­i­ty.

Eliz­a­beth Bekiroğlu

→ No yel­low cards for Icosavax as the Seat­tle-based vac­cine biotech push­es for­ward with Neil King’s VLP “soc­cer ball” tech­nol­o­gy — and Eliz­a­beth Bekiroğlu in­tends to keep it that way as gen­er­al coun­sel. Bekiroğlu stays in Seat­tle af­ter be­ing Seagen’s as­so­ciate gen­er­al coun­sel, and once up­on a time she was gen­er­al coun­sel at Emer­gent BioSo­lu­tions. Icosavax end­ed up rais­ing $182 mil­lion in an up­sized IPO this sum­mer.

Hex­Trans­for­ma has reeled in Kevin Mor­ris as chief tech­nol­o­gy of­fi­cer. Mor­ris pre­vi­ous­ly served as VP of en­gi­neer­ing at Me­di­da­ta So­lu­tions. Mor­ris al­so brings with him ex­pe­ri­ence from his roles at Rovi Eu­rope (now Ti­Vo), Macro­vi­sion and Shal­bourne Tech­nol­o­gy.

→ Neu­rode­gen­er­a­tive dis­ease-fo­cused Alzheon has brought on two new hires with the ap­point­ments of Adem Al­bayrak as head of op­er­a­tions and Earvin Liang as VP of clin­i­cal de­vel­op­ment. Al­bayrak comes from Health Cat­a­lyst’s life sci­ences busi­ness, where he served as SVP for tech­nol­o­gy. Ear­li­er in his ca­reer, Al­bayrak worked at Knome and the Dana-Far­ber Can­cer In­sti­tute.

Mean­while, Liang brings with him ex­pe­ri­ence from his time at Elan Phar­ma­ceu­ti­cals, Janssen, Alzheimer’s Im­munother­a­py and Tran­si­tion Ther­a­peu­tics.

Bri­an Di Do­na­to

Jim Wil­son‘s new start­up iECURE, which came from his work with Tachi Ya­ma­da, has reeled in Bri­an Di Do­na­to to its board of di­rec­tors. Di Do­na­to is cur­rent­ly CFO and head of strat­e­gy at Im­muno­core. Pri­or to his work with Im­muno­core, Di Do­na­to was SVP and CFO at Achillion.

Don Nichol­son

→ Ex-Nim­bus CEO Don Nichol­son has been elect­ed in­de­pen­dent chair­man of the board at Dan­ish-Bel­gian neu­rode­gen­er­a­tive dis­ease biotech Mu­na Ther­a­peu­tics. Nichol­son, who’s on the boards of Kymera and Gen­er­a­tion Bio, al­so chairs Disc Med­i­cine, Jnana Ther­a­peu­tics and NodThera.

→ ROME if you want to: Up­on the news of the Se­ries B fi­nanc­ing at Rosana Kapeller’s ROME Ther­a­peu­tics, Steven Kaf­ka and Jim Tren­kle have tak­en seats on the board of di­rec­tors. Kaf­ka is man­ag­ing part­ner at Sec­tion 32 and Tren­kle leads in­vest­ments at Sanofi Ven­tures, two VCs that fac­tored heav­i­ly in­to the $77 mil­lion round.

Deb­o­rah Dun­sire

Deb­o­rah Dun­sire has been ap­point­ed to the board of di­rec­tors at Sy­ros, which is pre­sent­ing Phase I da­ta for its can­cer drug SY-5609 at ES­MO. For­mer­ly a board mem­ber at Alex­ion and Al­ler­gan, Dun­sire has helmed Lund­beck since 2018 and is on the board of di­rec­tors at Ul­tragenyx.

John John­son

Chris­t­ian Itin’s crew at CAR-T out­fit Au­to­lus has named long­time biotech ex­ec John John­son chair­man of the board. The Big Phar­ma vet chaired the board at Strong­bridge Bio­phar­ma un­til he took over as CEO in Ju­ly 2020, but John­son has re­tained his board seat af­ter Garheng Kong suc­ceed­ed him as chair­man.

→ Gaithers­burg, MD-based Adap­tive Phage Ther­a­peu­tics, which scored a Se­ries B that ex­ceed­ed $40 mil­lion in May, has ap­point­ed George­town pro­fes­sor Jesse Good­man to the board of di­rec­tors. From 2009-14, Good­man was chief sci­en­tist at the FDA, and for three years with­in that pe­ri­od he took on the role of deputy com­mis­sion­er for sci­ence and pub­lic health.

Ruth Williams-Brink­ley

→ Two days be­fore reach­ing a li­cens­ing deal with Vi­for Phar­ma, for­mer Mar­tin Shkre­li com­pa­ny Tra­vere Ther­a­peu­tics added Ruth Williams-Brink­ley to its board of di­rec­tors. Williams-Brink­ley over­sees Kaiser Per­ma­nente’s op­er­a­tions in DC and sur­round­ing ar­eas, and was the CEO for mul­ti­ple hos­pi­tal sys­tems in her ca­reer.

→ Ex-Kymab CEO Si­mon Sturge’s next en­deav­or will be as ex­ec­u­tive chair­man of fi­bro­sis biotech Me­di­ar Ther­a­peu­tics out of Cam­bridge, MA. Sturge helmed Kymab un­til it was sold for close to $1.5 bil­lion in one of sev­er­al M&A deals Paul Hud­son has made at Sanofi this year.

Jen­nifer Her­ron

→ ADC Ther­a­peu­tics SVP and chief com­mer­cial of­fi­cer Jen­nifer Her­ron has joined the board of di­rec­tors at Chip Clark-led can­cer biotech Geno­cea Bio­sciences. The 10-year Bris­tol My­ers vet has al­so been CCO at Im­muno­Gen and Ari­ad Phar­ma­ceu­ti­cals.

→ Gilead and Pfiz­er vet Roger Mills has made his way to the board of di­rec­tors at Philadel­phia-based En­terin. Mills was EVP of de­vel­op­ment and then CMO at Aca­dia Phar­ma­ceu­ti­cals af­ter his tenure as Pfiz­er’s VP of glob­al R&D.

Ji­gar Raythatha

Ji­gar Raythatha be­comes a mem­ber of the board of di­rec­tors at Jounce Ther­a­peu­tics as Third Rock part­ner Cary Pf­ef­fer re­signs from the board on Dec. 31. Raythatha helmed Con­stel­la­tion Phar­ma­ceu­ti­cals from 2017 un­til its $1.7 bil­lion sale to Mor­phoSys, which was an­nounced in June.

Owl­stone Med­ical has ap­point­ed Mark Capone to its board of di­rec­tors as an in­de­pen­dent non-ex­ec­u­tive di­rec­tor. Capone is the for­mer pres­i­dent and CEO of Myr­i­ad Ge­net­ics and pre­vi­ous­ly held a 17-year stint at Eli Lil­ly.

Ruth McK­er­nan

Cu­mu­lus Neu­ro­science’s own founder and di­rec­tor, Ruth McK­er­nan, will be adding on the role of chair to her du­ties. McK­er­nan, who is a neu­ro­sci­en­tist, is al­so a ven­ture part­ner at the De­men­tia Dis­cov­ery Fund. Ad­di­tion­al­ly, McK­er­nan has pre­vi­ous­ly served as SVP at Pfiz­er and head of the Mer­ck Neu­ro­science Re­search Cen­tre.

→ Fun­gal dis­ease-fo­cused F2G has added Camil­la Soen­der­by to its board of di­rec­tors. Soen­der­by most re­cent­ly served as chief pa­tient val­ue & prod­uct strat­e­gy of­fi­cer at Take­da af­ter its ac­qui­si­tion of Shire. Pri­or to that, Soen­der­by was SVP, head of glob­al prod­uct strat­e­gy for Shire, and held roles at Roche, Ab­bott (now Ab­b­Vie) and Scher­ing-Plough.

Phase­Bio Phar­ma­ceu­ti­cals has brought on William Humphries to its board of di­rec­tors. Humphries is cur­rent­ly the CEO of Isosce­les Phar­ma­ceu­ti­cals and pre­vi­ous­ly served at Or­tho Der­ma­to­log­ics, the North Amer­i­can busi­ness of Merz and Stiefel Lab­o­ra­to­ries.

In ad­di­tion, an­oth­er di­rec­tor at Phase­Bio, Justin Klein, is step­ping down.

Snap­drag­on Chem­istry has ap­point­ed Don­na Black­mond to its sci­en­tif­ic ad­vi­so­ry board. Black­mond, a chem­i­cal en­gi­neer­ing pro­fes­sor, is cur­rent­ly the John C. Mar­tin en­dowed chair in chem­istry at the Scripps Re­search In­sti­tute.

Paul Schloess­er al­so con­tributed to this edi­tion.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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David Livingston (Credit: Michael Sazel for CeMM)

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

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

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

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

 

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

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

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Marty Duvall, Oncopeptides CEO

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

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

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

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

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

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