Ex-Mod­er­na com­mer­cial leader lands at Cel­sion as CEO; Schwan song: Chang­ing of the guard at Roche to take ef­fect next year

Corinne Le Goff

Less than 12 months in­to her job lead­ing the com­mer­cial roll­out of one of the world’s biggest-sell­ing biotech prod­ucts, Mod­er­na’s Covid-19 vac­cine, Corinne Le Goff de­part­ed the house­hold name in De­cem­ber 2021, but her fu­ture in the in­dus­try is just now com­ing in­to clear view.

The more than 30-year in­dus­try vet­er­an — whose posts have run the gamut across Pfiz­er, Sanofi, Mer­ck, Roche and Am­genis now CEO and pres­i­dent of Cel­sion, which it­self is po­ten­tial­ly look­ing to get in­to the SARS-CoV-2 vac­cine land­scape, al­beit way lat­er than her pre­vi­ous em­ploy­er.

Le Goff kicked off her stint at the New Jer­sey biotech on Ju­ly 18, re­plac­ing Michael Tar­dug­no, who held the top post for the past 15 years. He re­mains in his role as ex­ec­u­tive chair.

“She adds tremen­dous depth of knowl­edge and joins us at a key in­flec­tion point in our evo­lu­tion, as we work to rapid­ly ad­vance our GEN-1 pro­gram for the treat­ment of ad­vanced-stage ovar­i­an can­cer and build a pro­pri­etary vac­cine plat­form based on our PLAC­CINE tech­nol­o­gy,” the out­go­ing CEO said in a state­ment.

The 37-year-old com­pa­ny has for decades been work­ing on can­cer drugs and has been work­ing through a Phase III tri­al of its lead as­set, dubbed Ther­mo­D­ox, since the sec­ond half of 2014.

Cel­sion al­so has clin­i­cal-stage work in ovar­i­an can­cer, and is in the pre­clin­i­cal stages with glioblas­toma and blad­der can­cer as­sets. An­oth­er po­ten­tial av­enue go­ing for­ward is de­vel­op­ing a vac­cine can­di­date for the pan­dem­ic.

The new chief ex­ec­u­tive steps in­to a biotech with rel­a­tive­ly small cash re­serves of $47.3 mil­lion, which is about three times its mar­ket cap. Cel­sion said that amount, as of March 31, is good enough to fund op­er­a­tions in­to the sec­ond quar­ter of 2025.

Kyle LaHu­cik

Sev­erin Schwan

Sev­erin Schwan is the lat­est Big Phar­ma CEO to plan his ex­it, hand­ing the keys to Roche Di­ag­nos­tics chief Thomas Schi­neck­er on March 15, 2023. Roche will nom­i­nate Schwan, who has guid­ed the Swiss multi­na­tion­al since 2008, as chair­man to re­place Christoph Franz. A board mem­ber for 11 years, Franz has been chair­man since 2014 and won’t seek re-elec­tion.

Un­der Schwan’s watch, a num­ber of drugs achieved block­buster sta­tus at Roche, in­clud­ing Ocre­vus, Kad­cy­la, Actem­ra and Tecen­triq. An­a­lysts project that its spinal mus­cu­lar at­ro­phy drug Evrys­diap­proved in Au­gust 2020 — is head­ed down the same block­buster path, giv­ing Zol­gens­ma and Spin­raza a run for their mon­ey.

Schwan fol­lows the re­cent tran­si­tions of Mer­ck’s Ken Fra­zier and J&J’s Alex Gorsky in the land of phar­ma gi­ants, and Bio­gen is on the hunt for Michel Vounatsos’ suc­ces­sor. Both Fra­zier and Gorsky have served as ex­ec­u­tive chair­man of their re­spec­tive com­pa­nies af­ter their CEO days end­ed.

Kabir Nath

Com­pass Path­ways is point­ing in the di­rec­tion of a new CEO, as Kabir Nath takes over for George Gold­smith at the Lon­don psy­che­delics biotech on Aug. 1. From there, Gold­smith will be ex­ec­u­tive chair­man un­til Dec. 31, when he’ll set­tle in­to his role as chair­man. Nath is cur­rent­ly se­nior man­ag­ing di­rec­tor of Ot­su­ka’s glob­al phar­ma­ceu­ti­cal busi­ness, and ear­li­er he was pres­i­dent and CEO of the Ot­su­ka North Amer­i­ca phar­ma­ceu­ti­cal busi­ness. Nath al­so held sev­er­al posts at Bris­tol My­ers Squibb, in­clud­ing pres­i­dent of BMS Chi­na and SVP, vi­rol­o­gy, trans­plant & op­ti­mized brands.

Feng Ren vault­ed to co-CEO with Alex Zha­voronkov at In­sil­i­co Med­i­cine last month just af­ter a $60 mil­lion cash in­fu­sion, and the AI out­fit’s team has grown with Su­ja­ta Rao over­see­ing glob­al clin­i­cal de­vel­op­ment. At Eli Lil­ly, Rao was as­so­ciate VP of glob­al clin­i­cal de­vel­op­ment for such drugs as sin­til­imab, which has fa­mous­ly been struck down by the FDA for its re­liance on Chi­na-on­ly da­ta. Rao has fur­ther Big Phar­ma ties as im­muno-on­col­o­gy med­ical lead and on­col­o­gy sci­en­tif­ic ad­vi­sor at Bris­tol My­ers for nivolum­ab (Op­di­vo).

Baisong Mei

→ Not on­ly has Ed­i­tas Med­i­cine seen volatil­i­ty at the top with mul­ti­ple CEOs in short or­der, the CMO po­si­tion had been va­cant since Lisa Michaels’ sud­den and un­ex­plained ouster in Feb­ru­ary. Baisong Mei was named as her suc­ces­sor ear­ly this week, leav­ing Sanofi be­hind af­ter his tenure as se­nior glob­al project head, rare dis­eases and rare blood dis­or­ders. Fol­low­ing 10 years at Bay­er, he then moved on to Bio­gen in 2010, first as di­rec­tor, dis­cov­ery re­search and then as ther­a­peu­tic area head for hema­tol­ogy clin­i­cal de­vel­op­ment.

Ed­i­tas is on its fourth chief ex­ec­u­tive in three years af­ter Ka­trine Bosley’s de­par­ture in ear­ly 2019. In April, ex-Sarep­ta CMO Gilmore O’Neill re­placed Jim Mullen, who took con­trol when Cyn­thia Collins left in Feb­ru­ary 2021.

Kun­war Shailub­hai

Kun­war Shailub­hai has turned in his res­ig­na­tion as CEO, CSO and mem­ber of the board at Tiziana Life Sci­ences, and on Aug. 1, ex­ec­u­tive chair­man Gabriele Cer­rone will take charge as in­ter­im CEO. Shailub­hai’s de­ci­sion “is not re­lat­ed to any dis­agree­ment with the Com­pa­ny on any mat­ter re­lat­ing to the Com­pa­ny’s op­er­a­tions, poli­cies or prac­tices,” the state­ment reads. Tiziana has two can­di­dates in ear­ly-stage tri­als: foralum­ab, an an­ti-CD3 mon­o­clon­al an­ti­body; and mil­ci­clib, a pan-CDK in­hibitor.

Eliz­a­beth Formi­nard

→ J&J gen­er­al coun­sel Michael Ull­mann is call­ing it a ca­reer af­ter 33 years at the phar­ma gi­ant, re­tir­ing “at the end of this year” and as­sist­ing with the tran­si­tion as Eliz­a­beth Formi­nard takes the wheel on Oct. 17. Ull­mann start­ed out as an M&A at­tor­ney for J&J in 1989 and has spent the last 11 years as gen­er­al coun­sel, while Formi­nard joined from Pfiz­er in 2006 and was el­e­vat­ed to world­wide VP, gen­er­al coun­sel for the phar­ma­ceu­ti­cal sec­tor three years ago.

Mark Pruzan­s­ki

→ Life af­ter In­ter­cept is com­ing in­to clear­er fo­cus for Mark Pruzan­s­ki, tak­ing an­oth­er CEO gig at Ver­sa­nis Bio, Joe Jimenez and Mark Fish­man’s obe­si­ty play from the Adi­tum Bio fam­i­ly of com­pa­nies. “There were a num­ber of oth­er op­por­tu­ni­ties that I was look­ing at, but Ver­sa­nis just be­came ut­ter­ly com­pelling to me,” Pruzan­s­ki told End­points News this week. “And the rea­son for that starts with the fact that we’re look­ing at ad­dress­ing what I con­sid­er to be the chron­ic dis­ease epi­dem­ic of our age.”

And at this point, where isn’t John Maraganore grab­bing a board seat or an ad­vi­so­ry post? The Maraganore Me­ter is up and run­ning again, and ex-In­ter­cept CFO Bar­bara Dun­can joins him on Ver­sa­nis’ board.

Stephen Dil­ly

Stephen Dil­ly is mak­ing a quick come­back to the biotech scene as the new CEO of en­zyme en­gi­neer Codex­is. Dil­ly makes the jump not long af­ter sell­ing Sier­ra On­col­o­gy to GSK in Feb­ru­ary. Dil­ly is tak­ing over the reins from John Nicols, who is re­tir­ing af­ter a decade of ser­vice to fo­cus on fam­i­ly and to de­vote his time to Solve ME/CFS — the non­prof­it he chairs that is ded­i­cat­ed to myal­gic en­cephalomyelitis/chron­ic fa­tigue syn­drome. Dil­ly has worn the CEO hat not on­ly at Sier­ra, but at Aim­mune Ther­a­peu­tics as well, which was sold to Nestlé Health Sci­ence af­ter se­cur­ing the first FDA nod for a peanut al­ler­gy treat­ment.

Volk­er Knap­pertz

Max Co­lao is out as chief com­mer­cial of­fi­cer of Au­rinia “to tend to per­son­al mat­ters” as CEO Pe­ter Green­leaf lines up Scott Habig as his re­place­ment. The re­volv­ing door is get­ting a work­out at the Lup­ky­nis mak­er, which has al­so wel­comed Volk­er Knap­pertz as EVP of R&D and DeDe Sheel as VP of in­vestor re­la­tions.

Habig just end­ed a 10-year run at UCB as head of glob­al SLE (sys­temic lu­pus ery­the­mato­sus) and he’s al­so held sales and mar­ket­ing posts at Cen­to­cor. Knap­pertz spent near­ly five years as CMO and EVP of R&D at GW Phar­ma­ceu­ti­cals, now in the hands of Jazz Phar­ma­ceu­ti­cals af­ter a $7.2 bil­lion buy­out in 2021. Sheel owned the same ti­tle at Sier­ra On­col­o­gy and Aim­mune, and she al­so had in­vestor re­la­tions roles at Ex­elix­is and My­ovant.

Cathryn Clary

→ Fab Five: Notch­ing a $115 mil­lion Se­ries B in Jan­u­ary for its gene ther­a­py 3.0 am­bi­tions, Sali­o­Gen is brim­ming with new hires un­der CEO Ray Tabib­i­azar. First up is Cathryn Clary (SVP of clin­i­cal de­vel­op­ment and CMO), an ex-Pfiz­er and Ipsen ex­ec who was CSO and head of US med­ical af­fairs and clin­i­cal de­vel­op­ment in the gen­er­al med­i­cines di­vi­sion at No­var­tis.

Al­so, Pat Sac­co (SVP of man­u­fac­tur­ing, qual­i­ty, and op­er­a­tions) was SVP of tech­ni­cal op­er­a­tions at Trans­late Bio from 2019-20 af­ter a 16-year run at Shire; Joe Senn (SVP of non­clin­i­cal de­vel­op­ment) comes to Sali­o­Gen from Mod­er­na, where he fin­ished up eight years at the Covid-19 vac­cine ti­tan as VP, non­clin­i­cal sci­ences; Feng Yao (VP of re­search — mol­e­c­u­lar switch and gene reg­u­la­tion) in­vent­ed the T-REx tech­nol­o­gy used by Ther­mo Fish­er and al­so taught at Brigham and Women’s Hos­pi­tal and Har­vard Med­ical School; and Oleg Iartchouk (VP of ge­nomics and bio­mark­ers) was glob­al head of ge­nomics dur­ing his eight years at NI­BR.

Michele An­der­son

→ The HBV drug ve­bi­corvir will ride the pine at As­sem­bly Bio­sciences, and as a re­sult of the dis­con­tin­ued stud­ies, 30% of John McHutchi­son’s work­force will be shown the door, prompt­ing a game of mu­si­cal chairs in the C-suite. CMO Luisa Stamm and CFO Michael Samar are out in the com­ing weeks, but a cou­ple of col­leagues have been pro­mot­ed: Michele An­der­son, As­sem­bly Bio’s SVP of de­vel­op­ment op­er­a­tions, will move up to chief de­vel­op­ment of­fi­cer, and COO Ja­son Okaza­ki will add the role of pres­i­dent to his busi­ness card on Aug. 1. In du­el­ing state­ments, McHutchi­son didn’t see a way for­ward with ve­bi­corvir com­bos, while its HBV part­ner Ar­bu­tus Bio­phar­ma begged to dif­fer.

Pe­ter Mc­Na­ma­ra

Tim Springer and An­drew Kruse’s GPCR play Tec­ton­ic Ther­a­peu­tic, one of the End­points 11 win­ners last year and un­der the lead­er­ship of ex-Mer­ck R&D vet Alise Re­icin, has pro­mot­ed Pe­ter Mc­Na­ma­ra to CSO af­ter bring­ing him on board from the Ge­nomics In­sti­tute of the No­var­tis Re­search Foun­da­tion as head of re­search in May 2021. Tec­ton­ic has al­so in­tro­duced Bar­ry Ruben­stein as SVP, peo­ple and cul­ture and Wash­ing­ton Alves as VP, bi­o­log­ics man­u­fac­tur­ing. Ruben­stein makes a change here af­ter three years as VP, hu­man re­sources at Kala Phar­ma­ceu­ti­cals, and he al­so took on a se­ries of HR po­si­tions at AM­AG Phar­ma­ceu­ti­cals from 2010-19. A Pfiz­er and Mer­ri­mack vet, Alves had pre­vi­ous­ly been se­nior di­rec­tor, CMC op­er­a­tions for Gem­i­ni Ther­a­peu­tics.

Chris Mora­bito

→ You may have read last week that Chris Mora­bito left Ful­crum Ther­a­peu­tics, and it hasn’t tak­en him long to turn up at an­oth­er biotech. As­tria Ther­a­peu­tics, the com­pa­ny once named Cataba­sis Phar­ma­ceu­ti­cals un­til Sep­tem­ber 2021, has put down the wel­come mat for Mora­bito as CMO af­ter a year in the same po­si­tion at Ful­crum. The ex-Car­du­ri­on CMO has al­so held a num­ber of R&D posts at Take­da, Sanofi and Mer­ck. As­tria’s lead pro­gram STAR-0215 is in a Phase Ia tri­al for hered­i­tary an­gioede­ma.

Marel­la Thorell

→ While Evelo Bio­sciences’ $79.2 mil­lion di­rect of­fer­ing in May has done lit­tle for its fad­ing stock price, Marel­la Thorell will seek to put the Flag­ship in­flam­ma­to­ry dis­ease biotech on sol­id foot­ing as CFO on Sept. 1. Af­ter her dual role as CFO and COO of Realm Ther­a­peu­tics, Thorell be­came fi­nance chief of Pal­la­dio Bio­sciences, now a Centes­sa sub­sidiary. She was then named head of fi­nance at Centes­sa and had served as chief ac­count­ing of­fi­cer since April 2021.

Samuel Zhang

→ Chi­nese CAR-T play­er Gra­cell has se­lect­ed Samuel Zhang as CBO. His Big Phar­ma ex­pe­ri­ence runs the gamut, to wit: glob­al launch lead for block­buster drug Al­im­ta at Eli Lil­ly; med­ical di­rec­tor/glob­al med­ical head, im­muno-on­col­o­gy with Pfiz­er; head of prostate tu­mor strat­e­gy for Bris­tol My­ers; and head of im­muno-on­col­o­gy prod­uct and port­fo­lio strat­e­gy at No­var­tis. Most re­cent­ly, Zhang was the busi­ness chief at NeoIm­muneTech.

Pe­ter Høn­gaard An­der­sen

→ Eu­ro­pean ven­ture cap­i­tal firm For­bion, which made an ini­tial close of $504 mil­lion for its sec­ond growth fund last month, has tapped Pe­ter Høn­gaard An­der­sen as op­er­at­ing part­ner and Matt Coop­er as ven­ture part­ner. An­der­sen hails from Lund­beck and No­vo Nordisk and comes aboard with quite a few oth­er stints un­der his belt, in­clud­ing co-found­ing Aca­dia Phar­ma­ceu­ti­cals, Zealand Phar­ma­ceu­ti­cals, Gly­com and Ep­ither­a­peu­tics.

Mean­while, Coop­er has found­ed or co-found­ed com­pa­nies such as Sita­la and In­fla­zome and was the founder of the Cen­ter for Su­per­bug So­lu­tions, Com­mu­ni­ty for Open Ac­cess An­tibi­ot­ic Dis­cov­ery & Cen­ter for Drug Dis­cov­ery and De­sign at the Uni­ver­si­ty of Queens­land.

Ker­ry Went­worth

→ Try­ing to scrape it­self off the can­vas af­ter get­ting knocked down by a par­tial clin­i­cal hold with its CDK in­hibitor NUV-422, David Hung’s Nu­va­tion Bio has in­stalled David Liu as CMO and Ker­ry Went­worth as chief reg­u­la­to­ry of­fi­cer. Liu worked on Op­di­vo and Yer­voy for Bris­tol My­ers in Chi­na as group di­rec­tor, on­col­o­gy glob­al clin­i­cal re­search and was re­cent­ly the med­ical chief for Shang­hai-based 3D Med­i­cines. Went­worth was chief reg­u­la­to­ry of­fi­cer for Flex­ion be­fore Paci­ra Bio­sciences bought it for a song last year, and she al­so spent a decade with Agenus, where she was VP, clin­i­cal, reg­u­la­to­ry, and qual­i­ty.

Erin O’Neil

→ More ex­ecs are pour­ing in­to Opus Ge­net­ics, the new gene ther­a­py biotech for eye dis­eases based in the Re­search Tri­an­gle found­ed by Jean Ben­nett. Vikram Aro­ra (VP of non-clin­i­cal de­vel­op­ment) spent 11 years at Gri­fols and was di­rec­tor of phar­ma­col­o­gy & tox­i­col­o­gy at Tale­cris Bio­ther­a­peu­tics; Erin O’Neil (VP of clin­i­cal de­vel­op­ment) is a Google mar­ket­ing spe­cial­ist-turned-oph­thal­mol­o­gist at the Chil­dren’s Hos­pi­tal of Philadel­phia; and Sarah Tuller (VP of reg­u­la­to­ry and med­ical writ­ing) is an Astel­las reg­u­la­to­ry alum who comes to Opus af­ter a year as VP of reg­u­la­to­ry af­fairs at Disc Med­i­cine.

Kar­la Mac­Don­ald

→ With its En­do­so­mal Es­cape Ve­hi­cles (EEVs) go­ing af­ter Duchenne mus­cu­lar dy­s­tro­phy and my­oton­ic dy­s­tro­phy type 1 (DM1) first, Boston’s En­tra­da Ther­a­peu­tics has pro­mot­ed Kar­la Mac­Don­ald to chief cor­po­rate af­fairs of­fi­cer. Mac­Don­ald, for­mer­ly VP of cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions, was Ipsen’s VP, com­mu­ni­ca­tions and pa­tient ad­vo­ca­cy fol­low­ing an 11-year run at Mer­ck, where she rose to head of in­ter­na­tion­al com­mu­ni­ca­tions.

Robert Fo­er­ster

→ Back in May 2020, Robert Fo­er­ster and Bill Er­hardt joined New York neu­ro biotech Oligomer­ix as CFO and CMO, re­spec­tive­ly. Fo­er­ster has now tacked on the role of COO, while Er­hardt has been named pres­i­dent, head of de­vel­op­ment & op­er­a­tions to ac­com­mo­date Oligomer­ix’s shift to two busi­ness units. CEO James Moe will be head of re­search & strat­e­gy and han­dle Dis­cov­ery Group du­ties, while Er­hardt leads the De­vel­op­ment Group. Fo­er­ster and Er­hardt both worked for Pfiz­er at the same time and have more than 35 years of com­bined ex­pe­ri­ence at the phar­ma gi­ant.

Ze­lan­na Gold­berg

→ San Diego-based Repli­cate Bio­science has wel­comed Ze­lan­na Gold­berg as CMO and Mo­hit Trikha as a mem­ber of its board of di­rec­tors. Gold­berg joins the com­pa­ny af­ter a stint as CMO at Alpine Im­mune Sci­ences. Pri­or to that, Gold­berg was SVP of clin­i­cal de­vel­op­ment at Io­vance and had a nine-year gig at Pfiz­er. Mean­while, Trikha is a ven­ture part­ner at Ap­ple Tree Part­ners and is the for­mer VP and head of on­col­o­gy ear­ly de­vel­op­ment at Ab­b­Vie.

Kate Sur­dez

Kate Sur­dez has signed on to be chief hu­man re­sources of­fi­cer of re­gen­er­a­tive med­i­cine biotech MiMedx. She was glob­al HR di­rec­tor dur­ing her eight-year run at As­traZeneca, then led HR at the phar­ma gi­ant’s spin­off Viela Bio un­til it was sold to Hori­zon for $3 bil­lion last year. Since then, Sur­dez had been head of HR for Vaxxin­i­ty.

Ren­ovoRx has named James Ahlers as CFO, suc­ceed­ing Christo­pher Lehman, who is head­ing for green­er pas­tures. Ahlers most re­cent­ly served as CFO of Intar­cia Ther­a­peu­tics and served in fi­nance roles at Ti­tan Phar­ma­ceu­ti­cals and Ansan Phar­ma­ceu­ti­cals.

In ad­di­tion, the com­pa­ny has re­cruit­ed Ronald Ko­cak as VP and con­troller. Ko­cak hops aboard from Sen­sei Bio­ther­a­peu­tics, where he was con­troller and se­nior di­rec­tor of fi­nance.

→ Backed in part by Ox­ford Sci­ence En­ter­pris­es, which start­ed its week off with a bang by rais­ing $300 mil­lion (£250 mil­lion), OMass Ther­a­peu­tics has plugged in Jon Rof­fery as VP, head of med­i­c­i­nal chem­istry. Rof­fery had led drug dis­cov­ery at Nan­na Ther­a­peu­tics since Feb­ru­ary 2021, and he’s al­so been di­rec­tor of chem­istry at Az­e­ria Ther­a­peu­tics. Ox­ford Sci­ence En­ter­pris­es con­tributed to OMass’ $100 mil­lion Se­ries B in April along­side such in­vestors as Syn­cona and GV.

De­bra Hus­sain

→ Now that Ea­gle Phar­ma­ceu­ti­cals plunked down $103 mil­lion for Aca­cia Phar­ma and its ap­proved meds Barhem­sys and By­fa­vo in late March, De­bra Hus­sain will help with the re­launch of both prod­ucts as SVP, head of com­mer­cial. Hus­sain was Aca­cia’s chief com­mer­cial of­fi­cer un­til the deal was made, and she held a string of roles dur­ing a 22-year tenure at Eli Lil­ly that con­clud­ed in 2021 as se­nior di­rec­tor of mar­ket­ing.

→ Based in the small Cana­di­an bor­der town of Baudette, MN — tout­ed as the wall­eye cap­i­tal of the world — ANI Phar­ma­ceu­ti­cals has reeled in Mered­ith Cook as SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. Cook spent the last two years as VP and as­so­ciate gen­er­al coun­sel for Am­neal Phar­ma­ceu­ti­cals af­ter join­ing the com­pa­ny in 2019 as VP, trans­ac­tions.

Serene Forte

→ Swiss-based Re­lief Ther­a­peu­tics is bring­ing on Serene Forte as SVP, head of ge­net­ic med­i­cine. Forte hails from RCP Bio, where she served as CSO. Pri­or to that, she was VP, med­ical af­fairs — gene ther­a­py at Krys­tal Biotech. Ear­li­er in her ca­reer, Forte had gigs at PTC Ther­a­peu­tics, Sarep­ta and Med­im­mune.

Rel­ma­da Ther­a­peu­tics is reel­ing in John Hixon as head of com­mer­cial. Hixon had a 31-year stint at Eli Lil­ly, most re­cent­ly serv­ing as se­nior di­rec­tor for glob­al new prod­uct plan­ning — bio­med­i­cines.

Corvus Phar­ma­ceu­ti­cals has ap­point­ed James Rosen­baum as SVP of re­search. Rosen­baum is a rheuma­tol­o­gist and im­mu­nol­o­gist and is a for­mer pro­fes­sor of oph­thal­mol­o­gy, med­i­cine and cell bi­ol­o­gy at Ore­gon Health & Sci­ence Uni­ver­si­ty.

Jeff Hat­field

Vi­vid­ion CEO Jeff Hat­field has been named chair­man of the board of di­rec­tors at re­peatome-fo­cused ROME Ther­a­peu­tics, which fea­tures ARCH’s Kristi­na Burow, Nim­bus CEO Jeb Keiper and ROME CEO Rosana Kapeller. Hat­field, a Bris­tol My­ers vet and board mem­ber at George Scan­gosVir Biotech­nol­o­gy, re­placed Diego Mi­ralles as Vi­vid­ion chief in No­vem­ber 2020.

→ Cam­bridge, MA-based GV20 Ther­a­peu­tics is pick­ing up a trio of ad­vi­sors with the ap­point­ments of Alessan­dra Ce­sano (CMO of ES­SA Phar­ma­ceu­ti­cals), Julie Cher­ring­ton (for­mer CEO and pres­i­dent of ARCH On­col­o­gy) and Mike Var­ney (cur­rent chair of R&D with Eras­ca and ex-head of Genen­tech Re­search and Ear­ly De­vel­op­ment).

Dan­nielle Ap­pel­hans

→ Pick­ing up the pieces af­ter dis­as­trous an­i­mal stud­ies for its he­mo­phil­ia A gene ther­a­py pro­gram, Gen­er­a­tion Bio has elect­ed No­var­tis vet Dan­nielle Ap­pel­hans to the board of di­rec­tors. Ap­pel­hans sur­faced on Peer Re­view a year ago around this time when she took the COO job at Ru­bius.

→ We’re not done with Ru­bius ex­ecs get­ting board gigs, as Jose Car­mona joins the board at al­losteric drug de­vel­op­er HotSpot Ther­a­peu­tics. Car­mona, the CFO at Ru­bius for near­ly two years, is al­so on the board of di­rec­tors at Sen­da Bio­sciences.

→ Bel­gian biotech Apax­en, whose lead pro­gram is an NL­RP3 in­flam­ma­some in­hibitor for pul­monary ar­te­r­i­al hy­per­ten­sion, has pegged Gra­ham Dixon as chair­man of the board. The As­traZeneca alum has al­so been CSO of Gala­pa­gos, where CAR-T is now a part of ex-J&J star Paul Stof­fels’ turn­around project.

Bill Symonds

→ Af­ter pick­ing up GSK vet Amol Ketkar as chief de­vel­op­ment of­fi­cer at the start of the month, Lon­don-based Res­o­lu­tion Ther­a­peu­tics has now brought Bill Symonds on­to its board of di­rec­tors. Symonds serves as the CEO of Sum­i­to­vant sub­sidiaries Al­ta­vant Sci­ences and En­zy­vant Sci­ences and is al­so the for­mer chief de­vel­op­ment of­fi­cer of Roivant Sci­ences.

Mitch Gold has re­served space at Alpine Im­mune Sci­ences for Viela Bio co-founder Jörn Drap­pa on the board of di­rec­tors. Drap­pa, an Am­gen and Genen­tech vet, re­cent­ly left Ven­tyx Bio­sciences just eight months af­ter tak­ing the CMO job.

Car­los Al­bán

Car­los Al­bán is head­ed to the board of di­rec­tors at Pfiz­er spin­off Spring­Works Ther­a­peu­tics. Af­ter 26 years at Ab­bott, Al­bán be­came Ab­b­Vie’s EVP, com­mer­cial op­er­a­tions in 2018 and re­tired as chief com­mer­cial of­fi­cer in March 2021.

Eiger Bio­Phar­ma­ceu­ti­cals — the com­pa­ny that re­ceived an FDA OK back in 2020 in Prog­e­ria for a drug Mer­ck li­censed to them at no cost — has made the ad­di­tion of Lisa Kel­ly-Croswell to its board of di­rec­tors. Kel­ly-Croswell cur­rent­ly serves as SVP and chief hu­man re­sources of­fi­cer at Boston Med­ical Cen­ter Health Sys­tem and is the for­mer hu­man re­sources lead at Ver­tex.

→ Back in 2021, iOmx Ther­a­peu­tics bagged $75.3 mil­lion in a Se­ries B to search for im­mune check­point tar­gets on tu­mor cells. Now the Ger­man com­pa­ny is adding three new mem­bers to its ad­vi­so­ry board: Matthias Kro­may­er (man­ag­ing part­ner at MIG Cap­i­tal), Michael Burgess (head of R&D at Spring­Works Ther­a­peu­tics) and Rain­er Kramer (CBO at Im­mat­ics).

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,300+ biopharma pros reading Endpoints daily — and it's free.

BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,300+ biopharma pros reading Endpoints daily — and it's free.

No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,300+ biopharma pros reading Endpoints daily — and it's free.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,300+ biopharma pros reading Endpoints daily — and it's free.