With sotro­vimab in the bal­ance, Bio­gen vet re­unites with George Scan­gos at Vir; First woman to chair PhRMA has more in store at Take­da

Jo­han­na Friedl-Nader­er

Vir Biotech­nol­o­gy is get­ting an­oth­er Bio­gen vet to join up as the start­up’s new glob­al CBO and EVP.

While Jo­han­na Friedl-Nader­er of­fi­cial­ly doesn’t start her first C-suite role for an­oth­er few weeks on March 2, she will join the com­pa­ny in the midst of con­flict­ing da­ta re­gard­ing its Glax­o­SmithK­line-part­nered Covid-19 an­ti­body, and armed with decades of work­ing at the re­cent­ly-em­broiled Bio­gen.

Friedl-Nader­er re­cent­ly hint­ed at her up­com­ing de­par­ture from the com­pa­ny on a LinkedIn post: “Af­ter 21 won­der­ful years with Bio­gen, I am em­bark­ing on a new stage of what has been a re­mark­able jour­ney … Thank you to my dear col­leagues in Bio­gen and the many peo­ple work­ing tire­less­ly to change lives. Your work will con­tin­ue to change the world. I look for­ward to much more to come!”

With the move comes a bit of a re­union: Friedl-Nader­er and Vir CEO George Scan­gos used to work to­geth­er while Scan­gos was CEO at Bio­gen, be­fore he moved on to head up Vir in 2017. Oth­ers have joined the biotech from Bio­gen, such as board chair Vic­ki Sato — the for­mer pres­i­dent and CSO of Ver­tex who had spent time at Bio­gen as VP of re­search — and Howard Horn, Vir’s CFO and for­mer­ly Bio­gen’s VP, busi­ness plan­ning.

“Jo­han­na is an ex­pe­ri­enced com­mer­cial ex­ec­u­tive with an im­pres­sive range of glob­al op­er­a­tional ex­per­tise and lead­er­ship suc­cess, and I am thrilled to have the op­por­tu­ni­ty to work with her again,” Scan­gos said in a state­ment. “She will be crit­i­cal to the fu­ture growth and suc­cess of Vir, as we ac­cel­er­ate and build our port­fo­lio of med­i­cines aimed at se­ri­ous in­fec­tious dis­eases, and con­tin­ue to ex­pand pa­tient ac­cess to our first com­mer­cial prod­uct.”

Be­fore start­ing at Bio­gen in 2001, she orig­i­nal­ly hailed from Take­da — and worked her way up the ranks at Bio­gen from prod­uct spe­cial­ist to coun­try man­ag­er all the way up to her cur­rent role as pres­i­dent of Eu­rope, Cana­da and part­ner mar­kets since 2019. While it re­mains un­clear as to what ex­act­ly Friedl-Nader­er will do once she steps in­to her new job, Vir said she will be re­spon­si­ble for shap­ing the com­pa­ny’s cor­po­rate and port­fo­lio strat­e­gy and dri­ving the com­pa­ny’s BD ef­forts.

“Un­der the lead­er­ship of George Scan­gos and an im­pres­sive se­nior ex­ec­u­tive team, Vir’s sci­en­tif­ic tra­jec­to­ry has been swift and its im­pact on pa­tients around the world sig­nif­i­cant,” Friedl-Nader­er said. “I am de­light­ed to have the op­por­tu­ni­ty to con­tribute to such an im­por­tant mis­sion of ad­dress­ing some of the world’s most se­ri­ous in­fec­tious dis­eases, and to help fur­ther the com­pa­ny’s growth and evo­lu­tion.”

Vir has made a quick his­to­ry for it­self since Scan­gos joined up to helm the com­pa­ny five years ago, when ARCH Ven­tures co-founder Bob Nelsen com­mit­ted $150 mil­lion to the tech­nol­o­gy pre­sent­ed by Vir sci­en­tif­ic co-founders Louis Pick­er and Klaus Frueh. Af­ter of­fi­cial­ly “com­ing out” 10 months lat­er with more than half a bil­lion dol­lars in fund­ing and part­ner­ships with Al­ny­lam and Vis­ter­ra, the biotech then went pub­lic in 2019 — hop­ing to raise $150 mil­lion in an IPO, but end­ed up with $143 mil­lion. More re­cent­ly, the biotech teamed up with Gilead in a clin­i­cal col­lab­o­ra­tion for an HBV cure.

This week, Vir has got­ten caught up in com­pet­ing da­ta over sotro­vimab, the Covid-19 mon­o­clon­al an­ti­body un­der EUA that Vir has been co-de­vel­op­ing with GSK. Co­lum­bia Uni­ver­si­ty HIV re­searcher and an­ti­body ex­pert David Ho re­leased a preprint ear­li­er this week that sug­gest­ed that doc­tors might not be able to use the an­ti­body for much longer — say­ing that the an­ti­body isn’t ef­fec­tive against the BA.2 Omi­cron sub­vari­ant.

Vir re­spond­ed with a late night re­lease on Wednes­day night, say­ing their own lab analy­ses sug­gest the an­ti­body “re­tains neu­tral­iz­ing ac­tiv­i­ty” against the sub­vari­ant — and that the biotech will have its own preprint in the com­ing days.

Paul Schloess­er


Ra­mona Se­queira

→ Let’s sort out the lat­est from Take­da, as a new role awaits Ra­mona Se­queira — the first woman to chair the board of di­rec­tors at PhRMA. Se­queira, who ar­rived at Take­da in 2015 by way of Eli Lil­ly, will jump from pres­i­dent of the Japan­ese phar­ma’s US busi­ness unit to pres­i­dent of the new Glob­al Port­fo­lio Di­vi­sion on April 1. This di­vi­sion “will bring to­geth­er three glob­al teams and three re­gion­al busi­ness­es to en­sure the com­pa­ny can suc­cess­ful­ly bring new and ex­ist­ing glob­al prod­ucts to pa­tients,” the re­lease states.

Se­queira’s next chap­ter at Take­da sets off a string of in-house ap­point­ments: Julie Kim will re­place Se­queira as pres­i­dent of the US busi­ness unit and US coun­try head, and Giles Plat­ford will be slot­ted in­to the role Kim has held, Take­da’s pres­i­dent of the PDT (plas­ma de­rived ther­a­pies) busi­ness unit.

One ex­ec who has start­ed in his new post right away is Shire alum Gabriele Ric­ci, the ex-head of IT for the PDT unit who’s now get­ting ac­cli­mat­ed to his ap­point­ment as chief da­ta and tech­nol­o­gy of­fi­cer. All this re­fin­ing of the lead­er­ship has tak­en place at Take­da as vac­cines chief Ra­jeev Venkayya has al­so an­nounced his de­par­ture for an undis­closed CEO job.

Se­queira takes over for Lil­ly CEO David Ricks as chair of the board at PhRMA, which al­so named No­var­tis chief Vas Narasimhan as board chair-elect and Gilead CEO Dan O’Day as trea­sur­er.

Mark Vel­le­ca

→ Reemerg­ing as a CEO for the first time since de­camp­ing from G1 Ther­a­peu­tics at the start of 2021, Mark Vel­le­ca has re­placed Sapan Shah as the chief ex­ec­u­tive at AAV gene ther­a­py play­er Stride­Bio out of North Car­oli­na. In ad­di­tion to main­tain­ing a pres­ence at G1 as a board mem­ber and se­nior ad­vi­sor, Vel­le­ca has been an ad­vi­sor on Stride­Bio’s board since No­vem­ber and a ven­ture part­ner at Hat­teras Ven­ture Part­ners. The for­mer EVP at the Leukemia & Lym­phoma So­ci­ety is al­so on the board of di­rec­tors at Black Di­a­mond. Stride­Bio, which has sewn up pacts with Take­da and Sarep­ta, notched an $85 mil­lion Se­ries B in March 2021 to bring four pro­grams clos­er to the clin­ic.

Chris­tine Roth

Chris­tine Roth is next in line as head of the on­col­o­gy strate­gic busi­ness unit at Bay­er’s phar­ma­ceu­ti­cals di­vi­sion, re­plac­ing 26-year Bris­tol My­ers Squibb vet Robert La­Caze. Roth’s Big Phar­ma back­ground dates back to her own time at Bris­tol My­ers as an ex­ec­u­tive di­rec­tor, and sand­wiched in be­tween sep­a­rate tenures at GSK, she was VP, glob­al dis­ease leader and lat­er the head of the breast can­cer fran­chise at No­var­tis. Roth has a few more weeks left as GSK’s glob­al on­col­o­gy ther­a­py area head un­til she starts March 1 at Bay­er, which just called it quits on de­vel­op­ing cough drug eli­apix­ant with long­time dance part­ner Evotec.

Al San­drock

→ Chalk up an­oth­er board ap­point­ment for Al San­drock as life af­ter Bio­gen has tak­en him to AI up­start Verge Ge­nomics, a CNS-fo­cused com­pa­ny helmed by Al­ice Zhang that should be up his al­ley. Last week, San­drock was giv­en a seat on the board of Voy­ager Ther­a­peu­tics with his old com­pa­ny con­tin­u­ing to get lam­bast­ed over Aduhelm.

Alan Bash

Art Krieg has found his man to lead Check­mate Phar­ma­ceu­ti­cals. Alan Bash will end his 23-year as­so­ci­a­tion with Bris­tol My­ers and be­come pres­i­dent and CEO of Check­mate on March 1, re­liev­ing Alan Fuhrman of his in­ter­im du­ties in both ca­pac­i­ties. Bash, the US launch lead for Op­di­vo, is the drug gi­ant’s SVP, com­mer­cial mod­el in­no­va­tion for on­ly a few more weeks and he was pre­vi­ous­ly head of com­mer­cial for im­munol­o­gy and fi­bro­sis. Back in Oc­to­ber, Bar­ry Labinger an­nounced he would no longer be CEO of Check­mate, a biotech mired in pen­ny stock ter­ri­to­ry af­ter once trad­ing at $15 a share — a drop by as­so­ci­a­tion when TLR9 coun­ter­part Idera flopped in Phase III. Fuhrman will con­tin­ue as a mem­ber of the board of di­rec­tors.

Marie Trad

→ In the wake of Sarep­ta de­cou­pling from its part­ner­ship with Lyso­gene, the French gene ther­a­py biotech has ap­point­ed Marie Trad as CMO. Trad, the ex-VP and CNS ther­a­peu­tic area head at IQVIA, found­ed and was pres­i­dent of neu­ro con­sult­ing firm Neu­ral­tra. In Oc­to­ber 2020, Lyso­gene re­port­ed the death of a child with mu­copolysac­cha­ri­do­sis type II­IA (MPS II­IA) who was tak­ing Lyso­gene’s lead drug LYS-SAF302, the cen­ter­piece of a $125 mil­lion deal with Sarep­ta in 2018. Trad’s hir­ing al­so comes as Lyso­gene dos­es its third child with the gene ther­a­py LYS-GM101 for GM1 gan­gliosi­do­sis.

→ Re­mem­ber last week’s edi­tion of Peer Re­view when Marc Gras­so sig­naled his de­par­ture as CFO and CBO of Ku­ra On­col­o­gy? He’s now turned up as CFO of Alec­tor, which has snared its sec­ond ex­ec in as many months af­ter Sara Kenkare-Mi­tra left Genen­tech to be­come pres­i­dent and head of R&D. The de­fec­tions of pres­i­dent and COO Shehnaaz Suli­man (now CEO of Re­Code Ther­a­peu­tics) and CMO Robert Paul (now CEO at Nine Square Ther­a­peu­tics) have left Alec­tor’s lead­er­ship in a fur­ther state of flux, so we’ll keep a sharp eye on who fills those C-suite po­si­tions next at the GSK neu­ro part­ner.

Amy Pe­ter­son

Amy Pe­ter­son has been pro­mot­ed to pres­i­dent and COO of Cy­tomX. Pe­ter­son had been the CMO of im­muno-on­col­o­gy at BeiGene from 2016-19 be­fore shift­ing gears to Cy­tomX as chief de­vel­op­ment of­fi­cer. Her pro­mo­tion comes near­ly two years af­ter Cy­tomX, a biotech which has seen a de­cid­ed­ly mixed bag of Big Phar­ma part­ner­ships with the likes of Bris­tol My­ers and Pfiz­er, re­ceived a shot of adren­a­line from an I/O pact with Astel­las.

Lisa Michaels

→ Ac­cord­ing to an SEC fil­ing, Lisa Michaels is out as CMO of Ed­i­tas Med­i­cine ef­fec­tive im­me­di­ate­ly, 15 months in­to the job. Michaels’ ouster comes sev­er­al months af­ter a da­ta read­out for its CRISPR-based eye gene ther­a­py cre­at­ed more ques­tions than an­swers on ef­fi­ca­cy. Our Max Gel­man wrote about those da­ta when they were re­vealed and has more on this va­can­cy as CEO Jim Mullen goes back to the draw­ing board search­ing for an­oth­er med­ical chief.

Lau­rens Kruide­nier

Fab­rice Chouraqui’s AI drug dis­cov­ery up­start Cel­lar­i­ty has plugged in a triple threat of new ex­ecs. Tak­ing the open­ing kick­off, Lau­rens Kruide­nier has joined the Flag­ship com­pa­ny as CSO, shift­ing gears here from the CSO job at Prometheus Bio­sciences. Dri­ving it down the field is An­na O’Driscoll, who worked in HR at J&J and was the VP of hu­man re­sources at Al­ny­lam be­fore tak­ing on the role of chief peo­ple of­fi­cer. And to com­plete this im­promp­tu Su­per Bowl theme, spik­ing it in the end zone is Parul Doshi, who breaks away from Take­da af­ter 16 years to be­come SVP, head of da­ta and soft­ware en­gi­neer­ing.

Kim Strat­ton just re­placed the ail­ing An­ders Os­wald as CEO of Cen­to­gene, and the lat­est lead­er­ship news from the US-Ger­man rare dis­ease play­er is the res­ig­na­tion of CFO René Just, ef­fec­tive March 31. Miguel Co­ego Rios has been named as EVP of fi­nance & le­gal and in­ter­im CFO while a search is un­der­way for Just’s suc­ces­sor. Al­though there’s an Or­p­hazyme con­nec­tion with Rios and Strat­ton, their time at the biotech didn’t over­lap: Rios was VP & gen­er­al man­ag­er, South Eu­rope at Or­p­hazyme af­ter Strat­ton’s de­par­ture, and on­ly for sev­en short months. To fin­ish his eight years at Shire, Rios was gen­er­al man­ag­er of the An­dean re­gion (Colom­bia, Ecuador, Pe­ru and Venezuela).

Bi­joyesh Mook­er­jee

→ Chi­na’s Sim­cere, which inked an Alzheimer’s deal with Ger­man biotech Vivory­on Ther­a­peu­tics in June 2021 on the heels of the con­tentious Aduhelm ap­proval, has tapped Bi­joyesh Mook­er­jee as CMO, on­col­o­gy for phar­ma­ceu­ti­cals. Mook­er­jee has held posts at As­traZeneca, In­cyte and GSK, and he moves on to Sim­cere hav­ing spent the last sev­en years at No­var­tis On­col­o­gy, most re­cent­ly as VP & se­nior glob­al pro­gram clin­i­cal head.

An­toinette Paone

→ Non-vi­ral gene ther­a­py out­fit Gen­er­a­tion Bio has pro­mot­ed An­toinette Paone to COO, mov­ing up from her pre­vi­ous role as SVP and head of reg­u­la­to­ry af­fairs and qual­i­ty. Paone, a 12-year Ver­tex vet in reg­u­la­to­ry af­fairs, first be­came an ex­ec at Gen­er­a­tion Bio in 2018, and tak­ing over as COO will be no small task as the biotech tries to re­cov­er from a mon­u­men­tal blow it suf­fered with its lead he­mo­phil­ia gene ther­a­py pro­gram in De­cem­ber, crush­ing its stock af­ter strut­ting on­to Nas­daq with a $230 mil­lion IPO in the sum­mer of 2020.

Paula Cloghessy

→ Two lead­ing mi­cro­bio­me play­ers have ap­point­ments to share: First, Paula Cloghessy has been named chief peo­ple of­fi­cer at Seres Ther­a­peu­tics. Cloghessy held the same po­si­tion at Trans­late Bio, the mR­NA biotech that Sanofi snapped up for $3.2 bil­lion in one of the more promi­nent M&A deals of 2021. De­spite a sig­nif­i­cant set­back in ul­cer­a­tive col­i­tis last sum­mer, Seres CEO Er­ic Shaff was res­olute: “We’ve been here be­fore as a team and as a com­pa­ny, and we’re dis­ap­point­ed, but by no means are we de­terred,” he told End­points News.

Al­ka Baty­cky

→ Next on the mi­cro­bio­me radar, Mark Smith-led Finch Ther­a­peu­tics has a col­lec­tion of ap­point­ments, and chief tech­nol­o­gy of­fi­cer Bryan Gillis leads off. Gillis has a wealth of ex­pe­ri­ence from Am­gen, Lon­za, Sanofi and Alex­ion, and since 2018 he had served as VP of gene ther­a­py man­u­fac­tur­ing and sup­ply at Ru­bius Ther­a­peu­tics. AM­AG Phar­ma­ceu­ti­cals vet Al­ka Baty­cky (chief de­vel­op­ment of­fi­cer) just held the same post at now-de­funct Ohana Bio­sciences and is the ex-COO of Akashi Ther­a­peu­tics. Fi­nal­ly, Howard Franklin (SVP, late-stage de­vel­op­ment and GI ther­a­peu­tic area lead) ven­tures off to Finch af­ter a re­turn en­gage­ment at Sal­ix Phar­ma­ceu­ti­cals, this time as CMO — he had been VP, glob­al busi­ness de­vel­op­ment at Sal­ix from 2013-16.

Nan­cy Agraw­al

→ Back in No­vem­ber, Roche dumped Atea af­ter its Covid-19 an­tivi­ral pill failed to show pos­i­tive re­sults in a small study. Boston-based Atea hopes to turn things around in 2022 with the ap­point­ment of Nan­cy Agraw­al as EVP of pre­clin­i­cal de­vel­op­ment, tak­ing over for the re­tir­ing Steven Good. Agraw­al is a 25-year vet­er­an of Mer­ck, where she most re­cent­ly served as VP of phar­ma­co­ki­net­ics, phar­ma­co­dy­nam­ics, and drug me­tab­o­lism.

Samyang Bio­pharm has tapped Eun-Ju Ryu as pres­i­dent of Samyang Bio­pharm USA. Ryu had a 12-year stint at Pfiz­er and a 6-year gig at Pfiz­er Ko­rea. Dur­ing her time at Pfiz­er, Ryu start­ed as reg­u­la­to­ry man­ag­er and lat­er moved in­to roles in the clin­i­cal tri­al man­age­ment team, busi­ness de­vel­op­ment and glob­al mar­ket­ing. Lat­er on, she be­came head of on­col­o­gy and spe­cial­ty busi­ness unit at Pfiz­er Ko­rea.

Robert Crane

Flag­ship up­start Ax­cel­la — fo­cused on en­doge­nous meta­bol­ic mod­u­la­tors (EMM) to treat dis­eases like NASH and re­cur­rent overt he­pat­ic en­cephalopa­thy — has hand­ed CFO du­ties to Robert Crane. A one­time part­ner at Mont­gomery Ven­tures, Crane has been CFO at such com­pa­nies as Pfiz­er spin­out Pyx­is On­col­o­gy and TScan, which both made their Nas­daq de­buts in 2021.

Chuck Sil­ber­stein

Adel Na­da’s reg­u­la­to­ry T cell (Treg) team at Gen­tiBio, which has a hefty $157 mil­lion Se­ries A at its dis­pos­al, has wel­comed Chuck Sil­ber­stein as CFO. Sil­ber­stein rolls in­to Gen­tiBio from Ap­plied Ther­a­peu­tics, where he was CFO and head of busi­ness de­vel­op­ment. From 2018-20, the for­mer ex­ec­u­tive di­rec­tor and US health­care an­a­lyst at JP Mor­gan was SVP, cor­po­rate busi­ness de­vel­op­ment for Al­ler­gan.

Prashant Nam­biar

Prashant Nam­biar has signed on to be­come SVP, re­search and trans­la­tion­al de­vel­op­ment with Strand Ther­a­peu­tics, which sur­faced last June with a $52 mil­lion Se­ries A in its quest to use “ge­net­i­cal­ly pro­grammed log­ic cir­cuits” to de­vel­op mR­NA-based can­di­dates. Nam­biar, the ex-VP, pre­clin­i­cal and trans­la­tion­al de­vel­op­ment at blue­bird bio and then Nick Leschly’s on­col­o­gy-fo­cused spin­off 2sev­en­ty­Bio, no­tably held the role of se­nior di­rec­tor, strat­e­gy and op­er­a­tions dur­ing his 10-year run at Pfiz­er.

Bas­t­ian Dehmel

→ In May 2021, Oculis gath­ered up $57 mil­lion in a Se­ries C, giv­ing the Swiss com­pa­ny’s top­i­cal al­ter­na­tives to in-the-eye in­jecta­bles an ex­tra boost. This week Oculis has in­stalled Bas­t­ian Dehmel, who spent more than a decade at Am­gen and was in charge of the phar­ma gi­ant’s cal­cimimet­ic fran­chise, as chief de­vel­op­ment of­fi­cer. Since 2017, Dehmel had been CMO of Swedish pri­ma­ry hy­per­ox­aluria spe­cial­ist Ox­Thera.

Ja­son Leverone has joined Boul­der, CO-based OnKure Ther­a­peu­tics as CFO. Be­fore join­ing OnKure, Leverone was CFO and sec­re­tary of mi­Ra­gen Ther­a­peu­tics. Pri­or to that, he was se­nior di­rec­tor of fi­nance and con­troller for Repli­dyne.

Bernard Lam­bert

→ Backed by At­las Ven­ture and RA Cap­i­tal when it broke through with a $75 mil­lion Se­ries A round, new ra­dio­phar­ma play­er Curie Ther­a­peu­tics has tapped Bernard Lam­bert as chief tech­nol­o­gy of­fi­cer. Lam­bert leaps to Curie from Telix Phar­ma­ceu­ti­cals, where he was pres­i­dent and COO of its US sub­sidiary, and he’s al­so been Ze­va­cor Phar­ma’s VP, CMC and ra­dio­phar­ma­ceu­ti­cal de­vel­op­ment.

Ad­verum Biotech­nolo­gies, which when we last re­port­ed was left in murky wa­ters af­ter re­veal­ing safe­ty is­sues with its ex­per­i­men­tal gene ther­a­py, has tacked on Richard Beck­man as CMO. Beck­man most re­cent­ly served as CMO of ReNeu­ron. Be­fore that, Beck­man had served stints at a long line of com­pa­nies in­clud­ing Clear­side Med­ical, Neu­rotech Phar­ma­ceu­ti­cals, Al­con Re­search, Danube Phar­ma­ceu­ti­cals and Al­ler­gan.

Nick Rob­bins-Cher­ry

Joe Dupere’s car­dio­vas­cu­lar cell ther­a­py biotech Ix­a­ka — which got its new be­gin­ning last Jan­u­ary af­ter rais­ing $54 mil­lion — ex­pands its crew with two new ap­point­ments: Nick Rob­bins-Cher­ry as CFO and board di­rec­tor and George O’Rourke as VP and gen­er­al man­ag­er of Ix­a­ka France. Be­fore join­ing Ix­a­ka, Rob­bins-Cher­ry was CFO of Vor­boss Lim­it­ed, a pri­vate eq­ui­ty-backed tele­coms in­fra­struc­ture busi­ness. O’Rourke joins Ix­a­ka from No­var­tis Gene Ther­a­pies, where he was VP and gen­er­al man­ag­er of France.

TargIm­mune Ther­a­peu­tics, which re­cent­ly wel­comed aboard Roche vets Pe­ter Braun (CEO) and Christoph Rentsch (CFO), has now made the ad­di­tion of Veron­i­ca Hers­berg­er to its ex­ec team as CMO. Hers­berg­er comes aboard from As­traZeneca, where she was glob­al prod­uct leader for Calquence and Lu­mox­i­ti. Pri­or to that, Hers­berg­er was with Roche, de­vel­op­ing Her­ceptin SC, Kad­cy­la and Per­je­ta.

→ AI play­er CelerisTx — which, al­so this week, teed up a deal with Mer­ck KGaAhas brought on Friedrich Kroll as VP of drug dis­cov­ery and Markus Müll­ner as VP of bi­ol­o­gy. Kroll joins the Men­lo Park, CA-based biotech with stints from Gala­pa­gos, Lund­beck, Phar­ma­cia and En­vi­go un­der his belt; while Müll­ner is a Phore­Most alum.

Yomara Gomez-Naiden

→ With zan­delis­ib mov­ing for­ward in sev­er­al tri­als, small San Diego can­cer play­er MEI Phar­ma has re­cruit­ed Ale­jan­dro Ri­cart as SVP, clin­i­cal de­vel­op­ment and Yomara Gomez-Naiden as SVP, qual­i­ty. Ri­cart had spent the last four years at TG Ther­a­peu­tics as VP of clin­i­cal de­vel­op­ment, and the No­var­tis On­col­o­gy vet had a hand in Keytru­da’s break­through ther­a­py des­ig­na­tion while he was with Mer­ck from 2015-17. A Mer­ck alum in her own right, Gomez-Naiden was re­cent­ly VP of cor­po­rate qual­i­ty at AGC Bi­o­log­ics, and she’s al­so served as se­nior di­rec­tor, head of GMP qual­i­ty as­sur­ance and qual­i­ty sys­tems for Ac­er­ta Phar­ma.

Mar­ti­na Schinke

→ From the peo­ple who brought you the first Vedere Bio, the se­quel — apt­ly named Vedere Bio II with $77 mil­lion in Se­ries A cashhas brought on Mar­ti­na Schinke as VP, pro­gram leader. Schinke comes to Cyrus Moza­yeni’s oc­u­lar gene ther­a­py biotech from mi­cro­bio­me-fo­cused Finch Ther­a­peu­tics, where she was VP, pro­gram man­age­ment & lead­er­ship. The No­var­tis alum was se­nior di­rec­tor, pro­gram man­age­ment for blue­bird bio’s on­col­o­gy port­fo­lio, one of the lead­ers in the de­vel­op­ment of BC­MA CAR-T Abec­ma.

→ The old say­ing “when it rains, it pours” cer­tain­ly ap­plies to all of John Maraganore’s post-Al­ny­lam ap­point­ments, which we’ve doc­u­ment­ed here. Rain Ther­a­peu­tics want­ed to make it known this week that they too sought out Maraganore as a spe­cial ad­vi­sor at the San Diego-based can­cer biotech, and he’s been lend­ing a hand since March 2021, well be­fore his re­tire­ment from Al­ny­lam, the re­lease states.

No­ra Ku

There are four oth­er new ex­ecs to dis­cuss at Rain: First, No­ra Ku (VP of clin­i­cal de­vel­op­ment) had pre­vi­ous­ly been VP of med­ical for Loxo On­col­o­gy at Lil­ly; Bue­naflor Nico­las (VP, head of glob­al drug safe­ty and phar­ma­covig­i­lance) re­cent­ly served as Gilead’s se­nior di­rec­tor of op­er­a­tions in glob­al pa­tient safe­ty; Am­gen vet Tina Kim-Hafken (VP and head of glob­al reg­u­la­to­ry af­fairs) leaves Seagen af­ter six years of reg­u­la­to­ry posts; and fi­nal­ly, Bay­er alum Steve Flint (VP of peo­ple & cul­ture) puts on his Rain gear and was Al­tru­Bio’s VP, hu­man re­sources for less than a year be­fore piv­ot­ing here.

→ ALS-cen­tered QurAlis has brought on a trio of new ex­ecs with the ap­point­ments of Bryan Bog­gs as head of reg­u­la­to­ry af­fairs; Christo­pher Ger­ry Lo­han as head of clin­i­cal op­er­a­tions; and Guzide Ad­hikari as head of glob­al sup­ply chain man­age­ment. Bog­gs, an Eli Lil­ly vet, spent the last 3o years in a va­ri­ety of roles, but most re­cent­ly served as di­rec­tor, glob­al reg­u­la­to­ry and phar­ma­covig­i­lance. Mean­while, Lo­han comes aboard with ex­pe­ri­ence from Ed­i­tas Med­i­cine, Ave­dro, scPhar­ma­ceu­ti­cals, Iron­wood Phar­ma­ceu­ti­cals, Medtron­ic and Boston Sci­en­tif­ic. Last, but cer­tain­ly not least, Ad­hikari comes with gigs from Trans­late Bio and Take­da un­der her belt.

Dana Hu-Lowe

WuXi-backed Ada­gene, which inked its third clin­i­cal tri­al col­lab­o­ra­tion with Mer­ck last Au­gust, has signed on Liu Yuwen as an in­de­pen­dent board mem­ber, Jip­ing Zha as EVP clin­i­cal de­vel­op­ment and Dana Hu-Lowe as VP of glob­al prod­uct team lead­er­ship. Liu has served as chair and CEO of Suzhou In­dus­tri­al Park Biotech De­vel­op­ment Co. for near­ly a decade. Mean­while, Zha joins with stints at Genen­tech, NGM Bio­phar­ma­ceu­ti­cals and Med­Im­mune un­der his belt; while Pfiz­er On­col­o­gy alum Hu-Lowe re­cent­ly served in gigs at Turn­ing Point Ther­a­peu­tics and Well­spring Bio­sciences.

→ Helmed by ex-Pur­due Phar­ma CEO Mark Tim­ney, sys­temic amy­loi­do­sis biotech At­tralus has en­list­ed James Tes­ta as VP of fi­nance sev­er­al months af­ter its $116 mil­lion Se­ries B haul. Tes­ta, the ex-VP of fi­nance and in­ter­nal con­trols at The Med­i­cines Com­pa­ny, has spent the last year as VP of fi­nance at BioRef­er­ence Lab­o­ra­to­ries.

Amy Berkley

Amy Berkley has been ap­point­ed as VP of pro­gram team lead­er­ship and strate­gic al­liances at Zachary Horn­by’s CA-based biotech Bound­less Bio. Berkley most re­cent­ly served as head of al­liance man­age­ment at Io­n­is Phar­ma­ceu­ti­cals. Be­fore her stint at Io­n­is, Berkley spent nine years at Halozyme, where she was se­nior di­rec­tor, al­liance man­age­ment.

Al­fon­so Zu­lue­ta

Al­fon­so “Chi­to” Zu­lue­ta has been giv­en a seat on the board of di­rec­tors at on­colyt­ic virus biotech Ca­li­di Bio­ther­a­peu­tics in its first Peer Re­view ap­pear­ance in two years. Zu­lue­ta, who re­tired from Eli Lil­ly at the end of last year, joined the board at Turn­ing Point Ther­a­peu­tics just a few weeks ago.

→ Syn­thet­ic lethal­i­ty play­er Cyteir Ther­a­peu­tics, which hit Nas­daq in June 2021 when IPOs were fly­ing in all di­rec­tions, has made for­mer Amarin CEO John Thero a mem­ber of its board of di­rec­tions. Thero re­tired from the Vas­cepa mak­er in Au­gust 2021 and is on the board of Cin­Cor Phar­ma, led by ex-Cor­vidia CEO Marc de Garidel.

Erik Har­ris

De­nali snap-hooked one in­to the trees to start 2022 when the FDA im­posed a clin­i­cal hold on its Alzheimer’s pro­gram DNL919, and now it’s a mat­ter of putting it back in the fair­way as Erik Har­ris gets added to the board of di­rec­tors. Har­ris, an alum of Genen­tech and Bris­tol My­ers, is chief com­mer­cial of­fi­cer at Ul­tragenyx.

→ San Diego’s Am­brx Bio­phar­ma has elect­ed Paul Maier to the board of di­rec­tors. Maier, the for­mer CFO of Lig­and Phar­ma­ceu­ti­cals and Se­quenom, has sev­er­al oth­er board seats to his cred­it, in­clud­ing 4D phar­ma and Eton Phar­ma­ceu­ti­cals.

On­coin­vent has pulled out a seat for Adri­an Senderow­icz as a non-ex­ec­u­tive di­rec­tor, suc­ceed­ing Jonas Einar­son, who is step­ping down from the board. Senderow­icz has held po­si­tions as VP glob­al reg­u­la­to­ry on­col­o­gy at Sanofi, and as CMO of Igny­ta, Cerulean, Tokai and Con­stel­la­tion Phar­ma. Senderow­icz al­so sits on the boards of Step Phar­ma and Puma Biotech­nol­o­gy.

Cell­phire Ther­a­peu­tics has ap­point­ed Pamela Con­ley to its board of di­rec­tors. Con­ley most re­cent­ly served as SVP, re­search and pre-clin­i­cal de­vel­op­ment at Por­to­la Phar­ma­ceu­ti­cals (ac­quired by Alex­ion in Ju­ly 2020).

Derek Graf al­so con­tributed to this edi­tion.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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