With Aduhelm in tat­ters, the search is on for Michel Vounatsos' re­place­ment at Bio­gen; David Liu, Roger Perl­mut­ter join in­sitro's SAB

Michel Vounatsos

→ Be­cause of the dearth of Alzheimer’s treat­ments, Bio­gen pushed ag­gres­sive­ly to cross the reg­u­la­to­ry goal line with ad­u­canum­ab de­spite ear­ly tri­al wrap-ups and per­va­sive ef­fi­ca­cy ques­tions. The high­ly con­tro­ver­sial ap­proval of Aduhelm, and the calami­tous roll­out that fol­lowed, proved to be the un­do­ing of CEO Michel Vounatsos, who was hired from with­in to re­place George Scan­gos on Jan. 6, 2017. Dis­cus­sions in the in­dus­try should be live­ly over who gets the job next at Bio­gen as Vounatsos will re­tain his po­si­tion un­til the com­pa­ny finds a suc­ces­sor, which will be no lat­er than Feb. 28, 2023.

Bio­gen found a friend­ly al­ly in Bil­ly Dunn’s neu­ro group at the FDA, and the agency ap­proved the Alzheimer’s drug in June 2021 de­spite a unan­i­mous ad­comm vote against the com­pound. Three mem­bers of the com­mit­tee re­signed once their deep reser­va­tions about the drug fell on deaf ears.

The die was cast for Aduhelm in Jan­u­ary when CMS re­strict­ed cov­er­age of the drug on­ly to pa­tients par­tic­i­pat­ing in clin­i­cal tri­als. Faced with lay­offs and oth­er cost-cut­ting mea­sures, Bio­gen waved the white flag on Aduhelm’s com­mer­cial ef­forts, es­sen­tial­ly shut­ting down all such op­er­a­tions, and it will be Vounatsos who will even­tu­al­ly take the fall.

How did we get here in the first place? Two Phase III stud­ies of ad­u­canum­ab were halt­ed ear­ly in March 2019 due to fu­til­i­ty, but Bio­gen did a 180 the fol­low­ing Oc­to­ber and tried to re­store hope for the drug in a new analy­sis that showed a po­ten­tial ef­fi­ca­cy sig­nal in one of the stud­ies, prompt­ing the com­pa­ny to make the bee­line to the FDA. As John Car­roll wrote in Oc­to­ber 2019: “The cred­i­bil­i­ty of the ex­ec­u­tive crew in charge of Bio­gen is al­so on the line. Win­ning here will be a lega­cy vic­to­ry for R&D chief Al San­drock and CEO Michel Vounatsos. Los­ing, af­ter this brouha­ha, will trig­ger a de­fin­i­tive loss of faith.”

In the af­ter­math of Aduhelm, both will be gone.

David Liu

David Liu and Roger Perl­mut­ter head­line the new­ly-formed sci­en­tif­ic ad­vi­so­ry board at Daphne Koller’s ma­chine learn­ing up­start in­sitro. Perl­mut­ter, the ex-Mer­ck R&D chief and cur­rent CEO of Eikon Ther­a­peu­tics, is al­ready on in­sitro’s board and is part of the ther­a­peu­tic ad­vi­so­ry group along­side Gio­van­na Mal­luc­ci and Mount Sinai’s Scott Fried­man. Liu, the founder of such com­pa­nies as Ed­i­tas Med­i­cine and Prime Med­i­cine, joins Dana Pe’er, Oliv­er Ste­gle and Gene Yeo in the cel­lu­lar en­gi­neer­ing and dis­ease mod­el­ing area. For sta­tis­ti­cal and trans­la­tion­al ge­net­ics, in­sitro has sum­moned Sir John Bell, Daniel MacArthur and George Dav­ey Smith to the SAB, while MIT’s Tom­mi Jaakko­la is the lone ap­pointee for mol­e­c­u­lar de­sign and ma­chine learn­ing.

Sri­ni Ra­manathan

→ Tout­ing new part­ner­ships for its sub­sidiaries (Van­tAI with J&J’s Janssen and Boehringer In­gel­heim, Pro­teo­vant with Blue­print Med­i­cines), Roivant has se­lect­ed Sri­ni Ra­manathan as chief de­vel­op­ment of­fi­cer. Ra­manathan was SVP of R&D sci­ences and site head of the South San Fran­cis­co of­fice of Hori­zon Ther­a­peu­tics be­fore jump­ing to Roivant, now run by Matt Gline and ex­act­ly a year re­moved from an­nounc­ing its SPAC deal with Jim Mom­tazee’s Montes Archimedes Ac­qui­si­tion Corp. Af­ter 13 years at Gilead, where he was head of clin­i­cal phar­ma­col­o­gy, Ra­manathan be­came se­nior project leader, im­munol­o­gy de­vel­op­ment at Ab­b­Vie.

David Mau­ro, who de­camped from Pre­lude Ther­a­peu­tics and was suc­ceed­ed by for­mer BeiGene hema­tol­ogy ex­ec Jane Huang, has signed on to ex­o­some-fo­cused Co­di­ak Bio­Sciences as CMO. Mau­ro has al­so been CMO of Ad­vax­is and Check­mate Phar­ma­ceu­ti­cals, Art Krieg’s biotech that Re­gen­eron just bought for a song a cou­ple weeks ago. Mau­ro’s pre­de­ces­sor, Jen­nifer Whel­er, spent just sev­en months as Co­di­ak’s med­ical chief be­fore found­ing Nav­i­gate Bio­Con­sult­ing, where she’s al­so a prin­ci­pal.

Robert Arch

→ Part­ner­ing with Mer­ck on a Keytru­daTa­vo com­bo, On­coSec has found some­one to fill the top spot. Robert Arch has tak­en over as pres­i­dent and CEO af­ter Bri­an Leuth­n­er bridged the gap as in­ter­im chief when Dan O’Con­nor stepped down. The state of flux in the lead­er­ship isn’t lim­it­ed to Leuth­n­er, who’s no longer with the com­pa­ny af­ter ini­tial­ly com­ing on board as COO in Feb­ru­ary 2021. The de­par­ture of CSO Chris Twit­ty, the res­ig­na­tion of chair Mar­garet Dale­san­dro and the ap­point­ment of CFO George Chi all re­cent­ly oc­curred with­in a five-month pe­ri­od, and now Arch takes cen­ter stage af­ter be­ing head of re­search at Elpi­science Bio­phar­ma from 2019-21. His Big Phar­ma back­ground ex­tends to Pfiz­er, GSK, Take­da (glob­al head of liv­er dis­ease re­search) and No­var­tis (head of the liv­er dis­ease de­part­ment at NI­BR in Chi­na).

Ganesh Kaun­dinya

Roche, 5AM and Sofinno­va Part­ners con­tributed to a $49 mil­lion Se­ries A for Gly­co­Era, a Swiss gly­co­bi­ol­o­gy biotech, last No­vem­ber. This week Gly­co­Era has picked up Ganesh Kaun­dinya as pres­i­dent and CEO. Kaun­dinya helped found Mo­men­ta in 2001, and for the next 17 years he would take on the roles of CSO and COO for the com­pa­ny that J&J bought for $6.5 bil­lion in Au­gust 2020.

Aled Williams

→ Mi­lan-based En­thera Phar­ma­ceu­ti­cals is sad­dling up Aled Williams as CEO and mem­ber of its board. Aled makes his way over to the au­toim­mune dis­ease biotech from Polyneu­ron, where he served as CBO. Pri­or to that, Williams was CCO of Vec­tivBio and Ther­a­chon and has al­so held roles at Bris­tol My­ers Squibb, No­var­tis and Roche.

JSR Life Sci­ences is crown­ing Mark Wom­ack CEO of not one, but two of its af­fil­i­ate com­pa­nies: KBI Bio­phar­ma and Se­lex­is SA. Wom­ack is fa­mil­iar with man­ning the helm of the ship, hav­ing served as CEO and man­ag­ing di­rec­tor of Stelis Bio­phar­ma pri­or to his new gig. Pre­vi­ous­ly, Wom­ack al­so served as CBO of AGC Bi­o­log­ics.

→ Com­ing from acad­e­mia, Pe­ter Hill­men has been named head of hema­tol­ogy en­gage­ment for Apel­lis, chal­leng­ing Soliris with last year’s ap­proval of parox­ys­mal noc­tur­nal he­mo­glo­bin­uria drug Em­paveli last year and look­ing to break through with pegc­eta­coplan in ge­o­graph­ic at­ro­phy. Hill­men has served as pro­fes­sor of ex­per­i­men­tal hema­tol­ogy at Leeds In­sti­tute of Med­ical Re­search and led the Leeds Na­tion­al Com­mis­sion­ing Group Des­ig­nat­ed Cen­tre for PNH.

Joshua Reed

→ We have an­oth­er batch of ap­point­ments at Flag­ship’s epi­ge­net­ics play­er Omega Ther­a­peu­tics, where a $126 mil­lion Se­ries C was raised last year to ad­vance its lead can­di­date OTX-2002. Roger Sawh­ney will shift in­to the role of CBO, while Joshua Reed has been giv­en the nod to re­place Sawh­ney as CFO on May 23. Reed has been CFO of Aldeyra Ther­a­peu­tics since Ju­ly 2018 and he held var­i­ous po­si­tions in more than 12 years at Bris­tol My­ers, in­clud­ing VP and head of fi­nance op­er­a­tions for the US and Puer­to Ri­co. For the last year, he’s had a seat on a board at Schol­ar Rock that al­so fea­tures Ar­rakisMichael Gilman and ARCH’s Kristi­na Burow.

Zu­ra­nolone mak­er Sage in­sert­ed the ap­point­ment of Mark Pol­lack as SVP, med­ical af­fairs in­to its Q1 re­port this week. Pol­lack is a long­time pro­fes­sor of psy­chi­a­try at Har­vard who had been CMO of the neu­ro­science busi­ness unit at Myr­i­ad Ge­net­ics. Sage CEO Bar­ry Greene used the Q1 run­down to play up the ear­ly da­ta for SAGE-718 in pa­tients with Alzheimer’s that the biotech re­leased a month ago. The drug is al­so be­ing stud­ied in Parkin­son’s and Hunt­ing­ton’s dis­ease.

Stu­art Green

→ Re­plen­ish­ing the cash sup­ply with a $140 mil­lion Se­ries C led by the sec­ond Soft­Bank Vi­sion Fund and RA Cap­i­tal in Feb­ru­ary, Ven­tus Ther­a­peu­tics has tapped Stu­art Green as CMO. Green is a 21-year vet of Mer­ck Re­search Lab­o­ra­to­ries, where he spent the last decade as VP, late stage de­vel­op­ment and played a cru­cial role in the ap­provals of such drugs as the rag­weed al­ler­gy med­i­cine Rag­witek and Sun Phar­ma-part­nered Ilumya. This is an­oth­er ma­jor ex­ec mov­ing on from Mer­ck Re­search Lab­o­ra­to­ries fol­low­ing CMO Roy Baynesde­ci­sion to re­unite with Roger Perl­mut­ter at Eikon in Ju­ly.

Stephen Mul­len­nix

→ Back in Sep­tem­ber 2020, Peer Re­view told you about Stephen Mul­len­nix go­ing to CRO Pro­Scien­to as its fi­nance chief. Fast for­ward to this week, and Mul­len­nix has tak­en the CFO job at Per­ci­val Bar­reto-Ko’s pro­tein degra­da­tion biotech Plex­i­um, which struck a deal last week with Ab­b­Vie worth $35 mil­lion up­front af­ter team­ing up with Am­gen in Feb­ru­ary. Mul­len­nix has al­so been chief op­er­at­ing and fi­nan­cial of­fi­cer for Uro­Gen.

Joan­na Brew­er

Afa­mi-cel mak­er Adap­ti­m­mune has pro­mot­ed Joan­na Brew­er to CSO, strut­ting to the C-suite af­ter al­most two and a half years as SVP, al­lo­gene­ic re­search and 13 years over­all with the team. Adap­ti­m­mune has been study­ing the afore­men­tioned T cell ther­a­py in pa­tients with ad­vanced syn­ovial sar­co­ma or myx­oid/round cell li­posar­co­ma, and the Ox­ford-based biotech hopes to have a BLA sub­mit­ted “in late 2022.”

An­drea Pel­la­cani

→ Ex­am­in­ing Claudin-1’s role in fi­brot­ic dis­eases and haul­ing in a $67 mil­lion Se­ries B to do so, Swiss-based Alen­tis Ther­a­peu­tics has lined up Big Phar­ma vet An­drea Pel­la­cani as CMO. Af­ter se­nior med­ical and R&D posts at Mer­ck and GSK, Pel­la­cani then jumped ship for Am­gen in 2011 as ex­ec­u­tive med­ical di­rec­tor, glob­al de­vel­op­ment. From 2015-21, Pel­la­cani was in charge of R&D at Menar­i­ni Group.

Maude Tessier

→ And then there’s Maude: Jo Viney’s start­up Seis­mic Ther­a­peu­tic has ap­point­ed Maude Tessier as CBO, sev­er­al weeks af­ter Er­ic Lar­son and Heather Vi­tal joined the team. In her pre­vi­ous gig as busi­ness chief of Ike­na On­col­o­gy, the Bris­tol My­ers part­ner once known as Kyn Ther­a­peu­tics sprung on­to the Nas­daq scene with a nine-fig­ure IPO last spring. Be­fore mov­ing on to Ike­na, Tessier was ex­ec­u­tive di­rec­tor, busi­ness de­vel­op­ment and li­cens­ing at Mer­ck.

Chris­tine Bak­er

→ US-Aus­tri­an are­navi­ral im­munother­a­py biotech Hookipa Phar­ma has pro­mot­ed Chris­tine Bak­er to COO. Af­ter 14 years at No­var­tis On­col­o­gy, where she rose to VP, ear­ly com­mer­cial strat­e­gy, Bak­er had a brief stay as busi­ness chief of Epi­cen­tRx be­fore tak­ing the CBO job at Hookipa in the sum­mer of 2019. Sev­er­al weeks ago, she be­came a board mem­ber at Tyme Tech­nolo­gies, the slump­ing mi­cro­cap that just named Dou­glas Michels as chair­man.

Sim­rat Rand­hawa

→ Com­ing out of stealth, Di­anthus Ther­a­peu­tics launched with a $100 mil­lion Se­ries A and an­nounced the ap­point­ment of Sim­rat Rand­hawa as CMO. Rand­hawa jump­start­ed his ca­reer in biotech at Bio­Marin be­fore com­plet­ing a 13-year stint at No­var­tis and a 5-year gig at Au­rinia Phar­ma­ceu­ti­cals.

Rand­hawa isn’t the on­ly fresh face on the ex­ec team, the com­pa­ny’s CEO and pres­i­dent, Mari­no Gar­cia, joined not too long ago him­self back in No­vem­ber of last year — bring­ing ex­per­tise from his times at Zealand Phar­ma, Syn­er­gy, Pfiz­er and Eli Lil­ly, among oth­ers.

Do­minik Mum­berg

→ Copen­hagen-based Ad­cen­do, which fur­ther an­nounced its pres­ence in the ADC space with the largest fi­nanc­ing round for a Swedish biotech at $62 mil­lion, has pegged Do­minik Mum­berg as CSO a year lat­er. A man of many ex­ec­u­tive ti­tles in his 15 years at Bay­er, Mum­berg would even­tu­al­ly vault to trans­la­tion­al in­no­va­tion lead with­in the on­col­o­gy strate­gic busi­ness unit in March 2021.

Leopold Bertea

→ Fo­cused on den­drit­ic cell bi­ol­o­gy, Swedish can­cer biotech Im­mu­nicum has ush­ered in Leopold Bertea as chief tech­nol­o­gy of­fi­cer. A No­var­tis and Sanofi vet, Bertea’s pre­vi­ous stop was at Cel­lec­tis as SVP, tech­ni­cal op­er­a­tions Eu­rope. When Bertea helmed Cell­for­Cure, No­var­tis pur­chased the com­pa­ny to boost its CAR-T man­u­fac­tur­ing ca­pa­bil­i­ties, and he then slid in­to the role of gen­er­al man­ag­er and site head in Les Ulis just south­west of Paris.

Sandy Laz­zari

→ One of sev­er­al biotechs seek­ing to un­lock the po­ten­tial of Tregs (along with Gen­tiBio and Mozart Ther­a­peu­tics, to name a cou­ple), Boston-based Aba­ta Ther­a­peu­tics has brought in Sandy Laz­zari as chief peo­ple of­fi­cer. Laz­zari owns HR lead­er­ship ex­pe­ri­ence from Mil­li­pore, Quan­ter­ix, Ova­Science, Kala Phar­ma­ceu­ti­cals and Em­u­late Bio. At her most re­cent stop, she was Platelet­Bio’s VP of peo­ple and cul­ture.

Bran­di Howard

→ Gene­va-based Ob­sE­va will wel­come Bran­di Howard as chief clin­i­cal of­fi­cer start­ing Mon­day as Eliz­a­beth Gar­ner, the CMO of the women’s health biotech since Ju­ly 2019, steps down “to pur­sue a new op­por­tu­ni­ty.” Howard steered Phexxi to­ward ap­proval as head of med­ical and clin­i­cal af­fairs with Evofem Bio­sciences, and took on mul­ti­ple posts in an eight-year pe­ri­od at Te­va, cul­mi­nat­ing in her time as head of US field med­ical af­fairs.

Gwen Carscad­den

→ Peer Re­view is giv­ing its rapt at­ten­tion to three hires at South San Fran­cis­co’s RAPT Ther­a­peu­tics: Gwen Carscad­den (chief hu­man re­sources of­fi­cer) had been chief peo­ple of­fi­cer at medtech In­ter­sect ENT since 2016 and was an HR ex­ec at Car­dioDx; Jim Farmer (VP of clin­i­cal op­er­a­tions) is a Nan­tK­west and Co­herus vet who comes to the can­cer and in­flam­ma­tion biotech from Tra­vere Ther­a­peu­tics, where he was se­nior di­rec­tor of clin­i­cal de­vel­op­ment strat­e­gy and op­er­a­tions; and Shari Gef­fon (VP of pro­gram and al­liance man­age­ment) is the ex-COO of rene­gade.bio who has held project and pro­gram man­age­ment posts at Fi­bro­Gen, Alka­h­est, Aim­mune and Sat­suma Phar­ma­ceu­ti­cals.

→ Des­tiny’s Chief: Yuri Mar­ti­na has been named CMO of UK-based Des­tiny Phar­ma, whose lead can­di­date NTCD-M3 takes aim at C. dif­fi­cile in­fec­tion. Mar­ti­na had served as SVP, de­vel­op­ment and deputy CMO at Grü­nen­thal Group, and from 2014-17 he was VP, de­vel­op­ment and clin­i­cal op­er­a­tions for Sh­iono­gi Eu­rope.

Todd Coop­er

→ Tucked in­side pro­tein degra­da­tion biotech Kymera’s Q1 run­down is the ap­point­ment of Big Phar­ma alum Todd Coop­er as SVP, cor­po­rate af­fairs. Coop­er hails from Sanofi, a Kymera part­ner, where he was VP, glob­al head of sci­ence com­mu­ni­ca­tions. Ear­li­er, he was se­nior di­rec­tor, world­wide R&D com­mu­ni­ca­tions for Pfiz­er and led glob­al brand and sci­ence com­mu­ni­ca­tions at Bio­gen.

→ The Well­come Sanger In­sti­tute’s ge­nomics spin­out Con­geni­ca has in­stalled Tom Bar­ber as CSO. Dur­ing near­ly eight years with Eli Lil­ly, Bar­ber was group leader and prin­ci­pal re­search sci­en­tist, can­cer ge­net­ics and next-gen­er­a­tion se­quenc­ing (NGS). He’s spent the last five years as chief sci­en­tist for In­di­anapo­lis soft­ware com­pa­ny LifeOm­ic.

Ju­lianne Aver­ill

An­ji Phar­ma is ex­pand­ing its lead­er­ship team with the ap­point­ments of Ju­lianne Aver­ill as CFO and Kris­ten Richard­son as chief peo­ple and per­for­mance of­fi­cer. Aver­ill hails from Dan­forth Ad­vi­sors, where she was se­nior di­rec­tor and has al­so held roles at Alveo Tech­nolo­gies, Black­Thorn Ther­a­peu­tics, Man­i­fest MedEx and De­loitte. Mean­while, Richard­son brings ex­per­tise from stints at Kalei­do, Mi­croMed­i­cine and Gen­zyme.

Xcell Bio­sciences is pulling out the wel­come wag­on for Shan­non Eak­er as chief tech­nol­o­gy of­fi­cer. Eak­er for­mer­ly served an 11-year stint at Cy­ti­va Cell and Gene Ther­a­py and is a mem­ber of the In­ter­na­tion­al So­ci­ety for Cell Ther­a­py Process De­vel­op­ment and Man­u­fac­tur­ing.

→ Mi­cro­cap biotech Vista­Gen Ther­a­peu­tics, which plunged in­to pen­ny stock ter­ri­to­ry back in 2019 af­ter dis­heart­en­ing Phase II re­sults for its de­pres­sion drug, has brought on Reid Adler as chief le­gal of­fi­cer. Adler was part of law firm Cap­i­tal Tech­nol­o­gy Law Group pri­or to his ap­point­ment and has al­so served at Mor­ri­son & Fo­er­ster, Mor­gan Lewis, J. Craig Ven­ter In­sti­tute for ge­nomics and was found­ing di­rec­tor of the NIH of­fice of tech­nol­o­gy trans­fer.

→ As Parisian Quan­tom Ge­nomics is gear­ing to sub­mit an NDA for its lead drug firib­a­s­tat — for the treat­ment of hy­per­ten­sion and heart fail­ure — it’s bring­ing along some ex­tra help to help make the push to the FDA with the ap­point­ment of Sarah Merlen-Boulenger as head of reg­u­la­to­ry af­fairs. Merlen-Boulenger makes her way to Quan­tom Ge­nomics af­ter a near­ly decade long stint at Ethy­pharm. Pri­or to that, Merlen-Boulenger spent some time at Sanofi as glob­al reg­u­la­to­ry af­fairs, Eu­rope.

Bent Jakob­sen

→ At the same time as nab­bing $16.7 mil­lion from a seed fi­nanc­ing round co-led by Pure­os Bioven­tures and No­vo Hold­ings, En­gim­mune Ther­a­peu­tics is al­so bag­ging TCR pi­o­neer Brent Jakob­sen as chair­man of its board. Jakob­sen has a star-stud­ded ré­sumé: for­mer chief sci­en­tist and co-founder of Im­muno­core, for­mer CSO of Adap­ti­mune and founder and CEO of Ac­ces­sion Ther­a­peu­tics, to name a few. Ad­di­tion­al­ly, Jakob­sen will be joined on the board by Do­minik Es­ch­er (man­ag­ing part­ner at BB Pure­os Bioven­tures) and Jør­gen Søberg Pe­tersen (part­ner at No­vo Hold­ings), and Xim­ing Ding (as­so­ciate at Pure­os Bioven­tures) and João Ribas (se­nior as­so­ciate at No­vo Hold­ings) as ob­servers.

→ Paris-based Egle Ther­a­pau­tics is in­stalling Pierre Legault as chair­man of its board of di­rec­tors. In re­cent years, Legault has served as di­rec­tor of Syn­dax Phar­ma­ceu­ti­cals and chair­man of the boards of Ar­tios Phar­ma, Bi­cy­cle Ther­a­peu­tics and Sit­ryx Ther­a­peu­tics. Not on­ly has he been chair­man of a few boards, Legault has sat as a board mem­ber at such com­pa­nies as Amolyt Phar­ma, Urovant Sci­ences and Pro­sid­ion. Ear­li­er in his ca­reer, Legault was pres­i­dent, CEO and CFO at lega­cy com­pa­nies of the Sanofi-Aven­tis group.

Tom Hugh­es

→ Drug dis­cov­ery com­pa­ny To­tus Med­i­cines is bring­ing aboard sev­er­al sea­soned faces with the ap­point­ment of Tom Hugh­es (CEO of Nav­i­tor Phar­ma­ceu­ti­cals and for­mer CEO of Zaf­gen) as chair­man of the board and the re­cruit­ment of: Ke­van Shokat (co-founder of eF­FEC­TOR Ther­a­peu­tics, Eras­ca and Ku­ra On­col­o­gy); Chris Bow­den (for­mer CMO of Agios); Steve Crossan (prod­uct team lead at Deep­Mind); and Stephen Hale (for­mer SVP, glob­al head of R&D at Dew­point Ther­a­peu­tics and CSO of En­sem­ble Ther­a­peu­tics) to form its sci­en­tif­ic ad­vi­so­ry board.

Brit­tany Bradrick

→ One of many com­pa­nies caught in the bear mar­ket mael­strom, Spec­trum Phara­maceu­ti­cals, has re­served a seat for Neurelis CFO Brit­tany Bradrick on the board of di­rec­tors. Bradrick al­so spent a year as COO and CFO of Vi­a­Cyte. Spec­trum trimmed its work­force by 30% to start 2022 af­ter the FDA hand­ed down a CRL for its neu­trope­nia drug last Au­gust, and CFO Kurt Gustafson walked out the door in Feb­ru­ary.

→ For­mer Es­pe­ri­on CEO Tim Mayleben penned a can­did End­points News guest col­umn re­cent­ly that de­tailed where things went wrong with its cho­les­terol drug, be­mpe­doic acid. This past week Es­pe­ri­on added Stephen Ro­cam­boli to the board of di­rec­tors. Ro­cam­boli, the CEO of Per­la Ther­a­peu­tics, al­so sits on the board of TFF Phar­ma­ceu­ti­cals.

→ SaaS an­a­lyt­ics plat­form Sumo Log­ic is pulling out a chair for AveX­is co-founder and for­mer ex­ec­u­tive chair­man of the board of John Harkey on its board of di­rec­tors. This is far from Harkey’s first rodeo sit­ting on a board, serv­ing at Durvet, Di­alec­tic Ther­a­peu­tics, Ces­sa­tion Ther­a­peu­tics, MD An­der­son Can­cer Cen­ter and Bay­lor Health­care Foun­da­tion.

Char­lie New­ton

Jun­shi’s tori­pal­imab part­ner Co­herus Bio­Sciences has made room for Char­lie New­ton on the board of di­rec­tors. New­ton, the CFO of Lyell, cut his teeth in in­vest­ment bank­ing as a man­ag­ing di­rec­tor with Bo­fA Se­cu­ri­ties, Cred­it Su­isse and Mor­gan Stan­ley.

Mu­na Bhan­ji has tacked on an­oth­er board ap­point­ment at genome edit­ing ti­tan In­tel­lia, which shelled out $45 mil­lion in Feb­ru­ary for Rewrite Ther­a­peu­tics. Bhan­ji, who called it a ca­reer at Mer­ck in 2021 af­ter 35 years at the Big Phar­ma, is a board mem­ber at Cy­to­ki­net­ics, Arde­lyx and Ve­r­a­cyte.

Vic­to­ria Vakiener has punched her tick­et to the board of di­rec­tors at Ar­row­head Phar­ma­ceu­ti­cals, which has es­tab­lished Visir­na Ther­a­peu­tics with Vi­vo Cap­i­tal to ex­pand its reach in­to Chi­na. Vakiener, a board mem­ber at Chimerix, is a J&J alum who was chief com­mer­cial of­fi­cer at Epizyme from 2018-21.

Kathie Bish­op

→ Mak­ing her way to the west coast, Kathie Bish­op — cur­rent SVP, CSO and head of rare dis­ease at Aca­dia Phar­ma­ceu­ti­calsis hop­ping on­to the board of di­rec­tors of San Diego-based DTx Phar­ma. Bish­op al­so brings ex­per­tise with her from her roles as CSO at Lo­can­aBio, Oton­o­my and Tio­ga Phar­ma­ceu­ti­cals and she held lead­er­ship roles at Io­n­is and Cere­gene.

→ Lon­don T cell biotech Achilles Ther­a­peu­tics has elect­ed Bern­hard Ehmer to the board of di­rec­tors. The ex-CEO of Biotest and Fre­se­nius Biotech was al­so pres­i­dent of Im­Clone Sys­tems.

→ Aussie-based Ser­va­tus is bring­ing in some ex­tra fire­pow­er to its board of di­rec­tors with the ap­point­ment of Boehringer In­gel­heim vet Uwe Buechel­er as non-ex­ec­u­tive di­rec­tor. Buechel­er cur­rent­ly serves as se­nior ad­vi­sor at Boehringer and has pre­vi­ous­ly served in a va­ri­ety of roles for the com­pa­ny, such as site head and lead for BI’s glob­al op­er­a­tions net­work in Eu­rope, the US and Chi­na.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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