Swat­ting away a takeover at­tempt, Zymeworks keeps re­tool­ing staff; Af­ter Cyg­nal-ing her ex­it from Flag­ship, Pearl Huang starts afresh

Paul Moore

Zymeworks used a poi­son pill ma­neu­ver a cou­ple weeks ago as the coun­ter­punch to a $773 mil­lion takeover bid by All Blue Fal­cons, and new CEO Ken­neth Gal­braith isn’t done piec­ing the staff to­geth­er ei­ther.

Paul Moore will end his 14-year as­so­ci­a­tion with Macro­Gen­ics, where he was VP, cell bi­ol­o­gy, and im­munol­o­gy, and step up to the plate as CSO of Zymeworks on Ju­ly 18. Tony Polveri­no, the chief sci­en­tist who pre­ced­ed Moore, didn’t es­cape the sweep­ing changes that were en­act­ed by Gal­braith in Jan­u­ary, when half the C-suite and 25% of the staff over­all re­ceived pink slips. Neil Klom­pas and Neil Joseph­son were named COO and CMO, re­spec­tive­ly, and Chris As­tle took over as CFO a month lat­er.

Pearl Huang

Pearl Huang — one of our Women in Bio­phar­ma R&D hon­orees from 2020 — is a CEO again, this time at Cam­bridge, UK, pro­tein degra­da­tion biotech Dunad Ther­a­peu­tics. Huang was Roche’s head of ther­a­peu­tic modal­i­ties un­til 2018 and be­came CEO of Flag­ship’s ex­oneur­al bi­ol­o­gy com­pa­ny Cyg­nal Ther­a­peu­tics a short time lat­er. When Flag­ship com­bined Inzen and Cyg­nal to form Sonata Ther­a­peu­tics in mid-May, Volk­er Her­rmann was named chief ex­ec­u­tive, leav­ing Huang to ex­plore oth­er op­tions. She lands at Dunad af­ter No­var­tis inked a $1.3+ bil­lion deal with the start­up in No­vem­ber 2021.

Michael Sum­n­er

→ Hop­ing to re­vi­tal­ize a pipeline that has yet to see an FDA ap­proval in its 20-plus year his­to­ry, In­ovio has tapped Michael Sum­n­er as CMO, join­ing new chief ex­ec­u­tive Jacque­line Shea. For the last nine years, Sum­n­er was med­ical chief for Swedish biotech Orexo, and he’s worked in med­ical af­fairs for Shire and No­vo Nordisk. A month ago, Shea took over for Joseph Kim af­ter In­ovio hit mul­ti­ple pot­holes with its Covid-19 vac­cine, lead­ing to a dif­fer­ent ap­proach with INO-4800 as a het­erol­o­gous boost­er.

James Cullem

→ There’s a lot to sift through at the US-Dan­ish can­cer biotech Al­lar­i­ty Ther­a­peu­tics, start­ing with CEO Steve Carche­di, who has yield­ed the top spot to CBO James Cullem on an in­ter­im ba­sis. Cullem had been SVP of cor­po­rate de­vel­op­ment for sev­en years be­fore as­cend­ing to the role of busi­ness chief in De­cem­ber. CFO Jens Knud­sen is al­so out, and Al­lar­i­ty has lined up di­rec­tor of fi­nan­cial re­port­ing Joan Brown to pinch-hit. Mean­while, Thomas Jensen — who co-found­ed the com­pa­ny in 2004 — will now be SVP of in­vestor re­la­tions af­ter two years as SVP, in­for­ma­tion tech­nol­o­gy. Al­lar­i­ty’s board “ex­pects to name a per­ma­nent CEO and CFO in H1 2023,” ac­cord­ing to the press re­lease.

John Snis­arenko

→ The un­re­lent­ing job cuts in the in­dus­try haven’t spared hit eye dis­ease-fo­cused Oys­ter Point Phar­ma, which will scrap about 50 em­ploy­ees as part of its new “stream­lin­ing plan.” Changes have fil­tered in­to the se­nior lead­er­ship too as Genen­tech alum John Snis­arenko — the chief com­mer­cial of­fi­cer since 2019 — heads in­to re­tire­ment, while sales and com­mer­cial op­er­a­tions VP Michael Camp­bell be­comes head of com­mer­cial. Else­where at Oys­ter Point, Daniel Lochn­er will al­so tack­le the role of CBO in ad­di­tion to his CFO du­ties.

Vivek Shar­ma

→ In Oc­to­ber 2021, The Car­lyle Group jumped on the AI band­wag­on along­side the in­vest­ment arms of Pfiz­er, Mer­ck, Am­gen and McKesson with the $430 mil­lion buy­out of cloud-based Saa­ma Tech­nolo­gies. Saa­ma’s found­ing CEO Suresh Kat­ta has now stepped aside af­ter 25 years and will tran­si­tion to the role of chair­man emer­i­tus as Vivek Shar­ma takes con­trol at the Cal­i­for­nia AI play­er. Shar­ma has been a chief ex­ec­u­tive be­fore with De­ci­sion Re­sources Group, Pi­ra­mal Phar­ma So­lu­tions and more re­cent­ly, Adare Phar­ma So­lu­tions. In ad­di­tion to his new ti­tle at Saa­ma, Kat­ta will al­so be an ad­vi­sor for Car­lyle.

Tra­cy Cun­ning­ham

→ Fir­ing back at the FDA with a for­mal dis­pute res­o­lu­tion re­quest for its epi­der­mol­y­sis bul­losa drug Fil­su­vez, Am­ryt Phar­ma has pro­mot­ed Tra­cy Cun­ning­ham to CMO. Cun­ning­ham is a Sanofi alum who had been clin­i­cal lead for selume­tinib — now mar­ket­ed as Kosel­u­go — with As­traZeneca be­fore mak­ing her way to Am­ryt as head of de­vel­op­ment in 2020. Ear­li­er, Cun­ning­ham held med­ical af­fairs roles at No­var­tis and GSK.

Mark Sumer­ay

→ As for Cun­ning­ham’s pre­de­ces­sor, he on­ly has to switch out a few let­ters: Mark Sumer­ay has left Am­ryt to be­come CMO at Amolyt Phar­ma, a French-Amer­i­can en­docrine dis­ease biotech that filled the pig­gy bank with an $80 mil­lion Se­ries B round in Sep­tem­ber 2021. Be­fore his six years as CMO at Am­ryt, Sumer­ay was the med­ical chief for Aege­ri­on Phar­ma­ceu­ti­cals and VP, US car­dio­vas­cu­lar and meta­bol­ic med­ical af­fairs with Bris­tol My­ers Squibb.

Rami­ta Tan­don

→ To ac­com­mo­date its en­try in­to the clin­i­cal tri­al busi­ness, as re­port­ed from Cannes last week, Wal­greens has lined up a string of hires, with chief clin­i­cal tri­als of­fi­cer Rami­ta Tan­don bat­ting lead­off. Oth­er ap­point­ments in­clude: Kendal Whit­lock (head of dig­i­tal op­ti­miza­tion, re­al world ev­i­dence clin­i­cal tri­als), John Camp­bell (head of de­cen­tral­ized clin­i­cal tri­als), Liam Wood (head of prod­uct, clin­i­cal tri­als) and Adam Sam­son (head of clin­i­cal de­liv­ery op­er­a­tions, clin­i­cal tri­als).

Thier­ry Guil­laudeux has been pro­mot­ed to CSO of Seat­tle-based Kine­ta, which merged with Tony Coles’ Parkin­son’s play Yu­man­i­ty in ear­ly June. A long­time pro­fes­sor at the Uni­ver­si­ty of Rennes 1 in France, Guil­laudeux came to Kine­ta as SVP, im­muno-on­col­o­gy in 2019 and has helped de­vel­op its im­munother­a­py can­di­date KVA12.1, an IgG1 mon­o­clon­al an­ti­body.

Shirley Liu

→ Cam­bridge, MA-based GV20 Ther­a­peu­tics is lock­ing in Shirley Liu as CEO and bring­ing in duo Steven Lan­dau and Ying Gong as CMO and CBO, re­spec­tive­ly. Liu co-found­ed GV20 in 2016, hav­ing pre­vi­ous­ly served as pro­fes­sor of bio­sta­tis­tics and com­pu­ta­tion­al bi­ol­o­gy at the Dana-Far­ber Can­cer In­sti­tute and Har­vard TH Chan School of Pub­lic Health. Mean­while, Lan­dau for­mer­ly ran op­er­a­tions as CMO at Shape Phar­ma­ceu­ti­cals and Ten­sha Ther­a­peu­tics, while Gong most re­cent­ly served as project team leader for on­col­o­gy at Genen­tech.

Er­ic Sul­li­van

Er­ic Sul­li­van has been ap­point­ed CFO at next-gen T cell out­fit TCR² Ther­a­peu­tics. Sul­li­van, a blue­bird and Mer­ri­mack vet, served as pres­i­dent, CFO and COO at Triplet Ther­a­peu­tics, and has al­so served as SVP at Gem­i­ni Ther­a­peu­tics and On­corus pri­or to join­ing TCR², which is de­vel­op­ing its lead pro­gram ga­vo-cel in sev­er­al in­di­ca­tions.

Lin­ea As­pe­si

→ Hema­to­log­ic dis­ease biotech For­ma Ther­a­peu­tics will gain two ex­ecs on Ju­ly 11: Agustín Melián (head of R&D) left AlloVir at the end of 2021 and was the Di­ana Brainard-led biotech’s first CMO. Pri­or to this, he spent 13 years at Mer­ck and was SVP in glob­al clin­i­cal de­vel­op­ment and med­ical sci­ences. Lin­ea As­pe­si (chief hu­man re­sources of­fi­cer) is a Sanofi Gen­zyme alum who held the same po­si­tion at San­iona and led HR at So­bi.

Par­a­digm Bio­phar­ma­ceu­ti­cals has hand­ed over the CEO hat to Mar­co Polizzi. Pri­or to his new role, Polizzi was the founder and CEO of Oakrum Phar­ma. Polizzi has had a long ca­reer span­ning roles at Casper Phar­ma (EVP com­mer­cial op­er­a­tions and busi­ness de­vel­op­ment), San­doz (head of sales and mar­ket­ing in­sti­tu­tion­al), Mallinck­rodt (VP/GM) and Te­va.

Pe­ter Con­don

→ San Diego-based RNA play­er DTx Phar­ma has locked in Pe­ter Con­don as CBO. From 2018-21, Con­don was head of busi­ness de­vel­op­ment and al­liance man­age­ment at Gos­samer Bio, and af­ter 10 years at Genen­tech, he held the role of ex­ec­u­tive di­rec­tor, busi­ness de­vel­op­ment at Alex­ion and Google’s an­ti-ag­ing up­start Cal­i­co.

James Tay­lor

So­sei Hep­tares CBO James Tay­lor has left to fill the same po­si­tion at Achilles Ther­a­peu­tics, a T cell play­er that went pub­lic on the strength of a $175.5 mil­lion IPO in the spring of 2021. (Re­mem­ber those?) Tay­lor was al­so a se­nior di­rec­tor of busi­ness de­vel­op­ment at GSK and held posts at As­traZeneca, Sum­mit Ther­a­peu­tics and Cel­l­zome. Achilles has al­so added Cass­ian Yee, a pro­fes­sor at the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter, to its sci­en­tif­ic ad­vi­so­ry board.

Fletch­er Payne

→ We told you about Jotin Marango leav­ing Ap­tose for Ike­na On­col­o­gy in April, and this week Fletch­er Payne has re­placed Marango as CFO. Payne heads to Ap­tose af­ter near­ly three years as fi­nance chief at Syapse, and he’s al­so been CFO at Plexxikon, Cy­tomX and the now-shut­tered Cat­a­lyst Bio­sciences. Ap­tose’s lead as­set, HM43239, is in a Phase I/II tri­al for re­lapsed or re­frac­to­ry acute myeloid leukemia.

Gail Cawk­well

→ Now fo­cused on in­di­ca­tions like rheuma­toid arthri­tis and hidradeni­tis sup­pu­ra­ti­va with zunseme­tinib af­ter mis­fir­ing in alope­cia area­ta with ATI-502, Aclaris Ther­a­peu­tics has se­lect­ed Gail Cawk­well as CMO. Cawk­well, the ex-CMO and spe­cial ad­vi­sor to the board of di­rec­tors at Pur­due Phar­ma, spent the last four years as the SVP, med­ical af­fairs, safe­ty & phar­ma­covig­i­lance for In­ter­cept, and she al­so worked on Xel­janz in her 14 years with Pfiz­er. Cawk­well’s pre­de­ces­sor, David Gor­don, stepped aside at Aclaris on Jan. 7.

Paulette Dil­lon

Celli­no’s “GMP-in-a-box” idea made a be­liev­er out of Leaps by Bay­er, lead­ing the $80 mil­lion Se­ries A in Jan­u­ary. Fast for­ward to this week, where Celli­no has named Ab­hi­jit Kulka­rni as COO and Paulette Dil­lon as CBO. Kulka­rni had led the Neu­ro­mod­u­la­tion Tech­nol­o­gy De­vel­op­ment Cen­ter at Medtron­ic, while Dil­lon co-found­ed and was SVP of cor­po­rate de­vel­op­ment at re­cent­ly down­sized Atre­ca. “Their vi­sion is to be a cell man­u­fac­tur­ing foundry, where you can pro­duce tar­get­ed cells at a frac­tion of the cost,” Jür­gen Eck­hardt, the head of Leaps by Bay­er, said of Celli­no.

Siob­han Nolan Mangi­ni

NGM Bio­phar­ma­ceu­ti­cals — which has col­lab­o­rat­ed with Mer­ck — has an­nounced that its CFO Siob­han Nolan Mangi­ni will be tak­ing over as pres­i­dent on top of her cur­rent du­ties. Mangi­ni joined NGM in Ju­ly 2016 and hailed from Cast­light Health, where she was pres­i­dent and CFO. Ad­di­tion­al­ly, William Rieflin, NGM’s ex­ec­u­tive chair­man and for­mer CEO, is tran­si­tion­ing to the role of chair­man on NGM’s board of di­rec­tors.

Christo­pher Hoppe

→ Peer Re­view has learned that 64x Bio, the George Church gene ther­a­py man­u­fac­tur­ing start­up run by a 20 un­der 40 hon­oree from this year (Lex Rovn­er), has in­stalled Christo­pher Hoppe as head of op­er­a­tions. Hoppe joins from Nek­tar, where he was clin­i­cal, op­er­a­tional, and strate­gic ad­vance­ment lead for the biotech’s cy­tokine port­fo­lio.

Scott Bat­ty has joined au­toim­mune dis­ease biotech Ar­tax Bio­phar­ma as CMO. Bat­ty, the ex-glob­al di­rec­tor of med­ical af­fairs for the be­lat­a­cept im­muno­sup­pres­sion pro­gram at Bris­tol My­ers, had pre­vi­ous­ly been VP of reg­u­la­to­ry and sci­en­tif­ic af­fairs for CTI. He has al­so served as VP of glob­al med­ical af­fairs for Gen­zyme’s trans­plant and on­col­o­gy group.

Lau­na As­peslet

Lau­na As­peslet is set­tling in as COO of He­p­i­on Phar­ma­ceu­ti­cals, a New Jer­sey biotech us­ing AI to de­vel­op ther­a­pies for NASH and he­pa­to­cel­lu­lar car­ci­no­ma. As­peslet had helmed Trans­la­tion­al Re­search in On­col­o­gy, a clin­i­cal re­search or­ga­ni­za­tion out of Ed­mon­ton with of­fices in Paris and Mon­te­v­ideo, Uruguay, since 2015. She vault­ed to COO of an­oth­er Ed­mon­ton-based com­pa­ny, Isotech­ni­ka Phar­ma, be­fore it was sold to Au­rinia nine years ago.

In oth­er He­p­i­on news, cor­po­rate strat­e­gy ex­ecs Anand Red­di (Ad­verum) and Kaouthar Lbiati (Cy­tovia) have earned their seats on the board of di­rec­tors.

Der­mi­ra vet Luis Peña and his crew at Evom­mune have wel­comed Greg Moss as chief cor­po­rate strat­e­gy and le­gal of­fi­cer; he’ll al­so jug­gle the roles of cor­po­rate sec­re­tary and chief com­pli­ance of­fi­cer at the in­flam­ma­to­ry dis­ease biotech. Moss comes to Evom­mune af­ter a decade at Sanofi sub­sidiary Kad­mon, where he was gen­er­al coun­sel & cor­po­rate sec­re­tary, chief com­pli­ance of­fi­cer. This isn’t the first Kad­mon alum to be­come part of Evom­mune’s lead­er­ship: Ex-chief ac­count­ing of­fi­cer Kyle Carv­er has been CFO at Evom­mune since March.

Julie Per­son

→ Per­son to Per­son: Na­tal­ie Holles is grad­u­al­ly flesh­ing out her team at Third Har­mon­ic Bio with a new CFO (Robert Ho), CSO (Adri­an Ray) and CMO (Ed­ward Con­ner). This week Julie Per­son, who comes from ARCH’s “Re­al­ly Big Neu­ro­science Com­pa­ny” named Neumo­ra, is on board as chief ad­min­is­tra­tive of­fi­cer. Per­son spent a year as VP of hu­man re­sources at Sang­amo af­ter her time as glob­al head of tal­ent man­age­ment at Shire, and then had a brief run at Holles’ for­mer com­pa­ny, Au­dentes, pri­or to her ap­point­ment as Neumo­ra’s chief peo­ple of­fi­cer.

Pe­ter Led­dy has made his way to San Diego-based Mar­a­vai Life­Sciences as chief ad­min­is­tra­tive of­fi­cer. Pri­or to join­ing Mar­a­vai, Led­dy had such roles as chief hu­man re­sources of­fi­cer at Berke­ley Lights, chief peo­ple of­fi­cer at do­sist and EVP, glob­al hu­man re­sources and cor­po­rate in­tegri­ty at Nu­va­sive.

An­drea Paul

→ The lead­er­ship changes at Zen­tal­is haven’t de­cel­er­at­ed as the Pfiz­er part­ner brings in An­drea Paul as gen­er­al coun­sel and cor­po­rate sec­re­tary on Aug. 1. Paul, who filled le­gal roles at Mo­men­ta and Ake­bia Ther­a­peu­tics, had re­cent­ly been gen­er­al coun­sel and cor­po­rate sec­re­tary for a year at Log­icBio. Back in May, Kim­ber­ly Black­well suc­ceed­ed An­tho­ny Sun as Zen­tal­is’ CEO, while co-founder Cam Gal­lagher was el­e­vat­ed to pres­i­dent.

Bren­dan St. Amant

→ Syn­thet­ic bi­ol­o­gy play­er and Roche IBD part­ner Syn­log­ic has pro­mot­ed Bren­dan St. Amant to gen­er­al coun­sel and cor­po­rate sec­re­tary. Named VP, head of le­gal at Syn­log­ic in Ju­ly 2021, St. Amant was se­nior coun­sel at Ver­tex be­fore mov­ing to the now-de­funct Flag­ship com­pa­ny Ohana Bio­sciences as VP of le­gal in 2019.

→ What’s new at NeuBase? COO William Mann is tack­ing on the ti­tle of pres­i­dent to his cur­rent du­ties. Pri­or to his cur­rent stint, Mann was CEO and pres­i­dent of Helsinn Ther­a­peu­tics and held roles at Sap­phire Ther­a­peu­tics and No­var­tis.

Amol Ketkar

→ Lon­don-based Res­o­lu­tion Ther­a­peu­tics is bring­ing aboard Amol Ketkar as chief de­vel­op­ment of­fi­cer. Ketkar had a 21-year gig at GSK, most re­cent­ly serv­ing as VP, prod­uct de­vel­op­ment and sup­ply for the com­pa­ny’s cell and gene ther­a­py CMC group.

El­e­var Ther­a­peu­tics out of Salt Lake City is bring­ing in some new faces with the ap­point­ments of Jan Van Tornout as CMO and Gor­don Schoo­ley as chief reg­u­la­to­ry of­fi­cer. Van Tornout pre­vi­ous­ly served as CMO of Tyme Tech­nolo­gies while Schoo­ley jumps aboard af­ter a sev­en-year run with Be­yond­Spring.

→ Peer Re­view has been in­formed that Cam­bridge, MA medtech Cog­ni­to Ther­a­peu­tics has en­list­ed Steven Max­im as di­rec­tor of man­u­fac­tur­ing. Max­im owned the same ti­tle at Ave­dro (pur­chased by Glaukos in 2019) and has fur­ther man­u­fac­tur­ing ex­pe­ri­ence from IPG Med­ical and Palo­mar Med­ical Tech­nolo­gies.

Fa­heem Has­nain

→ Gos­samer Bio founder, CEO and chair­man Fa­heem Has­nain is adding an­oth­er board ap­point­ment to his ré­sumé with his lat­est chair­man stint at Sling Ther­a­peu­tics. Cur­rent­ly, Has­nain sits on the board of Ku­ra On­col­o­gy and serves as chair­man of the board for As­pen Neu­ro­science, Mi­rati Ther­a­peu­tics and SEN­TÉ.

→ With its NDA for va­morolone get­ting shelved for four to six months be­cause of con­tract man­u­fac­tur­ing hur­dles, Swiss biotech San­thera has named Thomas Meier chair­man of the board, re­plac­ing El­mar Schnee on Thurs­day. Meier, the chief ex­ec­u­tive at San­thera from 2011-19, has been a board mem­ber since 2017 and is man­ag­ing part­ner at Viopas Ven­ture Con­sult­ing in Zurich.

Tom­my Thomp­son

→ For­mer HHS Sec­re­tary and Wis­con­sin Gov. Tom­my Thomp­son has been named Covid-19 spe­cial con­sul­tant to CEO Hen­ry Ji at Sor­ren­to Ther­a­peu­tics. The 80-year-old Thomp­son was re­cent­ly at his al­ma mater as in­ter­im pres­i­dent of the Uni­ver­si­ty of Wis­con­sin Sys­tem from Ju­ly 2020 to March 2022.

→ Strik­ing a $1.25 bil­lion Gavre­to deal with Roy­al­ty Phar­ma and a sep­a­rate pact with Sixth Street, Blue­print Med­i­cines has re­served space for Habib Dable on to the board of di­rec­tors. Dable had a 22-year ca­reer at Bay­er be­fore his CEO stint at Ac­celeron, which was sold to Mer­ck last fall for $11.5 bil­lion.

Meenu Kar­son

→ Meenu Kar­son has suc­ceed­ed Ken­neth Fong as chair of the board at Apex­i­gen, which is merg­ing with Brook­line Cap­i­tal Ac­qui­si­tion Corp. de­spite a bat­tered mar­ket. The ex-Pro­teosta­sis Ther­a­peu­tics chief is al­so on the board of di­rec­tors at Fore Bio­ther­a­peu­tics.

Carsten Brunn

Sur­face On­col­o­gy is wel­com­ing Carsten Brunn to its ranks by pulling out a seat for the Se­lec­ta CEO and pres­i­dent on its board of di­rec­tors. Brunn for­mer­ly served in lead­er­ship roles at Bay­er (pres­i­dent of phar­ma­ceu­ti­cals for the Amer­i­c­as re­gion), Eli Lil­ly, No­var­tis, Basilea and Bausch + Lomb. Brunn cur­rent­ly sits on the board of BIO.

Led by GSK alum Jack Bai­ley, Cosela mak­er G1 Ther­a­peu­tics has added Jacks Lee to the board of di­rec­tors. Af­ter 19 years at Sanofi, Lee has been with Mer­ck since 2007 and is the phar­ma gi­ant’s SVP, man­u­fac­tur­ing & sup­ply.

Di­ane Seimetz

→ Chaired by for­mer HHS Sec­re­tary and ex-Kansas Gov. Kath­leen Se­be­lius, Lau­ra Nikla­son-led Hu­ma­cyte has added Bio­phar­ma Ex­cel­lence co-founder and for­mer CEO Di­ane Seimetz to the board of di­rec­tors. Seimetz al­so serves on the board at Cu­mu­lus On­col­o­gy.

Ax­el-Sven Malkomes and Don­ald Bergstrom are the newest ad­di­tions to the board of di­rec­tors at Cel­lec­tis. Malkomes, a Bar­clays vet, was CFO and CBO of Medi­gene from 2019 un­til the end of March. Bergstorm has been a board ob­serv­er at Cel­lec­tis since No­vem­ber and is head of R&D at Re­lay Ther­a­peu­tics, which took the cov­er off its in­ter­im da­ta for RLY-4008 in pa­tients with bile duct can­cer this week.

Tama­ra Joseph

→ UK-based Gen­flow Bio­sciences is swap­ping out some of its board mem­bers and trad­ing them in for Tama­ra Joseph (chief le­gal of­fi­cer at Spero Ther­a­peu­tics) and Guy-Charles Fan­neau de la Horie (for­mer chief ex­ec­u­tive at Eu­ronext Growth). Joseph and Fan­neau de la Horie suc­ceed Gabrielle Sil­ver and An­drew Scott, who are step­ping down.

Ay­tu Bio­Phar­ma is pulling Vi­vian Liu on­to its board of di­rec­tors. Liu cur­rent­ly serves as head of cor­po­rate af­fairs for PRE­MIA Hold­ings and pre­vi­ous­ly held the ti­tles of pres­i­dent, CEO and CFO of In­novus Phar­ma­ceu­ti­cals. Ear­li­er in her ca­reer, Liu was pres­i­dent and CEO of Fas­Track Phar­ma­ceu­ti­cals and NexMed.

Ca­li­di Bio­ther­a­peu­tics has brought on WK Al­fred Yung to its med­ical ad­vi­so­ry board. Yung is a pro­fes­sor, neu­ro-on­col­o­gy at the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter and ad­vised Pres­i­dent Biden’s Can­cer Moon­shot ini­tia­tive.

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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, just two weeks after submitting a supplemental BLA. 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.

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.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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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.

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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.

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