Hel­lo, I must be go­ing: Jorge Gomez is Mod­er­na CFO for on­ly a day; As set­backs mount, In­ovio’s Joseph Kim choos­es the ex­it ramp

Jorge Gomez

David Meline will have to put his re­tire­ment on hold.

In one of the more high-pro­file one-day tenures since Bill Be­lichick with the New York Jets, Jorge Gomez’s time as CFO at Mod­er­na is over be­fore it start­ed. Gomez had re­placed Meline this Mon­day, but the fol­low­ing day Gomez was gone af­ter his for­mer com­pa­ny, den­tal prod­ucts man­u­fac­tur­er Dentsply Sirona, re­vealed an in­ves­ti­ga­tion that be­gan in March in­to the “use of in­cen­tives to sell prod­ucts to dis­trib­u­tors in the third and fourth quar­ters of 2021, and whether those in­cen­tives were ap­pro­pri­ate­ly ac­count­ed for and the im­pact of those sales was ad­e­quate­ly dis­closed in the Com­pa­ny’s pe­ri­od­ic re­ports filed with the Se­cu­ri­ties and Ex­change Com­mis­sion,” as stat­ed in the SEC fil­ing.

Meline is back in the CFO slot while chief ex­ec­u­tive Stéphane Ban­cel goes back to the draw­ing board for a suc­ces­sor.

Joseph Kim

Joseph Kim was not short on blus­ter, claim­ing that In­ovio had “de­vel­oped a vac­cine in a mat­ter of hours” in the ear­ly days of Covid-19. A fusil­lade of bad news with its Covid-19 vac­cine can­di­date cur­tailed the Penn­syl­va­nia biotech’s ef­forts, from man­u­fac­tur­ing spats to clin­i­cal holds, and now Kim is on his way out af­ter 13 years at the helm. En­ter Jacque­line Shea, In­ovio’s COO since March 2019, to re­place Kim as CEO. Shea’s pre­vi­ous ex­pe­ri­ence as chief ex­ec­u­tive was with Aeras, a non­prof­it fo­cused on tu­ber­cu­lo­sis vac­cines, and she’ll need to re­cal­i­brate a lurch­ing pipeline at In­ovio that’s al­so been hit with a de­lay on VGX-3100, a cer­vi­cal can­cer drug which won’t have a BLA ready in 2023.

Ameet Mallik

Ameet Mallik is get­ting a shot at re­demp­tion af­ter the Phase III prat­fall with de­vimi­s­tat end­ed his tenure at Rafael Hold­ings. Mallik will re­place Chris Mar­tin as CEO of Swiss biotech ADC Ther­a­peu­tics, which has branched out to Chi­na through its joint ven­ture with Hill­house-backed Over­land Phar­ma­ceu­ti­cals and notched an FDA ap­proval in April 2021 for lon­cas­tux­imab tesirine-lpyl, an an­ti­body drug con­ju­gate now mar­ket­ed as Zyn­lon­ta. The de­vimi­s­tat re­sults were so wor­ri­some back in Oc­to­ber that it spurred a house­clean­ing that in­clud­ed Mallik, who spent 16 years at No­var­tis and was EVP and head of US on­col­o­gy from 2017-21.

Thibaut Mon­gon

J&J is lin­ing up top lead­er­ship for its con­sumer health spin­off, nam­ing Thibaut Mon­gon CEO des­ig­nate and Paul Ruh CFO des­ig­nate. Mon­gon, the EVP and world­wide chair­man of con­sumer health since 2019, joined J&J back in 2000, while Ruh left Pep­si­Co af­ter 17 years to take on the role of group CFO in the con­sumer health busi­ness five years ago. In No­vem­ber 2021, J&J mim­ic­ked oth­er Big Phar­mas be­fore them like Mer­ck, Pfiz­er and GSK by choos­ing to split the con­sumer di­vi­sion in­to what is still be­ing cre­ative­ly re­ferred to as the New Con­sumer Health Com­pa­ny in press re­leas­es.

Till­man Gern­gross

→ Not on­ly did he cut loose from the CEO gig at his Covid-19 an­ti­body play Ada­gio Ther­a­peu­tics — which had its hopes tor­pe­doed by the Omi­cron vari­antTill­man Gern­gross is al­so step­ping away as chief ex­ec­u­tive of Adimab af­ter co-found­ing the com­pa­ny 15 years ago. Gern­gross will shift gears as ex­ec­u­tive chair­man of the board and hand the keys to Philip Chase, Adimab’s gen­er­al coun­sel since 2011. Er­ic Krauland, who’s been with Gern­gross from the be­gin­ning here, will re­main CSO but will need new busi­ness cards that show he’s al­so been named pres­i­dent of the com­pa­ny.

“I have the ut­most con­fi­dence in this lead­er­ship team, who has been ex­e­cut­ing to­geth­er for more than a decade, and I am proud to of­fer them this growth op­por­tu­ni­ty,” Gern­gross said in a state­ment.

Ge­off Green

Ge­off Green is ex­it­ing stage left as CEO of Longeveron on June 1, leav­ing CMO Chris Min to look af­ter the Mi­a­mi-based com­pa­ny on an in­ter­im ba­sis. Green joined Longeveron at SVP of clin­i­cal op­er­a­tions in 2016 and was pro­mot­ed to CEO in No­vem­ber 2020. The fol­low­ing Au­gust, its ex­per­i­men­tal cell ther­a­py for ag­ing frailty, lome­cel-B, whiffed bad­ly com­pared to place­bo in a Phase IIb tri­al. Min had briefly led med­ical and clin­i­cal de­vel­op­ment at En­terin be­fore tak­ing the CMO job at Longeveron last month.

So­phie Ko­rnows­ki

Boston Phar­ma­ceu­ti­cals has been look­ing for some­one to re­place CEO Robert Arm­strong for a few months. And they still are. But for now, So­phie Ko­rnows­ki will step in as act­ing CEO and chair of the board, while the in­ter­im co-CEO sys­tem they had with Joanne Beck and Craig Bas­son will dis­solve. Beck will now con­cen­trate on her CMO du­ties, while Bas­son con­tin­ues his dual roles of COO and CMO. Ko­rnows­ki is a part­ner at Gur­net Point Cap­i­tal, which launched Boston Phar­ma­ceu­ti­cals in 2015 with ex-Sanofi chief Chris Viehbach­er as CEO. To close out her 11 years with Roche, Ko­rnows­ki was glob­al head of Roche Part­ner­ing.

Thomas Ap­pio

Thomas Ap­pio doesn’t ex­act­ly take con­trol at an op­ti­mal mo­ment, but in a pre­pared state­ment he nonethe­less ex­pressed that it is “an hon­or and priv­i­lege to lead Bausch Health at this piv­otal time in its his­to­ry.” Ap­pio’s pre­de­ces­sor Joe Pa­pa is now the chair­man and CEO of Bausch + Lomb, the eye care spin­off once named Valeant Phar­ma­ceu­ti­cals that re­turned to the NYSE in un­der­whelm­ing fash­ion with an IPO well be­low its range. Stocks tum­bled more than 25% af­ter a gris­ly Q1 earn­ings re­port at Bausch Health, which is al­so mired in a DOJ in­ves­ti­ga­tion over how they mar­ket­ed three plaque pso­ri­a­sis drugs (Siliq, Bry­hali, Duo­brii) and an an­ti­fun­gal drug (Jublia).

Lori Ma­comber

Ying Huang had been pulling dou­ble du­ty as chief ex­ec­u­tive and CFO of Leg­end, but he can now fo­cus sole­ly on his work as CEO with the pro­mo­tion of Lori Ma­comber to fi­nance chief. Ma­comber, the ex-as­so­ciate VP of fi­nan­cial plan­ning & analy­sis for Eli Lil­ly, was named VP of sup­ply chain fi­nance and con­troller at Leg­end in 2019 and would even­tu­al­ly be el­e­vat­ed to VP of fi­nance in the spring of 2021. We al­so learned last week that no charges will be brought against Huang’s pre­de­ces­sor Frank Zhang fol­low­ing the cus­toms in­ves­ti­ga­tion that placed him un­der house ar­rest in Sep­tem­ber 2020.

Erin Burkhart

Re­dou­bling its ef­forts to bring its he­mo­phil­ia A gene ther­a­py back to the FDA af­ter its re­jec­tion in 2020 and strik­ing an op­ti­mistic tone over­all in its Q1 call in late April, Bio­Marin has mined Big Phar­ma to fill two key posts. Hu­maira Ser­a­jud­din (chief mar­ket­ing of­fi­cer) was in sales and mar­ket­ing at No­var­tis On­col­o­gy be­fore mov­ing on to GSK, where she had re­mained for 11 years un­til 2019. In her fi­nal po­si­tion at the UK phar­ma gi­ant, she was VP & glob­al med­i­cines com­mer­cial­iza­tion leader for the COPD port­fo­lio. Mean­while, Erin Burkhart (group VP, chief ac­count­ing of­fi­cer) spent the last eight years at Eli Lil­ly, round­ing out her time there as as­so­ciate VP, US gross-to-net busi­ness analy­sis.

Meg Alexan­der

→ To ac­com­pa­ny the pipeline piv­ot to epilep­sy that was an­nounced in March, Ovid Ther­a­peu­tics has giv­en Meg Alexan­der the new role of chief cor­po­rate af­fairs of­fi­cer, ac­cord­ing to the biotech’s Q1 re­port. Alexan­der, who had been head of com­mu­ni­ca­tions for Je­re­my Levin at Ovid, for­mer­ly led the rep­u­ta­tion & risk man­age­ment prac­tice at Sy­neos Health.

No­ra Bren­nan

De­railed by a CRL for its would-be Neu­las­ta ri­val Rolon­tis and forced to trim down its work­force by 30% in an in­ten­si­fy­ing bear mar­ket, Spec­trum Phar­ma­ceu­ti­cals said good­bye to CFO Kurt Gustafson in Feb­ru­ary. Ef­fec­tive May 25, No­ra Bren­nan will re­place Gustafson as fi­nance chief af­ter serv­ing in the same role at Fore Bio­ther­a­peu­tics for the last year. Bren­nan has al­so been a CFO with TELA Bio and Xeris Phar­ma­ceu­ti­cals.

Bruce Rogers

More pro­mo­tions have been hand­ed out at Mor­phic Ther­a­peu­tic, with Bruce Rogers get­ting el­e­vat­ed to pres­i­dent and Blaise Lip­pa ris­ing to CSO. Rogers, the chief sci­en­tist at Mor­phic since 2016, was head of neu­ro-op­por­tu­ni­ties to close out his 13 years at Pfiz­er, while Lip­pa is a found­ing mem­ber of the staff who’s been SVP of mol­e­c­u­lar dis­cov­ery the past two years. Lip­pa came to Mor­phic from Cu­bist Phar­ma­ceu­ti­cals, where he was se­nior di­rec­tor of med­i­c­i­nal chem­istry. Last month, Aaron Pelta earned a pro­mo­tion to SVP, busi­ness and cor­po­rate de­vel­op­ment and Mor­phic al­so hired Bri­had Ab­hyankar as VP of clin­i­cal de­vel­op­ment.

Jer­ry St. Pe­ter

→ Hav­ing served as col­leagues back at Eye­vance Phar­ma­ceu­ti­cals, duo Jer­ry St. Pe­ter and Wes Brazell are now com­ing back to­geth­er at der­ma­to­log­ic and oph­thalmic ther­a­peu­tics-fo­cused Xe­quel Bio as CEO and CFO, re­spec­tive­ly. This isn’t St. Pe­ter’s first rodeo wear­ing the CEO hat, hav­ing manned the ship over at Eye­vance in the same role and as pres­i­dent pri­or to the com­pa­ny’s ac­qui­si­tion in 2020. Pri­or to that stint, St. Pe­ter was SVP and head of Sun Phar­ma­ceu­ti­cal’s oph­thalmics di­vi­sion, gen­er­al man­ag­er of Nicox’s oph­thalmic busi­ness in the US and SVP and head of the oph­thalmic di­vi­sion at In­spire Phar­ma­ceu­ti­cals (ac­quired by Mer­ck in 2011).

Mean­while, Brazell for­mer­ly served as CFO of Eye­vance and Tear­Lab and has ex­pe­ri­ence in lead­er­ship roles at Al­con dur­ing his 21-year gig there.

Ke Liu

→ FDA vet Ke Liu has bolt­ed from Sana Biotech­nol­o­gy and tak­en on the role of chief de­vel­op­ment of­fi­cer at Maren­go Ther­a­peu­tics, a TCR start­up tar­get­ing the Vβ chain which Ap­ple Tree Part­ners un­veiled in No­vem­ber 2021. Liu was just named Sana’s glob­al head of reg­u­la­to­ry strat­e­gy af­ter orig­i­nal­ly com­ing on board in late 2020 as head of reg­u­la­to­ry af­fairs & strat­e­gy, which Peer Re­view re­port­ed at the time. Else­where at Maren­go, Har­vard pro­fes­sor Bruce Chab­n­er — clin­i­cal di­rec­tor emer­i­tus for the Mass­a­chu­setts Gen­er­al Hos­pi­tal Can­cer Cen­ter — will lend a hand as se­nior strate­gic ad­vi­sor.

Pe­ter De­Muth

→ Launched in 2019 from the lab of MIT’s Dar­rell Irvine, can­cer up­start Eli­cio Ther­a­peu­tics has pro­mot­ed Pe­ter De­Muth to CSO and named Joy Sey­mour VP, head of reg­u­la­to­ry af­fairs. De­Muth, an Irvine dis­ci­ple, has been a part of Eli­cio from its in­fan­cy and had served as VP of re­search. Mean­while, Sey­mour ends her 14-year stay at Bris­tol My­ers Squibb as glob­al reg­u­la­to­ry lead for cel­lu­lar ther­a­py and worked close­ly on such drugs as Breyanzi and Abrax­ane.

William Sand­born

→ Encini­tas, CA-based im­mune mod­u­la­tion Ven­tyx Bio­sciences has tapped Shore­line Bio­sciences co-founder William Sand­born as pres­i­dent and CMO, suc­ceed­ing Jörn Drap­pa, who took the job in Sep­tem­ber 2021 when the biotech racked up $51 mil­lion in Se­ries B fi­nanc­ing. Sand­born turned up in Peer Re­view a year ago when he be­came med­ical chief at Shore­line not long af­ter the ap­point­ment of CFO Vanes­sa Ja­co­by.

Chris Bar­bazette

Chris Bar­bazette has been ap­point­ed chief com­mer­cial of­fi­cer of DNA Script, the DNA syn­the­sis out­fit that hit a $165 mil­lion Se­ries C jack­pot in Oc­to­ber with Cas­din Cap­i­tal lead­ing a clutch of in­vestors. Af­ter a se­ries of po­si­tions in a nine-year pe­ri­od at Affymetrix, cul­mi­nat­ing in a stint as SVP, glob­al com­mer­cial op­er­a­tions, Bar­bazette would then be­come CCO at Agen­dia and, most re­cent­ly, Ger­man-based Re­solve Bio­sciences.

→ French biotech Med­in­Cell has in­stalled Richard Mala­mut as CMO. A Bris­tol My­ers and As­traZeneca vet who’s held CMO roles at Col­legium Phar­ma­ceu­ti­cal and Avanir Phar­ma­ceu­ti­cals, Mala­mut al­so led ear­ly clin­i­cal strat­e­gy for TV-46000/mdc-IRM — the sub­cu­ta­neous schiz­o­phre­nia drug that was knocked back by a CRL a few weeks ago — at Med­in­Cell’s part­ner Te­va from 2013-16.

Mau­reen Hig­gins

→ Stay­ing in France, Step Phar­ma con­tin­ues to piece to­geth­er its clin­i­cal de­vel­op­ment team with the ap­point­ments of Bri­an Schwartz as CMO and Mau­reen Hig­gins as VP and head of clin­i­cal op­er­a­tions. Most re­cent­ly, Schwartz served as CMO and head of R&D at Ar­Qule, which was ac­quired by Mer­ck in 2020. Hig­gins was pre­vi­ous­ly VP for project man­age­ment at Pre­ci­sion for Med­i­cine, and she has al­so served as di­rec­tor for project man­age­ment at Chiltern On­col­o­gy.

Tim Obara

→ A cou­ple weeks af­ter Mark Sir­go took over for Stephen Squin­to as chair­man, Ital­ian gene ther­a­py play­er Genen­ta Sci­ence has made Tim Obara head of busi­ness de­vel­op­ment. Be­fore join­ing the biotech co-found­ed by Lui­gi Nal­di­ni, Obara worked at Jim Wil­son’s Gene Ther­a­py Pro­gram at Penn as ex­ec­u­tive di­rec­tor of re­search op­er­a­tions. Break­ing through in mar­ket­ing at Mer­ck, Obara then held sev­er­al busi­ness de­vel­op­ment po­si­tions at GSK and As­traZeneca, and pri­or to Penn he was VP tech­ni­cal op­er­a­tions, CMC gene ther­a­py man­u­fac­tur­ing op­er­a­tions lead for Am­i­cus.

→ Roche-backed NMD Phar­ma, which re­cent­ly hauled in a $40 mil­lion raise, has found a new CMO in Jorge Quiroz. Pri­or to join­ing the Dan­ish neu­ro­mus­cu­lar dis­or­der biotech, Quiroz served as CMO at a pair of gene ther­a­py com­pa­nies, Apic Bio and Sol­id Bio­sciences. The ex-Roche head of neu­rode­vel­op­ment and psy­chi­a­try al­so served as di­rec­tor of trans­la­tion­al med­i­cine at J&J.

Syl­vain Roy

→ Bit by bit, Ca­mar­il­lo, CA-based CAR-T de­vel­op­er Imm­PACT Bio is as­sem­bling its se­nior lead­er­ship af­ter a $111 mil­lion Se­ries A in Jan­u­ary. A few weeks af­ter Venkat Yepuri be­came COO, Bax­ter and Shire alum Syl­vain Roy has signed on to Imm­PACT Bio as chief tech­nol­o­gy of­fi­cer. Roy had spent the last year as VP of man­u­fac­tur­ing op­er­a­tions for Im­mu­ni­ty­Bio, and he was VP, man­u­fac­tur­ing & process sci­ences with Nan­tK­west be­fore Patrick Soon-Sh­iong merged the two com­pa­nies in late 2020.

Richard Wanstall has joined on­colyt­ic virus biotech On­corus — which hit Nas­daq dur­ing the go-go days of 2020 — as CFO. Wanstall pre­vi­ous­ly served as CFO and trea­sur­er at Aileron Ther­a­peu­tics, and he has al­so spent time at Mod­er­na as VP of fi­nance.

Joan Schmidt

Joan Schmidt has joined Phar­varis, which is look­ing to com­pete in the hered­i­tary an­gioede­ma space with an oral drug in­stead of the avail­able in­jecta­bles, as chief le­gal of­fi­cer, ef­fec­tive June 1. Most re­cent­ly Schmidt, a le­gal ex­ec for a decade at No­vo Nordisk, served as gen­er­al coun­sel and sec­re­tary at Are­na Phar­ma­ceu­ti­cals, and she was al­so gen­er­al coun­sel at DBV Tech­nolo­gies.

Scan­dion On­col­o­gy is bring­ing out the wel­come wag­on for Al­fre­do Zur­lo, who’s been ap­point­ed CMO. Zur­lo had a 7-year stint at Roche, serv­ing as in­ter­na­tion­al med­ical di­rec­tor of on­col­o­gy and head­ed the launch of be­va­cizum­ab (Avastin) in Eu­rope. Af­ter his tenure at Roche, Zur­lo picked up the CMO role at Gly­co­tope and Molo­gen.

Seb­by Bor­riel­lo

Carmell Ther­a­peu­tics — fo­cused on ac­cel­er­at­ing bone and soft tis­sue heal­ing — is bring­ing Se­bas­t­ianSeb­byBor­riel­lo in­to the fold as CBO. Bor­riel­lo spent 25 years of his ca­reer with J&J and most re­cent­ly served as CCO of SK Life Sci­ence, where he helped lead the US launch of Xco­pri in May 2020.

→ New Jer­sey-based Elite Phar­ma­ceu­ti­cals is ring­ing in Robert Chen as CFO, tak­ing over the reins from Marc Breg­man. Chen for­mer­ly served as CFO, VP of fi­nance for KBP Bio­sciences and has al­so held fi­nan­cial roles at Bradley Phar­ma­ceu­ti­cals, No­var­tis, Vic­to­ry Com­mer­cial Man­age­ment, Medimetriks Phar­ma­ceu­ti­cals and Tai­ho On­col­o­gy.

Jen­nifer Hunt

Opus Ge­net­ics is pick­ing up Jen­nifer Hunt as chief de­vel­op­ment of­fi­cer. Hunt joins the North Car­oli­na-based com­pa­ny with a wealth of ex­pe­ri­ence un­der her belt, hav­ing served at Voy­ager Ther­a­peu­tics, Ed­i­tas Med­i­cine, Retrophin and Sanofi-Aven­tis, among oth­ers.

→ Life sci­ence tools com­pa­ny Lu­micks has ush­ered in An­dre Nel as CFO. Nel joins the Am­s­ter­dam-based com­pa­ny from Dante Labs, hav­ing served in the same role as CFO. Pri­or to that, Nel had a 7-year stint at Il­lu­mi­na, cul­mi­nat­ing in his role as VP of fi­nance. Ad­di­tion­al­ly, ear­li­er in his ca­reer, Nel held roles at Pfiz­er.

→ Salt Lake City-based Re­cur­sion, which struck an AI pact with Roche and Genen­tech last De­cem­ber, has named Ryan Kel­ly as its first chief com­mu­ni­ca­tions of­fi­cer. Kel­ly most re­cent­ly served at Vir­gin Hy­per­loop One, where he over­saw glob­al mar­ket­ing and com­mu­ni­ca­tions. Pri­or to that Kel­ly had gigs at The New York Times, WPP, Me­dia-Corps and GWNewYork.

Eli­na Lav­it

→ To the Dal­las-Fort Worth metro­plex we go, where South­lake-based On­co­Nano Med­i­cine has wel­comed Eli­na Lav­it as VP, busi­ness de­vel­op­ment. Lav­it was pre­vi­ous­ly ex­ec­u­tive di­rec­tor, pro­gram man­age­ment of Taysha Gene Ther­a­pies, an­oth­er DFW biotech and one of many com­pa­nies in the in­dus­try be­set by lay­offs in the fe­ro­cious bear mar­ket. She’s al­so been di­rec­tor of pro­gram man­age­ment at MyoKar­dia and Bris­tol My­ers. On­co­Nano’s Phase II tri­al is on­go­ing for its lead as­set, a flu­o­res­cence imag­ing agent called pegsita­cia­n­ine.

→ Chica­go-based physIQ is bring­ing aboard John Wil­son as SVP and gen­er­al man­ag­er of life sci­ences and Chris En­glerth as VP of mar­ket­ing. Wil­son joins with stints from Or­a­cle, Me­di­da­ta So­lu­tions and Vee­va Sys­tems un­der his belt, while En­glerth for­mer­ly served in roles at Phlex­glob­al, Bio­clin­i­ca, Apria Health­care and the Amer­i­can Red Cross.

San­dra Horn­ing

San­dra Horn­ing has kept busy through a col­lec­tion of board ap­point­ments since her re­tire­ment in 2019, and this week the for­mer CMO and glob­al head of prod­uct de­vel­op­ment at Roche has gained a seat on the board at Fab­rice Chouraqui’s Flag­ship com­pa­ny Cel­lar­i­ty. She’s al­so a board mem­ber at the drug pric­ing dis­rup­tor she co-found­ed, EQRx, as well as Gilead, Mod­er­na and Sean Bo­hen-led Ole­ma On­col­o­gy.

Mary Lynne Hed­ley

Mary Lynne Hed­ley will be a mem­ber of Eli Lil­ly’s board of di­rec­tors ef­fec­tive May 15. Hed­ley, a board mem­ber at Centes­sa and Helsinn, is a se­nior sci­en­tif­ic fel­low at the Broad In­sti­tute and the co-founder, for­mer pres­i­dent and COO of Tesaro, which GSK pur­chased three years ago.

Leena Gand­hi

Nex­Im­mune has first-year CEO Kristi Jones in place and pro­mot­ed Math­ias Oelke to CSO a few weeks ago, and they’re now mak­ing a splash by elect­ing Leena Gand­hi to the board of di­rec­tors. Gand­hi re­turned to Dana-Far­ber in 2020 and is di­rec­tor of the Cen­ter for Can­cer Ther­a­peu­tic In­no­va­tion af­ter her stint as VP, im­muno-on­col­o­gy de­vel­op­ment at Eli Lil­ly.

→ CRISPR genome edit­ing play­er Cari­bou Bio­sciences re­leased ear­ly da­ta yes­ter­day for its al­lo­gene­ic CAR-T CB-010 and has ap­point­ed David John­son to the board of di­rec­tors. Af­ter al­most 15 years in sales and mar­ket­ing at Gilead, John­son has held the role of chief com­mer­cial of­fi­cer at Glob­al Blood Ther­a­peu­tics for four years.

An­toni Ribas

→ UCLA pro­fes­sor and re­searcher An­toni Ribas has been named chair­man of the board at the Is­raeli com­pa­ny he found­ed in 2015, Lutris Phar­ma. Ribas al­so co-found­ed Kalthera, which merged with Imm­PACT Bio last sum­mer.

Ger­hard Koenig

Au­gus­tine Ther­a­peu­tics is pulling in Ger­hard Koenig as chair­man of its board. Koenig co-found­ed Arku­da Ther­a­peu­tics, where he serves as pres­i­dent and CEO. Koenig is al­so an en­tre­pre­neur-in-res­i­dence with At­las Ven­ture and has for­mer­ly held roles at Quar­tet Med­i­cine (CEO), FO­RUM Phar­ma­ceu­ti­cals (CSO and SVP), Fi­deli­ty Bio­sciences and Bay­er.

Ad­di­tion­al­ly, the com­pa­ny has an­nounced the for­ma­tion of a sci­en­tif­ic ad­vi­so­ry board with David Pareyson, Jonathan Baets, Philip Van Damme, Gui­do Cav­alet­ti, Rain­er Freyn­hagen, Hans Wildiers and Janssen vet Nicholas Car­ruthers.

Mag­gie Fitz­Patrick

→ Tak­ing a dip in the treach­er­ous IPO wa­ters with a $69 mil­lion raise, AN2 Ther­a­peu­tics has added Mag­gie Fitz­Patrick to the board of di­rec­tors. The Cigna and J&J com­mu­ni­ca­tions ex­ec, who was al­so SVP, cor­po­rate af­fairs, phil­an­thropy and cus­tomer en­gage­ment for Ex­elon, is on Vista­Gen’s board of di­rec­tors.

→ Aussie-based Ser­va­tus is reel­ing in Uwe Buechel­er as non-ex­ec­u­tive di­rec­tor of its board. Buechel­er has spent more than 30 years at Boehringer In­gel­heim, cur­rent­ly serv­ing as the com­pa­ny’s se­nior ad­vi­sor bio­phar­ma­ceu­ti­cals for its board of man­age­ment di­rec­tors. Pri­or to that, Buechel­er led a num­ber of se­nior roles at Boehringer across CMC de­vel­op­ment, reg­u­la­to­ry, biosafe­ty, qual­i­ty and as site head and lead for an ex­pan­sion of the com­pa­ny’s glob­al op­er­a­tion net­work in Eu­rope, the US and Chi­na.

Rob Chess

BigHat Bio­sciences is pulling out a seat for for­mer Nek­tar Ther­a­peu­tics CEO Rob Chess on its board of di­rec­tors. Cur­rent­ly, Chess serves as chair­man of Nek­tar and lead di­rec­tor of Twist Bio­science. Pri­or to this, Chess co-found­ed Bio­ta Tech­nolo­gies and Pene­d­erm and was the first CEO of OPX Biotech­nolo­gies.

→ Ice­landic biotech Epi­En­do Phar­ma­ceu­ti­cals — which back in Au­gust land­ed a €20 mil­lion Se­ries A for the de­vel­op­ment of its an­ti-in­flam­ma­to­ry COPD treat­ment — has found two new non-ex­ec­u­tive board mem­bers, Isaac Co­hen and Eu­gen Stein­er, to suc­ceed de­part­ed mem­ber Robert Hel­ga­son. Co­hen is founder, pres­i­dent and CEO of Ia­te­ri­on and was pre­vi­ous­ly founder, chair­man and CEO of Biono­vo. Mean­while, Stein­er is a ven­ture part­ner at VC fund Health­cap and cur­rent­ly CEO of Nordic Vi­sion Clin­ics.

Eva Chin

→ Van­cou­ver-based SOLVE FSHD is wel­com­ing aboard Eva Chin as ex­ec­u­tive di­rec­tor. Chin comes with ex­pe­ri­ence from Pfiz­er, the Uni­ver­si­ty of Mary­land, MyoTher­a­peu­tics, Cy­to­ki­net­ics and NMD Phar­ma.

Pneu­ma­gen is tack­ing John Bea­dle on­to its board of di­rec­tors as non-ex­ec­u­tive di­rec­tor. Bea­dle is the founder and for­mer CEO of PsiOxus Ther­a­peu­tics and ear­li­er in his ca­reer served at Pow­erMed (founder and CMO), Pfiz­er and GSK.

Ajit Shet­ty

Re­ju­ve­nate Bio­med has re­cruit­ed Ajit Shet­ty as chair of its board. Shet­ty, pri­or to his re­tire­ment in 2017, was chair­man of Janssen Phar­ma­ceu­ti­ca and a mem­ber of the op­er­at­ing com­mit­tee of J&J. Dur­ing his long ca­reer at the phar­ma gi­ant, Shet­ty was pres­i­dent of Janssen in the US and spent near­ly a decade at Janssen as man­ag­ing di­rec­tor.

→ Cam­bridge, UK-based Do­mainex has ap­point­ed Scott Mar­tin as an­a­lyt­i­cal and bio­an­a­lyt­i­cal group leader. Mar­tin spent two decades over at As­traZeneca as as­so­ciate prin­ci­pal sci­en­tist with­in the on­col­o­gy DMPK de­part­ment and has held roles at Roche, Glax­oW­ell­come and Zeneca Agro­chem­i­cals.

Pre­mas Biotech is pluck­ing up Saumen Chakraborty as part of its board of di­rec­tors. Chakraborty pre­vi­ous­ly served as CFO and pres­i­dent of Dr. Red­dy’s.

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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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

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

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

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.