Let’s build some­thing to­geth­er: Ex-Lowe’s CFO to join Pfiz­er while Mod­er­na’s David Meline re­tires; The CEO-part­ner par­ty rolls on at Flag­ship

David Den­ton

→ The two ma­jor Covid-19 vac­cine com­peti­tors, Pfiz­er and Mod­er­na, will both have new fi­nance chiefs with­in a week of each oth­er: At Pfiz­er, David Den­ton will suc­ceed 15-year vet Frank D’Ame­lio as CFO on May 2 af­ter three years in charge of fi­nances at home im­prove­ment chain Lowe’s. With Pfiz­er’s M&A wheels al­ways spin­ning, Den­ton left as CFO of CVS Health short­ly af­ter play­ing an in­te­gral role in the ac­qui­si­tion of Aet­na in late 2017.

Mean­while, David Meline is call­ing it quits at Mod­er­na, head­ing back in­to re­tire­ment near­ly two years in­to his tenure as CFO and yield­ing the stage to Jorge Gomez on May 9. Be­fore tak­ing the CFO job at den­tal prod­ucts man­u­fac­tur­er Dentsply Sirona in 2019, Gomez was al­so fi­nance chief dur­ing a 13-year run at Car­di­nal Health. Meline had re­tired as Am­gen’s CFO un­til the Mod­er­na po­si­tion opened up.

Michelle Wern­er

→ On the heels of Mar­go Geor­giadis’ ap­point­ment, Flag­ship Pi­o­neer­ing has lined up two more CEO-part­ners, and Michelle Wern­er kicked things off as the new chief ex­ec­u­tive of tR­NA-fo­cused All­tr­na. Since the sum­mer of 2020, Wern­er was No­var­tis On­col­o­gy’s world­wide fran­chise head, sol­id tu­mors, and her Big Phar­ma cre­den­tials al­so ex­tend to Bris­tol My­ers Squibb and to As­traZeneca, where she rose to glob­al fran­chise head in hema­tol­ogy. Short­ly af­ter she de­camped for No­var­tis, Calquence won ap­proval in the EU for adult pa­tients with chron­ic lym­pho­cyt­ic leukemia, a year af­ter the FDA gave it the go-ahead in the same in­di­ca­tion.

Michael Sev­eri­no

Then, the biotech in­cu­ba­tor made a splash on Wednes­day by en­tic­ing Ab­b­Vie pres­i­dent and vice chair­man Michael Sev­eri­no in­to a CEO-part­ner job for a com­pa­ny to be named lat­er. Be­fore his ar­rival at Ab­b­Vie in 2014, Sev­eri­no closed out his 10 years at Am­gen as SVP, glob­al de­vel­op­ment and cor­po­rate CMO. Our Kyle LaHu­cik has more on each new CEO-part­ner.

Nis­han de Sil­va

The white-hot ra­dio­phar­ma space picked up an­oth­er chal­lenger in Oc­to­ber 2021 with Ra­dio­net­ics On­col­o­gy, and the Cri­net­ics spin­out — backed by 5AM Ven­tures and Fra­zier Health­care Part­nershas found a CEO. Nis­han de Sil­va, the pres­i­dent and COO at Po­sei­da from 2015-18, had helmed AFYX Ther­a­peu­tics and is cur­rent­ly a board mem­ber at Se­lec­ta Bio­sciences. He will al­so sit on the board at Ra­dio­net­ics while lead­ing a team that is pro­ject­ed “to more than dou­ble over the com­ing year,” ac­cord­ing to a re­lease.

Paulash Mohsen

Paulash Mohsen is get­ting his first op­por­tu­ni­ty as a CEO at Vesi­gen Ther­a­peu­tics, a Har­vard spin­out whose plat­form tech is dubbed AR­MMs (AR­RDC1 Me­di­at­ed Mi­crovesi­cles). Mohsen spent the last sev­en years as CBO of Yu­man­i­ty, a neu­ro biotech that’s hang­ing on for dear life af­ter lay­ing off 60% of the work­force. Yu­man­i­ty’s pipeline for­tunes have soured be­cause of a par­tial clin­i­cal hold on its lead Parkin­son’s can­di­date, and while the com­pa­ny ex­plores its op­tions to stay afloat, Mohsen has jumped ship to a com­pa­ny that launched in Ju­ly 2020 with help from Leaps by Bay­er and Morn­ing­side Ven­tures.

Mario David Saltarel­li is step­ping in­to atai Life Sci­ences plat­form com­pa­ny GA­BA Ther­a­peu­tics as CEO and CMO, suc­ceed­ing co-founder Ian Massey. Saltarel­li takes over the helm — as the com­pa­ny is en­ter­ing Phase II stud­ies in anx­i­ety, de­pres­sion and oth­er neu­ro­log­i­cal in­di­ca­tions for its lead com­pound — with a wealth of ex­pe­ri­ence from ex­ec roles at Neu­ron23 (CEO), En­tra­da Ther­a­peu­tics (CMO), Sytim­mune (CMO), An­nex­on Bio­sciences (CMO) and Mallinck­rodt (CSO). This is all on top of oth­er stints at Pfiz­er, Shire, Ver­tex, Alex­ion and Ab­bott.

Ran­na Parekh

→ The Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter will wel­come Ran­na Parekh as chief di­ver­si­ty, eq­ui­ty and in­clu­sion of­fi­cer on May 31. Parekh comes from the Amer­i­can Col­lege of Car­di­ol­o­gy in Wash­ing­ton, where she was the or­ga­ni­za1tion’s first chief di­ver­si­ty and in­clu­sion of­fi­cer, and she’s al­so held DEI lead­er­ship posts at the Amer­i­can Psy­chi­atric As­so­ci­a­tion.

Jo­erg Horn­stein

Jo­erg Horn­stein has bolt­ed from AC Im­mune to be­come CFO and head of cor­po­rate func­tions for Lund­beck, which pro­vid­ed a fore­taste of the in­dus­try-wide staff cuts we’re see­ing to­day by slash­ing 300 jobs and shut­ter­ing its fa­cil­i­ty in In­dia. Horn­stein had han­dled fi­nances at AC Im­mune since 2017 and al­so spent 12 years in mul­ti­ple lo­ca­tions at Mer­ck KGaA.

As for Horn­stein’s re­place­ment at the Swiss neu­ro biotech, Chris Roberts will pinch-hit as in­ter­im CFO and has been pro­mot­ed to VP, fi­nance. Roberts joined An­drea Pfeifer’s crew as an as­so­ciate VP in 2017 af­ter more than a decade at Ernst & Young.

AC Im­mune al­so made two oth­er lead­er­ship moves with Howard Dono­van as chief HR of­fi­cer and the pro­mo­tion of Ju­lian Snow to VP, US fi­nance & cor­po­rate de­vel­op­ment. Dono­van piv­ots here from the World Eco­nom­ic Fo­rum, where he was head of peo­ple and cul­ture part­ners, peo­ple ser­vices and glob­al re­ward. As with Roberts, Snow start­ed at AC Im­mune five years ago, fill­ing the role of as­so­ciate VP, fi­nan­cial re­port­ing.

Gi­na Con­syl­man

Gi­na Con­syl­man has land­ed at Cyrus Moza­yeni-led Vedere Bio II from blue­bird bio as CFO. Con­syl­man starts anew quick­ly at the oc­u­lar gene ther­a­py play­er, which de­buted in May 2021 with a $77 mil­lion Se­ries A, af­ter a dire quar­ter­ly fil­ing co­in­cid­ed with her de­par­ture from blue­bird bio. Con­syl­man joined blue­bird just eight months ago af­ter sev­en years as CFO of Iron­wood, which has had its own set of ob­sta­cles with its pipeline and saw CEO Mark Mal­lon leave for NeoGe­nomics last year.

John Frank

→ DNA se­quenc­ing pow­er­house Il­lu­mi­na has poached John Frank from Mi­crosoft, nam­ing him chief pub­lic af­fairs of­fi­cer. Frank, whose first day will be April 18, wraps up a 28-year ca­reer with the tech gi­ant, start­ing out as a se­nior at­tor­ney and as­cend­ing to deputy gen­er­al coun­sel & chief of staff. Since March 2020, Frank has tak­en on the role of VP, Unit­ed Na­tions af­fairs and in­ter­na­tion­al or­ga­ni­za­tions.

Sam Jack­son

→ Sit­ting pret­ty with a $100 mil­lion fi­nanc­ing round just a cou­ple weeks ago and tar­get­ing LRRK2 and TYK2, CNS-fo­cused Neu­ron23 has tapped Sam Jack­son as CMO. Jack­son hails from an­oth­er neu­ro play­er, Alec­tor, where he held the same po­si­tion and where for­mer Pas­sage Bio ex­ec Gary Ro­mano will soon re­place him. Jack­son is a Genen­tech and Am­gen vet who was al­so the CMO of Alka­h­est.

Raf­faele Baf­fa

Raf­faele Baf­fa has signed on to be CMO at CARs­gen, which is at­tempt­ing to wedge its way in­to the BC­MA CAR-T space with CT053 for mul­ti­ple myelo­ma. Baf­fa piv­ots to CARS­gen from Zio­pharm On­col­o­gy (now known as Alaunos af­ter the ac­tivist at­tack dust has set­tled), where he was CMO and EVP of R&D. The Sanofi and Pfiz­er vet has al­so been CMO of Servi­er and VP, ther­a­peu­tic area head of on­col­o­gy, glob­al clin­i­cal de­vel­op­ment at Shire.

Jan Pinkas has been el­e­vat­ed to CSO of Pyx­is On­col­o­gy as Ronald Herb­st parts ways with the Pfiz­er ADC spin­out. Last Au­gust, Pinkas joined Pyx­is — which hit Nas­daq the fol­low­ing Oc­to­ber on the strength of a $168 mil­lion IPO — as SVP, pre­clin­i­cal R&D af­ter a two-year stint at Ma­gen­ta Ther­a­peu­tics as SVP, trans­la­tion­al sci­ences. He al­so had a num­ber of re­spon­si­bil­i­ties over a 12-year pe­ri­od at Im­muno­Gen, name­ly VP, trans­la­tion­al R&D.

Ravi Rao

Eli Lil­ly im­munome­tab­o­lism part­ner Sit­ryx Ther­a­peu­tics out of Ox­ford has se­lect­ed Ravi Rao as CMO. Rao — a for­mer Glax­o­SmithK­line ex­ec in im­munol­o­gy and spe­cial­ty med­i­cines who was al­so a group med­ical di­rec­tor, im­munol­o­gy clin­i­cal de­vel­op­ment with Roche — was head of R&D and CMO at So­bi be­fore choos­ing a dif­fer­ent path here at GSK-backed Sit­ryx. An­ders Ull­man has since tak­en over Rao’s old posts at So­bi.

Mikael Elias­son

→ Helmed by Stan­ford’s Amit Etkin, psy­chi­a­try start­up Al­to Neu­ro­science has looked to­ward Genen­tech/Roche to ap­point Mikael Elias­son as COO. Elias­son, who was pre­vi­ous­ly Genen­tech/Roche’s glob­al head of in­no­va­tion in neu­ro­science prod­uct de­vel­op­ment, has al­so been glob­al head of new prod­ucts at No­var­tis. Chris­t­ian Anger­may­er and the folks at Ape­iron In­vest­ment Group led Al­to Neu­ro­science’s Se­ries A round last Oc­to­ber, bring­ing the to­tal raised to $40 mil­lion.

Jotin Marango has left Ap­tose to tack­le the dual roles of CFO and head of cor­po­rate de­vel­op­ment with Ike­na On­col­o­gy, which is part­ner­ing with Bris­tol My­ers on its oral AHR in­hibitor IK-175. Marango had been CFO and CBO at Ap­tose, prompt­ing a lead­er­ship shuf­fle in which CEO William Rice is pick­ing up the slack as chief ac­count­ing of­fi­cer and VP of fi­nance Janet Clen­nett “will as­sume fi­nan­cial re­spon­si­bil­i­ties un­til a per­ma­nent CFO is an­nounced.”

Karen Davies

→ Co-found­ed by Feng Zhang and padding its war chest with an $80 mil­lion Se­ries B last month, CRISPR di­ag­nos­tic play­er Sher­lock Bio­sciences has trained a mag­ni­fy­ing glass on Karen Davies as chief de­vel­op­ment of­fi­cer. For the past decade, Davies has held a se­ries of posts at fel­low di­ag­nos­tic de­vel­op­er Quidel — from 2017-20 she was VP of in­stru­ment sys­tems, and since 2020 she served as VP of busi­ness trans­for­ma­tion.

Aman­da Mur­phy

Aman­da Mur­phy has re­signed from her role as CFO at cell en­gi­neer­ing play­er Max­Cyte, ef­fec­tive April 15. Ron Holtz, the cur­rent SVP and chief ac­count­ing of­fi­cer, will take over as in­ter­im CFO. While Ko­rn Fer­ry helps in the search for a suc­ces­sor, Holtz is re­turn­ing to the role he first held at Max­Cyte from 2005-20. Else­where, Max­Cyte staffer Sean Menar­guez has been bumped up to di­rec­tor, in­vestor re­la­tions.

Shabir Hasham

→ Seek­ing to put a bow on an NDA fil­ing for its Duchenne mus­cu­lar dy­s­tro­phy drug va­morolone by June, San­thera has pro­mot­ed Shabir Hasham to CMO. Hasham left No­var­tis in 2015 to be­come San­thera’s head of med­ical af­fairs EU & RoW, and since 2019 he’s been glob­al de­vel­op­ment pro­gram lead & glob­al head med­ical af­fairs. While with No­var­tis, Hasham was EU med­ical di­rec­tor and glob­al as­so­ciate brand di­rec­tor for the Swiss phar­ma’s neu­ro­science fran­chise. Hasham’s first day as med­ical chief is slat­ed for May 1.

Cristi­na Oli­va

Cristi­na Oli­va is mak­ing her way over to Nor­way-based BerGen­Bio, where she’ll serve as CMO. Oli­va hops aboard af­ter a stint as VP, on­col­o­gy and head of on­col­o­gy cen­tre of ex­cel­lence at IQVIA. Oli­va’s ré­sumé in­cludes a star-stud­ded ca­reer with pre­vi­ous roles at Nordic Nanovec­tor, Take­da, GSK and Eli Lil­ly.

→ Un­der­go­ing a facelift by of­fi­cial­ly re­nam­ing it­self a cou­ple weeks ago, Swedish can­cer out­fit Vivesto — once known as Oas­miahas pegged Daniel Tes­fa as CMO. Tes­fa had been med­ical di­rec­tor, clin­i­cal and trans­la­tion sci­ence hema­tol­ogy at So­bi since lead­ing on­col­o­gy and hema­tol­ogy for Bay­er in Scan­di­navia from 2018-20. Vivesto will uti­lize Lon­za’s ex­pand­ed site in Nan­sha, Chi­na, strik­ing a deal in late March with the CD­MO to man­u­fac­ture late-stage ovar­i­an can­cer can­di­date Cantrix­il.

Al­liance Phar­ma is lock­ing in Patrick Ben­nett to helm the bio­an­a­lyt­i­cal ser­vices com­pa­ny as CEO, suc­ceed­ing founder Frank Li, who will re­main as pres­i­dent and on the board of di­rec­tors. Ben­nett brings with him ex­pe­ri­ence from his time at PPD Lab­o­ra­to­ries (VP, strat­e­gy and de­vel­op­ment) and Ther­mo Fish­er Sci­en­tif­ic (di­rec­tor of glob­al strate­gic mar­ket­ing).

Richard Bar­tram

→ Pep­tide spe­cial­ist MBX Bio­sciences is pick­ing up for­mer Es­pe­ri­on ex­ec Richard Bar­tram as CFO. Bar­tram served in the same role dur­ing his time at Es­pe­ri­on — help­ing to raise more than $1.2 bil­lion in cap­i­tal. Pri­or to that stint, Bar­tram was with Price­wa­ter­house­C­oop­ers.

Vaxxas, the com­pa­ny that Mer­ck teamed up with back in 2020 to tap in­to patch de­liv­ery tech, has named Dan Devine as CBO and gen­er­al coun­sel. Devine joins the Bris­bane, Aus­tralia-based com­pa­ny with ex­pe­ri­ence from his roles at Pfiz­er, Pa­trys and Mesoblast.

James Gru­ber

James Gru­ber has been named CFO at Alkin­di Sprin­kle mak­er Eton Phar­ma­ceu­ti­cals, tak­ing over the po­si­tion from Wil­son Trout­man, who will re­tire at the end of May. Gru­ber most re­cent­ly served as US con­troller at Hori­zon Ther­a­peu­tics and he al­so spent more than a decade work­ing in var­i­ous fi­nan­cial po­si­tions at Ab­bott.

Lib­bie Mansell

→ As the cal­en­dar flipped to 2022, Javier Szwar­cberg was named CEO of Spruce Bio­sciences, and now the Mike Grey-chaired biotech fo­cused on rare en­docrine dis­or­ders has brought in Lib­bie Mansell as chief reg­u­la­to­ry and qual­i­ty of­fi­cer. If it seems like it wasn’t that long ago since Mansell ap­peared in Peer Re­view, you’re right: Six months ago she joined NFLec­tion Ther­a­peu­tics as SVP of glob­al reg­u­la­to­ry af­fairs & qual­i­ty as­sur­ance, but it’s on to the next chal­lenge. Mansell was al­so part of the AskBio team as SVP of reg­u­la­to­ry af­fairs.

Gwen Weld

Nau­tilus Biotech­nol­o­gy — backed by Paul Allen and Jeff Be­zos and list­ed on Nas­daq via a re­verse merg­er with one of Per­cep­tive’s blank-check com­pa­nies last year — has signed on Gwen Weld as chief peo­ple of­fi­cer and Sheri Wilcox as VP of affin­i­ty reagent de­vel­op­ment. Pri­or to join­ing Nau­tilus, Weld was chief peo­ple of­fi­cer at Am­per­i­ty and for­mer­ly gen­er­al man­ag­er of hu­man re­sources at Mi­crosoft. Mean­while, Wilcox hails from So­ma­Log­ic. where she served as se­nior di­rec­tor of glob­al sci­en­tif­ic en­gage­ment. Be­fore that, she was with Phar­ma­cia.

Ka­ri­na Fedasz, who be­gan her ca­reer at JP Mor­gan and was re­cent­ly the CFO of IDW Me­dia Hold­ings, has been named head of busi­ness de­vel­op­ment at Evofem, the mak­er of con­tra­cep­tive gel Phexxi. In Feb­ru­ary, End­points News’ Beth Sny­der Bu­lik spoke with Evofem CEO Saun­dra Pel­leti­er about a num­ber of top­ics, name­ly Phexxi’s ad cam­paign fea­tur­ing “Schitt’s Creek” star An­nie Mur­phy.

Heather Vi­tal

Jo Viney’s Seis­mic Ther­a­peu­tic, us­ing ma­chine learn­ing to de­vel­op im­munol­o­gy drugs and launch­ing with a tec­ton­ic plate-shift­ing $101 mil­lion Se­ries A in Feb­ru­ary, has added two ex­ecs: Er­ic Lar­son (SVP of fi­nance) re­unites with Viney, the CEO of Pan­dion be­fore it was sold to Mer­ck for $1.85 bil­lion last year. Be­fore Lar­son was Viney’s VP of fi­nance, he served as cor­po­rate con­troller for Pro­teosta­sis Ther­a­peu­tics. Af­ter near­ly sev­en years with Bio­gen, Heather Vi­tal (VP of R&D strat­e­gy) jumped to De­ci­phera Phar­ma­ceu­ti­cals as se­nior di­rec­tor of pro­gram lead­er­ship and then moved on to her most re­cent gig as se­nior di­rec­tor, port­fo­lio strat­e­gy and op­er­a­tions for Re­lay Ther­a­peu­tics.

→ TCR biotech TScan Ther­a­peu­tics has a new VP, fi­nance in Lei­den Dworak, who was pre­vi­ous­ly VP, head of fi­nan­cial plan­ning and analy­sis and busi­ness op­er­a­tions at Avro­bio. Dworak has al­so served as the fi­nance lead for glob­al vac­cines busi­ness de­vel­op­ment at Mod­er­na.

Lyn­dah Dreil­ing

→ Cal­i­for­nia-based Ko­r­lym mak­er Cor­cept Ther­a­peu­tics has three new ex­ecs ready to roll: First, Daniel Ein­horn (VP, en­docrine strat­e­gy) was the pres­i­dent of Di­a­betes and En­docrine As­so­ci­ates and med­ical di­rec­tor of Scripps Whit­ti­er Di­a­betes In­sti­tute in San Diego. Amiel Bal­ag­tas (VP, de­vel­op­ment op­er­a­tions) joins the list of Gilead vets at Cor­cept that in­cludes chief HR and com­mu­ni­ca­tions of­fi­cer Amy Flood and chief de­vel­op­ment of­fi­cer William Guy­er, cap­ping off a 23-year ca­reer at the Big Phar­ma as ex­ec­u­tive di­rec­tor, de­vel­op­ment sys­tems. And Lyn­dah Dreil­ing (VP, glob­al on­col­o­gy de­vel­op­ment), who al­so has Gilead ties as se­nior di­rec­tor, clin­i­cal re­search on­col­o­gy, is an Am­gen alum who was re­cent­ly SVP, clin­i­cal de­vel­op­ment with Spec­trum Phar­ma­ceu­ti­cals.

→ New Jer­sey-based Cel­lec­tar Bio­sciences has two an­nounce­ments this week: Matthew Ha­gan has been ap­point­ed VP, mar­ket­ing and strate­gic al­liances, and David Lasec­ki has joined the on­col­o­gy biotech as ex­ec­u­tive di­rec­tor, strate­gic al­liances. Most re­cent­ly, Ha­gan served as ex­ec­u­tive di­rec­tor, hema­tol­ogy port­fo­lio mar­ket­ing at Bris­tol My­ers. Lasec­ki joins from Heron Ther­a­peu­tics, where he served as se­nior di­rec­tor, on­col­o­gy sales.

→ Ox­ford, UK-based Evox Ther­a­peu­tics is bring­ing in Pe­ter Jones as VP of CMC. Pri­or to his new role, Jones was se­nior ex­ec­u­tive di­rec­tor, process de­vel­op­ment at Au­to­lus Ther­a­peu­tics. Be­fore that, Jones was serv­ing at Ox­ford Bio­med­ica, GSK and Gen­zyme.

Michael Mor­ris­sey

Ex­elix­is pres­i­dent and CEO Michael Mor­ris­sey has been named chair­man of the board at Ve­ra Ther­a­peu­tics, step­ping in­to the spot pre­vi­ous­ly oc­cu­pied by Abing­worth’s Kurt von Em­ster. The at­aci­cept de­vel­op­er’s board al­so in­cludes Beth Sei­den­berg from West­lake Vil­lage BioPart­ners and Akero Ther­a­peu­tics CEO An­drew Cheng.

→ There’s a chang­ing of the guard on the board of di­rec­tors at Cy­to­ki­net­ics, as John Hen­der­son re­places the re­tir­ing Robert Gage. Hen­der­son, a 25-year Pfiz­er vet, has been on the board at Cy­to­ki­net­ics since 2009. Car­di­ol­o­gist and Stan­ford De­part­ment of Med­i­cine chair­man Robert Har­ring­ton has al­so earned a seat on Cy­to­ki­net­ics’ board.

Maria Fardis

CRISPR Ther­a­peu­tics has put Maria Fardis’ name for­ward to join the board of di­rec­tors. When her time was up as CEO of Io­vance, Fardis then be­came a ven­ture part­ner at Fra­zier Life Sci­ences. If elect­ed, Fardis would take a seat at a board that in­cludes SR One’s Sime­on George and AskBio’s Kathy High.

Michel De­theux, the pres­i­dent and CEO of iTeos Ther­a­peu­tics, has as­sumed the role of chair­man of the board at French rare bone dis­ease biotech In­noSkel. De­theux co-found­ed iTeos 10 years ago and is al­so chair­man of ONA Ther­a­peu­tics in Barcelona.

Houman Ashrafi­an

→ As Prile­nia Ther­a­peu­tics bags $10 mil­lion from its re­cent Se­ries B round — bring­ing its to­tal cap­i­tal to $144 mil­lion — with the help of new in­vestor SV Health In­vestors, the com­pa­ny is tack­ing on Houman Ashrafi­an to its board of di­rec­tors. Ashrafi­an is a man­ag­ing part­ner at SV Health In­vestors and has found­ed six com­pa­nies: Sit­ryx, Enara Bio, TRexBio, Alchemab, Cata­ma­ran Bio and Mestag, and serves on the board of four of these com­pa­nies.

→ As Be Bio re­ceived a $130 mil­lion cash in­fu­sion led by ARCH to help its pur­suit of B cell ther­a­pies for rare dis­ease and can­cer, the com­pa­ny has pulled out a seat for Steven Gillis on its board of di­rec­tors and ARCH co-founder and man­ag­ing di­rec­tor Robert Nelsen and Robert Plenge (SVP and head of im­munol­o­gy, car­dio­vas­cu­lar and fi­bro­sis the­mat­ic re­search cen­ter at BMS) are ob­servers. Gillis is man­ag­ing di­rec­tor at ARCH Ven­ture Part­ners and serves as di­rec­tor of ho­mol­o­gy med­i­cines at Take­da and di­rec­tor and chair­man of Co­di­ak Bio­sciences and VBI Vac­cines.

Lipocine has brought on Jill Jene and Spy­ros Pa­pa­petropou­los to its board of di­rec­tors. Jene is cur­rent­ly founder and prin­ci­pal of Jene Ad­vi­sors and has pre­vi­ous­ly served as VP and head of cor­po­rate de­vel­op­ment, strat­e­gy, port­fo­lio plan­ning and al­liance man­age­ment at Adamas. Mean­while, Pa­pa­petropou­los is the CMO of Vig­il Neu­ro­sciences and was for­mer­ly SVP, head of de­vel­op­ment at Aca­dia Phar­ma­ceu­ti­cals, CEO of Swan­Bio Ther­a­peu­tics and head of re­search & de­vel­op­ment and CMO at Cavion.

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.

Endpoints Premium

Premium subscription required

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

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

(Credit: Shutterstock)

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

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.