Flag­ship on cen­ter stage: Ax­cel­la’s new CMO likens the biotech to ‘pro­fes­sion­al sports team’; Life af­ter the FDA takes shape for Stephen Hahn as a chief ex­ec­u­tive

Mar­garet Koziel

Mar­garet Koziel has bounced back and forth be­tween acad­e­mia and biotech through­out her ca­reer — and af­ter 25 years, she has land­ed her first po­si­tion as part of a biotech’s top brass.

Koziel joined Ax­cel­la Ther­a­peu­tics — found­ed by Flag­ship’s Noubar Afeyan, Ge­of­frey von Maltzahn and David Berry as Ax­cel­la Health — in 2019, and as of Mon­day, she is now in the C-suite as the biotech’s new CMO.

As a self-de­scribed ap­plied sci­en­tist, Koziel’s ca­reer has been star-stud­ded: af­ter grad­u­at­ing from Dart­mouth and its med­ical school, she went to Har­vard Med­ical School, where she taught as an as­so­ciate pro­fes­sor of med­i­cine for 12 years. And af­ter Har­vard, Koziel first crossed over in­to biotech and took a job with No­var­tis as their head of trans­la­tion­al med­i­cine in in­fec­tious dis­ease.

Af­ter jump­ing from No­var­tis to Ver­tex, she re­turned to acad­e­mia — but this time at UMass, wear­ing a va­ri­ety of hats for the five years she was there: every­thing from pro­fes­sor of med­i­cine to di­rec­tor of clin­i­cal re­search and up to as­sis­tant vice provost in clin­i­cal re­search.

And then, she crossed right back in­to the realm of biotech with a job at Kalei­do Bio­sciences, which then led her to Ax­cel­la two and a half years ago, where she climbed the lad­der from glob­al pro­gram team lead to VP of clin­i­cal de­vel­op­ment and ul­ti­mate­ly to CMO.

For Koziel, she joined the com­pa­ny be­cause of its mod­el us­ing “en­doge­nous meta­bol­ic mod­u­la­tors” — mol­e­cules that could po­ten­tial­ly re­store health across a net­work of dis­reg­u­lat­ed path­ways.

But aside from the sci­ence, af­ter meet­ing oth­ers at Ax­cel­la, it be­come im­me­di­ate­ly ap­par­ent to her that “this was a cul­ture that I was go­ing to click in.”

Why? A high de­gree of pro­fes­sion­al­ism and cour­tesy.

“Peo­ple come to work. They know what their job is, they do their job, and they help each oth­er,” Koziel told End­points News. And in her mind, that’s kind of like a pro­fes­sion­al sports team — specif­i­cal­ly soc­cer.

“If you’ve ever watched a pro­fes­sion­al soc­cer team on the field, every­one has their role. And peo­ple are do­ing their role. And if some­body needs a back­stop, [it] doesn’t mat­ter whether you’re the for­ward or you’re the de­fend­er on a soc­cer team, you step in to help that per­son,” Koziel said. “And I im­me­di­ate­ly felt like I was walk­ing in­to a team of oth­er pro­fes­sion­als who were there with a com­mon pur­pose.”

Now on­ly a few days in­to her role as CMO, Koziel has one im­me­di­ate ob­jec­tive: ad­vance Ax­cel­la’s clin­i­cal pro­grams for its two planned drugs. Koziel point­ed at da­ta read­outs some­time mid-2022 and in­to 2023, adding, “that will help us de­ter­mine how quick­ly we can move.”

Paul Schloess­er

Stephen Hahn

→ Flag­ship has been throw­ing bones to Stephen Hahn ever since he clocked out as FDA com­mish, and this week is no dif­fer­ent as Hahn be­comes CEO of can­cer test­ing start­up Har­bin­ger Health. In mid-June, Flag­ship sought out Hahn to be CMO of its Pre­emp­tive Med­i­cine and Health Se­cu­ri­ty ini­tia­tive, and then he took an­oth­er CMO gig at Your­Bio Health three months lat­er. Be­fore Flag­ship court­ed him, Hahn joined the board of di­rec­tors at Black­fynn, which is chaired by Evelo Bio­sciences CEO Sim­ba Gill. Hahn did dis­cuss his new role at Har­bin­ger with our Zach Bren­nan via e-mail on Wednes­day, but he wasn’t par­tic­u­lar­ly chat­ty about his time at the top spot of the FDA.

Michael Sneed

→ An­oth­er high-pro­file ex­ec is step­ping down from J&J: EVP, glob­al cor­po­rate af­fairs and chief com­mu­ni­ca­tion of­fi­cer Michael Sneed has an­nounced his re­tire­ment ef­fec­tive April 1, 2022. Sneed, who start­ed out as a mar­ket­ing as­sis­tant for J&J sub­sidiary Per­son­al Prod­ucts Com­pa­ny in 1983, has been a mem­ber of the Ex­ec­u­tive Com­mit­tee since 2018. In oth­er J&J news, glob­al head of R&D Math­ai Mam­men tops a list of new Ex­ec­u­tive Com­mit­tee ap­point­ments, earn­ing the ti­tle of EVP, phar­ma­ceu­ti­cals, R&D. The oth­ers are EVP and chief in­for­ma­tion of­fi­cer Jim Swan­son; chief ex­ter­nal in­no­va­tion, med­ical safe­ty and glob­al pub­lic health of­fi­cer Bill Hait; and Vanes­sa Broad­hurst, who re­places Sneed as EVP, glob­al cor­po­rate af­fairs.

Ma­jor lead­er­ship changes were set in mo­tion in Au­gust, when Alex Gorsky said he would pass the CEO ba­ton to Joaquin Du­a­to on Jan. 3 and as­sume the role of ex­ec­u­tive chair­man. CSO and Ex­ec­u­tive Com­mit­tee vice chair­man Paul Stof­fels al­so ex­its the stage on Dec. 31.

James Mu­tam­ba

James Mu­tam­ba has tak­en on the role of CBO at Ar­rakis, Michael Gilman’s start­up aimed at drug­ging hard tar­gets which joined forces with Roche in April 2020 — an al­liance in which the phar­ma gi­ant paid $190 mil­lion up­front. A one-time prin­ci­pal at Long­wood Fund, Mu­tam­ba vaults to Ar­rakis af­ter a short stay at Pyx­is On­col­o­gy as VP of busi­ness and cor­po­rate de­vel­op­ment. Ar­rakis has plen­ty of com­pe­ti­tion in this space, rang­ing from Bill Haney’s Sky­hawk (part­nered with Mer­ck and Ver­tex) to Ex­pan­sion Ther­a­peu­tics.

Mar­ti­na Mols­ber­gen

→ As Mu­tam­ba leaves, Pyx­is On­col­o­gy has gained Mar­ti­na Mols­ber­gen as in­ter­im CBO. The long­time CEO of C14 Con­sult­ing Group, Mols­ber­gen has roamed the land­scape ex­ten­sive­ly as a busi­ness de­vel­op­ment ex­ec at such com­pa­nies as Cru­cell, Sor­ren­to, Se­lex­is and Ab­sci. The Pfiz­er-backed spin­out took its place on Nas­daq in Oc­to­ber with an up­sized IPO that to­taled $168 mil­lion.

Pe­ter Anas­ta­siou

→ Af­ter lead­ing the com­pa­ny to its April de­but, Bob Cud­di­hy will hand over the CEO keys to Pe­ter Anas­ta­siou at gene ther­a­py up­start Cap­si­da Bio­ther­a­peu­tics on Jan. 3. Anas­ta­siou will end a 12-year as­so­ci­a­tion with Lund­beck in which he rose to EVP and pres­i­dent of US and Cana­di­an busi­ness op­er­a­tions af­ter start­ing out as VP & gen­er­al man­ag­er, psy­chi­a­try. Else­where at Cap­si­da, co-founders Nicholas Fly­tza­nis and Nick Goe­den have been pro­mot­ed to CSO and chief tech­nol­o­gy of­fi­cer, re­spec­tive­ly. Fly­tza­nis and Goe­den both worked in Vi­viana Gră­d­i­naru’s lab at Cal­tech; Fly­tza­nis had been VP of re­search and Goe­den was VP of tech­nol­o­gy be­fore their pro­mo­tions.

Becky Lil­lie

→ Helmed by Ge­of­frey von Maltzahn, Tessera Ther­a­peu­tics is bring­ing in some new faces to its lead­er­ship team with the ap­point­ments of Michael Holmes as CSO; Iain Mc­Fadyen as chief da­ta of­fi­cer; and Becky Lil­lie as chief hu­man re­sources of­fi­cer. Holmes comes aboard from Am­bys Med­i­cines, where he served in the same ca­pac­i­ty. Pri­or to that, he held roles at Sang­amo Ther­a­peu­tics as SVP and chief tech­nol­o­gy of­fi­cer. Mc­Fadyen hails from LifeM­ine Ther­a­peu­tics and Mod­er­na while Lil­lie joins from Alex­ion, where she served as chief hu­man ex­pe­ri­ence of­fi­cer.

Ad­di­tion­al­ly, Tessera’s co-founder and CSO Ja­cob Rubens has tran­si­tioned to the role of chief in­no­va­tion of­fi­cer. But that’s not all the changes be­ing made. Tessera has al­so ap­point­ed Re­bec­ca Wais as VP, in­tel­lec­tu­al prop­er­ty and le­gal af­fairs and Ian O’Reil­ly as VP, head of GMP qual­i­ty.

Rachael Brake

Rachael Brake has left Take­da to be­come CSO at Nor­wood, MA-based Cor­bus af­ter the small biotech felt the sum­mer­time blues by turn­ing in a Phase III dud with its lead drug lenaba­sum. Brake, who had a nine-year run at the Japan­ese phar­ma, had led Take­da On­col­o­gy’s US med­ical af­fairs since June 2020 and was pre­vi­ous­ly VP, glob­al project leader in on­col­o­gy. She al­so spent eight years as a sci­en­tist with Am­gen. Lenaba­sum isn’t the on­ly game in town: Cor­bus re­cent­ly in-li­censed a pair of mon­o­clon­al an­ti­bod­ies, branch­ing out in­to sol­id tu­mors and fi­bro­sis.

→ A Tachi Ya­ma­da lega­cy play from Jim Wil­son named iECURE that launched in Sep­tem­ber with help from Ver­sant and Or­biMed has tapped David Gar­rett as CFO. Gar­rett hails from Dy­nacure, where he shep­herd­ed the biotech through a Se­ries C round that even­tu­al­ly yield­ed $55 mil­lion but couldn’t quite get an IPO over the hump. Be­fore his two years as Dy­nacure’s CFO, he was VP, cor­po­rate con­troller and head of in­vestor re­la­tions at Nabri­va Ther­a­peu­tics.

Kim Smith

Two more hires to men­tion at iECURE, which is tar­get­ing se­vere ge­net­ic liv­er dis­eases: Kim Smith has been named VP of fi­nance, and Ash­ley Kim is the Penn spin­out’s di­rec­tor of busi­ness de­vel­op­ment. Smith com­plet­ed a brief stay as man­ag­ing di­rec­tor at Gen­o­va Group and has held the VP of fi­nance role be­fore at Tmu­ni­ty, while Kim rolls in­to iECURE from Sean Nolan-chaired Jaguar Gene Ther­a­py, where she was di­rec­tor of busi­ness de­vel­op­ment and cor­po­rate strat­e­gy.

→ Af­ter 13 years at Arde­lyx, Jeff Ja­cobs has been named CSO of Gilead kid­ney dis­ease col­lab­o­ra­tor Goldfinch Bio. Hired as Arde­lyx’s VP of chem­istry in 2008, Ja­cobs rose to CSO in Jan­u­ary 2020, tak­ing charge of the biotech’s kid­ney and car­diore­nal dis­ease pro­grams. From 2000-08, he held sev­er­al posts at Sune­sis Phar­ma­ceu­ti­cals, in­clud­ing se­nior di­rec­tor, de­vel­op­ment chem­istry. Goldfinch’s lead drug GFB-887 is in Phase II for pa­tients with fo­cal seg­men­tal glomeru­loscle­ro­sis (FS­GS) and di­a­bet­ic nephropa­thy.

Mark Kauf­mann

→ Ja­cobs isn’t the on­ly Arde­lyx vet with a new gig lined up. Mark Kauf­mann, the Cal­i­for­nia biotech’s for­mer CFO and CBO who spent a por­tion of his ca­reer in Mon­tre­al revving up com­pa­nies like Al­lostera Phar­ma, has tak­en on both roles again at Es­cape Bio. The neu­ro start­up led by CEO Julie Ann Smith hauled in $73 mil­lion worth of fi­nanc­ing in Sep­tem­ber 2020 and its lead drug, ESB1609, is in de­vel­op­ment for Nie­mann-Pick type C and GBA Parkin­son’s.

Jan Matts­son

→ With cur­rent CMO Pat Horn de­part­ing at the end of the year, Al­bireo co-founder and CSO Jan Matts­son will take over as the com­pa­ny’s in­ter­im head of R&D. Al­bireo, which spe­cial­izes in treat­ments for rare liv­er dis­eases and has had their pru­ri­tus drug ap­proved this year, al­so named Sanofi and Eli Lil­ly vet­er­an Con­stan­tine Chino­poros as CBO last week.

→ An­oth­er com­pa­ny fo­cus­ing on liv­er dis­ease, Am­bys Med­i­cines, has an­nounced that co-founder Markus Grompe will take over as CSO as his pre­de­ces­sor, Michael Holmes, walks away “to pur­sue an ex­ter­nal op­por­tu­ni­ty.” Grompe, a pro­fes­sor at the Pa­pé Fam­i­ly Pe­di­atric Re­search In­sti­tute at Ore­gon Health and Sci­ence Uni­ver­si­ty, al­so found­ed Yecuris Cor­po­ra­tion. Am­bys is cur­rent­ly work­ing to ad­vance its lead pro­gram, AMI-918, in­to IND-en­abling stud­ies.

Arnon Aharon

Arnon Aharon has re­signed as CMO of Is­raeli liv­er dis­ease biotech Chemomab, led by ex-Lo­do Ther­a­peu­tics CEO Dale Pfost and chaired by cur­rent Gen­nao Bio CEO Stephen Squin­to. David Wein­er has been ap­point­ed in­ter­im CMO while Aharon stays for a two-month tran­si­tion pe­ri­od. Wein­er, the ex-CEO of Am­ath­us Ther­a­peu­tics and the for­mer in­ter­im CEO of Pro­teo­sta­tis Ther­a­peu­tics, is an Aca­dia vet who has been med­ical chief at Lu­mos Phar­ma and aTyr Phar­ma. Ad­di­tion­al­ly, he was VP, neu­rol­o­gy clin­i­cal de­vel­op­ment to close his four years with EMD Serono.

Michelle Zhang

→ Two pro­mo­tions have tak­en ef­fect at Boston’s Ike­na On­col­o­gy, a Bris­tol My­ers Squibb part­ner that broke through on Nas­daq ear­ly this spring with a $143.8 mil­lion IPO. One of Ike­na’s ear­li­est hires, Michelle Zhang has been el­e­vat­ed from SVP of trans­la­tion­al re­search and ear­ly de­vel­op­ment to CSO. Zhang, who once held a lead­er­ship role in the New In­di­ca­tions Dis­cov­ery Unit at No­var­tis In­sti­tutes for Bio­med­ical Re­search, has al­so been an en­tre­pre­neur in res­i­dence at At­las Ven­ture. Her pre­de­ces­sor, Jef­frey Ecsedy, has been bumped up to chief de­vel­op­ment of­fi­cer. Be­fore join­ing the biotech in 2017 when it was still called Kyn Ther­a­peu­tics, Ecsedy was the head of on­col­o­gy trans­la­tion­al med­i­cine at Take­da.

→ Mak­ing a ri­val drug to Amarin’s Vas­cepa, New Jer­sey-based Mati­nas Bio­Phar­ma has las­soed Thomas Hoover as CBO. Hoover was pro­mot­ed to chief com­mer­cial of­fi­cer and then CBO at Mil­len­do be­fore the bu­gler sound­ed taps on the com­pa­ny at the start of 2021 and it re­verse merged with Tem­pest Ther­a­peu­tics in March. Af­ter spend­ing six years in strat­e­gy po­si­tions at Glax­o­SmithK­line, Hoover was an ex­ec at Sunovion from 2007-16.

Steve Coats

→ Swiss can­cer play­er Im­munOs Ther­a­peu­tics has added an ex­tra lay­er of lead­er­ship with Big Phar­ma vet Steve Coats as chief de­vel­op­ment of­fi­cer. Coats had a 15-year run as an ex­ec with As­traZeneca/Med­Im­mune, ris­ing to VP R&D, glob­al project leader, and he was as­so­ciate di­rec­tor of on­col­o­gy re­search dur­ing his nine years with Am­gen. Back in Sep­tem­ber, Im­munOs made an­oth­er C-suite ap­point­ment by in­tro­duc­ing COO Jef­frey Abbey.

RTW-found­ed Yarrow Biotech­nol­o­gy — fo­cused on de­vel­op­ing an­ti­sense oligonu­cleotides for CNS dis­or­ders — has wel­comed Mark Keat­ing as CSO. Keat­ing hus­tles over to this lit­tle-known biotech af­ter serv­ing as VP and a dis­tin­guished fel­low at Al­ny­lam, pre­ced­ed by more than a decade at No­var­tis, where he grabbed a front-row seat to the de­vel­op­ment of En­tresto as VP and glob­al head of car­dio­vas­cu­lar and meta­bol­ic dis­eases.

Mo­ham­mad Ah­ma­di­an

Mo­ham­mad Ah­ma­di­an has signed on as VP, chem­istry and phar­ma­ceu­ti­cal de­vel­op­ment at San Diego’s Reg­u­lus Ther­a­peu­tics, a mi­croR­NA biotech with a check­ered past. Ah­ma­di­an makes this move af­ter his time as VP and res­i­dent di­rec­tor at Ki­no­vate Life Sci­ences. From 2016-18, Reg­u­lus suf­fered through a se­ries of set­backs, in­clud­ing an FDA hold on its hep C drug af­ter cas­es of jaun­dice were re­port­ed, a NASH part­ner­ship with As­traZeneca that fold­ed, and two sub­stan­tial staff re­duc­tions.

Ru­pert D’Souza

→ An­oth­er biotech that’s been through the wringer, gene ther­a­py de­vel­op­er Ad­verum Biotech­nolo­gies, has tapped Ru­pert D’Souza as CFO. D’Souza — who has served as CFO of Re­play Hold­ings for the last year — held fi­nan­cial posts at Genen­tech from 1999-2005, and he would spend an­oth­er six years at Bio­Marin, be­com­ing se­nior di­rec­tor, trea­sury & fi­nance. This year has test­ed a wob­bly Ad­verum: Its Phase II IN­FIN­I­TY tri­al for di­a­bet­ic mac­u­lar ede­ma hit the skids in April af­ter a pa­tient lost vi­sion, and the biotech de­cid­ed to ditch DME al­to­geth­er in Ju­ly when more safe­ty is­sues cropped up.

Meh­di Gas­mi

→ Speak­ing of Ad­verum, cur­rent board mem­ber and ex-pres­i­dent and CSO Meh­di Gas­mi has been se­lect­ed as COO of Spar­ingVi­sion, the French eye dis­ease start­up which cut a deal in Oc­to­ber to use In­tel­lia’s CRISPR tech­nol­o­gy on three tar­gets. Fur­ther, Spar­ingVi­sion has al­so brought in No­var­tis and Roche alum Flo­rence Paliar­gues as VP, port­fo­lio project man­age­ment and Spark vet Raf­fael­la Toso as VP, cor­po­rate de­vel­op­ment & al­liance man­age­ment.

Lee Giguere

→ Con­verse­ly, Ob­sid­i­an Ther­a­peu­tics has had an event­ful 2021 with a new part­ner in Ver­tex and a nine-fig­ure Se­ries B for good mea­sure. This week Ob­sid­i­an has brought on Lee Giguere as chief le­gal of­fi­cer and cor­po­rate sec­re­tary. Giguere moves on from Chi­as­ma, where he was gen­er­al coun­sel for near­ly two years, and from 2016-19 he was deputy gen­er­al coun­sel with Karyopharm.

Bob Langer lab spin­out Lyn­dra Ther­a­peu­tics is bring­ing on for­mer Ver­tex head of trea­sury Klas Holm­lund as CFO. Holm­lund spent a lit­tle over a decade at Ver­tex, build­ing the com­pa­ny’s trea­sury in­fra­struc­ture as its mar­ket cap­i­tal­iza­tion in­creased from $7 bil­lion to $52 bil­lion.

Mar­tin Wil­son

Rock­et Phar­ma­ceu­ti­cals, which shared pos­i­tive Phase I da­ta from its gene ther­a­py for Danon dis­ease sev­er­al weeks ago, has tak­en flight with Mar­tin Wil­son as gen­er­al coun­sel and chief com­pli­ance of­fi­cer. Wil­son is a for­mer as­sis­tant gen­er­al coun­sel with En­do Phar­ma­ceu­ti­cals who suits up for Gau­rav Shah’s crew af­ter a stint at Ich­nos Sci­ences, where he was gen­er­al coun­sel and chief cor­po­rate of­fi­cer.

Co­vis Phar­ma has two ex­ec­u­tive man­age­ment team ap­point­ments this week: Raghav Chari as chief in­no­va­tion of­fi­cer and Nico­las Ver­beke as SVP, Eu­rope & in­ter­na­tion­al. Chari has found­ed sev­er­al star­tups over the last five years, and al­so served as pres­i­dent at Promius Phar­ma. Ver­beke most re­cent­ly served as VP and gen­er­al man­ag­er, Eu­rope, Mid­dle East, and Africa for Astel­las Gene Ther­a­pies.

Bill Quirk

→ Liq­uid biop­sy com­pa­ny Kar­ius — which raked in $165 mil­lion from a Se­ries B fund­ing round ear­li­er this year — has named Bill Quirk as CFO and Steve Malas­ka as chief le­gal of­fi­cer. Quirk most re­cent­ly served as CFO of Freenome and has al­so spent near­ly 20 years as an an­a­lyst at RBC Cap­i­tal Mar­kets and Piper San­dler. Mean­while, Malas­ka comes from Das­ce­na, where he served as gen­er­al coun­sel. Ad­di­tion­al­ly, Malas­ka has served as co-founder and CEO of Ko­ta Bio­ther­a­peu­tics and has held roles at In­tel­lec­tu­al Ven­tures, Cep­tyr, Roche and Im­munex.

→ New York-based Oramed Phar­ma­ceu­ti­cals has tapped Ne­tanel Derovan as chief le­gal of­fi­cer (gen­er­al coun­sel) and com­pa­ny sec­re­tary. Derovan brings with him ex­pe­ri­ence from his times at Te­va Phar­ma­ceu­ti­cal In­dus­tries and Gold­farb Selig­man & Co.

→ What’s new in the VC world? First, Matthew Riz­zo and Pe­ter Thomp­son have been pro­mot­ed to gen­er­al part­ners at Or­biMed, join­ing six oth­er col­leagues in that ca­pac­i­ty. Riz­zo and Thomp­son both start­ed in 2010 at Or­biMed, which is at­tached to this week’s $218 mil­lion Se­ries A for Gary Glick’s lat­est ven­ture, Odyssey Ther­a­peu­tics.

Jen­nifer Grif­fin

→ Next, Mis­sion Bio­Cap­i­tal has made some moves to ac­com­mo­date the $275 mil­lion Mis­sion Bio­Cap­i­tal V, which is more than twice the size of its pre­vi­ous fund. Jen­nifer Grif­fin, who has been named part­ner for strat­e­gy and in­vestor re­la­tions, spent four years at the Mass­a­chu­setts Life Sci­ences Cen­ter and was VP of in­dus­try strat­e­gy and in­vest­ments. Else­where, Mis­sion Bio­Cap­i­tal has pro­mot­ed Cas­sidy Blun­dell and Zach Collins from as­so­ciate to prin­ci­pal.

Green­phire has tapped Alan Ma­tuszak as its new chief tech­nol­o­gy of­fi­cer. Pri­or to his new stint, Ma­tuszak was VP of en­gi­neer­ing at Me­di­da­ta So­lu­tions and for­mer­ly was CTO at eL­ynx.

Vi­jay Sabesan

Vi­jay Sabesan has been named SVP, tech­ni­cal op­er­a­tions at Nel­lo Main­olfi‘s pro­tein degra­da­tion shop Kymera Ther­a­peu­tics, which raised $173 mil­lion when it went pub­lic dur­ing the go-go days of 2020 IPOs. Most re­cent­ly, Sabesan held the same SVP po­si­tion at Ther­a­vance Bio­phar­ma.

Hua Zheng

Al­lied with In­novent on the ty­ro­sine ki­nase in­hibitor tale­trec­tinib for NSCLC, New York’s An­Heart Ther­a­peu­tics has turned to Big Phar­ma alum Hua Zheng to be SVP, head of glob­al reg­u­la­to­ry af­fairs. Zheng has built an im­pres­sive reg­u­la­to­ry ré­sumé with Janssen, Cel­gene and Ad­vax­is, and af­ter a year as glob­al reg­u­la­to­ry lead for Am­gen On­col­o­gy, he piv­ot­ed to Sor­ren­to, where he had been VP, in­ter­na­tion­al reg­u­la­to­ry af­fairs since 2019.

→ Swedish can­cer biotech Kancera has pegged Pe­ter Selin as EVP, cor­po­rate de­vel­op­ment. Selin had been the CBO of Oas­mia Phar­ma­ceu­ti­cal for a year, and ear­li­er he was So­bi’s VP of cor­po­rate de­vel­op­ment. Ac­cord­ing to the press re­lease, Selin “will take up his po­si­tion as soon as prac­ti­cal­ly pos­si­ble but at the lat­est on May 1, 2022.”

So­nia Brace­gir­dle

→ Se­r­i­al Peer Re­view en­trant Pep­Gen has ap­point­ed Isa­mi Sal­cedo as VP of pro­gram man­age­ment and pro­mot­ed So­nia Brace­gir­dle to SVP, strat­e­gy & op­er­a­tions. A Mer­ck alum, Sal­cedo worked in a num­ber of ca­pac­i­ties at Pro­teosta­sis Ther­a­peu­tics be­fore leav­ing as VP of pro­gram man­age­ment and op­er­a­tions. Brace­gir­dle, a for­mer part­ner at Syn­cona, joined the Ox­ford neu­ro spin­out in 2018 as head of busi­ness de­vel­op­ment. Pep­Gen’s lead can­di­date PGN-EDO51 is in the pre­clin­i­cal phase for Duchenne mus­cu­lar dy­s­tro­phy.

Nestlé chair­man Paul Bul­cke is not seek­ing re-elec­tion with the board of di­rec­tors at Roche when the Swiss phar­ma’s an­nu­al gen­er­al meet­ing comes around in March 2022. As a re­place­ment, Roche has nom­i­nat­ed Jemi­lah Mah­mood — ex­ec­u­tive di­rec­tor of the Sun­way Cen­tre for Plan­e­tary Health in Malaysia — to the board.

An­drew Lo

Bridge­Bio co-founder An­drew Lo, part of a new dream team with John Maraganore and Scott Mc­Clel­lan on Sali­o­Gen’s sci­en­tif­ic ad­vi­so­ry board, has been added to the board of di­rec­tors at Ab­Cellera. DCVC Bio part­ner John Hamer has re­signed af­ter three years on Ab­Cellera’s board, which is chaired by CEO Carl Hansen.

→ Pfiz­er’s for­mer head of glob­al reg­u­la­to­ry af­fairs Pe­ter Honig has joined the board of di­rec­tors at Karyopharm. He steps in for his old col­league, Pfiz­er CSO Mikael Dol­sten, who dropped out last week “due to com­pet­ing pro­fes­sion­al de­mands.”

Dol­ca Thomas

Ver­sant-backed Ven­tus Ther­a­peu­tics — which bagged $100 mil­lion in a Se­ries B fund­ing round ear­li­er this year — has brought on some ex­pe­ri­enced ex­ecs to its board of di­rec­tors with the ap­point­ments of Jane Hen­der­son (CFO at Ada­gio Ther­a­peu­tics); Dol­ca Thomas (EVP of R&D and CMO at Equi­lib­ri­um); and Markus War­muth (pres­i­dent and CEO of Monte Rosa Ther­a­peu­tics).

Charles Mc­Der­mott

→ Dutch phos­phatase biotech Ana­vo Ther­a­peu­tics launched in April and has now locked in Prim­mune Ther­a­peu­tics chief Charles Mc­Der­mott as its chair­man of the board. Mc­Der­mott has al­so served as pres­i­dent and CBO of Kala Phar­ma­ceu­ti­cals and Im­pact Bio­med­i­cines.

→ Lex­ing­ton, MA can­cer play­er Curis has named ex-Anokion pres­i­dent and CEO John Hohnek­er to the board of di­rec­tors. Hohnek­er has packed his post-Anokion ca­reer with a bunch of board seats, with Hu­mani­gen, Cyg­nal and Ar­a­vive lead­ing the list.

Saraswathy Nochur

Al­i­son Fin­ger and Saraswathy Nochur have joined the board of di­rec­tors at Deci­bel Ther­a­peu­tics as Chris­tine Poon steps aside. Fin­ger, a 21-year Bris­tol My­ers vet, is the for­mer chief com­mer­cial of­fi­cer for blue­bird bio, and Nochur be­came Al­ny­lam’s chief di­ver­si­ty, eq­ui­ty and in­clu­sion of­fi­cer in Jan­u­ary af­ter near­ly 15 years with John Maraganore’s crew in reg­u­la­to­ry af­fairs.

Ian Es­tepan

→ Flag­ship’s cell be­hav­ior up­start Cel­lar­i­ty, which pulled in a $125 mil­lion Se­ries B in Feb­ru­ary, has ap­point­ed Ian Es­tepan to the board of di­rec­tors. Es­tepan was pro­mot­ed to CFO in a De­cem­ber 2020 staff shake­up at Sarep­ta.

→ Tony Adamis has joined the board of di­rec­tors at Gy­ro­scope Ther­a­peu­tics, a Lon­don-based biotech fo­cus­ing on gene ther­a­pies for eye dis­eases like ge­o­graph­ic at­ro­phy. Adamis most re­cent­ly served as SVP of de­vel­op­ment in­no­va­tion at Genen­tech/Roche.

Or­p­hazyme has a new spot open on its board of di­rec­tors with the de­par­ture of Cather­ine Moukheibir. The com­pa­ny — which has been stuck in a rough patch and plans to lay off most of its staff af­ter a string of fail­ures for lead its ‘pipeline-in-a-prod­uct’ — has cho­sen An­drew Mer­cieca as her suc­ces­sor. Mer­cieca cur­rent­ly serves as CFO of LifeArc.

Derek Graf al­so con­tributed to this edi­tion.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.