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 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 → 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. → 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 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. → 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. → 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. → 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 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. 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. → 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. → 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 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. → 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. → 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 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. → 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. → 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 de­ve
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