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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.