Sier­ra On­col­o­gy brings on for­mer Aim­mune CEO to the helm; Flag­ship woos ex-No­var­tis ex­ec Fab­rice Chouraqui

Stephen Dil­ly

Mo­melo­tinib-fo­cused Sier­ra On­col­o­gy, which launched a Phase III tri­al in No­vem­ber for myelofi­bro­sis pa­tients, has made Stephen Dil­ly its pres­i­dent and CEO, ef­fec­tive June 1. Dil­ly was pre­vi­ous­ly the CEO at Aim­mune from 2014 un­til what was billed as his re­tire­ment in 2018, but now he’s back at the helm of an­oth­er com­pa­ny and is al­so a mem­ber of Sier­ra’s board of di­rec­tors. Ad­di­tion­al­ly, the sea­soned vet has held posts at Genen­tech, Ch­i­ron and GSK.

Mean­while, Velox­is Phar­ma­ceu­tics CEO Craig Col­lard was al­so named to Van­cou­ver-based Sier­ra’s board.

→ Fab­rice Chouraqui has added a new ti­tle to his ré­sumé. Af­ter steadi­ly ris­ing through the ranks and jour­ney­ing the globe to nab a top job as pres­i­dent of US phar­ma for the Basel-based No­var­tis, Chouraqui has hit the ex­it to head a hy­brid po­si­tion as a CEO-part­ner at Flag­ship. In his new po­si­tion, he’ll take a shot at lead­ing Cel­lar­i­ty — one of the VC’s lat­est par­a­digm-chang­ing com­pa­nies mold­ed on a ground­break­ing mod­el that as­pires to de­liv­er a new plat­form to the world of drug R&D. He’s chang­ing a top ex­ec­u­tive po­si­tion in a glob­al or­ga­ni­za­tion su­per­vis­ing thou­sands of staffers for a role run­ning a team of 50 en­gaged in deep sci­ence that mar­ries new in­sights in­to cel­lu­lar bi­ol­o­gy and AI in Cam­bridge, MA. And he’s com­mit­ted to a dual role as ven­ture part­ner, con­tribut­ing his own ideas to shap­ing the strat­e­gy and ex­e­cu­tion at Flag­ship.

Peg­gy Sotiropoulu

→ Celyad, the Bel­gian biotech now mak­ing a low-pro­file run for off-the-shelf CAR-T suc­cess along­side more promi­nent peers like Cel­lec­tis, Servi­er and Al­lo­gene, has pro­mot­ed Peg­gy Sotiropoulou to head of R&D. Sotiropoulou joined the com­pa­ny in 2017 and pre­vi­ous­ly served as di­rec­tor of R&D.

Just a lit­tle more than a month since tak­ing over as the lat­est CEO to helm Im­munomedics, Harout Se­mer­jian is ex­it­ing the com­pa­ny af­ter be­ing con­front­ed by “lo­gis­ti­cal” ob­sta­cles thrown up by the pan­dem­ic that made it im­pos­si­ble for him to move from Lon­don to car­ry out the job. And he’s get­ting a lit­tle over a mil­lion dol­lars in cash plus perks to grease the skids on the way out. Se­mer­jian, a long­time No­var­tis ex­ec who jumped to Ipsen for a 3-year stint as head of com­mer­cial op­er­a­tions, took the biotech job on April 16, grab­bing a salary of $675,000 a year, a bonus equal to a min­i­mum of 70% of that fig­ure, stock op­tions and a $225,000 bud­get for mov­ing from Ipsen to New Jer­sey. Now Be­hzad Ag­haz­adeh is back in charge and he’s in no hur­ry to restart their head­hunt­ing op­er­a­tion for a new CEO. That, says the com­pa­ny, will have to wait un­til the pan­dem­ic is over.

Yil­maz Mahshid

Swedish biotech Medi­vir will wel­come Yil­maz Mahshid as CEO in the fall, suc­ceed­ing Uli Hack­sell, who had been at the helm since Oc­to­ber 2018. Hack­sell will stay on as a mem­ber of Medi­vir’s board. Mahshid has been the CFO at an­oth­er Swedish com­pa­ny, Pled­Phar­ma, since De­cem­ber 2017. Be­fore Pled­Phar­ma, Mahshid was at In­dus­tri­fonden as in­vest­ment man­ag­er and con­troller.

Ni­ma Farzan is tak­ing over as CEO of San Diego pre­ci­sion on­col­o­gy play­er Kin­nate Bio­phar­ma, re­plac­ing Stephen Kaldor, who has been ap­point­ed chair­man. Farzan had been pres­i­dent and CEO of Pax­Vax from 2011-19 and is cur­rent­ly a board mem­ber at Keros Ther­a­peu­tics. Pri­or to Pax­Vax, Farzan was with No­var­tis in nu­mer­ous ca­pac­i­ties, in­clud­ing VP of US mar­ket­ing in the vac­cines & di­ag­nos­tics di­vi­sion.

Ex-Pfiz­er ex­ec Mark Schney­er will step up to the plate in the new­ly-cre­at­ed role of SVP, busi­ness de­vel­op­ment and CBO at Aca­dia Phar­ma­ceu­ti­cals, which re­vealed pos­i­tive Nu­plazid da­ta in De­cem­ber and a col­lab­o­ra­tion with Van­der­bilt Uni­ver­si­ty this month on tar­get­ing mus­carinic M1 re­cep­tors. Schney­er was at Pfiz­er for nine years, most re­cent­ly as their VP, busi­ness and cor­po­rate de­vel­op­ment for the Up­john di­vi­sion.

→ New­ly op­er­at­ing Lari­mar Ther­a­peu­tics — cre­at­ed from a merg­er be­tween Chon­dr­i­al Ther­a­peu­tics and Zaf­genhas en­list­ed some new faces in­to its ranks. Joseph Tru­itt has been named chair of the board of di­rec­tors, Nan­cy Ruiz as CMO and Michael Celano as CFO. Tru­itt for­mer­ly served as CEO of Achillion Phar­ma­ceu­ti­cals. Ruiz joins the com­pa­ny from Pro­long Phar­ma­ceu­ti­cals, where she served as VP of clin­i­cal de­vel­op­ment and head of drug safe­ty, while Celano most re­cent­ly served as CFO and COO at Re­cro Phar­ma.

Savi­ta Bernal has joined the ranks as CBO of French mi­cro­bio­me biotech MaaT Phar­ma, which racked up €18 mil­lion in Se­ries B fi­nanc­ing in Feb­ru­ary. Be­fore her ap­point­ment at the Ly­on-based biotech, Bernal spent 7 years at an­oth­er Ly­on-based com­pa­ny, Ado­cia, where she was di­rec­tor of strate­gic mar­ket­ing and cor­po­rate com­mu­ni­ca­tions, busi­ness de­vel­op­ment.

William De­laney

An­oth­er lead­er­ship tran­si­tion is un­fold­ing at South San Fran­cis­co-based As­sem­bly Bio­sciences, where Gilead vet William De­laney is re­plac­ing the re­tir­ing Richard Colon­no as CSO, vi­rol­o­gy, ef­fec­tive June 1. Colon­no now moves in­to a se­nior ad­vi­so­ry role. The Gilead con­nec­tions are strong, as As­sem­bly CEO John McHutchi­son spent 9 years at the big biotech, where he was CSO and head of R&D. De­laney spent 20 years at Gilead, start­ing as a re­search sci­en­tist in vi­rol­o­gy and ris­ing to ex­ec­u­tive di­rec­tor, bi­ol­o­gy.

Biodesy has un­veiled a new name this week: Blue­light Ther­a­peu­tics. The South San Fran­cis­co biotech al­so has a new CSO: Mark Gal­lop, a board mem­ber since 2018. An ex­ec­u­tive-in-res­i­dence at 5AM Ven­ture Part­ners, Gal­lop co-found­ed Rube­do Life Sci­ences, Nurix (where he was al­so CSO) and Xeno­Port (where he was al­so SVP of re­search).

→ Af­ter spend­ing a lit­tle over a year at Ap­plied Ther­a­peu­tics, CFO Mark Vi­g­no­la is hit­ting the ex­it. Charles (Chuck) Sil­ber­stein has been named as his suc­ces­sor and head of busi­ness de­vel­op­ment. Sil­ber­stein joins the com­pa­ny from re­cent­ly ac­quired Al­ler­gan, where he served as SVP of cor­po­rate busi­ness de­vel­op­ment. In ad­di­tion, Sil­ber­stein has served posts at Gold­man Sachs As­set Man­age­ment and JP Mor­gan As­set Man­age­ment.

→ Nathan Jor­gensen is head­ed to Cam­bridge, MA-based Vor Bio­phar­ma to be CFO. Be­fore go­ing to Vor, which en­gi­neers hematopoi­et­ic stem cells (eHSCs) to treat can­cer, Jor­gensen was most re­cent­ly with the Qatar In­vest­ment Au­thor­i­ty in a se­nior man­age­ment po­si­tion. Oth­er stops for Jor­gensen in the fi­nan­cial in­dus­try have in­clud­ed Calam­os In­vest­ments and Stifel Nico­laus.

Siob­han Nolan Mangi­ni

NGM Bio, which re­leased pos­i­tive da­ta in Feb­ru­ary in­volv­ing the use of aldafer­min in NASH pa­tients, will bring in Siob­han Nolan Mangi­ni as CFO, ef­fec­tive Ju­ly 13. Be­fore ar­riv­ing at NGM this sum­mer, Nolan Mangi­ni had been pres­i­dent and CFO of an­oth­er San Fran­cis­co-based com­pa­ny, Cast­light Health. She be­gan her Cast­light tenure in 2012 as di­rec­tor, strat­e­gy & busi­ness de­vel­op­ment.

Su­san Knud­son is mak­ing her way to San Diego-based re­gen­er­a­tive med­i­cine de­vel­op­er His­to­gen, where she will be­come EVP and CFO. She had held the same ti­tles at Pfenex since Feb­ru­ary 2018. Knud­son has al­so been the CFO of Neo­thet­ics and the se­nior di­rec­tor of fi­nance and ad­min­is­tra­tion at Av­era Phar­ma­ceu­ti­cals.

Bel­gian biotech Hy­loris Phar­ma­ceu­ti­cals, which cor­ralled a $15 mil­lion fund­ing round in late April, has se­lect­ed Patrick Jean­mart as CFO. Jean­mart jumps to Hy­loris from De­groof Pe­ter­cam In­vest­ment Bank, where he was their glob­al head of health­care. From 2007-18, he was al­so the CFO at Celyad.

Da­mon Sil­vestry has signed on at San Diego biotech Prog­en­i­ty to be their COO. Be­fore start­ing at Prog­en­i­ty, which de­vel­ops mol­e­c­u­lar test­ing prod­ucts, Sil­vestry spent 5 years at Nat­era, where he was SVP, op­er­a­tions and peo­ple, and 3 years at Mira­ca Life Sci­ences, where he end­ed his tenure as SVP of op­er­a­tions.

Gregg Mc­Connell

→ Next-gen T cell play­er TCR² Ther­a­peu­tics has added some new faces to its lead­er­ship team. The Cam­bridge, Mass­a­chu­setts-based com­pa­ny wel­comed Gregg Mc­Connell as head of busi­ness de­vel­op­ment and Viera Muzithras as VP of reg­u­la­to­ry af­fairs. Mc­Connell hails from Blue­Rock Ther­a­peu­tics, where he served as VP and head of busi­ness de­vel­op­ment un­til its ac­qui­si­tion by Bay­er. Pre­vi­ous­ly, Mc­Connell has served in roles at Pfiz­er. Muzithras steps in from Bris­tol My­ers Squibb (for­mer­ly Cel­gene), serv­ing as ex­ec­u­tive di­rec­tor of glob­al reg­u­la­to­ry af­fairs. Pri­or to that, Muzithras was se­nior di­rec­tor of reg­u­la­to­ry af­fairs and glob­al reg­u­la­to­ry di­rec­tor at No­var­tis.

→ Just days af­ter lin­ing up $145 mil­lion to pay for their first for­ay in­to the clin­ic, the Rally­bio team is go­ing back to Alex­ion for their lat­est hire. They’ve re­cruit­ed Róisín Arm­strong, who will head the de­vel­op­ment of RLYB211, a plas­ma-de­rived hy­per­im­mune glob­u­lin in de­vel­op­ment for the pre­ven­tion of fe­tal and neona­tal al­loim­mune throm­bo­cy­tope­nia. Arm­strong served as VP and glob­al med­i­cine team leader at Alex­ion.

Salt Lake City bio­phar­ma El­e­var Ther­a­peu­tics, with its lead can­di­dates rivo­ceranib (ap­a­tinib) and Apealea fo­cused on treat­ing can­cers, has called up­on Mark Gelder to be glob­al head of med­ical af­fairs. Gelder, who has spent time with Pfiz­er, Wyeth and Bay­er, was the CMO at Pier­ian Bio­sciences, Ac­celo­vance and Heron Ther­a­peu­tics.

Mol­ly Harp­er

New York-based Rel­ma­da Ther­a­peu­tics, which tar­gets CNS dis­eases, has brought on Mol­ly Harp­er as EVP of op­er­a­tions. Harp­er start­ed out as one of the ini­tial em­ploy­ees with Akcea Ther­a­peu­tics as their VP, com­mer­cial de­vel­op­ment, even­tu­al­ly be­com­ing SVP and glob­al fran­chise gen­er­al man­ag­er.

Amu­nix, which raised $73 mil­lion in a Se­ries A fi­nanc­ing round in March, has named Anne Keane SVP of reg­u­la­to­ry and qual­i­ty. Keane makes the leap to Amu­nix from Lyell Im­munophar­ma, where she was VP of reg­u­la­to­ry.

Fol­low­ing the pass­ing of Michael Wake­lam at the end of March, epi­ge­net­ics ex­pert Wolf Reik has been named act­ing di­rec­tor of the Babra­ham In­sti­tute. Reik has been the head of the In­sti­tute’s epi­ge­net­ics re­search pro­gram since 2008 and as­so­ciate di­rec­tor since 2004.

→ Ox­ford spin­out Evox Ther­a­peu­tics has en­list­ed Mar­tin An­drews as non-ex­ec­u­tive di­rec­tor. An­drews served as the SVP, rare dis­eases at Glax­o­SmithK­line and pre­vi­ous­ly served as SVP, glob­al vac­cines com­mer­cial at GSK’s vac­cines di­vi­sion.

David Lacey

→ A day be­fore Gilead‘s $2 bil­lion part­ner­ship deal, Ter­ry Rosen’s Ar­cus Bio­sciences ap­point­ed Am­gen vet David Lacey to its board of di­rec­tors. Lacey and Rosen are fa­mil­iar with each oth­er from their days at Am­gen, where Lacey was SVP of dis­cov­ery re­search.

→ Cam­bridge, MA-based An­chi­ano Ther­a­peu­tics has elect­ed Stan Polovets to be chair­man of its board of di­rec­tors. Polovets, the for­mer CEO of the Al­fa-Ac­cess-Ren­o­va (AAR) Con­sor­tium and the co-founder, chair­man and CEO of the Gen­e­sis Prize Foun­da­tion, has been on the board since April.

Ex-Al­ler­gan ex­ec James Hind­man has hopped aboard as a di­rec­tor at Urovant Sci­ences — which in March had Jim Robin­son step in and take over the reins of the com­pa­ny. Dur­ing his ca­reer at Al­ler­gan, Hind­man held var­i­ous roles lead­ing to his post as CFO un­til the com­pa­ny’s $70.5 bil­lion merg­er with Ac­tavis in 2015.

Bain-backed Pfiz­er spin­out Spring­Works Ther­a­peu­tics has wel­comed for­mer Ideaya Bio­sciences ex­ec Julie Ham­ble­ton, to its board of di­rec­tors. Ham­ble­ton joined the board at Arch On­col­o­gy in April. In ad­di­tion, Ham­ble­ton pre­vi­ous­ly served as VP, head of US med­ical at Bris­tol My­ers Squibb.

Joan­na Horobin

iOnc­tura — fo­cused on de­vel­op­ing mol­e­cules tar­get­ing can­cer and fi­bro­sis — has tapped for­mer CEO of Syn­dax Phar­ma­ceu­ti­cals Joan­na Horobin as non-ex­ec­u­tive chair of its board.

→ In­flam­ma­to­ry dis­ease-fo­cused Ac­quist Ther­a­peu­tics has added to its board of di­rec­tors, se­lect­ing Thomas Haver­ty and John Red­man. Haver­ty is cur­rent­ly the in­ter­im CMO at Eloxx Phar­ma­ceu­ti­cals, while Red­man is CEO of Pro­teus Ven­tures.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

Luciana Borio (Susan Walsh/AP Images)

UP­DAT­ED: Bob Nelsen's ARCH adds FDA, biode­fense ex­per­tise with ap­point­ment of Lu­ciana Bo­rio

Once vetted by the Biden team to lead the FDA as commissioner, Luciana Borio is now compiling quite the résumé.

Borio has now been named a venture partner at Bob Nelsen’s ARCH Venture Partners, and Nelsen told Endpoints News, “She will be involved in projects across the portfolio, including ongoing projects in manufacturing, clinical trials, gene therapy and gene editing, cell therapy, and delivery. We are exploring multiple projects in infectious disease, and next generation manufacturing.”