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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.