Diem Nguyen tapped to lead 'point of in­flec­tion' at Xalud Ther­a­peu­tics; Di­ana Es­co­lar dances her way to Avro­bio CMO

Diem Nguyen

Diem Nguyen con­sid­ers her­self a “point of in­flec­tion seer.”

Help­ing busi­ness­es strate­gize and scale up is “where my sweet spot is,” the Pfiz­er vet­er­an said. So when she was tapped to take the helm at gene ther­a­py-fo­cused Xalud Ther­a­peu­tics, she knew it would be a great fit.

Xalud, found­ed in 2009 and head­quar­tered in New York City, is work­ing on non-vi­ral gene ther­a­pies to treat patho­log­ic in­flam­ma­tion. The com­pa­ny’s lead can­di­date, XT-150, is a lo­cal­ly in­jectable plas­mid DNA gene ther­a­py ex­press­ing In­ter­leukin 10 (IL-10) — an up­stream mod­u­la­tor for many pro-in­flam­ma­to­ry and an­ti-in­flam­ma­to­ry me­di­a­tors.

Nguyen said IL-10 has evad­ed drug de­vel­op­ment for “quite a long time.” And as the com­pa­ny’s new CEO, she’s ready to “crack that chal­lenge.”

XT-150 is cur­rent­ly in a Phase II/III tri­al for os­teoarthri­tis, and Nguyen ex­pects to read out topline Phase IIb da­ta in Q4. Xalud is al­so look­ing to test its plat­form in a va­ri­ety of oth­er ar­eas, from oph­thal­mol­o­gy to neu­rol­o­gy.

“This gene ther­a­py plat­form is not for a niche pop­u­la­tion. It is ac­tu­al­ly meant for, what we like to call … gene ther­a­py for the mass­es,” Nguyen said, adding that hun­dreds of mil­lions of pa­tients could po­ten­tial­ly ben­e­fit.

Nguyen hails from PPD, a con­tract re­search or­ga­ni­za­tion where she served as ex­ec­u­tive VP. But a ma­jor­i­ty of her ca­reer (10 years of it) was spent at Pfiz­er, where she built the biosim­i­lars busi­ness unit from the ground up. Af­ter con­vinc­ing ex­ec­u­tive lead­er­ship and the board to in­vest in the unit Nguyen helped iden­ti­fy five mon­o­clon­al an­ti­bod­ies, cre­ate cell lines, then move in­to clin­i­cal de­vel­op­ment and ul­ti­mate­ly com­mer­cial­iza­tion. Biosim­i­lars is now one of Pfiz­er’s high­est growth ar­eas, she said.

From there, Nguyen took on a num­ber of dif­fer­ent com­mer­cial roles across bi­o­log­ics, sol­id oral dose, ster­ile in­jecta­bles, and de­vices across mul­ti­ple ther­a­peu­tic ar­eas. Her last role was glob­al pres­i­dent of the US, Latin Amer­i­ca and Cana­da and glob­al ster­ile in­jecta­bles for Pfiz­er Es­sen­tial Health.

Nguyen said all that ex­pe­ri­ence makes her well equipped to see and build on Xalud’s po­ten­tial.

“We have been work­ing on re­al­ly try­ing to bring this great sci­ence to a de­gree that I think it de­serves for pa­tients that are suf­fer­ing,” she said. —Nicole De­Feud­is 


Di­ana Es­co­lar

Avro­bio an­nounced a key new hire in nam­ing Di­ana Es­co­lar as chief med­ical of­fi­cer this past Tues­day. But many years ago, Es­co­lar had imag­ined her­self in a dif­fer­ent ca­reer en­tire­ly.

Es­co­lar spent much of her child­hood and young adult life as a bal­le­ri­na, and by age 22 had reached what she con­sid­ered the pin­na­cle of her danc­ing pas­sion — per­form­ing in a show of the Bal­lad of Don Quixote in San Ju­na, Ar­genti­na. Ul­ti­mate­ly, she was of­fered a po­si­tion as a pro­fes­sion­al dancer in one of the world’s pre­miere bal­let com­pa­nies.

Hav­ing reached all she set out to do in bal­let, she in­stead went in­to med­i­cine, look­ing for a new chal­lenge.

“I love chal­lenges, I love to achieve things,” Es­co­lar told End­points News. “When I get to the top, I en­joy it for a lit­tle while and then go ‘what’s next?’ That’s sort of what hap­pened. I was a gift­ed bal­le­ri­na, I worked very hard to get where I was, it was a love and pas­sion.”

Es­co­lar said there wasn’t a spe­cif­ic mo­ment where she re­al­ized she wants to change ca­reer paths. It was more of a grad­ual re­al­iza­tion, with the un­der­stand­ing that danc­ing pro­fes­sion­al­ly ul­ti­mate­ly re­sults in a short ca­reer, and most end up as danc­ing teach­ers or chore­o­g­ra­phers. That’s where she’d be at this point in her life had she gone in the oth­er di­rec­tion, she says.

While grow­ing up, Es­co­lar had her hands in many ac­tiv­i­ties as a stu­dent. She took bi­ol­o­gy and chem­istry class­es at the Uni­ver­si­ty of Buenos Aires, hav­ing al­ways been in­ter­est­ed in the sci­ences. She stud­ied Eng­lish, Ger­man and French, none of which were her na­tive lan­guage. She even played gui­tar and was in a band.

In med school, Es­co­lar set­tled on neu­ro­sciences be­cause “it was one of the few things that didn’t make me fall asleep.” She en­joyed learn­ing how CNS dis­eases could af­fect the whole body and man­i­fest in dif­fer­ent ways, set­ting a new goal to help pa­tients in these ar­eas and en­sure that care could be ad­min­is­tered eq­ui­tably around the world.

That even­tu­al­ly led to co-found­ing the Co­op­er­a­tive In­ter­na­tion­al Neu­ro­mus­cu­lar Re­search Group in 1999, which cre­at­ed a cen­tral in­fra­struc­ture for sci­en­tif­ic, trans­la­tion­al, and clin­i­cal re­search in neu­ro­mus­cu­lar dis­eases. Es­co­lar con­sid­ers this her Quixote per­for­mance in the in­dus­try.

“That com­plete­ly changed the land­scape of drug tri­als and ad­vance­ment of treat­ment for all the neu­ro­mus­cu­lar and neu­ro­ge­net­ic dis­or­ders,” Es­co­lar said. “There’s been a lot of the in­dus­try that fol­lowed that, and the Eu­ro­peans cre­at­ed a sim­i­lar net­work that end­ed up part­ner­ing with CIN­RG, so it be­came a glob­al net­work.”

In the ear­ly 2010s, she then went in­to the pri­vate sec­tor, most re­cent­ly serv­ing as CMO at the now-for­mer mi­Ra­gen Ther­a­peu­tics. — Max Gel­man


Jonathan Vi­o­lin

Virid­i­an Ther­a­peu­tics was bought out in Oc­to­ber by mi­rA­gen, and now the lat­ter has de­cid­ed to change its name to Virid­i­an — and change its top ex­ec. Virid­i­an co-founder Jonathan Vi­o­lin, who had been pres­i­dent and COO, will rosin up the bow as pres­i­dent and CEO af­ter his pre­de­ces­sor’s very brief tenure. Lee Rauch had been named CEO of Boul­der, CO-based mi­rA­gen in Sep­tem­ber af­ter ini­tial­ly com­ing on board in June as COO, and she will now be a strate­gic ad­vi­sor. Vi­o­lin co-found­ed Treve­na and served in var­i­ous ca­pac­i­ties there, in­clud­ing SVP, sci­en­tif­ic af­fairs and in­vestor re­la­tions of­fi­cer.

Virid­i­an is al­so boost­ing the lead­er­ship team with Bar­rett Katz as CMO. Katz was with two sub­sidiaries at Bridge­Bio: pres­i­dent and CMO of Reti­na­genix and CEO of For­ti­fy Ther­a­peu­tics. Pri­or to that, he was CMO at Gen­Sight Bi­o­log­ics.

→ Just a cou­ple weeks af­ter its lead drug IMR-687 failed to im­press in a Phase IIa tri­al for sick­le cell dis­ease — send­ing shares tum­bling — Imara has re­cruit­ed Ken­neth At­tie as CMO. At­tie, who cut his teeth as a clin­i­cal sci­en­tist at Genen­tech, was pre­vi­ous­ly Ac­celeron’s VP of med­ical re­search for more than 11 years, steer­ing glob­al clin­i­cal de­vel­op­ment of such drugs as Re­blozyl (lus­pa­ter­cept), which could have block­buster po­ten­tial.

Frank Neu­mann

→ In a sur­pris­ing about-face, Frank Neu­mann has stepped away as Ve­rastem’s CMO af­ter on­ly two blink-and-you-miss-it weeks on the job, prompt­ing their stock $VSTM to slide 10% on Wednes­day af­ter the an­nounce­ment. Neu­mann was just in last week’s Peer Re­view af­ter tak­ing the Ve­rastem job and leav­ing his po­si­tion as VP, head of on­col­o­gy clin­i­cal re­search at blue­bird bio. Ve­rastem can on­ly say that Neu­mann “ac­cept­ed a role at a cell ther­a­py com­pa­ny to con­tin­ue work in that space.”

Amir Re­ich­man

Biond­Vax’s com­plete mis­fire in a Phase III study of its uni­ver­sal flu vac­cine sent in­vestors to the hills — and sig­naled a chang­ing of the guard at CEO. With Ron Babecoff no longer at the helm of the place he co-found­ed, Amir Re­ich­man steps in ef­fec­tive March 2, while Babecoff tran­si­tions to a se­nior ad­vi­so­ry role. In the mean­time, Re­ich­man will wrap up his run as GSK’s head of glob­al vac­cines en­gi­neer­ing core tech­nolo­gies and as­set man­age­ment. Re­ich­man’s tenure pre­dates the 2015 ac­qui­si­tion of No­var­tis Vac­cines, where he held posts in the glob­al vac­cines sup­ply chain man­age­ment or­ga­ni­za­tion.

Anil Sing­hal

Tizona spin­out Tr­ishu­la Ther­a­peu­tics, which is part­ner­ing with Ab­b­Vie on their an­ti-CD39 an­ti­body TTX-030, has se­lect­ed Anil Sing­hal as CEO. Tizona CEO Scott Clarke had been in­ter­im CEO of Tr­ishu­la, which launched last Au­gust. It’s a fa­mil­iar face to their part­ner: Sing­hal was once Ab­b­Vie’s VP of ear­ly on­col­o­gy de­vel­op­ment and head of the phar­ma gi­ant’s site in Red­wood City, CA. He was CEO of Adicet Bio for two years un­til it merged with No­var­tis spin­out reSTOR­bio last spring, leav­ing its CEO Chen Schor to take the helm at Adicet.

→ Big Phar­ma vet Michael Flana­gan has been in­stalled as chief tech­ni­cal of­fi­cer at an­ti­body oligonu­cleotide con­ju­gate out­fit Avid­i­ty Bio­sciences, part­ner­ing with CSO Art Levin “to deep­en the pipeline and broad­en the AOC plat­form,” pres­i­dent and CEO Sarah Boyce said in a state­ment. Flana­gan had pre­vi­ous­ly been Genen­tech’s se­nior di­rec­tor and project team leader, on­col­o­gy and im­munol­o­gy, and be­fore that, he was se­nior di­rec­tor of RNA sci­ences at Mer­ck. In the 1990s, Flana­gan was a se­nior sci­en­tist at Gilead.

Thomas Soloway

Ver­sant-backed T cell ther­a­py play­er T-knife, which pulled in a Se­ries A worth more than $78 mil­lion in the dog days of last sum­mer, is re­fash­ion­ing its C-suite with Thomas Soloway as CEO and Camille Lan­dis as CBO and CFO. Soloway, who re­places Elisa Kieback, had logged five years at Au­dentes as their EVP, COO and had a brief run as CFO at As­cendis Phar­ma AS from 2014-15. Lan­dis heads to T-knife from Uni­ty Biotech­nol­o­gy, where she was SVP, cor­po­rate de­vel­op­ment, and she’s al­so been CBO at Ei­dos.

→ In ad­di­tion to Lan­dis at T-knife, the ex­o­dus from Uni­ty Biotech­nol­o­gy con­tin­ues af­ter deep job cuts and the loss of their lead pro­gram cast a pall on their 2020. Dou­glas Rich has be­come chief tech­ni­cal of­fi­cer at Ap­plied Mol­e­c­u­lar Trans­port, a South San Fran­cis­co biotech which raised a shade more than $177 mil­lion in a June IPO. Rich had been with Uni­ty since 2017 as SVP, op­er­a­tions, and has ex­pe­ri­ence from Kythera Bio­phar­ma­ceu­ti­cals (SVP, op­er­a­tions), Boehringer In­gel­heim (VP, qual­i­ty) and Am­gen in sev­er­al op­er­a­tions roles spread over 18 years.

Jim Caggiano

→ Just a short time ago, Jim Caggiano took the CEO reins at Targazyme. Now he’s ready for an­oth­er CEO chal­lenge at Evolve Bi­o­log­ics, an out­fit from On­tario fo­cused on plas­ma-de­rived ther­a­peu­tics. Caggiano helmed Den­dreon and was pres­i­dent of Valeant Phar­ma­ceu­ti­cals, which sold Den­dreon to San­pow­er Group in ear­ly 2017. He’s al­so been a sales and mar­ket­ing ex­ec at Al­ler­gan and Ab­bott.

→ With its sights set on an $86 mil­lion IPO, Nex­Im­mune hired Jerome Zeld­is as their new R&D chief ear­li­er this month, and a fel­low Cel­gene alum will join him as CMO. Robert Knight spent 16 years as a VP in clin­i­cal re­search at Cel­gene and then took charge of the Yescar­ta clin­i­cal pro­gram at Kite. Be­fore these stops, Knight was Sor­ren­to’s head of clin­i­cal re­search. Phase I/II tri­als are on­go­ing for Nex­Im­mune’s lead can­di­dates NEXI-001 and NEXI-002.

Else­where at Nex­Im­mune, Grant Ver­standig has been elect­ed to the Gaithers­burg, MD biotech’s board of di­rec­tors. Ver­standig is the chief dig­i­tal of­fi­cer at Unit­ed­Health Group, which ac­quired his com­pa­ny Ral­ly Health in 2017.

Hen­ri­et­ta Uk­wu

→ Mean­while, at an­oth­er promi­nent Gaithers­burg biotech, No­vavax keeps on adding new folks as they push for­ward in a piv­otal Phase III with their Covid-19 vac­cine. This time it’s Hen­ri­et­ta Uk­wu mak­ing her way to No­vavax as chief reg­u­la­to­ry and qual­i­ty of­fi­cer. A Mer­ck and Pfiz­er vet in reg­u­la­to­ry af­fairs, Uk­wu de­vot­ed eight years to Ot­su­ka Phar­ma­ceu­ti­cals, where she was most re­cent­ly chief reg­u­la­to­ry of­fi­cer and glob­al head of qual­i­ty and reg­u­la­to­ry.

Christo­pher Mox­ham logged al­most 20 years in two sep­a­rate stints in drug dis­cov­ery at Eli Lil­ly de­vel­op­ing the phar­ma gi­ant’s on­col­o­gy pipeline be­fore swing­ing to Ful­crum Ther­a­peu­tics two years ago as SVP, dis­cov­ery re­search. Now Ful­crum, which saw its Phase II study fal­ter with old GSK drug losmapi­mod last sum­mer, has pro­mot­ed Mox­ham to CSO. He re­places fel­low Eli Lil­ly alum Owen Wal­lace, who was Ful­crum’s chief sci­en­tist since 2017.

Kel­ly Mac­Don­ald

Michael Os­tra­ch an­nounced his re­tire­ment last fall as CFO of Dy­navax, and this week the hep B vac­cine mak­er named Kel­ly Mac­Don­ald as his suc­ces­sor. Mac­Don­ald hails from Iron­wood Phar­ma­ceu­ti­cals, where she held a va­ri­ety of ti­tles, be­gin­ning as a se­nior man­ag­er, tech­ni­cal ac­count­ing and ex­ter­nal re­port­ing and cap­ping her time as chief ac­count­ing of­fi­cer and VP, fi­nance.

John Doyle has been ap­point­ed CFO at Chi­as­ma, which won FDA ap­proval back in June for its acromegaly drug My­capssa. He suc­ceeds Mark Fitz­patrick, who will stick around as a con­sul­tant un­til June 30. Doyle ar­rives at Chi­as­ma from a near­ly three-year stint at Ve­rastem, even­tu­al­ly be­com­ing the can­cer biotech’s VP of fi­nance and in­vestor re­la­tions.

Matthew Plun­kett

Snap­ping up $80 mil­lion in Se­ries C fi­nanc­ing in No­vem­ber — with a hint of prep­ping an IPO some­time this year — South San Fran­cis­co blood can­cer biotech Ima­go Bio­Sciences has pegged Matthew Plun­kett as CFO. Plun­kett is com­ing off a two-year run as CFO for Nkar­ta Ther­a­peu­tics, and he’s al­so been chief fi­nan­cial and busi­ness of­fi­cer at Mede­or Ther­a­peu­tics.

Fred­er­ic Fasano has been named pres­i­dent and COO of Que­bec-based Va­leo Phar­ma, cen­tered on com­mer­cial­iz­ing pre­scrip­tion prod­ucts in Cana­da. Fasano, a long­time Servi­er vet who even­tu­al­ly climbed his way to CEO of Servi­er Cana­da from 2011-20, will al­so be a mem­ber of Va­leo’s board of di­rec­tors. At the same time, Va­leo CEO Steve Sav­iuk will slide in­to the role of vice-chair­man of the board.

Amit Mun­shi’s neu­ro sub­sidiary Long­board Phar­ma­ceu­ti­cals has a new CFO with the ar­rival of Bran­di Roberts. Roberts hails from Lin­eage Cell Ther­a­peu­tics, hold­ing the CFO post for two years un­til re­sign­ing last week. Lin­eage CEO Bri­an Cul­ley will be in­ter­im CFO there un­til a re­place­ment is found.

Else­where at Long­board, for­mer Are­na board mem­ber and ex-Idec Phar­ma­ceu­ti­cals CFO Phillip Schnei­der, along with eGe­n­e­sis CEO Paul Sekhri, have jumped on to the board of di­rec­tors.

Con­nie Chang

→ Reti­nal dis­ease-fo­cused ONL Ther­a­peu­tics from Ann Ar­bor, MI has wel­comed Con­nie Chang as their new COO. A Pfiz­er vet in mar­ket­ing, Chang was pre­vi­ous­ly VP of cor­po­rate af­fairs at Mil­len­do Ther­a­peu­tics, which is be­ing forced to re-eval­u­ate where they are as a com­pa­ny by slash­ing their staff and clos­ing up shop on NK3R an­tag­o­nist MLE-301 ear­li­er this month.

→ Bel­gian phar­ma Ox­u­ri­on NV, fo­cused on eye dis­eases con­nect­ed with di­a­betes, chose a new CFO and CMO last year, and they’ve reached in­to acad­e­mia to tap Alan Stitt as CSO. Stitt has been the chair of ex­per­i­men­tal oph­thal­mol­o­gy at Queen’s Uni­ver­si­ty Belfast since 2001 and has spe­cial­ized in re­search­ing reti­nal dis­eases. Stitt suc­ceeds the re­tir­ing Jean Feyen, who had been Ox­u­ri­on’s CSO since 2013.

Quentin Mc­Cub­bin

→ With its lead drug FX-322 tar­get­ing sen­sorineur­al hear­ing loss, Fre­quen­cy Ther­a­peu­tics has in­stalled Quentin Mc­Cub­bin as chief man­u­fac­tur­ing of­fi­cer, a month and a half af­ter Pe­ter Pfre­und­schuh was ap­point­ed CFO. Mc­Cub­bin hails from Tony Coles’ team at Cerev­el, where he led their tech­ni­cal op­er­a­tions. He al­so had a 19-year tenure with Take­da/Mil­len­ni­um, with the last three-and-a-half years as VP, glob­al head of chem­i­cal de­vel­op­ment lab­o­ra­to­ries.

→ Dutch biotech Sapreme, fo­cused on de­vel­op­ing macro­mol­e­cule ther­a­peu­tics, has cor­ralled Hen­rik Luessen as CBO. Luessen has pre­vi­ous­ly been CBO at Bel­gian cell ther­a­py de­vel­op­er Promethera Bio­sciences and start­ed life sci­ence ad­vi­so­ry group Ty­to­nis BV, serv­ing as man­ag­ing di­rec­tor.

Car­la Poul­son

Car­la Poul­son’s re­cent stop at Akcea was a brief one as she moves on to an­ti­body-drug con­ju­gate (ADC) play­er Mer­sana Ther­a­peu­tics as chief hu­man re­sources of­fi­cer. As Peer Re­view told you, Poul­son left Ver­tex last May to join Akcea in the same role she now fills at Mer­sana. In Poul­son’s near­ly decade-long stay at Ver­tex, she was head of in­ter­na­tion­al hu­man re­sources and was lat­er pro­mot­ed to VP, hu­man re­sources.

Richard Wood­man

Ei­sai has named Richard Wood­man as chief clin­i­cal of­fi­cer of its on­col­o­gy busi­ness group. Most re­cent­ly, Wood­man was CMO and head of re­search and de­vel­op­ment at On­cono­va Ther­a­peu­tics. Pri­or to that, Wood­man had a 12-year stint at No­var­tis, serv­ing as fran­chise head for hema­tol­ogy in glob­al med­ical af­fairs. Wood­man jumped in­to the in­dus­try as se­nior med­ical di­rec­tor at J&J.

Zim­mer Bio­met has en­list­ed El­li­son (El­lie) M Humphrey as chief trans­for­ma­tion of­fi­cer. Humphrey hails from Medtron­ic, where she most re­cent­ly served as VP of en­ter­prise ex­cel­lence and busi­ness trans­for­ma­tion.

Steven Tuch has been cho­sen as head of cor­po­rate de­vel­op­ment at Rally­bio, which has $145 mil­lion in Se­ries B fi­nanc­ing squared away for pro­grams that in­clude RLYB211 for fe­tal and neona­tal al­loim­mune throm­bo­cy­tope­nia. Tuch leaves his gig at BMO Cap­i­tal Mar­kets as man­ag­ing di­rec­tor, head of US eq­ui­ty cap­i­tal mar­kets orig­i­na­tions.

Gwe­nan White

→ Ef­fec­tive in March, Big Phar­ma vet Gwe­nan White will join Ipsen — now helmed by for­mer Sanofi ex­ec David Loew — as EVP, com­mu­ni­ca­tions and pub­lic af­fairs. White, who’s worked in com­mu­ni­ca­tions at GSK, Ab­bott and Ab­b­Vie, is com­ing from No­var­tis, where she was glob­al head of phar­ma com­mu­ni­ca­tions and pa­tient ad­vo­ca­cy.

Jean-Pierre Som­ma­dos­si’s crew at Atea Phar­ma­ceu­ti­cals has added two new ex­ecs, start­ing with SVP of reg­u­la­to­ry af­fairs Jayan­thi Wolf. A 19-year Mer­ck alum, Wolf closed her time at the phar­ma gi­ant as ex­ec­u­tive di­rec­tor, glob­al reg­u­la­to­ry af­fairs. In ad­di­tion, Atea has se­lect­ed Jon­ae Barnes as SVP of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Barnes, who got her start at Sepra­cor (now Sunovion) from 1996-2009, had been Pox­el’s SVP, in­vestor re­la­tions, cor­po­rate com­mu­ni­ca­tions & pub­lic re­la­tions.

AGC Bi­o­log­ics, the CD­MO that com­mit­ted $194 mil­lion to ex­pand­ing its Copen­hagen site last month, has called up­on David Stew­art to over­see their site in Boul­der, CO. The new gen­er­al man­ag­er/site head comes to AGC with lead­er­ship ex­pe­ri­ence in man­u­fac­tur­ing from Bio­gen and Genen­tech.

Bryan Wahl

Tar­sus Phar­ma­ceu­ti­cals, which is de­vel­op­ing its lead drug for the eye dis­ease De­mod­ex ble­phar­i­tis, has made Bryan Wahl gen­er­al coun­sel, a cou­ple weeks af­ter the ap­point­ment of chief hu­man re­sources of­fi­cer Di­anne Whit­field. Wahl was for­mer­ly a part­ner at Knobbe Martens since 2005.

Black Di­a­mond Ther­a­peu­tics has made the ad­di­tion of Kapil Dhin­gra to its board of di­rec­tors. Dhin­gra served as clin­i­cal and strate­gic ad­vi­sor to the com­pa­ny since 2017. Dhin­gra joins with near­ly a decade of ex­pe­ri­ence at Roche, serv­ing in roles such as VP, head of on­col­o­gy dis­ease bi­ol­o­gy lead­er­ship team and head of on­col­o­gy clin­i­cal de­vel­op­ment. His ap­point­ment comes months af­ter Black Di­a­mond reeled in ex-GSK CEO Bob In­gram as chair­man for its board.

John McHutchi­son

→ Ox­ford-based ex­o­some play­er Evox Ther­a­peu­tics has re­served a seat for John McHutchi­son on the board of di­rec­tors. Since Au­gust 2019, McHutchi­son has been pres­i­dent and CEO at As­sem­bly Bio­sciences af­ter nine years at Gilead.

SOPHiA GE­NET­ICS has nom­i­nat­ed Kathy Hi­bbs to their board of di­rec­tors. Cur­rent­ly, Hi­bbs is chief le­gal and reg­u­la­to­ry of­fi­cer at 23andMe. Hi­bbs al­so sits on the boards of Ge­nom­ic Health and Mono­gram Bio­sciences.

Al­i­son Law­ton

→ Launched by Syn­cona, AAV-based gene ther­a­py shop Swan­Bio has wel­comed Al­i­son Law­ton to their board of di­rec­tors fol­low­ing the No­vem­ber ap­point­ments of Pat­ty Allen, Dan­ny Bar-Zo­har and Alex Hamil­ton. The for­mer pres­i­dent and CEO of Kalei­do Bio­sciences, Law­ton al­so joined the board of X4 Phar­ma­ceu­ti­cals in Oc­to­ber.

CMR Sur­gi­cal has tapped Cather­ine Moukheibir as non-ex­ec­u­tive di­rec­tor. Moukheibir joins the com­pa­ny with ex­pe­ri­ence as non-ex­ec­u­tive di­rec­tor of Iron­wood Phar­ma­ceu­ti­cals, Kymab and Or­p­hazyme. Pre­vi­ous­ly, Moukheibir was CFO of Movetis NV (ac­quired by Shire in 2010).

Hi­ber­Cell has made two new ad­di­tions to its sci­en­tif­ic ad­vi­so­ry board. Lisa Coussens will be join­ing the board with Ronald Wek. Coussens is chair of the de­part­ment of cell, de­vel­op­men­tal and can­cer bi­ol­o­gy and as­so­ciate di­rec­tor for ba­sic re­search at the Knight Can­cer In­sti­tute at Ore­gan Health & Sci­ences Uni­ver­si­ty. Mean­while, Wek is the Showal­ter pro­fes­sor of bio­chem­istry at In­di­ana Uni­ver­si­ty School of Med­i­cine.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

As Co­di­ak en­ters 'next phase of growth,' Jen­nifer Whel­er steps in­to CMO role; Mark Tim­ney lines up his sec­ond CEO op­por­tu­ni­ty af­ter Pur­due Phar­ma reign

Most CMOs don’t start out as art students. But after getting her bachelor’s in art history from Princeton University, Jennifer Wheler decided to go after an MD from Cornell, kicking off a decades-long career in biopharma. Her next move? Leading the team at Codiak BioSciences to deliver therapeutics using a form of cellular postal service called exosomes.

“I was captivated by the science and the potential for exosomes to have transformational impact in cancer and other disease areas,” the incoming CMO told Endpoints News via email. “Codiak has a potent combination of great science and wonderfully experienced and kind people — it doesn’t get much better.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).