Hen­ry Skin­ner buys time in the fight against an­timi­cro­bial re­sis­tance; Ver­tex's Michael Pari­ni be­comes pres­i­dent and COO at Free­line while CFO Bri­an Sil­ver plans his ex­it

When Hen­ry Skin­ner was in charge of an­tibi­otics-fo­cused Se­lec­tX Phar­ma­ceu­ti­cals about 15 years ago, the com­pa­ny had “very good sci­ence,” but couldn’t keep it cap­i­tal­ized. So when the Big Phar­ma-backed AMR Ac­tion Fund was launched in Ju­ly to spur the de­vel­op­ment of new an­tibi­otics, he said it was a “clar­i­on call.”

Hen­ry Skin­ner

The lack of progress across an­ti-in­fec­tives isn’t due to a short­age of in­no­va­tion, Skin­ner said, “but be­cause of the dif­fi­cul­ty in cap­i­tal­iz­ing those in­no­va­tions due to mar­ket con­straints.” The fund is meant to “bridge that gap, and give our pol­i­cy­mak­ers and gov­ern­ments time to make ad­just­ments on a macro sense to reestab­lish the mar­ket.”

Skin­ner threw his hat in the ring and land­ed the top spot at the fund. Now, as em­ploy­ee num­ber 1, he’s lead­ing the charge to pump over a bil­lion dol­lars in­to an­ti-in­fec­tive R&D and bring two to four new an­tibi­otics to pa­tients by 2030. On Thurs­day, he closed a $140 mil­lion round from the Boehringer In­gel­heim Foun­da­tion, the Eu­ro­pean In­vest­ment Bank and the Well­come Trust.

“I can’t imag­ine some­thing more rel­e­vant for me to do,” Skin­ner said of the job.

Re­sis­tance has been form­ing against an­tibi­otics since Day 1, he ex­plained. But de­spite the ris­ing threat, Big Phar­ma has re­treat­ed from the risky field, where cheap gener­ics and poor fi­nan­cial re­turns loom large. In­vestors aren’t in­vest­ing, and a slew of bank­rupt­cies have been heed­ed as a warn­ing.

“We need to stay a step ahead,” Skin­ner said, re­fer­ring to an­timi­cro­bial re­sis­tance. “I think we haven’t been in the last cou­ple of decades. The sci­ence is tough but we can ad­dress that. But the cap­i­tal to do that just hasn’t been there based on mar­ket lim­i­ta­tions.”

Funds like CARB-X and No­vo Hold­ings’ RE­PAIR Im­pact Fund have been cre­at­ed to sup­port re­search and ear­ly de­vel­op­ment, and Skin­ner sees the AMR Ac­tion Fund as a com­ple­ment to that. He ex­pects to fo­cus on mid-to-late-stage de­vel­op­ment.

“Hope­ful­ly with these ear­li­er en­deav­ors such as CARB-X and the Im­pact Fund ma­tur­ing some of the ear­ly stuff, we will have a good pipeline” in the com­ing years, he said.

While the $140 mil­lion raise pales in com­par­i­son to the amount of VC dol­lars raised in oth­er ar­eas, like on­col­o­gy, over the last sev­er­al years, Skin­ner says it buys time.

“We need some changes at the gov­ern­ment lev­el with pol­i­cy to make this a sus­tain­able mar­ket dri­ven ap­proach to in­no­va­tion,” he said. — Nicole De­Feud­is

Michael Pari­ni

→ While Free­line Ther­a­peu­tics re­assess­es their sit­u­a­tion af­ter CMC is­sues halt­ed their he­mo­phil­ia B gene ther­a­py tri­al on Feb. 8, they’ve been busy bol­ster­ing their lead­er­ship struc­ture, with Michael Pari­ni kick­ing things off as pres­i­dent and COO. Free­line al­so an­nounced that CFO and head of cor­po­rate de­vel­op­ment Bri­an Sil­ver will step aside at the end of April. No specifics were giv­en about next steps for Sil­ver, who’s been Free­line’s fi­nance chief since No­vem­ber 2018.

Ef­fec­tive March 15, Pari­ni slides in­to the dual role af­ter five years at Ver­tex, leav­ing Resh­ma Ke­wal­ra­mani’s team as EVP and chief ad­min­is­tra­tive, le­gal and busi­ness de­vel­op­ment of­fi­cer. Pari­ni al­so held a se­ries of le­gal po­si­tions at Pfiz­er from 2004-15.

Else­where at Free­line, Stephen Di­a­mond has been se­lect­ed as SVP and gen­er­al coun­sel, while David Ar­ring­ton has joined the Lon­don biotech as VP of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Di­a­mond has more than a decade of le­gal ex­pe­ri­ence at Pfiz­er, where he was as­sis­tant gen­er­al coun­sel, busi­ness trans­ac­tions be­fore his ar­rival at Free­line. Ar­ring­ton hails from Co­herus Bio­Sciences, where he was VP of in­vestor re­la­tions and cor­po­rate af­fairs.

Na­tal­ie Holles

→ A week af­ter rais­ing $130 mil­lion in Se­ries B fund­ing with the aim of treat­ing pe­di­atric brain can­cers, San Fran­cis­co-based Day One Bio­phar­ma­ceu­ti­cals has wel­comed Au­dentes CEO Na­tal­ie Holles to the board of di­rec­tors. While Holles joins the board of a com­pa­ny tack­ling a dif­fi­cult field, these are al­so try­ing times for Au­dentes as three deaths were re­port­ed last sum­mer on the high dosage of the gene ther­a­py AT132, but the biotech looks to re­group as the FDA lift­ed its hold on the pro­gram at the end of 2020.

In ad­di­tion to Holles’ ap­point­ment, Day One has al­so cor­ralled Charles York as chief op­er­at­ing and fi­nan­cial of­fi­cer. Since 2014, York had been CFO and head of cor­po­rate de­vel­op­ment at Ae­glea Bio­Ther­a­peu­tics.

Charles Al­bright

→ Just as the Jim Mullen era be­gins at Ed­i­tas Med­i­cine, Charles Al­bright’s post-Ed­i­tas land­ing spot is at Affinia Ther­a­peu­tics. Affinia’s new chief sci­en­tist, who had been CSO at Ed­i­tas since the sum­mer of 2016, al­so de­vot­ed a dozen years as an ex­ec at Bris­tol My­ers Squibb. “I came to Affinia be­cause I thought we had the po­ten­tial to ad­dress some of the fun­da­men­tal is­sues in AAV gene ther­a­py,” Al­bright told End­points News. “And af­ter my first 4 weeks here I be­lieve that even more than when I took the job.”

Pe­tra Kauf­mann

CEO Rick Mo­di wasn’t through with big ap­point­ments this week. NIH alum Pe­tra Kauf­mann al­so joins Affinia as CMO af­ter a short run as SVP and head of clin­i­cal de­vel­op­ment, an­a­lyt­ics and trans­la­tion­al med­i­cine at No­var­tis Gene Ther­a­pies (the crew for­mer­ly known as AveX­is, where Affinia chair­man Sean Nolan was CEO). From 2015-18, Kauf­mann was di­rec­tor of the Of­fice of Rare Dis­eases Re­search at the NIH.

→ Belfast-based CRO Fu­sion An­ti­bod­ies has reeled in Richard Jones as its next CEO — suc­ceed­ing Paul Kerr who is leav­ing to pur­sue oth­er op­por­tu­ni­ties. Jones takes on the reins with a pletho­ra of ex­pe­ri­ence, most re­cent­ly serv­ing as CEO of BrYET. That’s not the on­ly CEO post that Jones has held. Jones al­so pre­vi­ous­ly helmed the com­pa­nies of Holostem Ad­vanced Ther­a­pies and Akin­ion Phar­ma­ceu­ti­cals. In ad­di­tion, Jones has had stints at Akcea Ther­a­peu­tics, No­var­tis and GSK.

Kevin Guo

→ Shang­hai-based Ever­est Med­i­cines  — which nabbed $310 mil­lion in Se­ries C fi­nanc­ing back in June be­fore go­ing on for a Hong Kong IPO — has tapped Kevin Guo as CCO. Guo hops aboard af­ter a stint at Ei­sai, where he most re­cent­ly served as VP and deputy glob­al brand lead for Lenvi­ma. Be­fore his var­i­ous roles in Ei­sai, Guo was VP of the on­col­o­gy busi­ness unit 1 at Shang­hai Roche Phar­ma­ceu­ti­cal. In ad­di­tion, Guo has served in roles at GSK, Wyeth Phar­ma­ceu­ti­cals, Shang­hai Squibb Phar­ma­ceu­ti­cal and Eli Lil­ly Asia.

Chris Lowe

→ Pri­or to the FDA’s an­nounce­ment of a clin­i­cal hold on their Alzheimer’s pro­gram be­cause of liv­er prob­lems as­so­ci­at­ed with tak­ing the drug, Cor­texyme nonethe­less is full steam ahead with two pro­mo­tions and one new mem­ber of the squad. Chris Lowe has been pro­mot­ed to COO and CFO, and Ted Mono­hon has been bumped up to chief ac­count­ing of­fi­cer. Lowe, the CFO at Cor­texyme the last two years, was CFO and CBO at An­thera Phar­ma­ceu­ti­cals and the in­ter­im CEO of Hansen Med­ical. Mono­hon orig­i­nal­ly came to Cor­texyme as VP, fi­nance.

Al­so, Cor­texyme has ap­point­ed Drew Sukovich VP, reg­u­la­to­ry and qual­i­ty. Sukovich, who most re­cent­ly had the same ti­tle at Trex­i­mo, has reg­u­la­to­ry ex­pe­ri­ence from Genen­tech, Zo­genix and Bio­Marin.

Richard Kol­len­der

→ Dublin-based Strong­bridge Bio­phar­ma, seek­ing ap­proval for its Cush­ing’s syn­drome treat­ment Recor­lev, has tapped Richard Kol­len­der as pres­i­dent and CFO ef­fec­tive March 3. Kol­len­der gets pro­mot­ed at Strong­bridge af­ter 17 months as COO, and he al­so served on the Strong­bridge board for four years be­fore tak­ing the COO post. Kol­len­der has Big Phar­ma ex­pe­ri­ence at GSK in sales, mar­ket­ing and world­wide busi­ness de­vel­op­ment, and while there, he was SR One’s in­vest­ment man­ag­er.

→ What about Kol­len­der’s pre­de­ces­sor at Strong­bridge? We’re glad you asked. Robert Lutz has moved on to iBio as the Bryan, TX con­tract man­u­fac­tur­er’s chief fi­nan­cial & busi­ness of­fi­cer. Lutz had been CFO at Strong­bridge since Au­gust 2019 and CBO since 2014, and his time at Shire spanned near­ly a decade in a mul­ti­tude of posts, in­clud­ing VP, strat­e­gy and new prod­ucts with­in the neu­ro­science busi­ness unit. Lutz’s ap­point­ment fur­ther shores up the team as iBio wel­comed COO Randy Mad­dux and CSO Mar­tin Bren­ner at the tail end of 2020.

Lin­da Richard­son

→ As the tem­pest tries to push out to sea from the FDA’s re­jec­tion of obeti­cholic acid, CEO Mark Pruzan­s­ki’s fiery re­sponse to it and his sub­se­quent de­par­ture, In­ter­cept is mov­ing for­ward and pro­mot­ing Lin­da Richard­son to chief com­mer­cial of­fi­cer. Since 2018, Richard­son had been In­ter­cept’s head of the glob­al cholesta­sis pro­gram. The Sanofi and GSK alum al­so spent some time as the chief strat­e­gy and com­mer­cial of­fi­cer for Chimerix.

Al­so at In­ter­cept, VP of in­vestor re­la­tions Lisa De­Francesco now owns the ti­tle of SVP, cor­po­rate af­fairs & in­vestor re­la­tions. De­Francesco, an Al­ler­gan vet, has been with In­ter­cept since Sep­tem­ber 2019.

→ The door opens for Richard­son while Richard Kim clos­es his at In­ter­cept, mak­ing the tran­si­tion to sleep dis­or­der-fo­cused Avadel Phar­ma­ceu­ti­cals as their chief com­mer­cial of­fi­cer. Kim got bumped up to In­ter­cept’s pres­i­dent of US com­mer­cial & strate­gic mar­ket­ing three years ago af­ter his ar­rival in 2015. Be­fore that, the Scher­ing-Plough alum han­dled var­i­ous re­spon­si­bil­i­ties over a pe­ri­od of near­ly 11 years at Bris­tol My­ers Squibb, cul­mi­nat­ing in his work as gen­er­al man­ag­er, he­pati­tis C world­wide com­mer­cial­iza­tion.

Samir Mody

→ Just a week re­moved from Shan­non Blalock grab­bing the CEO reins, eye dis­ease biotech jCyte has made three oth­er changes as chief com­mer­cial of­fi­cer Samir Mody leads off. A J&J and As­traZeneca vet, Mody comes from a sev­en-year run at Medtron­ic, the last two of those years as VP, CRHF strat­e­gy, health eco­nom­ics and re­im­burse­ment.

Al­so on board at jCyte are Friedrich As­mus (SVP, clin­i­cal de­vel­op­ment & med­ical af­fairs) and Joel Cen­teno (SVP, man­u­fac­tur­ing, qual­i­ty & sup­ply chain). As­mus, an ex-glob­al clin­i­cal leader in oph­thal­mol­o­gy at Bay­er, is for­mer­ly the VP, clin­i­cal de­vel­op­ment at Pro­QR Ther­a­peu­tics. Cen­teno has had re­cent reg­u­la­to­ry gigs at Epige­nomics and Alt­heaDx.

Mc­David Stil­well

Jean-Frédéric Viret has re­signed as CFO of Sil­i­con Val­ley’s Co­herus Bio­Sciences, which plunked down $150 mil­lion for the rights to tori­pal­imab in a part­ner­ship with Jun­shi Bio­sciences ear­ly this month. Viret will ex­it on March 7 and pave the way for suc­ces­sor Mc­David Stil­well, the cur­rent EVP, cor­po­rate de­vel­op­ment, in­vestor re­la­tions, and fi­nan­cial strat­e­gy. Stil­well piv­ot­ed to Co­herus back in Oc­to­ber af­ter four years at Sang­amo, where he was SVP, com­mu­ni­ca­tions and in­vestor re­la­tions.

→ Co-found­ed by Bob Langer, ENT biotech Lyra Ther­a­peu­tics out of Wa­ter­town, MA has reached in­to acad­e­mia to choose Robert Kern as CMO. Kern has chaired the oto­laryn­gol­o­gy de­part­ment at North­west­ern’s Fein­berg School of Med­i­cine since 2006 and will re­main so in ad­di­tion to his Lyra du­ties. Lyra’s IPO last May grossed around $64 mil­lion as their chron­ic rhi­nos­i­nusi­tis drug LY-210 is be­ing test­ed in a Phase II tri­al.

→ An­tivi­ral drug de­vel­op­er Maxwell Bio­sciences has made two new ap­point­ments to its lead­er­ship team: Kent Kir­shen­baum as CSO and Shee­tal Vali as di­rec­tor of drug de­vel­op­ment. Kir­shen­baum is NYU’s pro­fes­sor of chem­istry and is the co-founder of New York Uni­ver­si­ty’s Bio­med­ical Chem­istry In­sti­tute. Mean­while, Vali hops aboard from AROG Phar­ma­ceu­ti­cal, where she served as head of drug de­vel­op­ment.

Vafa Ja­mali

→ The new spin­out from med­ical de­vice mak­er Zim­mer Bio­met — with the place­hold­er name “New­Co”has re­cruit­ed Vafa Ja­mali as CEO. Ja­mali joins the spine and den­tal com­pa­ny from Rock­ley Pho­ton­ics, where he most re­cent­ly served as CCO. Pri­or to that, he was SVP and pres­i­dent of res­pi­ra­to­ry, gas­troin­testi­nal & in­for­mat­ics at Medtron­ic. In ad­di­tion, he has served in roles at Co­vi­di­en, Car­di­nal Health and Bax­ter.

Arte­lo Bio­sciences has plucked An­drew Yates as its SVP and CSO. Yates joins with ex­pe­ri­ence from his time with As­traZeneca, where he was re­spon­si­ble for their car­dio­vas­cu­lar and di­a­betes in­ter­nal port­fo­lio, in­clud­ing the ac­qui­si­tion of Bris­tol My­ers Squibb’s di­a­betes pipeline.

Tam­ra Adams

→ On the heels of elect­ing Patrick Hig­gins to the board of di­rec­tors last week, At­lanta-based hep B biotech An­tios Ther­a­peu­tics is bring­ing on Tam­ra Adams as their first ever CFO start­ing March 1. Be­fore join­ing Greg Mayes’ crew, Adams found­ed and was man­ag­ing part­ner of Ac­count­ing Con­cepts, which pro­vides CFO, ac­count­ing and fi­nan­cial ser­vices to com­pa­nies in the biotech sec­tor. An­tios is ready to roll on Phase II tri­als for their HBV pro­gram next month.

Frank Watan­abe-led Ar­cutis Bio­ther­a­peu­tics is flesh­ing out its C-suite fur­ther af­ter rock­ing pos­i­tive Phase III da­ta ear­li­er this month for its top­i­cal cream ARQ-151 to treat plaque pso­ri­a­sis. Court­ney Bar­ton has got­ten the call to be chief com­pli­ance of­fi­cer and chief of staff at South­ern Cal­i­for­nia-based Ar­cutis, as well as their chief pri­va­cy of­fi­cer. Bar­ton hails from Cipla Ther­a­peu­tics, where she was VP, com­mer­cial ex­cel­lence & chief com­pli­ance of­fi­cer, and oth­er com­pli­ance roles in­clud­ed stops at Bausch + Lomb, Al­ler­gan and Kythera.

Pe­ter Calve­ley

→ Co-found­ed by Beth Sei­den­berg and Sean Harp­er and rak­ing in $500 mil­lion from two funds back in De­cem­ber, West­lake Vil­lage BioPart­ners has ap­point­ed Pe­ter Calve­ley as COO. Calve­ley de­vot­ed nine years to SVB Leerink as man­ag­ing di­rec­tor in the in­vest­ment bank­ing group.

Brid­get O’Ke­effe has left Nek­tarteam­ing up with Mer­ck on a Keytru­da col­lab­o­ra­tion while al­so in the throes of an in­vestor law­suit — to join On­coSec as VP of clin­i­cal de­vel­op­ment. For the last two years, O’Ke­effe had been Nek­tar’s se­nior di­rec­tor of clin­i­cal de­vel­op­ment, tak­ing the lead on a Phase III com­bo tri­al of be­m­pe­galdesleukin with Op­di­vo for re­nal cell car­ci­no­ma. She’s al­so held clin­i­cal de­vel­op­ment po­si­tions at Genen­tech, Ex­elix­is and Achao­gen.

Ute Dugan

→ The Park­er In­sti­tute for Can­cer Im­munother­a­py (PI­CI) has en­list­ed Ute Dugan as SVP, clin­i­cal re­search. Dugan hails from Bris­tol My­ers Squibb, where she served as head of world­wide on­col­o­gy ex­ter­nal med­ical af­fairs. Dur­ing her time at BMS, Dugan’s work in­clud­ed ex­ten­sive clin­i­cal part­ner­ships with PI­CI.

Lau­ra Kel­ly has signed on as di­rec­tor of clin­i­cal op­er­a­tions at can­cer biotech Monopar, which fi­nal­ly got its IPO off the ground to­ward the end of 2019 af­ter some false starts (back when the IPO ap­petite wasn’t as in­sa­tiable). Kel­ly makes her Monopar de­but af­ter a short stint as se­nior man­ag­er, clin­i­cal site lead at EMD Serono, and be­fore that she held strate­gic and clin­i­cal posts at Ab­b­Vie, Ab­bott Labs and Am­gen.

Mat­teo Leviset­ti

→ Start­ing Mon­day, Big Phar­ma vet Mat­teo Leviset­ti will be SVP of clin­i­cal de­vel­op­ment at Cam­bridge, MA-based Cue Bio­phar­ma, which de­vel­ops T cell im­muno-on­col­o­gy ther­a­pies. Leviset­ti, whose most re­cent stop was as CMO of DNA­trix, has served as glob­al head & VP, trans­la­tion­al med­i­cine, im­munol­o­gy and in­flam­ma­tion at the pRED di­vi­sion of Roche and brings clin­i­cal re­search ex­pe­ri­ence from Pfiz­er and Mer­ck.

Im­muno­core has pulled in Ralph Tor­bay as its new head of com­mer­cial and Roy Herb­st to its board of di­rec­tors. Tor­bay joins the com­pa­ny from As­traZeneca, where he helped launch Imfinzi, Tagris­so and Calquence. Pri­or to that, Tor­bay was at No­var­tis On­col­o­gy. Herb­st cur­rent­ly serves as En­sign pro­fes­sor of med­i­cine (med­ical on­col­o­gy), pro­fes­sor of phar­ma­col­o­gy, chief of med­ical on­col­o­gy and as­so­ciate can­cer cen­ter di­rec­tor for trans­la­tion­al re­search at Yale Can­cer Cen­ter and Smilow Can­cer Hos­pi­tal.

Gar­ry Neil has been named chair­man of the board at Are­na Phar­ma­ceu­ti­cals, while the Amit Mun­shi-led biotech has added Naw­al Ouzren to the board. Neil, an Are­na board mem­ber since 2017, is the CSO of Cere­cor, while Ouzren has spent al­most four years as the CEO of Sen­so­ri­on.

Ron Coop­er

Al­bireo Phar­ma CEO Ron Coop­er has a new board ap­point­ment at Gen­er­a­tion Bio a few weeks af­ter re­ceiv­ing some good news on Al­bireo’s lead can­di­date ode­vix­i­bat. “I am over the moon,” Coop­er told End­points up­on re­ceiv­ing pri­or­i­ty re­view from the FDA and a Ju­ly 20 PDU­FA date for the drug. Coop­er heads to Gen­er­a­tion Bio’s board on March 1.

David Wilkes, the dean of the Uni­ver­si­ty of Vir­ginia School of Med­i­cine, has re­served his place on the board of di­rec­tors at Bax­ter. Mean­while, 17-year di­rec­tor Al­bert Strouck­en has been named lead in­de­pen­dent di­rec­tor. He re­places Thomas Stal­lkamp, who held that ti­tle for al­most sev­en years and will re­main on Bax­ter’s board.

Sim­ba Gill’s Evelo Bio­sciences has giv­en John Hohnek­er a seat at the board of di­rec­tors. Hohnek­er, a GSK and No­var­tis vet who’s the ex-R&D chief at For­ma Ther­a­peu­tics, just wrapped a three-year tenure as pres­i­dent and CEO of au­toim­mune dis­ease-fo­cused Anokion.

→ Sin­ga­pore-based ASLAN Phar­ma­ceu­ti­cals has named Neil Gra­ham as in­de­pen­dent di­rec­tor. Cur­rent­ly, Gra­ham serves as CMO of Tiziana Life Sci­ences and a di­rec­tor of Phar­max­is. Pri­or to that, he spent a decade at Re­gen­eron as VP of strate­gic pro­gram di­rec­tion, im­munol­o­gy and in­flam­ma­tion.

Ju­dith Swain

→ Af­ter se­cur­ing a $130 mil­lion raise last No­vem­ber, Prometheus Bio­sciences — which had been cre­at­ed by the ac­qui­si­tion of Prometheus Labs by Pre­ci­sion IBD — has made the ad­di­tions of Ju­dith Swain and He­len Adams to its board of di­rec­tors. Adams will as­sume the po­si­tion of chair of the au­dit com­mit­tee. Swain is the cur­rent CMO at med­ical de­vice com­pa­ny Phys­ioWave and sits on the boards of Lex­i­con Phar­ma­ceu­ti­cals, Up­stream Med­ical Tech­nolo­gies and the In­sti­tute for Life Chang­ing Med­i­cines. Mean­while, Adams has served as the San Diego area man­ag­ing part­ner for Haskell & White and part­ner in the life sci­ences and tech­nol­o­gy group at De­loitte & Touche.

→ DNA­trix has made the ad­di­tion of Herb Cross to its board of di­rec­tors. Cross cur­rent­ly serves as CFO of Atre­ca and sits on the board of di­rec­tors, and is chair of the au­dit com­mit­tee, of Apex­i­gen. Cross has a long his­to­ry of serv­ing as CFO for a num­ber of com­pa­nies, in­clud­ing AR­MO Bio­Sciences, Bal­ance Ther­a­peu­tics, Kalos­Bios Phar­ma­ceu­ti­cals and Affy­max.

Lisa Kel­ly-Croswell

Syn­log­ic has reeled in Lisa Kel­ly-Croswell to its board of di­rec­tors. Cur­rent­ly, Kel­ly-Croswell serves as SVP and chief hu­man re­sources of­fi­cer for Boston Med­ical Cen­ter Health Sys­tem. Pri­or to that, she was SVP, HR and cor­po­rate ser­vices at Ver­tex Phar­ma­ceu­ti­cals and had a stint at Ni­tromed.

Dew­point Ther­a­peu­tics has added Regi­na Barzi­lay to its board of di­rec­tors. Barzi­lay is a pro­fes­sor for AI and health in the de­part­ment of elec­tri­cal en­gi­neer­ing and com­put­er sci­ence and a mem­ber of the Com­put­er Sci­ence & Ar­ti­fi­cial In­tel­li­gence Lab at MIT.

He­lix Bio­phar­ma has ap­point­ed Frank Gary Ren­shaw to its sci­en­tif­ic ad­vi­so­ry board. Ren­shaw comes from Zhe­jiang DTRM Bio­phar­ma, where he cur­rent­ly serves as CMO. Ren­shaw’s pre­vi­ous roles in­clude serv­ing at Ei­sai, Cel­gene, Cel­sion and Bay­er Health Care.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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