No­vavax grabs an­oth­er CFO while Pat Cotro­neo re­tires from Fi­bro­Gen; Eli Lil­ly re­assem­bles key staff af­ter bio­med­i­cines unit split

Jim Kel­ly

→ The peren­ni­al Char­lie Brown of vac­cine de­vel­op­ment, No­vavax is grap­pling with Lucy’s knack for pulling the foot­ball away once again, this time with its Covid-19 vac­cine as the FDA pushed back an­oth­er bid for an EUA ear­li­er this month. In the mean­time, No­vavax has found Jim Kel­ly to re­place Greg Covi­no as CFO, leav­ing John Trizzi­no one less C-suite ti­tle to jug­gle. Kel­ly, the ex-CFO at Van­da Phar­ma­ceu­ti­cals, was just in this space in Oc­to­ber 2020 when he suc­ceed­ed Greg Patrick as CFO of Su­per­nus, and now he makes a quick change to a biotech that can’t seem to avoid tak­ing on Sisyphean qual­i­ties no mat­ter what it does.

Fur­ther­more, No­vavax has hired Nasir Egal away from Sanofi to be SVP of qual­i­ty as­sur­ance. Egal round­ed out near­ly 10 years at Sanofi by lead­ing glob­al qual­i­ty ex­ter­nal af­fairs, and be­fore that, he was re­spon­si­ble for qual­i­ty and com­pli­ance in sev­er­al re­gions for No­var­tis.

Pat Cotro­neo

→ Fi­nal­ly catch­ing a break with Eu­rope’s ap­proval of rox­adu­s­tat af­ter the FDA re­ject­ed it last week, Fi­bro­Gen is chang­ing CFOs, with Pat Cotro­neo re­tir­ing on La­bor Day to pave the way for Juan Gra­ham on Sept. 7. Thus ends a 20-year as­so­ci­a­tion with J&J for Gra­ham, the last two of those years as glob­al CFO / VP, fi­nance sup­ply chain. Cotro­neo had served as CFO since 2007 and will be CEO En­rique Con­ter­no’s ex­ec­u­tive ad­vi­sor un­til March 31, 2022. A month ago, CSO Per­cy Carter came on board the same week that an FDA ad­comm vot­ed against the ane­mia drug by wide mar­gins.

Anne White

→ Us­ing the Aduhelm af­fair to make the case for its own po­ten­tial Alzheimer’s com­peti­tor do­nanemab, Eli Lil­ly is caught up in the fer­vor and has split Lil­ly Bio­med­i­cines in­to Lil­ly Neu­ro­science and Lil­ly Im­munol­o­gy. Anne White, pres­i­dent of Lil­ly On­col­o­gy, will now be pres­i­dent of Lil­ly Neu­ro­science, while Loxo On­col­o­gy at Lil­ly CEO Jake van Naar­den will re­place her and be re­spon­si­ble for bring­ing Loxo and Lil­ly On­col­o­gy’s brands to­geth­er. Pa­trik Jöns­son, a Lil­ly staffer since 1990, has been ap­point­ed pres­i­dent of Lil­ly Im­munol­o­gy and will al­so con­tin­ue in his du­ties as SVP and pres­i­dent, Lil­ly USA and chief cus­tomer of­fi­cer.

Ad­di­tion­al­ly, Lil­ly In­ter­na­tion­al pres­i­dent Al­fon­so “Chi­to” Zu­lue­ta is re­tir­ing at the end of the year, with Lil­ly Bio­med­i­cines pres­i­dent Ilya Yuf­fa wait­ing to suc­ceed him. Zu­lue­ta has been with the phar­ma gi­ant since 1988, while Yuf­fa has de­vot­ed near­ly a quar­ter cen­tu­ry to Lil­ly. Our Kyle Blanken­ship has more on this cas­cade of changes.

Michael Pari­ni

Free­line Ther­a­peu­tics is plac­ing enough con­fi­dence in Michael Pari­ni on­ly five months in­to his tenure as pres­i­dent and COO to pro­mote him to CEO. There­sa Heg­gie leaves Free­line af­ter an 18-month run that was marked by the Lon­don biotech’s IPO in Au­gust 2020 and a two-year de­lay on a piv­otal tri­al for he­mo­phil­ia B can­di­date FLT180a six months lat­er be­cause of CMC is­sues. Be­fore Pari­ni climbed aboard on March 15, Pari­ni was EVP and chief ad­min­is­tra­tive, le­gal and busi­ness de­vel­op­ment of­fi­cer at Ver­tex.

Wolf­gang Brysch

→ There’s a pass­ing of the torch forth­com­ing at Swiss-based Metrio­Pharm — fo­cused on chron­ic in­flam­ma­to­ry dis­eases — as Thomas Christé­ly takes over the CEO job from Wolf­gang Brysch start­ing Oct. 1. Brysch, who co-found­ed Metrio­Pharm and has been chief ex­ec­u­tive since 2016, will set­tle in­to the dual roles of CSO and CMO. Christé­ly was man­ag­ing di­rec­tor and CFO of Ger­man HDV and HBV play­er MYR GmbH, which an­nounced its sale to Gilead in De­cem­ber for $1.7 bil­lion be­fore Gilead’s head of vi­rol­o­gy Di­ana Brainard jumped to AlloVir.

→ RNA pro­cess­ing biotech Remix Ther­a­peu­tics brought out the VIPs in its Se­ries A round as ARCH, Fore­site, The Col­umn Group and At­las all par­tic­i­pat­ed. Pres­i­dent and CSO Pe­ter Smith, an en­tre­pre­neur in res­i­dence at At­las, has been bumped up to pres­i­dent and CEO at Remix eight months af­ter its launch. For­mer­ly in the on­col­o­gy group at Mil­len­ni­um/Take­da, Smith was CSO at H3 Bio­med­i­cine be­fore co-found­ing Remix with At­las part­ner Kevin Bit­ter­man.

→ Un­like Fi­bro­Gen, My­ovant and Pfiz­er earned the FDA’s ap­proval with Myfem­bree for heavy men­stru­al bleed­ing as­so­ci­at­ed with uter­ine fi­broids in May, and on Sept. 7, My­ovant wel­comes Un­eek Mehra as chief fi­nan­cial and busi­ness of­fi­cer. Mehra, the CFO at PACT Phar­ma since Oc­to­ber 2019, spent 13 years with No­var­tis in a num­ber of ca­pac­i­ties, from CFO of the US in­te­grat­ed care and crit­i­cal care busi­ness units to glob­al head of port­fo­lio man­age­ment, li­cens­ing and M&A for the on­col­o­gy busi­ness. The Myfem­bree ap­proval was an ear­ly win for My­ovant CEO David Marek, who re­placed Lynn Seely at the start of 2021.

Richard Buck­ley

Richard Buck­ley has part­ed ways with As­traZeneca to be­come chief cor­po­rate af­fairs of­fi­cer at EQRx, one of many com­pa­nies get­ting in on the SPAC craze by re­verse merg­ing with CM Life Sci­ences III in a deal worth $1.8 bil­lion. To close out his 17 years at As­traZeneca, Buck­ley was Pas­cal So­ri­ot’s VP, glob­al cor­po­rate af­fairs, and has al­so served as Eli Lil­ly’s di­rec­tor of fed­er­al gov­ern­ment af­fairs. Mak­ing cheap­er drug prices their main ob­jec­tive, EQRx al­so made a CEO change when the SPAC deal was an­nounced, as pres­i­dent and COO Melanie Nal­licheri takes the top spot and Alex­is Borisy shifts to the role of chair­man on Sept. 1.

→ A sea of Yu­man­i­ty: There’s been no short­age of hir­ing at Yu­man­i­ty since it re­verse merged last sum­mer with Pro­teosta­sis Ther­a­peu­tics, and CFO Michael Wyz­ga con­tin­ues the trend. Wyz­ga, who was VP in the health­care in­vest­ment bank­ing group dur­ing his eight years at Need­ham & Com­pa­ny, joins the list of such new­com­ers as head of R&D Ajay Ver­ma and gen­er­al coun­sel Devin Smith.

Lin­da Couto

→ North Car­oli­na-based gene ther­a­py group At­se­na Ther­a­peu­tics, which land­ed a $55 mil­lion Se­ries A in De­cem­ber for clin­i­cal tri­als on oc­u­lar gene ther­a­py, has brought on Lin­da Couto as its new CSO. For­mer­ly the head of phar­ma­col­o­gy, tox­i­col­o­gy and oc­u­lar re­search at Spark Ther­a­peu­tics, Couto joins Spark co-founder Jen­nifer Well­man at At­se­na, who was named to the board of di­rec­tors last month.

→ Port­land-based start­up Spar­row Phar­ma­ceu­ti­cals, look­ing to cut down cor­ti­cos­teroid use with its lead can­di­date SPI-62, has tapped Frank Cz­er­wiec as CMO and Jamie MacPher­son as VP of reg­u­la­to­ry af­fairs and qual­i­ty. Af­ter 20 years with Ot­su­ka, Cz­er­wiec be­came CMO at Goldfinch Bio, a po­si­tion he had held since De­cem­ber 2018. And MacPher­son, the ex-di­rec­tor of reg­u­la­to­ry af­fairs at Alex­ion, has been a reg­u­la­to­ry ex­ec with Akcea the last four years. Or­biMed-backed Spar­row took flight in May with $50 mil­lion in Se­ries A fi­nanc­ing.

Ju­bi­lant Ther­a­peu­tics has re­cruit­ed Leila Al­land to its board of di­rec­tors and Je­re­my Bar­ton as strate­gic ad­vi­sor and in­ter­im CMO. Al­land cur­rent­ly serves as CMO of PMV Phar­ma­ceu­ti­cals and was pre­vi­ous­ly the CMO of Af­fimed and Tarve­da Ther­a­peu­tics. As for Bar­ton, he was pre­vi­ous­ly CMO at Bio­gen, eF­FEC­TOR Ther­a­peu­tics and Mi­rati Ther­a­peu­tics. In ad­di­tion to those stints, Bar­ton was head of ear­ly on­col­o­gy de­vel­op­ment at Pfiz­er.

Jeff Gulcher

→ Con­cur­rent with the Ge­nu­ity Sci­ence buy­out, Hi­ber­Cell has poached sev­er­al Ge­nu­ity em­ploy­ees: Chief tech­nol­o­gy of­fi­cer Tom Chit­ten­den has been with the com­pa­ny since 2015 and was once chief da­ta sci­ence of­fi­cer; Ge­nu­ity co-founder and CSO Jeff Gulcher be­comes CSO of ge­nomics; and chief in­for­mat­ics of­fi­cer Hákon Guðb­jarts­son is Gulcher’s long­time col­league from their days at de­CODE ge­net­ics and, be­fore it be­came Ge­nu­ity, NextCode Health. The $100 mil­lion all-stock deal comes af­ter Hi­ber­Cell’s $67.4 mil­lion Se­ries B raise in May, all part of the biotech’s quest to see how stress bi­ol­o­gy and in­nate im­mu­ni­ty con­tribute to can­cer re­cur­rence.

→ Im­munother­a­py start­up Im­mu­ni­tas Ther­a­peu­tics pro­mot­ed Aman­da Wag­n­er this week to CBO, cou­pled with Im­mu­ni­tas’ re­cent suc­cess in ob­tain­ing $58 mil­lion in Se­ries B fi­nanc­ing for their lead pro­gram, a CD161-block­ing an­ti­body. Wag­n­er was one of the ear­li­est em­ploy­ees when she joined Im­mu­ni­tas in Oc­to­ber 2019 as VP of strat­e­gy, one month be­fore they of­fi­cial­ly launched. Be­fore join­ing Im­mu­ni­tas, she was VP of cor­po­rate de­vel­op­ment at Q32 Bio af­ter leav­ing Con­cert Phar­ma­ceu­ti­cals, where she was VP of busi­ness de­vel­op­ment and prod­uct strat­e­gy for a decade.

Tushar Mis­ra

→ An­ti­body-drug con­ju­gate (ADC) biotech Mer­sana Ther­a­peu­tics re­cent­ly hired Tushar Mis­ra as their CMO, suc­ceed­ing the re­tir­ing Michael Kauf­man, who will stay for a tran­si­tion pe­ri­od that lasts un­til Sept. 10. A Take­da and Wave Life Sci­ences alum, Mis­ra was the for­mer head of man­u­fac­tur­ing at Flag­ship-backed Laronde, a biotech start­up led by Diego Mi­ralles that of­fi­cial­ly launched in May with a $50 mil­lion Se­ries A.

→ Go­ing pub­lic in Feb­ru­ary with the help of SPAC-ti­cian Ra­jiv Shuk­la in a $255 mil­lion deal, Lau­ra Nikla­son-led Hu­ma­cyte has locked in B.J. Scheesse­le as chief com­mer­cial of­fi­cer. Scheesse­le, a for­mer mar­ket­ing di­rec­tor at Life­Cell who stayed on at Al­ler­gan when Brent Saun­ders pur­chased the com­pa­ny in 2017, com­pletes a three-year stay as Quest Med­ical Imag­ing’s EVP of glob­al mar­ket­ing.

Caryn Parlavec­chio

→ Long­time No­var­tis vet Caryn Parlavec­chio has signed on as chief hu­man re­sources of­fi­cer at Cam­bridge, MA-based Schol­ar Rock, which just re­placed CEO Tony Kings­ley a cou­ple weeks ago with founder Nagesh Ma­han­thap­pa. Parlavec­chio rose to VP and glob­al HR head, on­col­o­gy and phar­ma de­vel­op­ment dur­ing her 19 years at No­var­tis, and for the last year she’s been chief hu­man re­sources of­fi­cer at Holy Name Med­ical Cen­ter in Tea­neck, NJ.

→ Chi­na-based bio­con­ju­gate de­vel­op­er GeneQuan­tum Health­care has se­lect­ed Kai­da Wu as CMO. His ex­pe­ri­ence reads like a ver­i­ta­ble who’s-who of phar­ma: more than five years as a sci­en­tist of dis­cov­ery med­i­cine at As­traZeneca; three years as an on­col­o­gy re­search in­ves­ti­ga­tor at Sanofi; an­oth­er three years at Janssen; and fi­nal­ly, the last four years at Cel­gene/Bris­tol My­ers Squibb, where he was re­cent­ly in­volved in hema­tol­ogy/on­col­o­gy and cell ther­a­py (HOCT) at the Mech­a­nisms of Can­cer Re­sis­tance The­mat­ic Re­search Cen­ter.

Cyn­thia Hu

→ Hear­ing loss biotech Deci­bel Ther­a­peu­tics — which fol­lowed its Se­ries D fi­nanc­ing with a nine-fig­ure IPO in Feb­ru­ary — has named Cyn­thia Hu chief le­gal of­fi­cer and cor­po­rate sec­re­tary. Hu joined CASI Phar­ma­ceu­ti­cals back in 2006 when it was known as En­treMed and was COO as well as VP, gen­er­al coun­sel and sec­re­tary. In June, ex-Ot­su­ka CEO William Car­son be­came chair­man of Deci­bel’s board.

→ This isn’t Evan Bal­lan­tyne’s first rodeo in the CFO seat as he hops aboard to take on the ti­tle at On­cX­er­na Ther­a­peu­tics. Bal­lan­tyne has served as the CFO of sev­er­al com­pa­nies, in­clud­ing Or­ches­tra Bio­med, Cerecin, Clin­i­cal Da­ta, Syn­thet­ic Bi­o­log­ics, Ave­dro and ZymeQuest.

Sarah Glass

→ Found­ed and chaired by CEO Stan­ley Crooke, the non-prof­it n-Lorem Foun­da­tion has brought in its first-ever chief de­vel­op­ment of­fi­cer with the ap­point­ment of Sarah Glass. Glass joins the com­pa­ny from Parex­el, where she served as glob­al head of rare dis­eases.

→ Am­s­ter­dam-based Lu­micks has en­list­ed Paul Wheel­er to be the com­pa­ny’s first CCO. Wheel­er brings with him ex­pe­ri­ence from his time at Lu­minex, Mer­ck, PRW Bio­science, Sin­gulex, Gy­ros, Ox­ford Im­munotec and Gua­va Tech­nolo­gies.

Vanes­sa Ri­breau

→ AI com­pa­ny Bench­Sci has wel­comed Vanes­sa Ri­breau as chief peo­ple of­fi­cer. Ri­breau was for­mer­ly the glob­al VP of peo­ple, places, and tech­nolo­gies at Alay­aCare. Ad­di­tion­al­ly, Bench­Sci has pulled out a seat for Boni­ta Stew­art on its board of di­rec­tors. Stew­art is a board part­ner at Google‘s ven­ture fund Gra­di­ent Ven­tures. Pri­or to that role, Stew­art spent 15 years at Google, most re­cent­ly serv­ing as their VP, glob­al part­ner­ships.

Re­cur­sion made every­one take no­tice with a gar­gan­tu­an $436 mil­lion IPO in April, and the Salt Lake City-based AI drug de­vel­op­er has now en­list­ed Jor­dan Chris­tensen as VP of en­gi­neer­ing. Since 2017, Chris­tensen has been VP of en­gi­neer­ing at ecobee, which spe­cial­izes in smart ther­mostats and oth­er home au­toma­tion tech­nol­o­gy.

→ All too ac­cus­tomed to FDA road­blocks with its Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py, Sol­id Bio has pegged Michael In­bar as VP of fi­nance. In­bar, a for­mer as­so­ciate di­rec­tor of SEC re­port­ing at Ac­celeron, has spent the last four years as VP, ac­count­ing and cor­po­rate con­troller at Sy­ros Phar­ma­ceu­ti­cals. Sol­id Bio has re­mained ac­tive on Peer Re­view this year since the pro­mo­tion of COO Joel Schnei­der with the ap­point­ment of a chief reg­u­la­to­ry of­fi­cer and SVP of clin­i­cal de­vel­op­ment, among oth­er new ex­ecs.

Angèle Ma­ki

Re­Code Ther­a­peu­tics, the ge­net­ic med­i­cines biotech backed by MPM and Or­biMed and led by for­mer Am­i­cus CSO David Lock­hart, has brought on Angèle Ma­ki as SVP of busi­ness de­vel­op­ment. Ma­ki hails from Eli Lil­ly, where she was the In­di­anapo­lis phar­ma’s VP, ven­ture sci­ence, cor­po­rate busi­ness de­vel­op­ment, and she al­so owns BD ex­pe­ri­ence at Genen­tech, 23andMe and Mer­ck.

Mary Cole­man has been named VP, head of in­vestor re­la­tions with Fir­dapse mak­er Cat­a­lyst Phar­ma­ceu­ti­cals out of the Mi­a­mi area. Cole­man, who just held the same ti­tle at BioX­cel, was VP, in­vestor re­la­tions and com­mu­ni­ca­tions for Ju­bi­lant Phar­ma­ceu­ti­cals and cov­ered sim­i­lar bases dur­ing her time as se­nior di­rec­tor at Savient Phar­ma­ceu­ti­cals from 2007-13.

Pre­mier Re­search has brought some new ex­ecs in­to the fold with the ap­point­ments of Sla­womir Wo­j­tow­icz-Pra­ga (VP, glob­al head of med­ical af­fairs), Ayesha Pan­dit (VP, med­ical on­col­o­gy strat­e­gy), and Ash­ley Her­rick (ex­ec­u­tive di­rec­tor, on­col­o­gy strat­e­gy). Wo­j­tow­icz-Pra­ga hops aboard with ex­pe­ri­ence from stints at Genen­tech/Roche, Talon Ther­a­peu­tics, Sankyo Phar­ma De­vel­op­ment, Aven­tis and Ther­adex. Mean­while, Pan­dit pre­vi­ous­ly served in roles at Ab­b­Vie, J&J and the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter. Last, but not least, Her­rick joins from MD An­der­son, where she served as se­nior clin­i­cal re­search pro­gram co­or­di­na­tor.

Mark Gold­berg

Mark Gold­berg is adding an­oth­er stint to his ré­sumé as non-ex­ec­u­tive di­rec­tor of can­cer im­munother­a­py-fo­cused Avac­ta. Gold­berg is a med­ical on­col­o­gist and hema­tol­o­gist on the fac­ul­ty of Brigham & Women’s Hos­pi­tal and Har­vard Med­ical School. Cur­rent­ly, Gold­berg sits on the board of di­rec­tors of Im­muno­Gen, Idera Phar­ma­ceu­ti­cals, Gly­coMimet­ics, Walden Bio­sciences and Blue­print Med­i­cines. In ad­di­tion, Gold­berg pre­vi­ous­ly served on the board of Au­dentes.

→ Backed by the Uni­ver­si­ty of Pitts­burgh Med­ical Cen­ter, T cell ther­a­py play­er Blue­Sphere Bio has made ex-Am­gen CFO Jonathan Pea­cock chair­man of the board. Pea­cock is al­so a board mem­ber at Gen­mab and UCB, and he’s the lead di­rec­tor at Avan­tor.

Sara Bon­stein

→ Equipped with a Se­ries C round to pro­pel its an­ti-CT­LA-4 an­ti­body and IL-2 ag­o­nist in­to the clin­ic, Xilio Ther­a­peu­tics has elect­ed Sara Bon­stein to the board of di­rec­tors. Cur­rent­ly the CFO at In­smed, Bon­stein was al­so CFO and COO at On­coSec from 2018-20.

Neil Ku­mar’s Bridge­Bio has a trio of new board mem­bers, with for­mer Scher­ing-Plough CEO and cur­rent War­burg Pin­cus part­ner Fred Has­san lead­ing the group. An­drea El­lis, the CFO of trans­porta­tion out­fit Lime, and for­mer AIG chief in­vest­ment of­fi­cer Dou­glas Dachille al­so have seats on the board.

Tama­ra Sey­mour has hopped on­to the board of di­rec­tors of Kem­Pharm. Sey­mour cur­rent­ly sits on the board of Arte­lo Bio­sciences and Kin­tara Ther­a­peu­tics. Pre­vi­ous­ly, Sey­mour has served as CFO of Sig­nal Ge­net­ics (now Virid­i­an Ther­a­peu­tics) and HemaQue­st Phar­ma­ceu­ti­cals.

Scott Gar­land

→ PACT Phar­ma CEO Scott Gar­land has joined the board of di­rec­tors at pe­di­atric can­cer biotech Day One Bio­phar­ma­ceu­ti­cals, which raised $160 mil­lion in an up­sized IPO this spring. The Mer­ck, Am­gen and Genen­tech vet al­so helmed Por­to­la from 2018 un­til Alex­ion’s 2020 ac­qui­si­tion.

Rekha Hem­ra­jani and Ja­son Colo­ma have been giv­en seats on the board of di­rec­tors at an­ti-ag­ing up­start BioAge Labs — a board that al­so in­cludes Vi­jay Pande. The ex-pres­i­dent and CEO of Ar­a­vive, Hem­ra­jani is on the boards of Max­Cyte and ALX On­col­o­gy, while Colo­ma has helmed Maze Ther­a­peu­tics since 2019.

David En­loe

Vi­ro­Cell Bi­o­log­ics has tapped Re­cro Phar­ma CEO David En­loe to be a part of its board of di­rec­tors. Pri­or to his cur­rent role, En­loe was pres­i­dent and CEO of Aji­nomo­to Bio-Phar­ma Ser­vices and head of Lon­za’s vi­ral ther­a­peu­tics busi­ness unit. In ad­di­tion to En­loe’s ap­point­ment, the com­pa­ny has al­so brought on CAR-T ex­pert Mar­tin Pule to its sci­en­tif­ic ad­vi­so­ry board.

→ Gas­troin­testi­nal dis­ease-fo­cused Azur­Rx Bio­Phar­ma has added BioDe­liv­ery Sci­ences EVP and CFO Ter­ry Coel­ho to the board of di­rec­tors. Coel­ho spent the back half of her sev­en years at No­var­tis as glob­al head of on­col­o­gy de­vel­op­ment fi­nance.

→ San Diego-based Oton­o­my has reeled in Jill Broad­foot to its board of di­rec­tors. Broad­foot cur­rent­ly serves as the CFO of aTyr Phar­ma and has pre­vi­ous­ly been the CFO of Emer­ald Health Phar­ma­ceu­ti­cals and Emer­ald Health Bio­ceu­ti­cals. Ad­di­tion­al­ly, she has held roles at GW Phar­ma­ceu­ti­cals and Vi­cal.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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