Flag­ship keeps ex-FDA com­mish Stephen Hahn busy with an­oth­er CMO gig; Daphne Koller makes key hire at in­sitro by wel­com­ing Google and Face­book vet

Stephen Hahn

→ What’s next for Stephen Hahn, you ask? It’s an in­ter­im CMO post at Flag­ship’s Your­Bio Health, the mak­er of kits that side­step the con­ven­tion­al meth­ods of blood col­lec­tion in fa­vor of push-but­ton de­vices. Hahn joined Flag­ship in June as CMO of its Pre­emp­tive Med­i­cine and Health Se­cu­ri­ty ini­tia­tive af­ter a top­sy-turvy run as FDA com­mis­sion­er in the Trump ad­min­is­tra­tion. Hahn re­ceived his share of flak when he ex­tolled the virtues of con­va­les­cent phar­ma be­fore the emer­gency use au­tho­riza­tions of the Mod­er­na and Pfiz­er/BioN­Tech Covid-19 vac­cines, even­tu­al­ly walk­ing back his com­ments. Con­verse­ly, Hahn re­ceived ku­dos for stay­ing res­olute on safe­ty fol­lowup from clin­i­cal tri­als. A month af­ter his FDA tenure, Hahn joined the board of di­rec­tors at Black­fynn.

Tom Stocky

Tom Stocky’s post-Google and Face­book jour­ney takes him to Daphne Koller’s crew at in­sitro as VP of prod­uct, putting him in charge of en­hanc­ing the user ex­pe­ri­ence for its ma­chine-learn­ing ap­pa­ra­tus. Be­sides his years as Google’s di­rec­tor of project man­age­ment (help­ing build the Google App En­gine) and as Face­book’s VP of search & pro­file, he’s fa­mil­iar with the biotech land­scape as a tech­nol­o­gy fel­low and a mem­ber of the sci­en­tif­ic ad­vi­so­ry board at De­nali, which re­leased less-than-sat­is­fy­ing Hunter syn­drome da­ta in Ju­ly. Ad­di­tion­al­ly, Stocky ran the learn­ing plat­form at the Chan Zucker­berg Ini­tia­tive.

Joseph Ca­mar­do

→ There’s a CMO shift that has tak­en place at Swiss biotech ADC Ther­a­peu­tics, with Jay Fein­gold hand­ing over the keys to VP of med­ical af­fairs Joseph Ca­mar­do. Be­fore mak­ing his way to ADC in ear­ly 2020, Ca­mar­do spent 10 years as an ex­ec at Cel­gene, where he was SVP of glob­al med­ical af­fairs and cor­po­rate med­ical op­er­a­tions, then SVP of Cel­gene Glob­al Health be­fore the Bris­tol My­ers Squibb deal closed. The Chris Mar­tin-led ADC has ex­pand­ed its reach in­to Chi­na with its joint ven­ture Over­land AD­CT Bio­Phar­ma, which named Er­ic Koo as its CEO in April.

Marc Blaustein has been named COO at mi­cro­bio­me play­er Finch Ther­a­peu­tics, which nabbed an up­sized $128 mil­lion IPO in March — near­ly six months af­ter its Se­ries C that to­taled $90 mil­lion for CEO Mark Smith’s bunch. The di­rec­tor of busi­ness de­vel­op­ment at Alk­er­mes from 1999-2004, Blaustein co-found­ed and helmed Akashi Ther­a­peu­tics and lat­er be­came CEO of NED Biosys­tems. In his lat­est gig, Blaustein led busi­ness de­vel­op­ment at Guide Ther­a­peu­tics, a Geor­gia Tech spin­out that Beam bought for $120 mil­lion up­front in Feb­ru­ary.

Jeff Hack­man

→ With a mod­est $10 mil­lion Se­ries B in the hop­per and ex-Gen­zyme CFO Jim Sherblom as ex­ec­u­tive chair­man, Re­Form Bi­o­log­ics has tapped Jeff Hack­man as pres­i­dent and CEO. His pre­de­ces­sor, John Sorvil­lo, will chair the ad­vi­so­ry board. Once in charge of the US in­ter­nal med­i­cine and on­col­o­gy fran­chis­es at Shire, Hack­man leaves his post as pres­i­dent of US op­er­a­tions with EU­SA Phar­ma. Based in Woburn, MA, Re­Form Bi­o­log­ics fo­cus­es on what they de­scribe as “gen­tler med­i­cines” for chil­dren and the el­der­ly.

Lau­ren Sabel­la

→ Ac­com­pa­ny­ing the news that Acor­da is un­der­go­ing an­oth­er re­vamp and trim­ming its staff by 15%, Lau­ren Sabel­la is get­ting pro­mot­ed to COO and Ker­ry Clem is step­ping in­to the CCO job that Sabel­la pre­vi­ous­ly held. Sabel­la’s tenure at Acor­da be­gan in 2010 as EVP of com­mer­cial de­vel­op­ment, while Clem has spent a decade him­self at Acor­da, mov­ing out of his role as EVP of sales, mar­ket ac­cess, and op­er­a­tions.

Leslie Meltzer

Bob­by Gas­par’s gene ther­a­py biotech Or­chard Ther­a­peu­tics has re­fash­ioned its C-suite con­sid­er­ably, pro­mot­ing Leslie Meltzer to CMO while adding two fresh pick­ings to the lead­er­ship bas­ket: CSO Ful­vio Mav­ilio and chief tech­ni­cal of­fi­cer Nico­let­ta Log­gia. Af­ter stints at Acte­lion and Bio­gen, Meltzer joined Or­chard in 2018 as VP of US med­ical af­fairs, climb­ing to SVP of med­ical af­fairs, clin­i­cal op­er­a­tions and di­ag­nos­tics. Mav­ilio, the cur­rent CSO at Smart Im­mune, is the ex-SVP of trans­la­tion­al sci­ence for Au­dentes and will con­sult at Or­chard un­til he of­fi­cial­ly be­gins as chief sci­en­tist in Jan­u­ary 2022. Log­gia spent the last 17 years at No­var­tis in a num­ber of ca­pac­i­ties and since last April had been glob­al head of cell and gene ther­a­pies.

Kat Lange

→ Padding the C-suite fur­ther af­ter the ar­rivals of CSO John Leonard and CMO Ed­ward Con­ner, CRISPR up­start Lo­can­abio — nine months re­moved from its Se­ries B megaround — has se­lect­ed Kat Lange as CFO. Lange takes the plunge in­to the biotech world af­ter 12 years at JP Mor­gan; since 2019 she had been ex­ec­u­tive di­rec­tor in JPM’s health­care in­vest­ment bank­ing group. You may re­call that an­oth­er Lo­can­abio ex­ec, VP of R&D Ran­jan Ba­tra, was fea­tured as one of End­points News20 un­der 40 lead­ers this year.

→ Af­ter Patrick Soon-Sh­iong’s much-bal­ly­hooed “can­cer moon shot” fiz­zled on the launch pad at Nan­tK­west, he re­verse-merged the com­pa­ny with his cell ther­a­py out­fit Im­mu­ni­ty­Bio in De­cem­ber and hand­ed the con­trols to Rich Ad­cock. The team con­tin­ues to take shape with He­len Luu as Im­mu­ni­ty­Bio’s first chief com­mer­cial of­fi­cer and Sigrid Schrein­er, who starts Mon­day as SVP of glob­al mar­ket ac­cess. Luu’s clipped reign as CEO of Cell BT be­gan in May af­ter step­ping in as COO in Sep­tem­ber 2020, and ear­li­er she led busi­ness de­vel­op­ment with­in her 10-year stint at can­cer vac­cine mak­er Den­dreon. Schrein­er, al­so a Den­dreon vet, had been pro­mot­ed to SVP, glob­al mar­ket ac­cess & dis­tri­b­u­tion at Stem­line Ther­a­peu­tics in the spring of 2020.

Mel Hayes

→ Last month, Ful­crum’s stock rose by 125% af­ter some ini­tial suc­cess in their Phase I study to treat in­her­it­ed blood dis­or­ders — a huge up­swing con­sid­er­ing the is­sues they en­coun­tered on the mar­ket last sum­mer af­ter a Phase II dud. This week, Ful­crum brings on Mel Hayes as chief com­mer­cial of­fi­cer. Hayes has made stops along the way at Bris­tol My­ers, Bay­er and Bax­al­ta, and he was re­cent­ly Sanofi Gen­zyme’s glob­al head com­mer­cial, VP, rare blood dis­or­ders.

Karen Tubridy

→ Bed­ford, MA-based Verseau Ther­a­peu­tics, de­vel­op­ing can­cer drugs with a line of at­tack it calls macrophage re­po­lar­iza­tion, has ush­ered in Karen Tubridy as chief de­vel­op­ment of­fi­cer. Tubridy, the ex-chief de­vel­op­ment of­fi­cer at Eleven Bio­ther­a­peu­tics, moves on from her dou­ble du­ty as SVP, glob­al pro­grams and chief de­vel­op­ment of­fi­cer at Ake­bia. Verseau, co-found­ed by Bob Langer with a first-year CEO in John Ed­wards, de­buted in Oc­to­ber 2019.

→ As Tubridy gets start­ed at Verseau, Tim Smith walks away — writ­ing a new chap­ter as SVP, head of cor­po­rate de­vel­op­ment at New Jer­sey p53-fo­cused biotech PMV Phar­ma­ceu­ti­cals, chaired by Rich Hey­man. Smith, the CBO at Verseau since 2019, is a sev­en-year Cel­gene alum who has been a CBO be­fore at Cleave Bio­sciences and led cor­po­rate de­vel­op­ment at Ideaya. PMV added $53 mil­lion to its cof­fers in a Se­ries D from Au­gust 2020 to con­tin­ue its fo­cus on mu­tant p53 pro­teins, an es­pe­cial­ly tough nut to crack against can­cer.

Thomas Tan

Long­wood-backed im­munother­a­py start­up Im­mu­ni­tas Ther­a­peu­tics, flush with $58 mil­lion in Se­ries B cash, has picked up Thomas Tan as CSO af­ter he held the same ti­tle at Bicara Ther­a­peu­tics. Tan, a Roche vet, has al­so been head of im­munol­o­gy at For­ma Ther­a­peu­tics and El­star Ther­a­peu­tics. Co-found­ed by Dana-Far­ber’s Kai Wucherpfen­nig and Genen­tech R&D chief Aviv Regev, Im­mu­ni­tas is try­ing to push its CD161-block­ing an­ti­body IMT-009 in­to the clin­ic and al­so pro­mot­ed Aman­da Wag­n­er to CBO in Au­gust.

Ne­oleukin has been al­lowed to pass go on the FDA mo­nop­oly board with its IL-2/IL-15 ag­o­nist af­ter a three-month hold, and the Seat­tle biotech has just tapped Bill Arthur as VP and head of re­search. All Arthur has to do is dri­ve down In­ter­state 5 from his pre­vi­ous stop, Seagen, where he was se­nior di­rec­tor & head of can­cer bi­ol­o­gy dur­ing his 10 years there. While with Mer­ck from 2006-11, Arthur was team lead in bio­mark­er dis­cov­ery for in­ves­ti­ga­tion­al on­col­o­gy drugs.

Mary DiB­i­ase

Mary DiB­i­ase has been pro­mot­ed to COO at ma­vorix­afor de­vel­op­er X4 Phar­ma­ceu­ti­cals af­ter serv­ing as SVP, tech­ni­cal op­er­a­tions and qual­i­ty. The 16-year Bio­gen alum ini­tial­ly jumped on board at X4 in 2017 in the role of VP, pro­gram and al­liance man­age­ment. Back in No­vem­ber, Art Taveras left Bio­gen to be­come X4’s CSO, and a month lat­er the com­pa­ny poached CMO Diego Ca­david from Ful­crum. Tri­als are un­der­way for ma­vorix­afor to treat such dis­eases as WHIM syn­drome (Phase III), Walden­ström’s macroglob­u­line­mia (Phase Ib with ibru­ti­nib) and se­vere con­gen­i­tal neu­trope­nia (al­so Phase Ib).

Bio­phytis — eval­u­at­ing its sar­cope­nia drug Sar­co­neos (BIO101) in Covid-19 pa­tients with se­vere res­pi­ra­to­ry fail­ure — has giv­en Rob van Maa­nen the nod as CMO af­ter Jean Mar­i­ani held the fort for a cou­ple months. Mar­i­ani had tem­porar­i­ly re­placed Sam Agus and re­mains on the sci­en­tif­ic ad­vi­so­ry board. As for van Maa­nen, he ex­its the CMO post at mi­to­chon­dr­i­al dis­ease-fo­cused Khon­dri­on to join the Paris-based biotech. Else­where, he was a se­nior med­ical di­rec­tor dur­ing a six-year run at Astel­las and the CNS di­rec­tor at Ei­sai from 2005-10.

Tram Tran

Car­o­line Loew’s biosen­sor shop Glympse, us­ing its plat­form to catch in­di­ca­tions of NASH in pa­tients, has ap­point­ed Tram Tran as CMO. Tran says farewell to Gilead, where she was VP of med­ical af­fairs, glob­al head, liv­er dis­eases, fi­bro­sis and Covid-19. She made the leap to Gilead in 2018 af­ter 16 years both at Cedars-Sinai and in acad­e­mia as a pro­fes­sor of med­i­cine at UCLA.

In­fin­i­ty Phar­ma­ceu­ti­cals brought on Robert Ilar­ia to be its new CMO. Ilar­ia most re­cent­ly came from Bris­tol My­ers as part of their de­vel­op­ment team, and was the ex­ec­u­tive med­ical di­rec­tor for clin­cal R&D for Cel­gene be­fore that. At the same time, In­fin­i­ty is mov­ing their con­sult­ing chief physi­cian Bri­an Schwartz, a for­mer act­ing CMO at Tarus, to the board of di­rec­tors.

Pamela Gar­zone is tak­ing over as chief de­vel­op­ment of­fi­cer at Anixa Bio­sciences af­ter hold­ing ex­ec­u­tive roles with Cal­i­br at the Scripps Re­search In­sti­tute and Pfiz­er. The sigh of re­lief you hear may be com­ing from San Jose af­ter the FDA grant­ed Anixa’s IND ap­pli­ca­tion for its Mof­fitt-part­nered CAR-T im­munother­a­py in late Au­gust; the agency had placed a clin­i­cal hold on it in April.

Randy Pritchard

Pil­lar Bio­sciences has picked up Randy Pritchard as CEO — tak­ing over for founder Gang Song, who will tran­si­tion to chair­man of the board. Pritchard joins the in vit­ro di­ag­nos­tics com­pa­ny af­ter hold­ing po­si­tions at POC Di­ag­nos­tics & Core Reagents (as SVP of US di­ag­nos­tics mar­ket­ing and SVP & life­cy­cle leader) and Roche Di­ag­nos­tics (VP of mar­ket­ing).

Ja­cob Mich­lewicz

→ Swedish cell ther­a­py biotech Anoc­ca, rak­ing in $47 mil­lion from a Se­ries B round in Ju­ly, has wel­comed Ja­cob Mich­lewicz as CFO. Mich­lewicz re­cent­ly logged two years as CFO of Stock­holm-based medtech Bioser­vo Tech­nolo­gies, a mak­er of wear­ables to help strength­en mus­cles which lists the ex­oskele­ton glove Iron­hand among its prod­ucts.

Cyrus Ar­man

Cyrus Ar­man has signed on to Madi­son, WI pep­tide drug de­vel­op­er Nim­ble Ther­a­peu­tics as CBO. Af­ter five years at Am­gen where he was el­e­vat­ed to di­rec­tor of cor­po­rate strat­e­gy, Ar­man then piv­ot­ed to im­muno-on­col­o­gy biotech Neu­vo­gen in 2019 as VP of cor­po­rate de­vel­op­ment and strat­e­gy.

Ali Hariri has been named CMO of Wa­ter­town, MA-based Eloxx Phar­ma­ceu­ti­cals, which ac­quired Zikani Ther­a­peu­tics this spring. Hariri, a clin­i­cal de­vel­op­ment leader at Io­n­is and Take­da, comes to Eloxx af­ter his time as Sanofi’s se­nior glob­al project head in rare dis­ease clin­i­cal de­vel­op­ment. Helmed by ex-Zikani CEO Sum­it Ag­gar­w­al, Eloxx is shoot­ing for da­ta in Q4 with its lead can­di­date ELX-02 for cys­tic fi­bro­sis pa­tients with non­sense mu­ta­tions.

Se­mi Trot­to

→ It’s full steam ahead with more hires at Third Rock start­up MO­MA Ther­a­peu­tics af­ter Asit Parikh rolled in as CEO and CSO Pe­ter Ham­mer­man fol­lowed him three months lat­er, with Se­mi Trot­to join­ing the mol­e­c­u­lar ma­chine biotech as chief peo­ple and ex­pe­ri­ence of­fi­cer. Trot­to, who spent 11 years in hu­man re­sources and glob­al tal­ent ac­qui­si­tion at Bris­tol My­ers, shift­ed to gen­er­al man­ag­er at Thrive Ear­li­er De­tec­tion af­ter Ex­act Sci­ences pur­chased it for a near steal of a $2.5 bil­lion deal last fall. She al­so led HR at Ed­i­tas Med­i­cine from 2016-19.

→ Our Max Gel­man just cov­ered Vec­tivBio’s buy­out of Comet Ther­a­peu­tics last week, and now CEO Lu­ca Santarel­li brings in Scott Ap­ple­baum as chief le­gal of­fi­cer and cor­po­rate sec­re­tary. For­mer­ly se­nior coun­sel at Bris­tol My­ers with 10 ad­di­tion­al years at Shire un­der his belt, Ap­ple­baum joins Vec­tivBio from Tra­ve­na, where he was chief le­gal & com­pli­ance of­fi­cer and SVP of reg­u­la­to­ry af­fairs.

→ Pa­lo Al­to, CA-based Med­able has plucked up MaryAnne Rizk as chief strat­e­gy of­fi­cer. Rizk joins the com­pa­ny with ex­pe­ri­ence from her time at Or­a­cle, Me­di­da­ta, Mer­ck and IQVIA.

Is­abel Car­mona

Is­abel Car­mona has joined New Jer­sey-based Rock­et Phar­ma­ceu­ti­cals as chief hu­man re­sources of­fi­cer and SVP. Car­mona held a sim­i­lar po­si­tion at Ich­nos Sci­ences and was in­volved in HR at Shire and Te­va. Rock­et ran in­to some is­sues back in May when the FDA stalled its Phase I tri­al for a gene ther­a­py can­di­date to treat Danon dis­ease, and it wasn’t un­til Au­gust that Rock­et was able to get the tri­al back off the ground.

Rani Ther­a­peu­tics, which is work­ing on a ro­bot­ic pill and pulled in $69 mil­lion worth of new fund­ing in De­cem­ber, has tapped Er­ic Groen as gen­er­al coun­sel. Groen, an Am­gen vet, most re­cent­ly served as the com­pa­ny’s re­gion­al gen­er­al coun­sel for its com­mer­cial busi­ness in Cana­da, Latin Amer­i­ca, Mid­dle East and Africa.

Michael Ger­ard

Michael Ger­ard de­parts from his role as as­so­ciate gen­er­al coun­sel at Spark to take on the gen­er­al coun­sel po­si­tion at Ca­balet­ta Bio. Last year, the biotech teamed with Ar­ti­san Bio on CAAR-T (chimeric au­to-an­ti­body re­cep­tor) cell ther­a­py de­vel­op­ment. Now it hopes that Ger­ard’s le­gal and cor­po­rate ex­pe­ri­ence, which al­so in­cludes a stint at San­doz, will help push more gene ther­a­pies through the pipeline.

An­drew Welch­man is leav­ing his post at the Well­come Trust to hop aboard ieso as the com­pa­ny’s first-ever EVP for im­pact. Welch­man served as head of neu­ro­science and men­tal health at the Well­come Trust and pre­vi­ous­ly served as a pro­fes­sor of neur­al in­tel­li­gence at the Uni­ver­si­ty of Cam­bridge.

Scott Plevy

Scott Plevy is mak­ing his way over to Pro­tag­o­nist Ther­a­peu­tics as EVP and ther­a­peu­tic head, gas­troen­terol­o­gy. Plevy brings with him ex­pe­ri­ence from his time as CSO at Sen­da Bio­sciences and Syn­log­ic Ther­a­peu­tics. Plevy has al­so served as VP, im­munol­o­gy re­search and de­vel­op­ment at Janssen.

Ra­mana Kuchib­hat­la is tak­ing over the torch as SVP and head of re­search & de­vel­op­ment from re­tir­ing ex­ec Jay Saoud at Waltham, MA-based Min­er­va Neu­ro­sciences. Kuchib­hat­la comes to the com­pa­ny from PRA Health Sci­ences, a sub­sidiary of Icon, where he was ex­ec­u­tive di­rec­tor of glob­al drug de­vel­op­ment. Pri­or to his role at PRA, Kuchib­hat­la was with Me­lior Phar­ma­ceu­ti­cals, QED Phar­ma­ceu­ti­cal Ser­vices, Tar­ga­cept, and Glax­o­SmithK­line.

→ Ox­ford-based En­e­si Phar­ma has named Eliz­a­beth Eagling-Vose as SVP, op­er­a­tions. Eagling-Vose hails from Ox­ford Uni­ver­si­ty spin­out Vac­citech, where she served as se­nior di­rec­tor and head of clin­i­cal op­er­a­tions. Pri­or to her role at Vac­citech, Eagling-Vose was project di­rec­tor and di­rec­tor of pa­tient en­gage­ment at Co­v­ance.

Pas­sage Bio, the Penn­syl­va­nia-based gene ther­a­py de­vel­op­er co-found­ed by Jim Wil­son, has ap­point­ed Max­ine Gowen as its new chair­woman of the board of di­rec­tors. The CEO of Tamuro­Bio and for­mer Treve­na CEO has been a mem­ber of the board since Feb­ru­ary, and was brought on as chair­woman fol­low­ing for­mer chair­man Tachi Ya­ma­da’s death in Au­gust.

Tom Civik

Tom Civik has re­placed Ver­sant’s Jer­el Davis as chair­man of the board at syn­thet­ic lethal­i­ty start­up Re­pare Ther­a­peu­tics, al­though Davis will keep his seat on the board. Civik takes this role at the pre­ci­sion on­col­o­gy play­er af­ter a year as pres­i­dent and CEO of Five Prime, which Am­gen swooped in to buy for $2 bil­lion in April.

→ You think Civik is done in this edi­tion of Peer Re­view? In the words of ES­PN col­lege foot­ball icon Lee Cor­so, “Not so fast, my friend!” Civik is al­so in a new crop of board mem­bers at Pyx­is On­col­o­gy, which just named Pamela Yanchik Con­nealy as CFO last week. Join­ing Civik are ex-Pfiz­er CMO Fre­da Lewis-Hall, Dar­ren Cline and Mark Chin.

Steve Altschuler

Steve Altschuler has been elect­ed chair­man of the board at Azu­ra Oph­thalmics based in Tel Aviv. The co-founder and for­mer chair­man at Spark is now man­ag­ing di­rec­tor of health­care ven­tures at Ziff Cap­i­tal Part­ners and al­so chairs the board at up­start Lex­eo Ther­a­peu­tics.

→ An­oth­er Spark co-founder, Jean Ben­nett, has head­ed to the board of di­rec­tors at Rockville, MD-based AAV gene ther­a­py biotech Re­genxbio. George Mi­gausky, a board mem­ber at Im­muno­vant and the ex-CFO of Dyax, is al­so claim­ing a board seat at Re­genxbio.

→ Chaired by CEO (and Alex­ion co-founder) Stephen Squin­to, Gen­nao Bio has added Gary Sender to the board of di­rec­tors. From 2016 un­til his re­tire­ment this year, Sender was CFO at Nabri­va Ther­a­peu­tics and is a board mem­ber at Schrödinger, Har­mo­ny Bio­sciences, iBio and Elu­ci­da On­col­o­gy.

Sid­dhartha Ka­dia has earned a seat on the board of di­rec­tors at “dig­i­tal cell bi­ol­o­gy” com­pa­ny Berke­ley Lights, a par­tic­i­pant in the epic IPO boom of 2020. The ex-pres­i­dent and CEO of EAG Lab­o­ra­to­ries, Ka­dia is on the boards of Iso­Plex­is and Nu­Va­sive, among oth­ers.

→ Flag­ship-backed Evelo Bio­sciences, which joined the Covid-19 hunt last May, has brought on Iain McInnes — a leader in the fields of rheuma­toid and pso­ri­at­ic arthri­tis re­search — to its board of di­rec­tors. McInnes is cur­rent­ly vice prin­ci­pal and head of col­lege to the Col­lege of Med­ical, Vet­eri­nary and Life Sci­ences, Muir­head pro­fes­sor of med­i­cine, and hon­or con­sul­tant rheuma­tol­o­gist at the Uni­ver­si­ty of Glas­gow in Scot­land.

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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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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