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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.