Take­da on­col­o­gy vet drills down the 'ba­sic­s' at cell ther­a­py start­up; Sarep­ta pro­motes new R&D chief

Kathryn Cor­zo

Kathryn Cor­zo — an on­col­o­gy vet­er­an and the pro­gram head be­hind Sanofi’s mul­ti­ple myelo­ma mon­o­clon­al an­ti­body isat­ux­imab — is now in the C-suite.

The newest mem­ber at cell ther­a­py play­er bit.bio as their COO, the long­time drug de­vel­op­er left Take­da (where she served, in turn, as the head of on­col­o­gy cell ther­a­py and then a part­ner in its ven­ture arm) to join the small biotech. For Cor­zo, bit.bio pre­sent­ed a unique op­por­tu­ni­ty to try and solve is­sues that had been plagu­ing cell ther­a­py — and one of the three rea­sons why she left Take­da.

Aside from bit.bio’s cell cod­ing plat­forms and “their abil­i­ty to pret­ty much tar­get any hu­man cell,” ac­cord­ing to Cor­zo, she left Take­da to both lever­age her ex­pe­ri­ence in drug de­vel­op­ment and build up­on skills that she learned at MIT just a few years pri­or, while get­ting her MBA.

Cor­zo’s jour­ney in­to the world of biotech and med­i­cine be­gan ear­ly in life — born in­to a fam­i­ly of en­gi­neers. And it was when she was grow­ing up that she re­al­ized the im­por­tance of prob­lem solv­ing, along­side a keen in­ter­est in math and sci­ence.

But her pas­sion for on­col­o­gy and can­cer ther­a­py re­al­ly start­ed to come in­to view when a fam­i­ly mem­ber was di­ag­nosed with can­cer — Hodgkin’s lym­phoma.

“And I saw that in­di­vid­ual go through treat­ment, and re­al­ly, re­al­ly suf­fer through treat­ment. Now, the pos­i­tive out­come is that he’s in re­mis­sion. He has lived his life, and he is do­ing ex­treme­ly well. But that, for me, gal­va­nized my in­ter­est in work­ing to de­vel­op new can­cer ther­a­pies,” Cor­zo told End­points News.

Af­ter she grad­u­at­ed from the Mass­a­chu­setts Col­lege of Phar­ma­cy and Health Sci­ences in the mid 1980s, she then went on to work with sev­er­al no­table biotechs, in­clud­ing Roche, Eli Lil­ly, Sanofi and Take­da be­fore join­ing bit.bio.

And while at Sanofi, 28 years in­to her pro­fes­sion­al ca­reer, Cor­zo de­cid­ed to go to MIT and get her MBA in 2017, fin­ish­ing the pro­gram two years lat­er.

Cor­zo joined bit.bio on Nov. 1, the same week bit.bio an­nounced its $103 mil­lion Se­ries B raise — along­side some im­pres­sive names join­ing bit.bio’s board. The pitch re­volved around a gene en­gi­neer­ing ap­proach that en­ables the com­pa­ny to pro­duce any num­ber of batch­es of any hu­man cell for re­search, drug dis­cov­ery and ther­a­peu­tic pur­pos­es.

With the new cash, Cor­zo said there is a ton of op­por­tu­ni­ty to go in­to dif­fer­ent in­di­ca­tions with bit.bio’s cur­rent plat­form — so over the next few months, bit.bio will be work­ing on pri­or­i­tiz­ing where the com­pa­ny wants to go in its port­fo­lio.

In her first few weeks at bit.bio, Cor­zo has fo­cused on the ba­sics, as she called it, to get the ball rolling. Those “ba­sics” are de­cent­ly ex­pan­sive, such as fig­ur­ing out bit.bio’s “key pri­or­i­ties,” what they can de­liv­er in the next six to 24 months, and how bit.bio can ex­pand more in­to cell ther­a­py. Ac­cord­ing to Cor­zo, that’s just step one.

Num­ber two? Get­ting bit.bio to build out what it still needs. Bit.bio is work­ing on set­ting up a project man­age­ment of­fice, Cor­zo said — to “not on­ly de­fine the [bit.bio’s] strat­e­gy, but we can drill that down and ex­e­cute on the strat­e­gy we’re look­ing at.” And with the biotech cur­rent­ly head­quar­tered in Cam­bridge in the UK, the biotech is al­so look­ing at if they need a foot­print in the US, should bit.bio de­cide to ex­pand.

And the third thing? Part­ner­ships. Cor­zo em­pha­sized how im­por­tant they are to small biotechs, but re­mained mum on any ne­go­ti­a­tions or talks with oth­er com­pa­nies to part­ner with bit.bio.

Paul Schloess­er


Louise Rodi­no-Kla­pac

Sarep­ta R&D chief Gilmore O’Neill is on his way out at the end of the month, paving the way for Louise Rodi­no-Kla­pac to slide in­to his job while re­main­ing CSO of the Duchenne biotech. In Feb­ru­ary, the FDA ap­proved Sarep­ta’s third DMD drug, Amondys 45, with­out much fan­fare. And af­ter a failed study of its gene ther­a­py SRP-9001-102, Sarep­ta de­clared it­self back in the game with safe­ty re­sults from 103 that it re­vealed in May to cat­a­pult the drug in­to Phase III. Rodi­no-Kla­pac was el­e­vat­ed to CSO in a De­cem­ber 2020 staff reshuf­fling that in­clud­ed Ian Es­tepan mov­ing to CFO. In oth­er Sarep­ta news, Mer­ck board mem­ber and Cal­tech bi­ol­o­gy and chem­istry pro­fes­sor Stephen Mayo has joined the board of di­rec­tors.

Mike Grey

Mike Grey has jumped back in­to the fold as a CEO once again, step­ping in at San Fran­cis­co’s Spruce Bio­sciences on an in­ter­im ba­sis. Richard King, Spruce’s CEO since 2019, has an­nounced his re­tire­ment and will be a strate­gic ad­vi­sor un­til the end of the year. Grey, the chair­man at Spruce since 2017, chairs the board at two oth­er com­pa­nies he’s helmed, Mirum Phar­ma­ceu­ti­cals and Re­neo Phar­ma­ceu­ti­cals. He’s al­so chair­man at Plex­i­um, which just named Astel­lasPer­ci­val Bar­ret­to-Ko as CEO, and is on the board of di­rec­tors at Hori­zon.

That’s not all: Pamela Wedel, the for­mer SVP of clin­i­cal op­er­a­tions at an­oth­er biotech where Grey has been chief ex­ec­u­tive — Am­plyx — has been ap­point­ed VP of de­vel­op­ment op­er­a­tions. Spruce, part of the IPO avalanche of 2020, is con­tin­u­ing de­vel­op­ment of its drug for clas­sic con­gen­i­tal adren­al hy­per­pla­sia (CAH), tildac­er­font.

Jakob Lind­berg

→ This week in “meet the new boss, same as the old boss” (non-Robert Califf di­vi­sion), Jakob Lind­berg re­turns as CEO of On­copep­tides af­ter lead­ing the com­pa­ny from 2011-20. Lind­berg takes over from Mar­ty Du­vall, whose die was cast last month when mul­ti­ple myelo­ma drug Pepax­to was yanked from the US mar­ket, dec­i­mat­ing the stock. Du­vall — for­mer­ly CEO of Toca­gen, the brain can­cer biotech that merged with Forte Bio­sciences — had on­ly been chief ex­ec­u­tive at On­copep­tides since Ju­ly 1, 2020, at which point Lind­berg slid in­to the CSO post.

Al San­drock

→ When ad­u­canum­ab was ap­proved in June — cause for cel­e­bra­tion un­der nor­mal cir­cum­stances — the groundswell of con­tro­ver­sy kicked in al­most im­me­di­ate­ly. From in­dus­try an­a­lysts to FDA ad­comm mem­bers re­sign­ing in protest, the big biotech has faced strong head­winds from the get-go. Now cou­pled with a rocky roll­out, marked by a steep price tag and ma­jor in­sur­ers telling Bio­gen they may not even cov­er the drug, Al San­drock has de­cid­ed to re­tire as R&D chief be­gin­ning Dec. 31. Tim­ing is every­thing, so the say­ing goes, and the tim­ing of this sur­prise move on­ly adds to the shad­ow Aduhelm has cast.

Priya Sing­hal

San­drock, a 23-year Bio­gen vet who had led R&D since Oc­to­ber 2019 and was CMO from 2012-20, hands the ba­ton to Priya Sing­hal — Bio­gen’s head of glob­al safe­ty and reg­u­la­to­ry sci­ences — on an in­ter­im ba­sis. And the push­back doesn’t ap­pear it will slow down any time soon: On Wednes­day, two days af­ter the San­drock an­nounce­ment, an EMA pan­el hand­ed Bio­gen a “neg­a­tive trend vote” on its mar­ket­ing ap­pli­ca­tion in the re­gion.

Pfiz­er’s C-suite con­tin­ues to be in a state of flux with the re­tire­ment of CFO Frank D’Ame­lio af­ter 14 years on the job. D’Ame­lio is leav­ing Pfiz­er in ex­cep­tion­al­ly strong shape, as the phar­ma gi­ant and BioN­Tech ex­pect a $36 bil­lion wind­fall from the Covid-19 vac­cine and sales for its an­tivi­ral pill, Paxlovid, are pro­ject­ed to reach some­where be­tween $15 bil­lion and $25 bil­lion.

Frank D’Ame­lio

D’Ame­lio, who’s al­so been EVP of glob­al sup­ply, will be re­placed in this ca­pac­i­ty by Mike Mc­Der­mott, whose ti­tle will be tweaked to chief glob­al sup­ply of­fi­cer start­ing Jan. 1. Mc­Der­mott, Pfiz­er’s pres­i­dent of glob­al sup­ply since 2019, be­gan his Pfiz­er ca­reer in 2003 as the head of Wyeth’s biotech man­u­fac­tur­ing op­er­a­tions in Pearl Riv­er, NY. D’Ame­lio joins CMO Mace Rothen­berg, CBO John Young and chief de­vel­op­ment of­fi­cer Rod MacKen­zie as ma­jor ex­ecs who have left or are prepar­ing to leave Pfiz­er.

→ While on the hunt to prove the next big I/O tar­get, Im­mu­ni­tas’ chief deal­mak­er Aman­da Wag­n­er has tak­en over the reins from for­mer Akcea COO Jef­frey Gold­berg as CEO. Wag­n­er’s pro­mo­tion from her CBO post comes on the heels of the com­pa­ny’s re­cent close of a $58 mil­lion round. Wag­n­er’s start to her bio­phar­ma ca­reer be­gan at Con­cert Phar­ma­ceu­ti­cals, where she spent a decade as VP, busi­ness de­vel­op­ment & prod­uct strat­e­gy. From there, Wag­n­er moved to Al­tas Ven­ture as VP, cor­po­rate & busi­ness de­vel­op­ment and lat­er con­sult­ed for the Long­wood Fund in 2019.

Hei­di Ha­gen

→ It’s good to be Hei­di Ha­gen this week: Not on­ly has she signed on to Jeff Blue­stone’s cell ther­a­py play Sono­ma Bio­ther­a­peu­tics as chief tech­ni­cal of­fi­cer, she’s al­so tak­en a seat on the board of di­rec­tors at Ob­sid­i­an Ther­a­peu­tics. Ha­gen, who held the in­ter­im CEO role at Zio­pharm On­col­o­gy af­ter the sturm und drang of the ac­tivist at­tack, co-found­ed and was chief strat­e­gy of­fi­cer for Vineti un­til she re­placed Lau­rence Coop­er in Feb­ru­ary. She’s al­so spent 10 years at Den­dreon and served as the Provenge mak­er’s SVP of op­er­a­tions.

Young Kwon

→ With ex-Ra Phar­ma­ceu­ti­cals CEO Doug Tre­co at the con­trols, Alchemab Ther­a­peu­tics has picked up Young Kwon as chief fi­nan­cial and op­er­at­ing of­fi­cer. Af­ter five years at Bio­gen, Kwon joined Mo­men­ta in 2011, ris­ing to CBO and lat­er chief fi­nan­cial and busi­ness of­fi­cer in ear­ly 2020. Then, J&J pur­chased Mo­men­ta last sum­mer, with Kwon play­ing a cru­cial role in the ne­go­ti­a­tions. In our Am­ber Tong’s play-by-play of the $6.5 bil­lion buy­out, Kwon and Mo­men­ta CEO Craig Wheel­er “had been try­ing cau­tious­ly to snatch a bet­ter deal from J&J. The of­fer price from the ini­tial pro­pos­al, they said, was in­suf­fi­cient — and ‘lim­it­ed high-pri­or­i­ty dili­gence’ might help them prove the case.” You can re­fresh your mem­o­ry on the sale here.

Dar­rin Miles

Dar­rin Miles is de­camp­ing from Agios “to pur­sue a chief ex­ec­u­tive of­fi­cer role at a pri­vate biotech­nol­o­gy com­pa­ny,” and on Dec. 6, Jack­ie Fouse’s crew has lined up Richa Pod­dar to re­place Miles as chief com­mer­cial of­fi­cer. An eight-year Roche/Genen­tech vet, Pod­dar has filled nu­mer­ous po­si­tions at Agios in the last five years, and in Au­gust she was pro­mot­ed to SVP, head of cor­po­rate strat­e­gy and busi­ness de­vel­op­ment. Back in De­cem­ber 2020, Agios com­plete­ly re­versed course from can­cer to fo­cus on mi­tapi­vat, a pyru­vate ki­nase R (PKR) ac­ti­va­tor for he­molyt­ic ane­mias that se­cured a Feb. 17, 2022 PDU­FA date.

Rachel Zolot Schwartz

→ One of Agios’ co-founders is fu­ture Dana-Far­ber fac­ul­ty mem­ber Lewis Cant­ley, who al­so co-found­ed Volas­tra, the New York can­cer biotech that added some ex­tra punch by an­nounc­ing a part­ner­ship with Mi­crosoft along­side a Se­ries A in April. This week Volas­tra has a huge batch of ap­point­ments as Scott Drut­man (head of trans­la­tion­al sci­ence) and Rachel Zolot Schwartz (head of busi­ness de­vel­op­ment and com­mer­cial) get things rolling. Drut­man hails from Re­gen­eron, where he was a di­rec­tor in on­col­o­gy clin­i­cal de­vel­op­ment, while Schwartz spent six years at Pfiz­er in var­i­ous ca­pac­i­ties — as a se­nior di­rec­tor of busi­ness de­vel­op­ment in on­col­o­gy, she was a key cog in Pfiz­er’s 2019 ac­qui­si­tion of Ar­ray Bio­Phar­ma.

Else­where at Volas­tra, the ros­ter of sci­en­tif­ic ex­ecs un­der CSO Michael Su has been fi­nal­ized: Sarah Bet­tigole, VP, im­munol­o­gy; Derek Co­gan, VP, chem­istry; Christi­na Eng, VP, bi­ol­o­gy; Al Swis­ton, VP, head of da­ta sci­ence; and Ru­min Zhang, VP, head of bio­chem­istry.

Jen­ny Mar­lowe

→ Fre­quent Peer Re­view dweller Aa­van­tiBio has se­lect­ed Jen­ny Mar­lowe to be CSO as blue­bird bio los­es an­oth­er ex­ec fol­low­ing a split in­to two com­pa­nies that of­fi­cial­ly took ef­fect this month. Mar­lowe was blue­bird’s be­ta tha­lassemia pro­gram lead and VP, pre­clin­i­cal & trans­la­tion­al de­vel­op­ment af­ter a decade in in­ves­tiga­tive tox­i­col­o­gy and pre­clin­i­cal safe­ty with No­var­tis. Aa­van­tiBio CEO Bo Cum­bo has me­thod­i­cal­ly filled po­si­tions at the gene ther­a­py up­start that we’ve cov­ered since its Oc­to­ber 2020 launch, nam­ing a CFO, CMO, COO and sev­er­al oth­ers over the last eight months.

Teri Lox­am

Teri Lox­am will jug­gle the dual roles of CFO and COO at im­mune-me­di­at­ed dis­ease biotech Ki­ra Phar­ma­ceu­ti­cals, which de­buted last No­vem­ber and is led by ex-Si­en­na Bio­phar­ma­ceu­ti­cals CEO Fred­er­ick Bed­ding­field. Af­ter work­ing in in­vestor re­la­tions with Bris­tol My­ers Squibb and Mer­ck, Lox­am took the CFO job at SQZ Biotech­nolo­gies and had been there since 2019. Lox­am was al­so on our radar in Sep­tem­ber when Vax­Cyte added her to the board of di­rec­tors.

Ann Neale

→ Res­cu­ing an old Am­gen drug out of moth­balls to tar­get mus­cle ag­ing, Bay Area an­ti-ag­ing up­start BioAge Labs has nabbed Dov Gold­stein as CFO and Ann Neale as chief de­vel­op­ment of­fi­cer. We had Gold­stein in this space last year when he be­came chief fi­nan­cial and busi­ness of­fi­cer at In­dap­ta Ther­a­peu­tics — the for­mer Loxo On­col­o­gy CFO al­so re­sides on the board of di­rec­tors at Gain Ther­a­peu­tics, Neubase Ther­a­peu­tics and Coya Ther­a­peu­tics. Neale comes to BioAge af­ter a three-year stay at Prin­cip­ia, where she was SVP of de­vel­op­ment op­er­a­tions af­ter a light­ning-fast turn as Sci­ence 37’s SVP, clin­i­cal op­er­a­tions and pa­tient af­fairs.

→ Co-found­ed by George Church and de­vel­op­ing pro­tein ther­a­peu­tics from non-stan­dard amino acids (NSAAs), GRO Bio­sciences scored a Se­ries A ear­li­er this month with an as­sist from Leaps by Bay­er and this week has named Tad Stew­art CBO. Dur­ing more than 15 years at Mer­ri­mack, Stew­art was SVP of busi­ness de­vel­op­ment and head of com­mer­cial, and since 2019 he had served as CBO of Ri­bon Ther­a­peu­tics.

Nan­cy Whit­ing

→ As men­tioned along­side a $60 mil­lion Se­ries A round, Re­cludix Phar­ma has snagged Seagen vet Nan­cy Whit­ing as CEO. Whit­ing, a 15-year vet of Seagen, most re­cent­ly served as EVP of cor­po­rate strat­e­gy. Pri­or to that, Whit­ing was Seagen’s EVP of late-stage de­vel­op­ment, SVP of clin­i­cal de­vel­op­ment and med­ical af­fairs and head of ex­per­i­men­tal med­i­cine. Dur­ing her time at Seagen, Whit­ing was in­stru­men­tal in the de­vel­op­ment of Ad­cetris for lym­phoma, Pad­cev for blad­der can­cer, Tukysa for breast can­cer and Tiv­dak for cer­vi­cal can­cer. Whit­ing cur­rent­ly sits on the board of Cari­bou Sci­ences.

Pen­rose Ther­a­peuTx has bagged David Sher­ris as pres­i­dent and CEO. Sher­ris brings with him ex­pe­ri­ence from his roles at Serono, Cen­to­cor, Unilever Re­search and Ma­teon Ther­a­peu­tics. Pri­or to his newest C-suite role, Sher­ris was CEO of GenAdam Ther­a­peu­tics, Palo­ma Phar­ma­ceu­ti­cals and Vas­cu­loMedics.

Mar­guerite Hutchin­son

→ South San Fran­cis­co-based Fron­tier Med­i­cines, try­ing to nudge in­to the KRAS sweep­stakes af­ter Am­gen’s mile­stone ap­proval of Lumakras, has $88.5 mil­lion in Se­ries B cash in the bank and a new CBO in Mar­guerite Hutchin­son. She be­gan her time at Plexxikon as se­nior di­rec­tor, busi­ness de­vel­op­ment in 2013, ris­ing to COO and gen­er­al coun­sel this sum­mer be­fore mak­ing the switch to Fron­tier, which signed a pro­tein degra­da­tion deal in De­cem­ber 2020 with Ab­b­Vie for $55 mil­lion up­front.

Puneet Aro­ra

→ Backed by Fra­zier Health­care Part­ners and tak­ing aim at IL-11, San Diego-based Lassen Ther­a­peu­tics has wel­comed Puneet Aro­ra as CMO. Af­ter near­ly eight years at Genen­tech, Aro­ra jumped to Prin­cip­ia in 2019, and when Sanofi forked over $3.7 bil­lion for the com­pa­ny last sum­mer, he be­came the French phar­ma’s head of clin­i­cal, in­flam­ma­tion and im­munol­o­gy. A month ago, Lassen made room for Ma­gen­ta CSO and head of re­search Lisa Ol­son on the board of di­rec­tors.

Kris­ten Har­ring­ton-Smith

Kris­ten Har­ring­ton-Smith is on board as chief com­mer­cial of­fi­cer at ADC play­er Im­muno­Gen, seek­ing re­demp­tion with IMGN632 in re­lapsed or re­frac­to­ry blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm af­ter the FDA’s smack­down of mirve­tux­imab so­rav­tan­sine in Phase III. Har­ring­ton-Smith con­cludes a 21-year run at No­var­tis that saw her take on an as­sort­ment of roles — since March 2020 she had been the phar­ma gi­ant’s US com­mer­cial head of hema­tol­ogy. More from Im­muno­Gen: Ex-Sanofi Gen­zyme head of le­gal and cur­rent Blue­print Med­i­cines chief le­gal and com­pli­ance of­fi­cer Tracey Mc­Cain has joined the board of di­rec­tors.

→ Uni­ver­si­ty of Texas spin­out Do­lormics has named Chris Flo­res as pres­i­dent and chief re­search and de­vel­op­ment of­fi­cer. Flo­res joins af­ter a 19-year stint at J&J, where he served in a num­ber of po­si­tions, in­clud­ing VP of neu­ro­science, La Jol­la R&D site head and glob­al ex­ter­nal in­no­va­tion head of dis­cov­ery sci­ences at Janssen Re­search & De­vel­op­ment, to name a few.

Tr­ish­na Goswa­mi

Tr­ish­na Goswa­mi has tak­en on the role of CMO at IN8bio, the NY-based gam­ma delta T cell biotech that went pub­lic in Ju­ly. Most re­cent­ly, Goswa­mi was VP, clin­i­cal de­vel­op­ment at Im­munomedics and con­tin­ued as an ex­ec at Gilead af­ter the buy­out. She has al­so served as se­nior med­ical di­rec­tor at Stem­line and as med­ical di­rec­tor at As­traZeneca/Med­Im­mune.

Lynx Bio­sciences (LynxBio) has brought on for­mer J&J ex­ec Syl­vaine Cas­es to the team as the com­pa­ny’s first-ever CBO. Dur­ing her ca­reer at J&J, Cas­es served as VP of on­col­o­gy strate­gic part­ner­ing. Pri­or to that, Cas­es served at Sanofi, Arete Ther­a­peu­tics (as head of phar­ma­col­o­gy) and Cy­to­ki­net­ics (as se­nior group leader).

San­jay Ag­gar­w­al has been named CMO of Apol­lo Ther­a­peu­tics, a UK trans­la­tion­al med­i­cine biotech that reached for the stars with a $145 mil­lion raise in June. Ag­gar­w­al, who will be based out of Apol­lo’s Cam­bridge, MA fa­cil­i­ty, spent the last year as the med­ical chief for An­giocrine Bio­science and over­saw the Phase II and III pro­grams for Rezurock as Kad­mon’s SVP of clin­i­cal de­vel­op­ment. Apol­lo is the prod­uct of a joint ven­ture with Uni­ver­si­ty of Cam­bridge, Im­pe­r­i­al Col­lege Lon­don, Uni­ver­si­ty Col­lege Lon­don and three Big Phar­mas: GSK, J&J and As­traZeneca.

Pa­tri­cia Françon

→ With a new name and $39 mil­lion worth of new cash an­nounced this sum­mer, French gene ther­a­py biotech Coave Ther­a­peu­tics — the erst­while Ho­ra­mahas in­stalled Thomas Blaet­tler as CMO and Pa­tri­cia Françon as COO. Be­fore spend­ing the last five years as CMO of Or­p­hazyme, Blaet­tler was with the clin­i­cal neu­ro­science di­vi­sions at Bris­tol My­ers and then Roche. Françon leaves her post at Ski­nosive as chief op­er­at­ing/tech­nol­o­gy of­fi­cer and has jumped around in clin­i­cal de­vel­op­ment with com­pa­nies like Sanofi and Cel­lec­tis.

→ Hous­ton-based Mem­gen has las­soed up Kevin Coveney as CFO. Coveney makes his way to the com­pa­ny af­ter a stint as CFO of Q-State Bio­sciences. Ear­li­er in his ca­reer, Coveney was SVP of fi­nance, hu­man re­sources and in­for­ma­tion tech­nol­o­gy at Vedan­ta Bio­sciences.

Bar­ry Deutsch

→ Res­pi­ra­to­ry and chron­ic dis­ease-fo­cused Aera­mi Ther­a­peu­tics has tapped Bar­ry Deutsch as CFO. Deutsch joins the Durham, NC-based com­pa­ny from Xeris Phar­ma­ceu­ti­cals, where he was CFO and pre­vi­ous­ly VP of busi­ness de­vel­op­ment. Pri­or to his time at Xeris, Deutsch was with Bax­ter Bio­Science, Bax­al­ta In­cor­po­rat­ed and Ova­tion Phar­ma­ceu­ti­cals among oth­ers.

Re­be­ca Sanchez Sarmien­to is join­ing both In­sight­ful Sci­ence and Dot­mat­ics as CFO. Sanchez Sarmien­to brings with her ex­pe­ri­ence from her times as CFO at In­vest­Cloud and AT­TOM Da­ta So­lu­tions. Ad­di­tion­al­ly, Sanchez Sarmien­to was a sell-side eq­ui­ty re­search an­a­lyst at Deutsche Bank and Cit­i­group.

Jus­tine Levin-Aller­hand

Flag­ship Pi­o­neer­ing has brought on Jus­tine Levin-Aller­hand as se­nior part­ner, cor­po­rate de­vel­op­ment. Levin-Aller­hand had been with the Broad In­sti­tute for the last eight years, and in April she be­gan the new role of EVP, de­vel­op­ment, busi­ness and ex­ter­nal re­la­tions. Flag­ship’s lat­est start­up, the tR­NA-fo­cused All­tr­na, made its de­but last week and is helmed by Pfiz­er and As­traZeneca alum Lo­visa Afzelius.

Bassem El­mank­aba­di

→ One of the lat­est com­pa­nies to do a SPAC dance, South San Fran­cis­co’s Blade Ther­a­peu­tics has re­cruit­ed Bassem El­mank­aba­di as SVP of clin­i­cal de­vel­op­ment. El­mank­aba­di says good­bye to Fi­bro­Gen, where he was ex­ec­u­tive med­ical di­rec­tor and ther­a­peu­tic area lead for fi­bro­sis and on­col­o­gy, and be­fore that he was a se­nior med­ical di­rec­tor, glob­al clin­i­cal safe­ty of­fi­cer with Am­gen. With ex-Pur­due Phar­ma CEO Mark Tim­ney as chair­man, Blade re­verse merged this month with Biotech Ac­qui­si­tion Com­pa­ny in a $254.3 mil­lion SPAC, and its id­io­path­ic pul­monary fi­bro­sis drug cud­e­tax­e­s­tat is slat­ed for a Phase II tri­al next year.

When­ev­er I call you Friend: To Aus­tralia we go, where John Friend has joined Syd­ney can­cer biotech Kazia Ther­a­peu­tics as CMO. Friend served as SVP of med­ical and sci­en­tif­ic af­fairs at the end of his sev­en-year tenure at Helsinn and CMO at NJ-based Cel­lec­tar Bio­sciences.

Cedil­la and CEO San­dra Glucks­mann have plugged in two new ex­ecs with VP of bi­ol­o­gy Joshua Murtie and VP of fi­nance Chris Lind­blom. Murtie was just a se­nior di­rec­tor ever so briefly at Servi­er af­ter sev­en years at Agios, as­cend­ing to se­nior di­rec­tor and head of can­cer bi­ol­o­gy. Mean­while, Lind­blom has held the same post at IFM Ther­a­peu­tics, Co­gen Im­mune Med­i­cine (which merged with Torque and is now Reper­toire Im­mune Med­i­cines) and Warp Dri­ve Bio. Last month Cedil­la, fo­cused on small mol­e­cules that take aim at can­cer, topped off its lat­est round of fund­ing with $25 mil­lion, giv­ing them a new Se­ries B to­tal of $82.6 mil­lion.

Moya Daniels

Moya Daniels has moved on from His­to­gen af­ter Richard Pas­coe’s de­par­ture as CEO to be­come SVP of reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance at Aru­vant, a gene ther­a­py “vant” from the Roivant sta­ble of com­pa­nies. We had Daniels in Peer Re­view in Oc­to­ber 2020 when she was named head of reg­u­la­to­ry, qual­i­ty and clin­i­cal op­er­a­tions at His­to­gen af­ter a short tenure in qual­i­ty as­sur­ance at San­Bio. Af­ter 12 years at Osiris Ther­a­peu­tics, Daniels was a reg­u­la­to­ry ex­ec at Fate Ther­a­peu­tics and Or­chard Ther­a­peu­tics. Aru­vant’s lentivi­ral gene ther­a­py for sick­le cell dis­ease, ARU-1801, is in a Phase I/II tri­al.

→ Af­ter ex­pe­ri­enc­ing a roller­coast­er ride of highs and lows in the first half of 2021, Proven­tion Bio has now ush­ered in Jan Hill­son as SVP of clin­i­cal de­vel­op­ment. Hill­son comes to the NJ-based com­pa­ny from Alpine Im­mune Sci­ences, where she served as SVP, clin­i­cal de­vel­op­ment. Pri­or to that, Hill­son was with Chemo­Cen­tryx, Mo­men­ta, Zy­mo­Ge­net­ics, Bris­tol My­ers and Xcyte Ther­a­pies.

→ Ox­ford, UK-based VLP vac­cine play­er and Serum In­sti­tute of In­dia part­ner Spy­Biotech has turned to Si­mon Jones to be VP, fi­nance and op­er­a­tions af­ter Vien Phan’s stint as in­ter­im fi­nance di­rec­tor. Be­fore head­ing to Su­mi Biswas’ team, Jones was CFO dur­ing his eight years with an­oth­er British biotech, Karus Ther­a­peu­tics.

Nachu Narasimhan

→ Nes­tled in­to The­seus Phar­ma­ceu­ti­cals’ Q3 re­port are the ap­point­ments of two ex­ecs. Mer­ck vet Nachu Narasimhan takes on the role of SVP, drug me­tab­o­lism and pre­clin­i­cal safe­ty for Tim Clack­son’s squad af­ter his time with Ve­rastem as VP of drug me­tab­o­lism and clin­i­cal phar­ma­col­o­gy, while Len Roza­mus has turned up at The­seus as SVP, tech­ni­cal op­er­a­tions. Be­fore get­ting in­to the con­sult­ing game in 2017, Roza­mus logged 21 years at Ari­ad Phar­ma­ceu­ti­cals and was se­nior di­rec­tor of man­u­fac­tur­ing op­er­a­tions.

→ Cam­bridge, MA CAR-NK play­er Cata­ma­ran Bio floats back in­to Peer Re­view by nam­ing Tara Place VP, hu­man re­sources and or­ga­ni­za­tion­al ef­fec­tive­ness. Place, who comes to Cata­ma­ran af­ter lead­ing hu­man re­sources at Chi­as­ma, spent sev­en years in tal­ent ac­qui­si­tion with Ver­tex and Bio­gen. Cata­ma­ran launched al­most ex­act­ly one year ago with a $42 mil­lion Se­ries A.

→ Life sci­ence tools com­pa­ny Lu­micks has made two new ad­di­tions to its man­age­ment team with the ap­point­ments of Jos Maas (gen­er­al man­ag­er, dy­nam­ic sin­gle mol­e­cule (DSM) busi­ness) and Geerte Hes­en (gen­er­al coun­sel). Maas joins the Am­s­ter­dam-based com­pa­ny with ex­pe­ri­ence from his time at Ther­mo Fish­er Sci­en­tif­ic, Nearfield In­stru­ments, Phe­nom-World and ASML. Mean­while, Hes­en hops aboard from ASML and Philips Per­son­al Health busi­ness.

Roy Bev­eridge

Grit­stone CEO An­drew Allen has re­signed from the board of di­rec­tors at Epizyme af­ter sev­en years, while the door opens for Roy Bev­eridge and Car­ol Stuck­ley. Bev­eridge, the ex-CMO of Hu­mana, is cur­rent­ly with Avalere Health as a con­sul­tant. Stuck­ley had a 22-year ca­reer with Pfiz­er that end­ed in 2007 and sits on the board at Centes­sa.

Di­ana Brainard

Nek­tar has giv­en its board of di­rec­tors a boost with the ar­rival of Di­ana Brainard. Now the CEO of AlloVir, Brainard is best known for her 10 years at Gilead where, as vi­rol­o­gy chief, she helped lead the ef­fort to clinch an emer­gency use au­tho­riza­tion for remde­sivir to treat Covid-19.

→ Now chaired by for­mer Strong­bridge Bio­phar­ma CEO John John­son, obe-cel de­vel­op­er Au­to­lus has named Bill Young to the board of di­rec­tors. Now a se­nior ad­vi­sor at Black­stone, Young put an ex­cla­ma­tion point on 19 years at Genen­tech by serv­ing as its COO from 1997-99.

Alise Re­icin

→ Af­ter shelling out $29.5 mil­lion up­front to li­cense five an­ti­body-drug con­ju­gate pro­grams from LegoChem Bio­sciences ear­li­er this week, Czech biotech So­tio has en­list­ed Alise Re­icin (CEO of Tec­ton­ic Ther­a­peu­tic), Josep Tabernero (head of med­ical on­col­o­gy de­part­ment at Vall d’He­bron Uni­ver­si­ty Hos­pi­tal) and An­tho­ny Tolch­er (CEO and founder of NEXT On­col­o­gy) to its strate­gic ad­vi­so­ry board.

→ Austin, TX-based Ae­glea Bio­Ther­a­peu­tics has a seat for Rhythm Phar­ma­ceu­ti­cals CFO Hunter Smith on the board of di­rec­tors. The in­ter­im CEO un­til David Meek­er came along at Rhythm, Smith has al­so been VP of fi­nance and CFO of Cel­gene’s in­flam­ma­tion and im­munol­o­gy busi­ness unit.

Hei­di Hunter

→ San Fran­cis­co’s Sutro Bio­phar­ma, which was grant­ed fast track des­ig­na­tion in Au­gust for its ovar­i­an can­cer drug STRO-002, has added Car­di­nal Health pres­i­dent Hei­di Hunter to the board of di­rec­tors. The for­mer Boehringer In­gel­heim ex­ec was pre­vi­ous­ly SVP of the glob­al im­munol­o­gy busi­ness unit at UCB.

Adicet Bio has space re­served for Michael Kauff­man on its board of di­rec­tors. Kauff­man, who co-found­ed and was the CEO of Karyopharm, is al­so a board mem­ber for Ve­rastem and Kezar Life Sci­ences in ad­di­tion to Karyopharm.

Lyn Bara­nows­ki

→ San Jose-based Rani Ther­a­peu­tics has ap­point­ed Lyn Bara­nows­ki to its board of di­rec­tors. Bara­nows­ki, the cur­rent COO at Al­ta­vant, has al­so served as SVP, cor­po­rate de­vel­op­ment and strat­e­gy at Melin­ta Ther­a­peu­tics.

Ed Barac­chi­ni is adding yet an­oth­er board seat to his ré­sumé with his lat­est ap­point­ment at Durham, NC-based CoIm­mune. Barac­chi­ni for­mer­ly served as CBO of Ima­go Bio­sciences and Xen­cor. Ad­di­tion­al­ly, he has held stints at Eli­tra Phar­ma­ceu­ti­cals, Io­n­is and Agouron Phar­ma­ceu­ti­cals, among oth­ers. Barac­chi­ni cur­rent­ly sits on the boards of IN­mune Bio and 4D Phar­ma.

Michelle Mc­Mur­ry-Heath-led BIO has re­cruit­ed Carine Bous­tany to its board of di­rec­tors. Bous­tany serves as Boehringer In­gel­heim’s glob­al head, de­vel­op­ment sci­ence and head, de­vel­op­ment site US. Bous­tany joined Boehringer in 2011 and pre­vi­ous­ly served in the com­pa­ny’s dis­cov­ery re­search team.

No­ra Bren­nan is now a mem­ber of the board of di­rec­tors at No­var­tis DNA re­pair part­ner Ar­tios, which hit a $153 mil­lion jack­pot on its Se­ries C in Ju­ly. This spring, Bren­nan was ap­point­ed CFO of Philadel­phia on­col­o­gy biotech Fore Bio­ther­a­peu­tics.

Cel­lares has ap­point­ed Ezekiel Emanuel to its board of ad­vi­sors. Emanuel cur­rent­ly serves as vice provost for glob­al ini­tia­tives, the Di­ane v.S. Levy and Robert M. Levy Uni­ver­si­ty pro­fes­sor, and co-di­rec­tor of the Health­care Trans­for­ma­tion In­sti­tute at the Uni­ver­si­ty of Penn­syl­va­nia. Ad­di­tion­al­ly, Emanuel was one of the ar­chi­tects of the Af­ford­able Care Act and ad­vised the Biden ad­min­is­tra­tion on Covid-19 re­sponse.

Derek Graf al­so con­tributed to this edi­tion.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.