Joseph Ar­ron march­es to the beat of his own drum at 23andMe; Ex-Voy­ager CFO joins Sek Kathire­san at Verve Ther­a­peu­tics

Joseph Ar­ron

Joseph Ar­ron is some­times re­ferred to as the black sheep of his fam­i­ly. While every­one else is a pro­fes­sion­al mu­si­cian, he was al­ways more in­ter­est­ed in sci­ence.

“I played mu­sic, but I was nev­er that keen on pur­su­ing that as a ca­reer,” Ar­ron says, adding that his dad played in or­ches­tras, his mom was the di­rec­tor of Carnegie Hall, and his broth­er is a pro­fes­sion­al cel­list.

Ar­ron is a mae­stro in a dif­fer­ent kind of field — and now, ge­net­ic da­ta will be the mu­sic to his ears as he leaves a 15-year ca­reer at Genen­tech to be­come 23andMe’s new CSO.

“23andMe’s strate­gic ad­van­tage is ob­vi­ous­ly its data­base,” Ar­ron says in an in­ter­view with End­points News. “What at­tract­ed me here at this par­tic­u­lar time was the re­al­iza­tion of how large the data­base re­al­ly is.”

The com­pa­ny — large­ly known for its sali­va col­lec­tion prod­ucts that can map out an in­di­vid­ual’s an­ces­try and de­ter­mine ge­net­ic risks to cer­tain dis­eases — now has around 12 mil­lion cus­tomers, about 80% of whom have con­sent­ed for re­search to be done on their ge­net­ic da­ta.

“Do­ing genome-wide analy­ses can be very chal­leng­ing. And here we’ve got this scale that, based on all of the phe­no­typ­ic da­ta that we have, even if we want to zoom in on a small sub­set of the pop­u­la­tion, there’s still quite an im­pres­sive num­ber there,” Ar­ron says.

The Stan­ford grad was lured to 23andMe by head of ther­a­peu­tics Ken­neth Hillan, whom he met while work­ing at Genen­tech. The two had kept in touch af­ter Hillan left Genen­tech, and sev­er­al months ago Hillan reached out about an open­ing he told Ar­ron would be “right up your al­ley.”

Ar­ron didn’t al­ways know he want­ed to go in­to in­dus­try. When he was a post­doc stu­dent at Stan­ford back in the late ’90s, he re­calls go­ing to ca­reer days where a pan­el of 10 or so alum­ni would re­turn to speak about their jobs. He al­ways thought the most in­ter­est­ing pan­elists were the one or two who went in­to the in­dus­try or FDA — but it wasn’t un­til a Genen­tech re­cruiter reached out to him as a post­doc that he con­sid­ered go­ing in­to drug­mak­ing him­self.

“They said there’s a biotech com­pa­ny that’s look­ing for an im­mu­nol­o­gist with med­ical train­ing to join them to sort of launch an ef­fort to do bio­mark­er dis­cov­ery and trans­la­tion­al re­search in in­flam­ma­to­ry dis­eases,” Ar­ron said.

He’d heard of Genen­tech, and it was a short dri­ve away, so he de­cid­ed to hear them out. Af­ter vis­it­ing the com­pa­ny sev­en times, he was con­vinced the po­si­tion was per­fect. He stayed for the next 15 years, work­ing his way up from sci­en­tist to VP of im­munol­o­gy re­search.

Now Ar­ron will be tasked with lead­ing a ma­jor shift for 23andMe, as it con­tin­ues to build up its ther­a­peu­tics unit. In 2018, the com­pa­ny signed a $300 mil­lion deal giv­ing Glax­o­SmithK­line ac­cess to its ge­net­ic data­base — and just last sum­mer, the part­ners launched their first clin­i­cal study for a CD96-block­ing an­ti­body aimed at di­rect­ing the im­mune sys­tem to at­tack can­cer cells. 23andMe hit an­oth­er ma­jor mile­stone al­most two years ago, when it out-li­censed the first drug pro­gram it de­vel­oped in-house to a Span­ish der­ma­tol­ogy com­pa­ny called Almi­rall.

“Our in­ten­tion is to be able to de­vel­op our own projects as we go along,” Ar­ron said. “I just think we have to be ju­di­cious about where does it make sense to do this with a part­ner or where does it make sense to go it alone.”

Nicole De­Feud­is

Al­li­son Dor­val

Verve Ther­a­peu­tics has ex­e­cut­ed the 1-2 punch of a Se­ries B round and a size­able IPO in 2021, and this week Sek Kathire­san’s car­dio­vas­cu­lar dis­ease-fo­cused biotech has brought in Al­li­son Dor­val as CFO. Ac­cord­ing to a Form 8-K, Dor­val in­formed Voy­ager Ther­a­peu­tics of her de­ci­sion to leave on Nov. 16 af­ter three years as fi­nance chief; back in May, pres­i­dent and CEO An­dre Turenne left Voy­ager along with R&D head Omar Khwa­ja, but the tur­moil with­in the biotech eased up a bit as it struck a gene ther­a­py deal with Pfiz­er in Oc­to­ber. In ad­di­tion to this new gig, Dor­val is on the board of di­rec­tors at Puma Biotech­nol­o­gy and Aerovate Ther­a­peu­tics.

→ On Wednes­day, No­var­tis Gene Ther­a­pies tweet­ed out the in­tro­duc­tion of Chris Fox as pres­i­dent. Fox steps away from Am­gen, where she was VP and US gen­er­al man­ag­er of the fol­low­ing ther­a­peu­tic ar­eas: car­diometa­bol­ic, bone and nephrol­o­gy. She al­so spent more than a dozen years in sev­er­al ca­pac­i­ties at Take­da, name­ly VP of sales and VP of op­er­a­tions.

Eli Lil­ly vet Jude Onyia has been named CSO of Neu­ro­crine, which inked a deal with So­sei Hep­tares a cou­ple weeks ago for $100 mil­lion up­front that ze­roes in on the schiz­o­phre­nia drug HTL-0016878. Onyia, who was re­cent­ly chief sci­en­tist at Bob Cud­di­hy’s gene ther­a­py shop Cap­si­da Bio­ther­a­peu­tics, spent a quar­ter cen­tu­ry with Eli Lil­ly and round­ed out his tenure at the In­di­anapo­lis phar­ma as VP of biotech­nol­o­gy dis­cov­ery re­search. With the new So­sei Hep­tares pact, Neu­ro­crine looks to bounce back af­ter a swing and a miss on the pri­ma­ry end­point with one of the pro­grams in its $2 bil­lion deal with Take­da.

Jul­lian Jones

→ Speak­ing of Lil­ly alums, Jul­lian Jones has been pro­mot­ed to CBO at “mol­e­c­u­lar glue” biotech Monte Rosa Ther­a­peu­tics. Jones was se­nior di­rec­tor of on­col­o­gy busi­ness de­vel­op­ment at Lil­ly be­fore join­ing Monte Rosa as head of busi­ness de­vel­op­ment in Sep­tem­ber 2020, and she al­so took on a num­ber of roles at Boehringer In­gel­heim from 2013-16. Monte Rosa has been a Peer Re­view fre­quent fly­er as chief ex­ec­u­tive Markus War­muth gets his C-suite in or­der; mean­while, the com­pa­ny con­tin­ues to rack up the fi­nanc­ing prizes and made a splash on Nas­daq this sum­mer with an IPO north of $200 mil­lion.

Tamas Oravecz

→ Aim­ing to “re­pro­gram” the tu­mor mi­croen­vi­ron­ment with a fresh $65 mil­lion Se­ries A in its hip pock­et, Parthenon Ther­a­peu­tics has pegged Big Phar­ma alum Tamas Oravecz as CSO. Oravecz makes his way to Parthenon af­ter he was el­e­vat­ed to VP, head of cell ther­a­py plat­form and dis­cov­ery at Janssen. Ear­li­er, he was Cel­gene’s ex­ec­u­tive di­rec­tor of bi­ol­o­gy and phar­ma­col­o­gy.

Char­maine Lykins

Char­maine Lykins has signed on to Boston neu­ro play­er Karuna Ther­a­peu­tics as chief com­mer­cial of­fi­cer, 10 months af­ter re­plac­ing cur­rent Vi­a­Cyte CEO Michael Yang un­der the new ti­tle of SVP, glob­al prod­uct plan­ning and chief mar­ket­ing of­fi­cer of Nu­plazid mak­er Aca­dia. Af­ter 15 years at Eli Lil­ly do­ing mar­ket­ing with­in sev­er­al ther­a­peu­tic ar­eas, in­clud­ing di­a­betes and bipo­lar & de­pres­sion, Lykins jumped to be­come se­nior di­rec­tor of glob­al mar­ket­ing at Sunovion and then the VP of glob­al mar­ket­ing, schiz­o­phre­nia for Lund­beck.

→ In case you missed the news from ear­li­er in the week, GSK poached Pfiz­er’s vi­ral vac­cines lead Philip Dor­mitzer in a rush to cap­i­tal­ize on the fu­ture of mR­NA like its ri­vals at Pfiz­er and BioN­Tech. Dor­mitzer, the for­mer CSO of Pfiz­er’s vi­ral vac­cine unit who al­so was re­spon­si­ble for Pfiz­er’s RNA-based in­fluen­za vac­cine can­di­date de­vel­oped in col­lab­o­ra­tion with BioN­Tech, will now be tak­ing up the man­tle as glob­al head of vac­cines R&D at GSK. Pri­or to his stint at Pfiz­er, Dor­mitzer had a sev­en-year long ca­reer with No­var­tis, where he even­tu­al­ly served as US head of re­search and head of glob­al vi­rol­o­gy for the com­pa­ny’s vac­cines and di­ag­nos­tics unit.

John Maraganore

→ In oth­er big ap­point­ment news from ear­li­er this week, John Maraganore, Al­ny­lam’s CEO who is set to re­tire at the end of the year, is mak­ing his way to ARCH Ven­ture as a new ven­ture part­ner along­side ex-FDA of­fi­cial Lu­ciana Bo­rio, Jake Bauer (pre­vi­ous­ly at MyoKar­dia), Ax­el Bou­chon (for­mer head of Leaps by Bay­er) and Sabah Oney (of Alec­tor fame). Maraganore’s in­ter­est to be like a “grand­fa­ther” to the next gen­er­a­tion of biotech star­tups has al­ready drawn him to the board of di­rec­tors at Beam Ther­a­peu­tics and on­to a sim­i­lar role with Sali­o­Gen.

Ifey­in­wa Os­unkwo

→ With its sick­le cell drug etavopi­vat yield­ing pos­i­tive Phase I re­sults in Q2, For­ma Ther­a­peu­tics has ap­point­ed some­one who’s de­vot­ed her ca­reer to the dis­ease as chief pa­tient of­fi­cer. Ifey­in­wa Os­unkwo found­ed and is the di­rec­tor of the Sick­le Cell Dis­ease En­ter­prise at Levine Can­cer In­sti­tute in Char­lotte, NC, and is a pro­fes­sor of med­i­cine and pe­di­atrics at Atri­um Health. Os­unkwo is slat­ed to join CEO Frank Lee’s team at For­ma some­time in Q1 of 2022.

Jeb Ledell

Aveo On­col­o­gy picked it­self up and dust­ed it­self off af­ter a dev­as­tat­ing re­jec­tion in which all but one mem­ber of the FDA pan­el vot­ed against tivozanib in 2013. Earn­ing the agency’s bless­ing with that very drug through an ap­proval in March for re­lapsed or re­frac­to­ry ad­vanced re­nal cell car­ci­no­ma, Aveo has re­cruit­ed Jeb Ledell as COO. Since 2019, Ledell had been COO at En­zy­vant — which just nabbed an ap­proval of its own for the con­gen­i­tal athymia drug Rethymic — and he’s al­so held the same po­si­tion at Com­pass Ther­a­peu­tics.

Erin Brubak­er

Erin Brubak­er has ven­tured off to greater Philly-based Code Bio­ther­a­peu­tics as COO. Like CEO Bri­an McVeigh, Brubak­er had a long ca­reer at GSK, spend­ing 22 years at the phar­ma gi­ant and leav­ing in 2018 as VP, R&D strat­e­gy de­vel­op­ment and de­ploy­ment. Right be­fore join­ing McVeigh’s team, Brubak­er was VP, cor­po­rate de­vel­op­ment for Pas­sage Bio. On the hunt for gene ther­a­py 2.0 along­side such com­peti­tors as Gen­er­a­tion Bio and the new Michael Ehlers joint In­ter­galac­tic Ther­a­peu­tics, Code Bio de­buted in April with $10 mil­lion in seed fi­nanc­ing.

Sra­van Emany

→ Un­der the new lead­er­ship of Tom Mc­Court, Iron­wood paid Cour Phar­ma­ceu­ti­cal De­vel­op­ment Com­pa­ny $20 mil­lion up­front for the pri­ma­ry bil­iary cholan­gi­tis drug CNP-104 a month ago. With Phase I ahead, Iron­wood will greet Sra­van Emany as CFO on Mon­day. Emany was cor­po­rate VP, com­mer­cial ex­cel­lence and chief strat­e­gy of­fi­cer of In­te­gra Life­Sciences be­fore join­ing the Linzess mak­er.

Jane Pritch­ett Hen­der­son

→ A cleanup crew has been sore­ly need­ed at Sesen Bio af­ter its blad­der can­cer drug Vicineum got smacked with a CRL in Au­gust and more than 2,000 vi­o­la­tions were dis­cov­ered in the tri­al, so it stands to rea­son that the Cam­bridge, MA biotech has en­list­ed Do­mini­ka Kowal­s­ki as se­nior di­rec­tor of glob­al drug safe­ty fol­low­ing stints at Hori­zon, Ab­b­Vie and Ab­bott. Else­where at Sesen Bio, Jane Pritch­ett Hen­der­son — a for­mer board mem­ber and cur­rent CFO at Till­man Gern­grossAda­gio Ther­a­peu­ticswas named as an ad­vi­sor to CEO Thomas Can­nell.

→ Eli Lil­ly’s bam­lanivimab part­ner Ab­Cellera, which al­so shook hands with Mod­er­na in an mR­NA al­liance in Sep­tem­ber, has cor­ralled Neil Aubu­chon as chief com­mer­cial of­fi­cer. Aubu­chon makes the trek to the promi­nent Cana­di­an an­ti­body dis­cov­ery play­er af­ter his time at Am­gen as glob­al mar­ket­ing lead for the drug gi­ant’s gen­er­al med­i­cine ear­ly port­fo­lio. In his 17 years at Lil­ly, Aubu­chon took on a num­ber of posts, in­clud­ing head of strat­e­gy & op­er­a­tions for Lil­ly Bio-Med­i­cines and chief mar­ket­ing of­fi­cer in Aus­tralia and Japan.

Con­stan­tine Chino­poros

Con­stan­tine Chino­poros has been named CBO of Al­bireo, the re­cip­i­ent of twin ap­provals this sum­mer for its pru­ri­tus drug ode­vix­i­bat, now known as Byl­vay. Most re­cent­ly, Chino­poros held the same po­si­tion at Boston Phar­ma­ceu­ti­cals, and he’s al­so been a se­nior leader at such big names as Sanofi, Gen­zyme and Eli Lil­ly.

Alyssa Wyant

Mar­cio Souza-led Prax­is Pre­ci­sion Med­i­cines has tak­en the Peer Re­view stage with a quar­tet of an­nounce­ments. First, the neu­rol­o­gy biotech has ap­point­ed Mer­ck busi­ness de­vel­op­ment vet Megan Sniecin­s­ki as CBO. Sniecin­s­ki had held the same post at BioCryst since 2019 and has al­so spent five years as an ex­ec at PTC Ther­a­peu­tics. Alyssa Wyant, a PTC alum in her own right, has been pro­mot­ed to chief reg­u­la­to­ry and qual­i­ty of­fi­cer at Prax­is, while long­time Am­gen staffer Karl Hansen (not to be con­fused with Ab­Cellera’s Carl Hansen) gets the bump to chief tech­ni­cal op­er­a­tions of­fi­cer af­ter serv­ing as SVP of CMC. Fi­nal­ly, co-founder Steven Petrou has ex­it­ed stage left as di­rec­tor of The Flo­rey In­sti­tute of Neu­ro­science and Men­tal Health to fo­cus on his Prax­is re­spon­si­bil­i­ties.

Jessie Richard­son

Ven­rock-backed mi­cro­bio­me up­start Fed­er­a­tion Bio, helmed by for­mer 23andMe ex­ec Emi­ly Con­ley, has wel­comed An­dreas Grauer as CMO and Jessie Richard­son as gen­er­al coun­sel. Grauer, a 10-year Am­gen vet in glob­al de­vel­op­ment, had pre­vi­ous­ly been the med­ical chief with Cor­cept Ther­a­peu­tics, and Richard­son — an ex-se­nior patent coun­sel at Genen­tech — jumps to Fed­er­a­tion Bio af­ter her time as PACT Phar­ma’s VP of le­gal. Fed­er­a­tion Bio’s lead drug can­di­date tar­gets a re­nal con­di­tion called en­teric hy­per­ox­aluria.

Su Zhang

→ Chi­nese gene ther­a­py out­fit Neu­roph­th Ther­a­peu­tics, which just raised $60 mil­lion in a Se­ries C last week, has se­lect­ed Su Zhang as CFO. Zhang had been the CFO of As­cen­t­age Phar­ma since 2019, when the Suzhou-based biotech be­gan trad­ing on the Hong Kong stock ex­change. He was al­so di­rec­tor of health­care eq­ui­ty re­search at Chi­na Mer­chant Se­cu­ri­ties. Neu­roph­th’s lead can­di­date, NFS-01, is in de­vel­op­ment for ND4-me­di­at­ed Leber’s hered­i­tary op­tic neu­ropa­thy.

And what about that As­cen­t­age va­can­cy? That CFO job goes to Yiqing Chen, the for­mer vice CFO and gen­er­al man­ag­er of in­vestor re­la­tions and cap­i­tal de­ploy­ment at Fo­s­un Phar­ma. He’s al­so been gen­er­al man­ag­er, CFO and COO at Shen­zhen-based se­quenc­ing com­pa­ny BGI Ge­nomics.

Philippe Tin­mouth

→ Covid-19 pill de­vel­op­er Pardes Bio­sciences went pub­lic in June thanks to a $275 mil­lion SPAC deal from Jim Tanan­baum and Fore­site Cap­i­tal, and this week the Carls­bad, CA biotech has locked in Philippe Tin­mouth as chief busi­ness and strat­e­gy of­fi­cer. Tin­mouth had re­tired as VP and head of busi­ness de­vel­op­ment at Ver­tex, where he held mul­ti­ple roles since 2002, and for the last two years, he’s been on the board of di­rec­tors at Scynex­is.

Har­bour Bio­Med, team­ing up with Dana-Far­ber on can­cer drugs in a mul­ti­year col­lab­o­ra­tion, has brought on Wei­hao Xu as chief strat­e­gy of­fi­cer. Xu, who will be Har­bour Bio­Med’s glob­al head of busi­ness de­vel­op­ment and cor­po­rate de­vel­op­ment. al­so served as CFO at Al­pham­ab On­col­o­gy and CASI Phar­ma­ceu­ti­cals.

Sherin Al-Safa­di

→ Lots to sort out at ra­dio­phar­ma­ceu­ti­cal play­er Point Bio­phar­ma, so let’s get to it: Justy­na Kel­ly has earned a pro­mo­tion to COO af­ter a year as VP, med­ical iso­tope de­vel­op­ment and op­er­a­tions; se­nior di­rec­tor of pre­clin­i­cal de­vel­op­ment Robin Hal­lett is mov­ing on up to VP, dis­cov­ery and trans­la­tion­al sci­ences; and on Dec. 13, Sherin Al-Safa­di will be­gin her tenure as VP, med­ical af­fairs. Al-Safa­di moves on from Bay­er, where she was the Ger­man phar­ma gi­ant’s glob­al med­ical af­fairs on­col­o­gy strat­e­gy di­rec­tor.

A cou­ple more items from Point: Sanofi Gen­zyme vet Michael Got­tlieb stepped aside last week as chief com­mer­cial of­fi­cer af­ter near­ly two years on the job, and board mem­ber Jonathan Ross Good­man has been named lead in­de­pen­dent di­rec­tor.

Juho Jalka­nen

→ To Scan­di­navia we go, where Mat­ti Kar­vo­nen has stepped down as CMO of Finnish im­muno-on­col­o­gy and ARDS biotech Faron Phar­ma­ceu­ti­cals af­ter five years with the com­pa­ny. As the search gets un­der­way for Kar­vo­nen’s suc­ces­sor, chief de­vel­op­ment of­fi­cer Juho Jalka­nen will be in­ter­im CMO.

→ Over in Copen­hagen, Ad­cen­do — an ADC out­fit that notched a $62 mil­lion Se­ries A be­fore tap­ping Michael Pehl as CEO in Ju­ly — has ex­pand­ed the team with chief de­vel­op­ment of­fi­cer Carmel Lynch and chief tech­nol­o­gy of­fi­cer Pernille Høyrup Hem­mingsen. Af­ter sev­en years at Seagen where she moved up to se­nior di­rec­tor, non­clin­i­cal sci­ence & clin­i­cal phar­ma­col­o­gy, Lynch was ap­point­ed SVP, non­clin­i­cal de­vel­op­ment at Ox­ford Bio­Ther­a­peu­tics. Hem­mingsen, a Gen­mab alum in CMC, had been Savara’s VP, glob­al prod­uct de­vel­op­ment and sup­ply. One more Ad­cen­do note: For­mer long­time Seagen ex­ec Den­nis Ben­jamin has been named chair­man of the SAB and a re­search fel­low.

Deep­ti Sod­hi Jag­gi

Deep­ti Sod­hi Jag­gi has joined San Fran­cis­co-based pre­scrip­tion dig­i­tal ther­a­peu­tics (PDT) play­er Bet­ter Ther­a­peu­tics as CSO. Jag­gi pre­vi­ous­ly served as glob­al head of pa­tient in­sights & so­lu­tions at Astel­las and as pres­i­dent and CMO at Cli­nakos.

→ Dublin-based Prio­thera, which is work­ing on de­vel­op­ing a po­ten­tial treat­ment for pa­tients with acute myeloid leukemia, has snatched up Elis­a­beth Kueen­burg as CMO. Kueen­burg joins the com­pa­ny from Cel­gene, where she served as clin­i­cal de­vel­op­ment lead.

Re­lief Ther­a­peu­tics has made some changes to its ex­ec­u­tive team with the ap­point­ment of Ner­meen Varawal­la as a suc­ces­sor to CMO Gilles Del­la Corte (who is leav­ing the com­pa­ny to pur­sue oth­er op­por­tu­ni­ties) and the pro­mo­tions of Je­re­my Meinen and Mar­co Marot­ta to chief ac­count­ing of­fi­cer and CBO, re­spec­tive­ly. Varawal­la makes her way to Re­lief from At­lantic Health­care, where she served as CMO and head of clin­i­cal de­vel­op­ment. Mean­while, Meinen for­mer­ly served as Re­lief’s VP of fi­nance and ad­min­is­tra­tion while Marot­ta came aboard to Re­lief from its ac­qui­si­tion of APR Ap­plied Phar­ma Re­search.

Glenn Mor­ri­son

→ Sit­ting pret­ty af­ter its gar­gan­tu­an $436 mil­lion IPO this past spring, Re­cur­sion has en­ticed two ex­ecs with Big Phar­ma ties to jump on board. First, Glenn Mor­ri­son (VP, clin­i­cal de­vel­op­ment) just fin­ished a year as VP of neu­rol­o­gy clin­i­cal de­vel­op­ment at Alec­tor, and dur­ing six years with Genen­tech/Roche, he was in charge of glob­al clin­i­cal de­vel­op­ment for a pair of Alzheimer’s an­ti-amy­loid an­ti­bod­ies. Re­cur­sion poach­es Ir­it Rap­p­ley (VP, neu­ro­science and trans­la­tion­al re­search) from Bris­tol My­ers Squibb, where she was sci­en­tif­ic di­rec­tor of dis­cov­ery and trans­la­tion­al re­search. Ad­di­tion­al­ly, Re­cur­sion has giv­en Ic­ahn School of Med­i­cine pro­fes­sor Tim Ah­feldt the role of fel­low, neu­ro­science.

Alex­ey Sere­gin has been ap­point­ed VP of R&D at Boston-based gene ther­a­py biotech Remedi­um Bio. Af­ter his years at Bio­gen, Sol­id Bio and Biover­a­tiv, Sere­gin heads to Remedi­um Bio af­ter two years at Take­da, where he was the phar­ma’s as­so­ciate di­rec­tor, glob­al gene ther­a­py re­search.

Janet Hurt

Found­ed by Stan­ford’s Ed En­gle­man and launched in Ju­ly 2020 with a $30 mil­lion round, Tran­quis Ther­a­peu­tics has ush­ered in Janet Hurt as SVP of clin­i­cal ev­i­dence gen­er­a­tion and Faisal Shawwa as SVP of fi­nance. Hurt has made nu­mer­ous stops as a clin­i­cal op­er­a­tions leader be­fore her ar­rival at Tran­quis, in­clud­ing at Onyx Phar­ma­ceu­ti­cals, De­nali and, most re­cent­ly, Jasper Ther­a­peu­tics. Shawwa had been with Cat­a­lyst Bio­sciences since April 2008 and was the com­pa­ny’s VP of fi­nance.

→ Be­fore Thanks­giv­ing, New Jer­sey oph­thalmic dis­ease biotech Oys­ter Point Phar­ma made a pair of ap­point­ments, nam­ing Rae­gan Mc­Clain as chief com­pli­ance of­fi­cer and long­time No­var­tis vet Bar­ry Rosen­feld as SVP, gen­er­al coun­sel. Mc­Clain just held the same ti­tle at Opti­nose and is an ex-as­sis­tant gen­er­al coun­sel at Sanofi, while Rosen­feld was VP, gen­er­al coun­sel & cor­po­rate sec­re­tary for No­var­tis Fi­nance Cor­po­ra­tion be­fore join­ing Oys­ter Point in No­vem­ber 2020 as se­nior di­rec­tor, cor­po­rate coun­sel.

Su­san Mc­Clatchey

Su­san Mc­Clatchey has tak­en on the role of VP and head of qual­i­ty at Brook­lyn Im­munoTher­a­peu­tics, which is de­vel­op­ing its cy­tokine ther­a­py IRX-2 for head and neck can­cer. Mc­Clatchey served as head of qual­i­ty dur­ing her 12 years at Vi­a­Cyte and was briefly IQVIA’s se­nior di­rec­tor, prod­uct de­vel­op­ment, cell and gene ther­a­py.

Lisa DeLu­ca

→ With up­ro­le­se­lan in Phase III for re­lapsed/re­frac­to­ry acute myeloid leukemia, Gly­coMimet­ics has picked up Lisa DeLu­ca as VP, reg­u­la­to­ry af­fairs. DeLu­ca, Nu­va­tion Bio’s SVP of reg­u­la­to­ry af­fairs since Jan­u­ary, was a reg­u­la­to­ry ex­ec for a lit­tle more than two years at Ra­dius Health. Her pre­de­ces­sor, Myra Rosario Her­rle, is now the EVP of reg­u­la­to­ry af­fairs for Point Bio­phar­ma.

Sean Mack­ay-led Iso­Plex­is, which strut­ted on­to Nas­daq last month with its per­son­al­ized pro­tein “bar­codes,” has in­stalled three new staffers. Among the tri­umvi­rate: Richard Rew (gen­er­al coun­sel and sec­re­tary) comes to Iso­Plex­is af­ter six years at Lu­minex, where he was chief com­pli­ance of­fi­cer and SVP, gen­er­al coun­sel and sec­re­tary; Raj Khakhar (VP of fi­nance) was Ther­mo Fish­er’s di­rec­tor of fi­nance for the cor­po­rate FP&A team; and Man­ny Re­sendes (glob­al con­troller) had served as fi­nance di­rec­tor, glob­al in­stru­ment op­er­a­tions for PerkinElmer.

Ro­ry Cur­tis

→ Cam­bridge, UK-based Metri­on Bio­sciences has ap­point­ed Ro­ry Cur­tis as VP, US com­mer­cial op­er­a­tions. Cur­tis’ ex­pe­ri­ence in drug dis­cov­ery ex­tends to Re­gen­eron, Mil­len­ni­um and Elixir, and he was in charge of the TR­PA1 pro­gram while he was with Cu­bist Phar­ma­ceu­ti­cals from 2009-15.

Fux­in Shi

Ac­cured­it Ther­a­peu­tics has named Fux­in Shi as head of drug dis­cov­ery & pre­clin­i­cal re­search and gen­er­al man­ag­er of its US sub­sidiary. Sad­dling on­to the Suzhou, Chi­na-based gene edit­ing com­pa­ny, Shi brings with her ex­pe­ri­ence from her times at No­var­tis, Deci­bel Ther­a­peu­tics and Fre­quen­cy Ther­a­peu­tics.

As­cendis Phar­ma‘s founder, pres­i­dent and CEO Jan Møller Mikkelsen has be­come chair­man of the board at Hum­ming­bird Bio­science. No­vo Hold­ings led the way on Hum­ming­bird’s $125 mil­lion Se­ries C in the spring.

Sandy Zweifach

→ Penn spin­out Caris­ma Ther­a­peu­tics has named Sandy Zweifach chair­man of the board. The co-founder and for­mer CEO of Nu­ve­lu­tion Phar­ma, Zweifach al­so chaired Pal­la­dio Bio­sciences and Jan­pix, two of the biotechs Francesco De Ru­ber­tis com­bined to form Centes­sa.

→ Star Stan­ford I/O sci­en­tist Irv Weiss­man — the co-founder of Forty Sev­en be­fore it was swooped up in a $4.7 bil­lion buy­out by Gileadhas hopped on­to the sci­en­tif­ic ad­vi­so­ry board of LA-based Ap­pia Bio. Weiss­man will al­so be joined by stem cell bi­ol­o­gy and NKT cell bi­ol­o­gy ex­pert Mark Ex­ley, the for­mer VP, cel­lu­lar im­munol­o­gy for Agen­Tus.

Daniel Fa­ga has been added to the board of di­rec­tors of San Diego-based Anap­tys­Bio, which sold an 8% slice of the roy­al­ties it owned of GSK check­point in­hibitor Jem­per­li to Sagard Health­care Roy­al­ty Part­ners last month for $250 mil­lion. Fa­ga was COO at Mi­rati be­fore leav­ing that post sev­er­al weeks ago along­side CMO Joseph Lev­eque.

Mee­ta Gulyani

Mee­ta Gulyani, the EVP, head of strat­e­gy, busi­ness de­vel­op­ment and trans­for­ma­tion for the life sci­ence busi­ness of Mer­ck KGaA, has joined the board of di­rec­tors at Seer. This marked Seer’s sec­ond board ap­point­ment in three weeks af­ter the ad­di­tion of Cari­bou CEO Rachel Hau­r­witz.

Austin Che

→ Men­lo Park, CA-based en­zyme en­gi­neer­ing com­pa­ny Aether Bio­ma­chines has made Austin Che a mem­ber of its board. Che co-found­ed Gink­go Bioworks, which land­ed a mon­ster SPAC deal in May to the tune of $2.5 bil­lion — but Gink­go has since tried to ward off a short at­tack.

Lau­ra Brege

Lau­ra Brege is the lat­est mem­ber of San Fran­cis­co can­cer play­er T-knife Ther­a­peu­tics’ board of di­rec­tors, which al­so in­cludes folks who helped con­tribute to the biotech’s fi­nanc­ing: Ver­sant’s Alexan­der May­weg and RA Cap­i­tal’s Josh Resnick. The ex-pres­i­dent and CEO of Nodal­i­ty, Brege is on the boards of Aca­dia, Mirum Phar­ma­ceu­ti­cals, Paci­ra Phar­ma­ceu­ti­cals and HLS Ther­a­peu­tics.

→ New York’s In­dap­tus Ther­a­peu­tics has made room for Mark Gilbert on the board of di­rec­tors. Gilbert, the ex-CMO of Juno Ther­a­peu­tics, is the EVP of R&D for Ace­po­dia, which an­nounced its Se­ries C round yes­ter­day.

Atri­va Ther­a­peu­tics — the Ger­man-based com­pa­ny work­ing on test­ing their small mol­e­cule in the treat­ment of mod­er­ate to se­vere Covid-19 in hos­pi­tal­ized pa­tients — has brought in for­mer Gala­pa­gos CSO Piet Wiger­inck to its sci­en­tif­ic ad­vi­so­ry board.

Acel­Rx has re­served a spot for Jill Broad­foot on its board of di­rec­tors. Since Ju­ly 2018, Broad­foot — a mem­ber of the board at Oton­o­my — has been the fi­nance chief for aTyr Phar­ma.

→ Barcelona-based ONA Ther­a­peu­tics has pulled a seat out for Michel De­theux on its board of di­rec­tors. De­theux cur­rent­ly serves as pres­i­dent and CEO of iTeos Ther­a­peu­tics.

Derek Graf al­so con­tributed to this edi­tion.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.