GSK vet Antony Blanc signs on to be­come Cure­Vac's CBO and CCO; Chris Ca­bell out, Paul Streck in as Are­na Phar­ma­ceu­ti­cals CMO

Antony Blanc

→ En­thused about the Phase I da­ta for their Covid-19 mR­NA vac­cine and be­liev­ing they’ve cracked the cold-stor­age code in de­liv­er­ing them, Cure­Vac has brought Antony Blanc in­to the fray as CBO and chief com­mer­cial of­fi­cer. While at GSK from 2009-17, Blanc served in sev­er­al ca­pac­i­ties with GSK Vac­cines, in­clud­ing as in­te­gra­tion lead when the phar­ma gi­ant ac­quired No­var­tis Vac­cines in 2015. Be­fore his time at GSK, Blanc was CBO at Syn­osia Ther­a­peu­tics.

In mid-No­vem­ber, Cure­Vac struck a deal with the EU to pro­vide 405 mil­lion dos­es of their vac­cine, and the Ger­man biotech hopes to get ap­proval by the third quar­ter of 2021.

Chris Ca­bell start­ed at Are­na Phar­ma­ceu­ti­cals three years ago and had just been bumped up to EVP, head of R&D and CMO in June. Now he’s on his way out af­ter an­nounc­ing his re­tire­ment and res­ig­na­tion, paving the way for Paul Streck to suc­ceed him as CMO ef­fec­tive this week. Streck, who will al­so be SVP, clin­i­cal de­vel­op­ment at Amit Mun­shi-led Are­na, is a Shire and Am­gen alum who pre­vi­ous­ly held the CMO ti­tle at Alder Bio­Phar­ma­ceu­ti­cals, bought by Lund­beck in a $2 bil­lion deal. He al­so brings ex­pe­ri­ence from GSK as VP, glob­al med­ical lead, im­muno-in­flam­ma­tion.

Streck takes over just weeks af­ter Are­na’s lead drug etrasi­mod — an S1P in­hibitor to treat atopic der­mati­tis — missed the mark on its pri­ma­ry end­point in a Phase II tri­al, but Mun­shi plans to sol­dier on to a Phase III.

Greg Mayes

→ At­lanta-based hep B play­er An­tios Ther­a­peu­tics, which launched 2 years ago with help from for­mer Phar­mas­set and Idenix ex­ecs, has put Greg Mayes in charge as CEO. His pre­de­ces­sor, Abel De La Rosa, is re­tir­ing and is set­tling in­to a new chap­ter as chair­man of the com­pa­ny he co-found­ed two years ago. Mayes hails from En­gage Ther­a­peu­tics, which UCB snapped up for $125 mil­lion up­front in ear­ly June, where he was co-founder, pres­i­dent and CEO. One of his ear­ly gigs was as se­nior coun­sel at As­traZeneca and he lat­er served as VP, gen­er­al coun­sel and chief com­pli­ance of­fi­cer at Eli Lil­ly sub­sidiary Im­Clone Sys­tems.

→ Forg­ing col­lab­o­ra­tions on can­cer treat­ments with such Big Phar­mas as Bris­tol My­ers Squibb, Pfiz­er/Mer­ck KGaA and As­traZeneca, French biotech Trans­gene has made a change at the top with He­di Ben Brahim step­ping in as chair­man and CEO. In Sep­tem­ber Philippe Archi­nard an­nounced his in­ten­tion to step down from both po­si­tions to con­cen­trate on his new re­spon­si­bil­i­ty as EVP, tech­no­log­i­cal in­no­va­tion and sci­en­tif­ic part­ner­ships at In­sti­tut Mérieux, where Ben Brahim was VP of im­munother­a­py for the last two years. The torch is of­fi­cial­ly passed to Ben Brahim on Jan. 1.

Richie Cun­ning­ham

→ Hap­py days at Tyme Tech­nolo­gies: Richie Cun­ning­ham has been named CEO at the NJ-based can­cer me­tab­o­lism-based ther­a­py (CMBT) biotech, re­plac­ing Steve Hoff­man, who had been CEO the last five years and will now fo­cus on his chair­man and CSO du­ties. A for­mer All-Pro kick­er in the NFL for eight years with the Dal­las Cow­boys, among oth­er teams, Cun­ning­ham had been pres­i­dent and CEO of Ica­gen since 2014. And as an ex­ec with Boehringer In­gel­heim, he was in­volved in the launch of Gilotrif, the Ger­man phar­ma’s first for­ay in­to on­col­o­gy.

→ Jerusalem-based En­tera Bio, which has US op­er­a­tions in Boston and fo­cus­es on oral­ly-de­liv­ered macro­mol­e­cule ther­a­pies, has found a CEO with Spiros Ja­mas cap­tain­ing the ship. Roger Garceau had as­sumed the top spot on an in­ter­im ba­sis in Au­gust fol­low­ing Adam Gri­d­ley’s res­ig­na­tion. Ja­mas heads to En­tera af­ter 7 years as found­ing CEO of AO­Bio­me Ther­a­peu­tics, and he’s al­so helmed Tem­pero Phar­ma­ceu­ti­cals and Enan­ta Phar­ma­ceu­ti­cals.

Robert Fish­man

4D Mol­e­c­u­lar Ther­a­peu­tics scrapped its $100 mil­lion IPO in the sum­mer, then re­grouped a cou­ple weeks ago with a planned $75 mil­lion of­fer­ing. Now Emeryville, CA-based 4DMT is flesh­ing out its lead­er­ship with three ap­point­ments: Robert Fish­man (CMO & ther­a­peu­tic area head, pul­monolo­gy); Raphael Schiff­mann (SVP & ther­a­peu­tic area head, car­di­ol­o­gy); and Robert Kim (SVP & clin­i­cal ther­a­peu­tic area head, oph­thal­mol­o­gy).

Fish­man has been around the block as a CMO with Xoc Phar­ma­ceu­ti­cals and Cor­cept Phar­ma­ceu­ti­cals. Schiff­mann was pre­vi­ous­ly the di­rec­tor of the In­sti­tute of Meta­bol­ic Dis­ease at the Bay­lor Scott & White Re­search In­sti­tute. And Kim, a for­mer VP of clin­i­cal oph­thal­mol­o­gy at GSK, jumps to 4DMT af­ter CMO stints at View­Point Ther­a­peu­tics, Apel­lis and Vi­sion Med­i­cines.

Alan San­dler

Alan San­dler makes the leap from Genen­tech to be­come Zai Lab’s head of glob­al de­vel­op­ment, on­col­o­gy, tak­ing charge of a pipeline with PARP in­hibitor Ze­ju­la as their head­lin­er. San­dler was Genen­tech’s SVP and glob­al head of prod­uct de­vel­op­ment, on­col­o­gy, guid­ing teams through de­vel­op­ment and ap­proval of Tecen­triq and oth­er drugs.

WuXi-backed Ada­gene has brought in a slate of new hires to ex­pand its lead­er­ship team. They in­clude Pfiz­er vet Hua Gong as COO and head of pre­ci­sion med­i­cine, JC Xu as CSO and Qing­hai Zhao as chief man­u­fac­tur­ing of­fi­cer. Gong hops aboard from No­var­tis Nav­i­gate Bio­phar­ma, where she served as se­nior di­rec­tor, ge­nomics bio­mark­er de­part­ment. Pri­or to that, she held stints at Pre­mier Re­search Group and Prometheus Ther­a­peu­tics & Di­ag­nos­tics.

Mean­while, Xu comes from Cel­gene, where she was head of Chi­na strat­e­gy for re­search and ear­ly de­vel­op­ment. Be­fore that, she served in roles at Quan­ti­cel Phar­ma­ceu­ti­cals, Am­gen and Corixa. Mean­while, Zhao hails from Forty Sev­en, where he served as VP of tech­ni­cal de­vel­op­ment and man­u­fac­tur­ing. Pre­vi­ous­ly, he was at Anap­tys­Bio and Te­va Bio­phar­ma­ceu­ti­cals.

Arvin Yang

→ Cam­bridge, MA an­ti­body-drug con­ju­gate play­er Mer­sana Ther­a­peu­tics has called up­on Arvin Yang to be SVP and CMO, suc­ceed­ing Dirk Hueb­n­er, who will stay on to as­sist the tran­si­tion un­til Jan. 15. Yang spent a decade in clin­i­cal de­vel­op­ment with Bris­tol My­ers Squibb, con­tribut­ing to the ap­proval of Op­di­vo and the Op­di­vo + Ver­voy com­bi­na­tion. His se­ries of roles at BMS cul­mi­nat­ed with his time as VP and head of clin­i­cal hema­tol­ogy.

→ Long­time No­var­tis vet Stephen Mitch­en­er is now on board as CBO at Karyopharm, while Chen Schor has been added to the board of di­rec­tors. Mitch­en­er heads to Karyopharm af­ter 2 years as CBO at Ax­cel­la Health­care, and for 15 years be­fore that, he held many po­si­tions in the on­col­o­gy space at No­var­tis, in­clud­ing head of strat­e­gy, part­ner­ing and op­er­a­tions. Schor is pres­i­dent and CEO of Adicet Bio, where he is al­so a mem­ber of their board.

The saga re­gard­ing the da­ta and ap­proval of Karyopharm’s myelo­ma drug se­linex­or (Xpovio) has had many twists and turns, as re­flect­ed in the top­sy-turvy na­ture of its stock. Phase III re­sults were pub­lished on­line in No­vem­ber in The Lancet.

Pe­ter Pfre­und­schuh

→ Woburn, MA biotech and Astel­las part­ner Fre­quen­cy Ther­a­peu­tics, which flashed pos­i­tive da­ta in Sep­tem­ber for their lead drug FX-322 that’s aimed at im­prov­ing sen­sorineur­al hear­ing loss (SNHL), has turned to Pe­ter Pfre­und­schuh to be CFO. Pfre­und­schuh, who has worked in busi­ness de­vel­op­ment for such Big Phar­mas as As­traZeneca and J&J, heads to Fre­quen­cy af­ter his tenure at Uro­Gen as CFO, chief com­pli­ance of­fi­cer and cor­po­rate sec­re­tary.

Pe­ony Yu

Pe­ony Yu is re­tir­ing from the CMO post she had kept for 12 years at Fi­bro­Gen, and for­mer Genen­tech ex­ec Mark Eis­ner is set to take her place on Dec. 21. Yu will stay on as an ex­ec­u­tive ad­vi­sor to the CEO un­til March 15, 2021. Be­fore the move to Fi­bro­Gen — which tout­ed pos­i­tive Phase III da­ta for rox­adu­s­tat a few weeks ago that could lead to an FDA OK for ane­mia as­so­ci­at­ed with CKD — Eis­ner spent more than 10 years and wore a va­ri­ety of hats at Genen­tech, leav­ing the Roche sub­sidiary as SVP and glob­al head of prod­uct de­vel­op­ment, im­munol­o­gy, in­fec­tious dis­ease, and oph­thal­mol­o­gy.

Mark Karch is locked in at Data­vant, one of the pletho­ra of Vivek Ra­maswamy “vants,” as chief com­mer­cial of­fi­cer. Be­fore his move to Data­vant, led by Travis May and team­ing up with J&J on a da­ta shar­ing pact in Sep­tem­ber, Karch logged more than six years as a VP at IQVIA lead­ing sales in their SaaS tech­nol­o­gy so­lu­tions.

Melis­sa Palmer

Melis­sa Palmer has signed on as CMO of Shang­hai-based NASH play­er Gan­nex, a sub­sidiary of As­cle­tis. Palmer has pre­vi­ous­ly led liv­er dis­ease clin­i­cal de­vel­op­ment at Take­da and was glob­al de­vel­op­ment lead, he­pa­tol­ogy at Shire. Else­where, she was SVP, clin­i­cal re­search and head of he­pa­tol­ogy at Kad­mon from 2012-15.

→ With $35 mil­lion in the bank to help de­vel­op its lead can­di­date INV-101 for Prad­er-Willi syn­drome, Mon­tre­al CB1 block­ade biotech In­ver­sa­go Phar­ma has re­cruit­ed GSK alum Glenn Crater as CMO. Crater held mul­ti­ple posts at Ther­a­vance, in­clud­ing VP, clin­i­cal de­vel­op­ment & med­ical af­fairs and VP, res­pi­ra­to­ry port­fo­lio head. He was VP and coun­try med­ical di­rec­tor for GSK Cana­da be­fore be­com­ing an ex­ec at Ae­ro­crine.

As­cen­t­age Phar­ma, which was grant­ed pri­or­i­ty re­view from Chi­nese reg­u­la­tors in Oc­to­ber for olverem­bat­inib in pa­tients with chron­ic myeloid leukemia, has tapped Gang Zhu as their chief com­mer­cial of­fi­cer. Pri­or to reach­ing As­cen­t­age, Zhu was gen­er­al man­ag­er of Cel­gene Chi­na and comes with ex­pe­ri­ence in lead­er­ship roles at phar­ma gi­ants such as Sanofi and No­var­tis, lead­ing com­mer­cial roll­outs of a wide range of hema­to­log­ic can­cer drugs.

Dar­rin Beaupre

→ Fo­cused on the Wnt sig­nal­ing path­way, San Diego biotech Sa­mumed has named Dar­rin Beaupre CMO, on­col­o­gy. As with their new CSO Michael White, Sa­mumed poached Beaupre from Pfiz­er, where he was SVP, head of ear­ly on­col­o­gy de­vel­op­ment and clin­i­cal re­search. Be­fore his tenure at Pfiz­er, Beaupre served as head of ear­ly de­vel­op­ment at Phar­ma­cyclics.

Co­gent Bio­sciences — for­mer­ly Unum — has been turn­ing the page with An­drew Rob­bins as their new CEO along with this week’s news of a $60 mil­lion pub­lic of­fer­ing. Now they’ve in­stalled Brad Bar­nett as chief tech­nol­o­gy of­fi­cer com­ing off near­ly 2 decades in sev­er­al ca­pac­i­ties at Ar­ray Bio­Phar­ma, then stick­ing around for just a while longer af­ter Pfiz­er ponied up $11.4 bil­lion for the com­pa­ny last year. Bar­nett brought on­col­o­gy drugs Mek­tovi and Braftovi to mar­ket as Ar­ray/Pfiz­er’s VP of sup­ply chain & man­u­fac­tur­ing.

David Clark

→ Un­veil­ing Phase I da­ta this week with its lead can­di­date ALLN-346 to treat hy­pe­r­uricemia, New­ton, MA-based Al­lena Phar­ma­ceu­ti­cals has se­lect­ed David Clark as CMO. A Pfiz­er and GSK alum in clin­i­cal de­vel­op­ment, Clark hails from Aldeyra Ther­a­peu­tics, where he had been CMO since 2016. Clark steps in to re­place An­na­maria Kausz, who will re­main with Al­lena as an ad­vis­er dur­ing the tran­si­tion pe­ri­od.

→ Pitts­burgh-based gene si­lenc­ing play­er NeuBase Ther­a­peu­tics con­tin­ues to fill out its lead­er­ship team with Curt Brad­shaw as CSO af­ter William Mann was named chief op­er­at­ing of­fi­cer this sum­mer. Brad­shaw spent the last year as CSO of J&J part­ner Ar­row­head Phar­ma­ceu­ti­cals, which just en­tered in­to a $1 bil­lion RNAi pact with Take­da in Oc­to­ber, in­clud­ing $300 mil­lion in cash. He has pre­vi­ous­ly been CSO at Tra­ver­sa Ther­a­peu­tics — where he pulled dou­ble du­ty as VP of R&D — and Sol­stice Bi­o­log­ics.

Charles Sem­ba

→ Dur­ing the Thanks­giv­ing hol­i­day, Elu­minex Bio­sciences closed on a $50 mil­lion Se­ries A that was co-led by Lil­ly Asia Ven­tures, while the Shang­hai oph­thalmic biotech has al­so brought on Charles Sem­ba as CMO. Sem­ba’s last CMO gig was at Grey­bug Vi­sion, and he’s been an oph­thal­mol­o­gy ex­ec at Shire as well as the oph­thal­mol­o­gy group head at Genen­tech.

Syn­cona vet Robert Coutts is tran­si­tion­ing in­to a new role at Achilles Ther­a­peu­tics as CFO af­ter start­ing out as the T cell ther­a­py biotech’s fi­nan­cial di­rec­tor when it was found­ed in 2017. Coutts’ C-suite ap­point­ment fol­lows Achilles’ de­ci­sion to put Karl Peg­gs, one of their founders, in the CMO slot be­gin­ning in Jan­u­ary.

Muthu Meyyap­pan

→ UK ge­nomics start­up and Well­come Sanger In­sti­tute spin­out Con­geni­ca, which amassed $50 mil­lion in a Se­ries C round last month, has brought in Muthu Meyyap­pan as chief com­mer­cial of­fi­cer. Meyyap­pan com­pletes a run as CCO for Vari­antyx, and the In­cyte alum has al­so been an ex­ec at Qi­a­gen, where he was VP, ad­vanced ge­nomics com­mer­cial op­er­a­tions.

→ Flori­da biotech Ma­rizyme has en­list­ed three new hirees to its lead­er­ship team: Steven Brooks as EVP of med­ical and reg­u­la­to­ry af­fairs, CMO; Don­ald Very as EVP, R&D; and William Hearl as an in­de­pen­dent mem­ber of the board. Brooks for­mer­ly served as prin­ci­pal of Brooks Medtech, while Very was SVP of Mo­saigen and pres­i­dent, CEO and founder of Naviter Bio­an­a­lyt­ics. Hearl found­ed and is chair­man and CEO of Im­mu­nom­ic Ther­a­peu­tics.

→ Bed­min­ster, NJ-based Mati­nas Bio­Phar­ma has ap­point­ed Hui Liu as chief tech­nol­o­gy of­fi­cer to ad­vance their pro­pri­etary lipid nanocrys­tal (LNC) drug de­liv­ery plat­form. Liu joins the Mati­nas team from Se­qiris, where he was di­rec­tor of for­mu­la­tion and de­liv­ery. He has al­so held CMC po­si­tions at Cellics Ther­a­peu­tics, Al­con and Al­ler­gan.

Tama­ra Joseph

Spero Ther­a­peu­tics has ush­ered in Tama­ra Joseph as chief le­gal of­fi­cer. Most re­cent­ly, Joseph served as gen­er­al coun­sel at Mil­len­do Ther­a­peu­tics and has had stints at En­zy­vant, In­Vi­vo Ther­a­peu­tics, Cu­bist Phar­ma­ceu­ti­cals, Mayne Phar­ma and Tran­skary­ot­ic Ther­a­pies.

→ NY-based Hi­ber­Cell has ap­point­ed Joseph Ta­lamo as CFO. Pri­or to hop­ping aboard the com­pa­ny, Ta­lamo served as CFO at Cal­adrius Bio­sciences and held roles at OSI Phar­ma­ceu­ti­cals. In ad­di­tion, the com­pa­ny has pro­mot­ed Ari Nowacek to the po­si­tion of CBO. Nowacek for­mer­ly served as VP of op­er­a­tions and busi­ness de­vel­op­ment and is a co-founder of Hi­ber­Cell. Cur­rent­ly, he is a prin­ci­pal at ARCH Ven­ture Part­ners.

Jonathan Rosin

Wave Life Sci­ences has wel­comed Jonathan Rosin as their new chief hu­man re­sources of­fi­cer. Be­fore join­ing the Cam­bridge, MA ge­net­ic med­i­cines biotech, Rosin held the same ti­tle for sev­en years at Iron­wood Phar­ma­ceu­ti­cals, and pri­or to that he was in lead­er­ship and or­ga­ni­za­tion de­vel­op­ment at Gen­zyme.

→ NY-based Ac­tini­um Phar­ma­ceu­ti­cals has fur­ther bol­stered its ros­ter of clin­i­cal ex­ecs with Mary Mei Chen as VP of clin­i­cal de­vel­op­ment, two weeks af­ter choos­ing Big Phar­ma vet Avinash De­sai as EVP and pres­i­dent of clin­i­cal de­vel­op­ment, op­er­a­tions and med­ical af­fairs. As se­nior med­ical di­rec­tor at Gly­coMimet­ics, Chen pi­lot­ed clin­i­cal tri­als of E-se­lectin in­hibitor up­ro­le­se­lan for acute myeloid leukemia. Be­fore that, she was med­ical di­rec­tor, glob­al clin­i­cal lead at Take­da.

Julie Iwashita

Ver­sant-backed neu­rore­gen­er­a­tion start­up Pipeline Ther­a­peu­tics has named Julie Iwashita VP of clin­i­cal op­er­a­tions af­ter bring­ing Pe­ter Slover in­to the fold as CFO in Oc­to­ber. Iwashita just com­plet­ed a three-year run at the same post for Cir­ius Ther­a­peu­tics, and she al­so has clin­i­cal op­er­a­tions ex­pe­ri­ence from her time at Ko­di­ak Sci­ences.

→ Look­ing to bounce back af­ter dual Phase II flops last year with their de­pres­sion drug AV-101, South San Fran­cis­co-based Vista­Gen Ther­a­peu­tics is turn­ing to Louis Mon­ti as VP, trans­la­tion­al med­i­cine. In 2018, Vista­Gen grabbed world­wide rights to de­vel­op the drug can­di­date PH94B — a nasal spray used for anx­i­ety dis­or­ders — from Pherin Phar­ma­ceu­ti­cals, where Mon­ti had worked since its 1991 in­cep­tion. For the last two years, he was Pherin’s pres­i­dent and CEO.

Gus Aromin

Jack Howarth is on board as SVP, in­vestor re­la­tions at MiMedx. For the last 8 years, Howarth was VP, cor­po­rate af­fairs for Antares Phar­ma­ceu­ti­cals and head­ed up cor­po­rate and in­vestor re­la­tions at King Phar­ma­ceu­ti­cals un­til Pfiz­er ac­quired it for $3.6 bil­lion in 2011. The ap­point­ment comes two weeks af­ter MiMedx’s ex-CEO and COO were con­vict­ed of se­cu­ri­ties fraud and con­spir­a­cy in the South­ern Dis­trict of New York.

El­e­var Ther­a­peu­tics has reeled in Gus Aromin as VP of reg­u­la­to­ry af­fairs. Aromin joins the com­pa­ny af­ter stints at Avanir Phar­ma­ceu­ti­cals, Al­ler­gan and Elan.

Einav Kraft

→ Cell ther­a­py biotech Cel­lares has re­cruit­ed Einav Kraft as VP of qual­i­ty. Kraft joins the com­pa­ny with ex­pe­ri­ence from Mil­tenyi Biotec, Taro Phar­ma­ceu­ti­cals and No­var­tis.

Leg­end Biotech has been em­broiled in chaos ever since their then-CEO Frank Zhang was put un­der house ar­rest in Chi­na as part of a cus­toms in­ves­ti­ga­tion in­volv­ing Gen­script. Since then the com­pa­ny has in­stalled a new per­ma­nent CEO and chair­woman sans Zhang. Now the Som­er­set, NJ-based com­pa­ny has brought on Patrick Casey to its board of di­rec­tors as an in­de­pen­dent di­rec­tor. Casey is the se­nior vice dean of re­search at the Duke-NUS Med­ical School and a pro­fes­sor of phar­ma­col­o­gy and can­cer bi­ol­o­gy at Duke Uni­ver­si­ty.

→ Lon­don-based ex­tra­cel­lu­lar ma­trix (ECM) biotech En­gi­tix, col­lab­o­rat­ing with Take­da on ther­a­pies for NASH and oth­er ad­vanced fi­brot­ic liv­er dis­eases, has elect­ed Ed­uar­do Bra­vo as chair­man of the board. Bra­vo has been CEO of Cel­ler­ix, TiGenix (ac­quired by Take­da in 2018) and Nordic Nanovec­tor.

Michael Kel­ly

John Crow­ley and his folks at Am­i­cus Ther­a­peu­tics have made Michael Kel­ly a mem­ber of the biotech’s board of di­rec­tors. Kel­ly, a long­time Am­gen ex­ec, is the founder and pres­i­dent of Sen­try Hill Part­ners and was just added to the board at Aprea Ther­a­peu­tics this fall.

Jon Wig­gin­ton, who joined Cul­li­nan On­col­o­gy as CMO in the spring, has earned a seat on the board of di­rec­tors at Sutro Bio­phar­ma out of South San Fran­cis­co. The Bris­tol My­ers Squibb vet left for Cul­li­nan af­ter near­ly 7 years as CMO at Macro­Gen­ics.

Jen­nifer Cook

→ The troi­ka of Jen­nifer Cook, David Fel­lows and Renée Galá has joined the board of di­rec­tors at Syn­cona-backed reti­nal gene ther­a­py play­er Gy­ro­scope Ther­a­peu­tics. Cook is the for­mer CEO at Grail and a board mem­ber at De­nali and Bridge­Bio; J&J vet Fel­lows helmed Night­star Ther­a­peu­tics and is chair­man at Ox­u­lar; and Galá is EVP and CFO at Jazz Phar­ma­ceu­ti­cals and worked with Cook as CFO at Grail.

→ Af­ter se­cur­ing a new CFO and chief tech­nol­o­gy of­fi­cer in the past few months, Adicet Bio has giv­en Bas­tiano San­na a place on their board of di­rec­tors. San­na, who helmed Sem­ma Ther­a­peu­tics, is now EVP and chief of cell and ge­net­ic ther­a­pies at Ver­tex, which bought Sem­ma last year.

Kazu­mi Sh­iosa­ki

→ Ital­ian biotech En­thera Phar­ma­ceu­ti­cals, which scored a €28 mil­lion Se­ries A in the sum­mer backed by Sofinno­va Part­ners and Ab­b­Vie, has made two ap­point­ments with 28-7 CEO Kazu­mi Sh­iosa­ki (board of di­rec­tors) and Lisa Ol­son (sci­en­tif­ic ad­vi­so­ry board). Sh­iosa­ki has al­so helmed Epizyme and Mi­to­bridge, while Ol­son is CSO and head of re­search at Ma­gen­ta Ther­a­peu­tics.

Pao­lo Puc­ci is the lat­est mem­ber of Tarus Ther­a­peu­tics’ board of di­rec­tors, join­ing David Ep­stein and David Nichol­son, who were added in the spring. Puc­ci is a Bay­er and Eli Lil­ly vet who’s the for­mer CEO of ar­Qule, which was pur­chased for $2.7 bil­lion by Mer­ck.

David Whead­on

→ For­mer GSK reg­u­la­to­ry ex­ec David Whead­on has been ap­point­ed to the board of di­rec­tors at Karuna Ther­a­peu­tics, while Ed Har­ri­g­an has de­cid­ed to step down from the board. Whead­on’s pre­vi­ous stop was at As­traZeneca as the phar­ma gi­ant’s SVP, glob­al reg­u­la­to­ry af­fairs, pa­tient safe­ty and qual­i­ty as­sur­ance.

→ Waltham, MA-based Ab­b­Vie part­ner Mor­phic Ther­a­peu­tic has se­lect­ed Mar­tin Ed­wards to be on the board of di­rec­tors. Ed­wards, the chair­man of KalVista Phar­ma­ceu­ti­cals, is a board mem­ber at Rea­ta, In­ozyme and Verona Phar­ma.

Deepa Pakianathan

Deepa Pakianathan is head­ed to the board of di­rec­tors at Palleon Phar­ma­ceu­ti­cals, with its “Gly­co-Im­mune Check­point” plat­form to at­tack can­cer cells. Pakianathan is a long­time man­ag­ing mem­ber at Del­phi Ven­tures and a board mem­ber at Calithera Bio­sciences, Karyopharm and Ther­a­vance.

Kati­na Dor­ton has earned a seat on the board of di­rec­tors and Mitchell Mutz has re­signed from the board at Pan­dion Ther­a­peu­tics, which nabbed an $80 mil­lion Se­ries B in April. Dor­ton is on the board at Ful­crum Ther­a­peu­tics and has been CFO at Re­pare Ther­a­peu­tics, Avro­bio and Im­mat­ics.

Mar­tin Schmieg is mak­ing a come­back to the board of di­rec­tors at Bri­a­Cell Ther­a­peu­tics. Pre­vi­ous­ly, Schmieg served as a mem­ber of the board from 2016 to 2019. Cur­rent­ly, Schmieg serves as co-founder and CEO of Clear­It. Schmieg brings ex­pe­ri­ence from his times at Cy­to­met­rics and Sir­na Ther­a­peu­tics among oth­ers.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.