With Mav­er­ick now in Takeda's hands, James Sci­bet­ta turns the page; Roivant CMO leaves in fa­vor of small IL-2 biotech

James Sci­bet­ta

→ An­oth­er CEO op­por­tu­ni­ty has pre­sent­ed it­self for James Sci­bet­ta, the chief ex­ec­u­tive of Mav­er­ick Ther­a­peu­tics when Take­da ponied up $525 mil­lion in March to buy its T cell col­lab­o­ra­tor and in­te­grate the staff in­to the R&D unit. Sci­bet­ta has signed on as CEO of an­ti­body start­up Im­muneID, co-found­ed and chaired by Long­wood Fund’s Christoph West­phal with tech com­ing from Stephen Elledge’s lab at Har­vard. So ends a fleet­ing CEO tenure for David Don­abe­di­an, who will stay close by as an ad­vi­sor. Sci­bet­ta, the CFO and lat­er pres­i­dent of Paci­ra Phar­ma­ceu­ti­cals un­til he joined Mav­er­ick in 2017, steps for­ward to lead a biotech that’s chalked up $70 mil­lion in fi­nanc­ing, in­clud­ing $50 mil­lion in a Se­ries A this sum­mer.

Roger Sid­hu

→ Roger, over and out: Roger Sid­hu has bolt­ed from Roivant — where he was CMO and head of R&D — to take the CMO job at IL-2 biotech Brook­lyn Im­munoTher­a­peu­tics, which is in a Phase IIb tri­al of its cy­tokine-based cell ther­a­py IRX-2 for head and neck can­cer. Sid­hu, an Am­gen vet, had been VP of clin­i­cal de­vel­op­ment at Kite be­fore fly­ing over to Roivant, the Vivek Ra­maswamy brain­child that coast­ed down the SPAC high­way to Nas­daq with Jim Mom­tazee’s Montes Archimedes Ac­qui­si­tion Corp this spring.

Michael Amoroso

Michael Amoroso has cy­cled through an en­tire ca­reer in a year’s time at Abeona. First, he was named chief com­mer­cial of­fi­cer in Ju­ly 2020; then he was pro­mot­ed to COO that Oc­to­ber; then he climbed up to CEO in March; and now he’s chair­man of the com­pa­ny as Vish­was Se­shadri takes over as pres­i­dent and CEO. The rise to the top spot is al­so a light­ning-quick one for Se­shadri, who just be­came Abeona’s head of re­search and clin­i­cal de­vel­op­ment in June and was a team lead for the Breyanzi launch with Bris­tol My­ers Squibb. The two changes take ef­fect Oct. 15 as Steven Rouhan­deh re­tires from his role as chair­man.

That’s not all at Abeona: Bren­dan O’Mal­ley and Bri­an Ke­vany have al­so re­ceived pro­mo­tions to SVP, gen­er­al coun­sel and VP, chief tech­ni­cal of­fi­cer, re­spec­tive­ly. Head of busi­ness op­er­a­tions Scott No­gi will branch out fur­ther and be­come site head at the cell and gene ther­a­py biotech’s fa­cil­i­ty in Cleve­land.

Wait, we’re not done yet: Carl Den­ny joins the re­tooled team as VP, reg­u­la­to­ry af­fairs and so does Kate Imhoff as se­nior di­rec­tor, reg­u­la­to­ry af­fairs. Both come from Sarep­ta — Den­ny was ex­ec­u­tive di­rec­tor, reg­u­la­to­ry strat­e­gy and Imhoff was di­rec­tor, reg­u­la­to­ry strat­e­gy.

Chris Benec­chi

Sage hopes the tide has turned af­ter zu­ra­nolone bombed in Phase III of the MOUN­TAIN study in De­cem­ber 2019, with the ma­jor de­pres­sive dis­or­der (MDD) drug hit­ting its pri­ma­ry end­point in a sec­ond Phase III this sum­mer. CEO Bar­ry Greene has added to his crew at Sage, poach­ing new chief com­mer­cial of­fi­cer Chris Benec­chi from Alex­ion, where he was glob­al head of com­mer­cial ex­cel­lence. Benec­chi’s eight years at UCB came to a close in 2019 as glob­al launch head, com­mer­cial and med­ical af­fairs, im­munol­o­gy, and be­fore that he logged an­oth­er eight years in sales lead­er­ship and mar­ket­ing posts at Take­da.

Mar­tin Babler

→ The band is tru­ly back to­geth­er with Mar­tin Babler as he be­comes CEO of Fore­site-backed Es­ker Ther­a­peu­tics, tak­ing a cast of thou­sands with him from Prin­cip­ia, the pre­vi­ous biotech he helmed that was sold to Paul Hud­son and Sanofi for $3.7 bil­lion in Au­gust 2020. The stam­pede of staffers from Prin­cip­ia is com­prised of CSO and head of CMC David Gold­stein; CBO and gen­er­al coun­sel Roy Hardi­man; head of re­search Ken­neth Brameld; SVP of im­munol­o­gy and bi­ol­o­gy Claire Lan­gr­ish; SVP of phar­ma­col­o­gy and project team leader Phil Nunn; and hu­man re­sources busi­ness part­ner Tori Low­ell. The on­ly new ap­pointee in this group who has no pre­vi­ous as­so­ci­a­tion with Prin­cip­ia is VP of tox­i­col­o­gy Mike Tay­lor, the founder and ex-prin­ci­pal of Non­Clin­i­cal Safe­ty As­sess­ment.

→ With an un­clear fu­ture at the helm of Fer­Gene af­ter its re­cent im­plo­sion, CEO David Meek has made a re­bound and stepped in­to the head hon­cho role at Mi­rati Ther­a­peu­tics, tak­ing over for found­ing CEO Charles Baum. Pri­or to his stint at Fer­Gene, Meek was CEO at Ipsen and pre­vi­ous­ly was an ex­ec­u­tive VP and pres­i­dent of on­col­o­gy at Bax­al­ta, which was ac­quired by Shire in 2016. Meek al­so held roles at En­do­cyte, No­var­tis and J&J over the course of his 30-year ca­reer.

Ian Sander­son

→ Com­pu­ta­tion­al chem­istry and drug dis­cov­ery trail­blaz­er Nim­bus has an­oth­er $105 mil­lion at its dis­pos­al and has tapped Ian Sander­son as CFO. Since 2016, Sander­son served in the same ca­pac­i­ty at Boston Phar­ma­ceu­ti­cals and was al­so CFO at Cataba­sis Phar­ma­ceu­ti­cals, which op­er­ates un­der the new name As­tria Ther­a­peu­tics. Nim­bus will use the lat­est round of cash on push­ing its ty­ro­sine ki­nase 2 (TYK2) in­hibitor in­to Phase II tri­als.

→ Big changes are un­der­way at Aerie Phar­ma­ceu­ti­cals: Af­ter eight years at the helm, Vi­cente Anido will no longer serve as chair­man and CEO. Ben­jamin Mc­Graw will take over as in­ter­im ex­ec­u­tive chair­man of the board while the com­pa­ny search­es for a new CEO. Aerie al­so an­nounced that Erik Pa­cy­ni­ak will be di­rec­tor of tox­i­col­o­gy and drug dis­po­si­tion. Aerie hopes to re­bound from its failed dry eye dis­ease tri­al ear­li­er this month, es­pe­cial­ly af­ter it de­fi­ant­ly claimed that the pri­ma­ry end­points of the tri­al were “not re­quired.”

Jes­si­ca Ballinger

Jes­si­ca Ballinger has been pro­mot­ed to pres­i­dent and COO of Lyn­dra Ther­a­peu­tics, co-found­ed by Bob Langer and rid­ing high with a Se­ries C in­jec­tion sur­pass­ing $60 mil­lion as the Wa­ter­town, MA biotech strives to make dai­ly pills ob­so­lete. Be­fore join­ing Lyn­dra in 2016 as VP of re­im­burse­ment and strate­gic al­liances, Ballinger spent 10 years at Pfiz­er in nu­mer­ous posts and an­oth­er four with Bio­gen. Run­ning along­side Ballinger’s pro­mo­tion, ex-AIG chief in­vest­ment of­fi­cer Doug Dachille and AIG man­ag­ing part­ner Jil­lian Moo-Young are now on Lyn­dra’s board of di­rec­tors.

Car­olin Barth

→ Ox­ford biotech Miro­Bio, de­vel­op­ing an­ti­bod­ies for au­toim­mune dis­eases, has named No­var­tis vet Car­olin Barth CEO. When she em­barked up­on her No­var­tis jour­ney 17 years ago, Barth was a glob­al brand leader for Lu­cen­tis; when she left for Miro­Bio, she was glob­al head of com­mer­cial and pipeline strat­e­gy, cell and gene. Miro­Bio launched al­most ex­act­ly two years ago with ex­ec­u­tive chair­man and SR One ven­ture part­ner Eliot Charles han­dling CEO du­ties on an in­ter­im ba­sis.

An­ja Harmeier

→ Bel­gium-based biotech Rewind Ther­a­peu­tics is bring­ing on An­ja Harmeier as CEO. Most re­cent­ly, Harmeier served as part­ner at Pure­os Bioven­tures. Pri­or to that, she held sev­er­al po­si­tions at Roche, work­ing her way up to fran­chise and se­nior project leader in the rare dis­eases di­vi­sion. Harmeier has al­so served on the board of di­rec­tors at Vivet Ther­a­peu­tics, En­tra­da and NMD Phar­ma.

Kathy Yi is out at Cerev­el af­ter two years as CFO “to pur­sue oth­er per­son­al and pro­fes­sion­al in­ter­ests,” and in the mean­time VP, fi­nance and chief ac­count­ing of­fi­cer Mark Bo­den­rad­er will take over as in­ter­im CFO. The Tony Coles-led Pfiz­er spin­out an­nounced an un­der­writ­ten pub­lic of­fer­ing in Ju­ly to­tal­ing $350 mil­lion fol­low­ing the re­lease of pos­i­tive schiz­o­phre­nia da­ta just days ear­li­er. Al­though this change goes in­to ef­fect im­me­di­ate­ly, Yi will help with the tran­si­tion un­til Nov. 15.

Ni­rav Jhaveri

→ Shy and re­served Alex Zha­voronkov is not, pulling in a hefty $255 mil­lion round a few months ago and as­sert­ing that In­sil­i­co is in po­si­tion to be the Ama­zon and Google of AI drug dis­cov­ery. This week, In­sil­i­co has brought on Ni­rav Jhaveri as CFO. Jhaveri re­cent­ly took care of CFO re­spon­si­bil­i­ties at Fortress Biotech sub Jour­ney Med­ical Cor­po­ra­tion, and from 2014-20 he was Fortress’ VP of busi­ness de­vel­op­ment.

Louis De­nis

Frank Neu­mann pulled a fast one when he left Ve­rastem On­col­o­gy two weeks in­to the job as CMO to lead clin­i­cal de­vel­op­ment at Kite in Feb­ru­ary. Ve­rastem now hopes Pfiz­er alum Louis De­nis can stay a lit­tle longer as its med­ical chief. Af­ter nine years in on­col­o­gy clin­i­cal de­vel­op­ment and med­ical af­fairs at Pfiz­er, De­nis then set off for Boehringer In­gel­heim in 2010, tak­ing charge of clin­i­cal de­vel­op­ment for afa­tinib, a lung can­cer drug at the cen­ter of a col­lab­o­ra­tion with Cure­Vac that will dis­solve in No­vem­ber. Since 2015, De­nis had been CMO with Asana Bio­Sciences.

→ In a press re­lease that ri­vals Michael Jor­dan’s 1995 de­c­la­ra­tion of “I’m Back” for its brevi­ty, He­lix Bio­Phar­ma an­nounced that chair­man Sła­womir Ma­jew­s­ki will be­come in­ter­im CEO. The for­mer chief ex­ec­u­tive of the Cana­di­an im­muno-on­col­o­gy biotech He­man Chao, Ma­jew­s­ki has chaired the sci­en­tif­ic ad­vi­so­ry board since he stepped down Sept. 1. The one-sen­tence re­lease does in­di­cate the search for a per­ma­nent CEO is on­go­ing.

Bren­dan De­laney

→ If it seems like just the oth­er day that Bren­dan De­laney changed jobs, then you’re an ob­ser­vant Peer Re­view read­er. De­laney — an on­col­o­gy mar­ket­ing vet with Bris­tol My­ers, Genen­tech and No­var­tis — took on the chief com­mer­cial of­fi­cer job at Con­stel­la­tion Phar­ma­ceu­ti­cals in Jan­u­ary, but he’s on the move again, be­com­ing COO at Los An­ge­les-based Aa­di Bio­science. He re­unites with chair­man Be­hzad Ag­haz­adeh, who was CEO at Im­munomedics when De­laney was his CCO be­fore the Gilead ac­qui­si­tion. In May, Aa­di Bio­science re­verse merged with Aer­pio Ther­a­peu­tics, rais­ing $155 mil­lion in the process.

Ro­muald Cor­bau

→ South San Fran­cis­co-based GenEd­it is ready for prime time with a $26 mil­lion round to solve the “de­liv­ery prob­lem” in gene ther­a­py, ap­point­ing Ro­muald Cor­bau as CSO and Aaron Mishel as CFO. Cor­bau, a Spark vet who spoke to our Nicole De­Feud­is for Thurs­day’s sto­ry on the Se­ries A fi­nanc­ing, was re­cent­ly in Peer Re­view when he left Free­line in late June af­ter get­ting pro­mot­ed to CSO in Sep­tem­ber 2020, clear­ing the path for co-founder Amit Nath­wani as his in­ter­im re­place­ment. Mishel comes to GenEd­it from the same po­si­tion at Mag­net­ic In­sight and is the ex-di­rec­tor of busi­ness & cor­po­rate de­vel­op­ment at Bio­Marin.

Sheila Gu­jrathi

→ Ear­ly this week im­mune mod­u­la­tion com­pa­ny Ven­tyx Bio­sciences topped off its ini­tial $114 mil­lion raise with a $51 mil­lion Se­ries B, and Sheila Gu­jrathi leads the list of lead­er­ship moves here as the new chair of Ven­tyx’s board. Gu­jrathi was CEO of Gos­samer Bio un­til tri­al fail­ures prompt­ed her to cede her po­si­tion to old Re­cep­tos col­league Fa­heem Has­nain. Akero Ther­a­peu­tics CFO William White nabs a seat on the board, while ex-Gos­samer CSO and cur­rent Pi­o­neer­ing Med­i­cines CSO Luisa Salter-Cid will al­so be on Ven­tyx’s sci­en­tif­ic ad­vi­so­ry board.

In the C-suite, Ven­tyx is bring­ing on Jörn Drap­pa as CMO. An alum of Am­gen, Genen­tech and Med­Im­mune, Drap­pa was most re­cent­ly EVP of R&D at Hori­zon Ther­a­peu­tics, and un­til the $3 bil­lion buy­out, he led R&D and was CMO of Viela Bio.

Mitchell Chan

→ Speak­ing of Viela Bio, CFO Mitchell Chan made his own ex­it, tak­ing the same po­si­tion on Joanne Smith-Far­rell’s team at Be Bio. Chan, who will al­so be head of cor­po­rate strat­e­gy, has plen­ty of Big Phar­ma ex­pe­ri­ence as As­traZeneca’s di­rec­tor of in­vestor re­la­tions along with gigs at Roche and Genen­tech. His ap­point­ment fills the C-suite fur­ther af­ter Be Bio greet­ed pres­i­dent and COO Kr­ish­nan Viswanad­han and chief peo­ple of­fi­cer Brad Hart­man last month.

→ Mean­while at Gos­samer, Bryan Gi­rau­do has tacked on the COO ti­tle along with the CFO post he’s held since May 2018. Be­fore he jumped to biotech, Gi­rau­do was se­nior man­ag­ing di­rec­tor at SVB Leerink for nine years.

Rob Ciap­penel­li

Doug Fam­brough has added to his line­up of ex­ecs at RNAi-fo­cused Dicer­na while shift­ing Rob Ciap­penel­li to chief strat­e­gy of­fi­cer and pro­mot­ing Marc Abrams. The CCO at Dicer­na since 2019, Ciap­penel­li was pre­vi­ous­ly head of com­mer­cial at Mo­men­ta and head of com­mer­cial ef­fec­tive­ness with Shire. Abrams, el­e­vat­ed to SVP of dis­cov­ery re­search, orig­i­nal­ly hopped on board at Dicer­na in 2014 as se­nior di­rec­tor, pre­clin­i­cal de­vel­op­ment af­ter 16 years at Mer­ck. Fi­nal­ly, Kris­ten Shep­pard has been named SVP of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. She had ful­filled the same re­spon­si­bil­i­ties at Ake­bia Ther­a­peu­tics.

Avinash De­sai

Avinash De­sai has been pro­mot­ed to CMO at ra­dio­ther­a­py play­er Ac­tini­um while two oth­er ex­ecs dive in as well. De­sai, ini­tial­ly named EVP, clin­i­cal de­vel­op­ment, op­er­a­tions and med­ical af­fairs in late 2020, had been in­volved in med­ical af­fairs with a batch of big names: Janssen, Ei­sai, Take­da, Eli Lil­ly, and be­fore he joined Ac­tini­um, Glax­o­SmithK­line. Al­so, Ac­tini­um has tapped Arun Swami­nathan as chief busi­ness and com­mer­cial of­fi­cer and Paul Di­a­mond as VP, patent and le­gal coun­sel. Swami­nathan was in com­mer­cial and busi­ness de­vel­op­ment at Bris­tol My­ers for 12 years, with a stop at Co­v­ance in be­tween, and comes to the New York biotech af­ter his tenure as CBO at Al­teogen. (Mark Ku­bik left his CBO post at Ac­tini­um to take the same po­si­tion at Genor Bio­Phar­ma.) At En­zo Biochem, Di­a­mond was se­nior coun­sel, patents and busi­ness de­vel­op­ment be­fore mov­ing on to Ac­tini­um.

→ Now helmed by for­mer Co­di­ak ex­ec Ben­ny Sorensen, Copen­hagen bleed­ing dis­or­der biotech Hemab has $55 mil­lion in Se­ries A fund­ing to work with — thanks to head­lin­ers No­vo Seeds and RA Cap­i­tal — and has re­cruit­ed Mads Behrndt as CFO. Behrndt has held a num­ber of posts at PwC the last 14 years, and since 2017 has been a part­ner for the cor­po­rate fi­nance team.

Maria Fuentes

Maria Fuentes has been named CSO at San Fran­cis­co ex­o­some out­fit Mantra Bio, which shed its stealth-mode skin with a $25 mil­lion Se­ries A last Ju­ly. Fuentes, a Big Phar­ma alum with Roche (re­search di­rec­tor and head of the res­pi­ra­to­ry drug dis­cov­ery group) and Bris­tol My­ers (group di­rec­tor, fi­bro­sis dis­cov­ery bi­ol­o­gy), has re­cent­ly been EVP of re­search at Blade Ther­a­peu­tics.

Kevin Tan

→ In its first big Peer Re­view de­vel­op­ment since Jude Samul­s­ki was named gene ther­a­py spe­cial ad­vi­sor, Se­lec­ta Bio­sciences has picked up Kevin Tan as CFO. Be­fore this op­por­tu­ni­ty at Carsten Brunn-led Se­lec­ta, Tan was on Doug In­gram’s team at Sarep­ta as trea­sur­er, and ear­li­er he held the role of se­nior port­fo­lio man­ag­er at CPP In­vest­ments.

→ Ger­man CD­MO Rentschler Bio­phar­ma, which will have a pres­ence at the Cell and Gene Ther­a­py Cat­a­pult in the UK by next year, has ap­point­ed Chris­t­ian Schet­ter as CSO. Schet­ter was man­ag­ing di­rec­tor at Ar­ix Bio­science and has al­so helmed Rigontec, the retinoic acid-in­ducible gene I (RIG-I) biotech that Roger Perl­mut­ter pur­chased at Mer­ck in 2017 for $150 mil­lion up­front and $603 mil­lion over­all.

Lau­ren Gor­don

Lau­ren Gor­don will lead all things HR as first chief peo­ple of­fi­cer of Boston AI life sci­ences com­pa­ny Con­cer­tAI. Gor­don comes to Con­cer­tAI af­ter al­so be­ing a chief peo­ple of­fi­cer at Tmu­ni­ty, the CAR-T biotech co-found­ed by Carl June which had to scrap its lead pro­gram af­ter two pa­tients died due to neu­ro­tox­i­c­i­ty in June.

En­deav­or Bio­Med­i­cines has plucked up Srikanth Pendyala as its first CMO. Pendyala joins the com­pa­ny from Bridge­Bio, where he served as VP of clin­i­cal de­vel­op­ment. Pri­or to that role, Pendyala held roles at Genen­tech/Roche, Mer­ck and Ther­a­vance.

Jor­dan Shin

→ Gene ther­a­py-fo­cused Ren­o­va­cor, which picked up Marc Sem­i­gran as CMO back in June among many oth­ers, has named Jor­dan Shin as SVP of clin­i­cal de­vel­op­ment and trans­la­tion­al sci­ence. Shin comes to the Philadel­phia-based com­pa­ny from Lung Biotech­nol­o­gy, where he served as VP of med­ical de­vel­op­ment. Pri­or to that, Shin was with Ac­celeron and Reify.

→ Hop­ping over to Den­mark, Evax­ion Biotech raised $30 mil­lion in a mod­est IPO ear­ly this year for its AI plat­form to de­vel­op im­muno-on­col­o­gy drugs, and Evax­ion has pro­mot­ed Bir­gitte Rønø to CSO, mak­ing the move up from se­nior di­rec­tor of I/O. Pri­or to her ar­rival at Evax­ion in 2017, Rønø had a four-year run that start­ed in im­munophar­ma­col­o­gy at No­vo Nordisk, and in her fi­nal po­si­tion there, she was a spe­cial­ist in di­a­betes pre­ven­tion re­search.

Has­san Aly

→ Dutch biotech Xenikos has named Has­san Aly as its new CMO. He joins the com­pa­ny close to two months af­ter for­mer CFO and CBO Stan Mu­sial joined Aru­vant as their CFO. Xenikos al­so se­cured just un­der $47 mil­lion over two weeks ago in con­vert­ible debt to fund a reg­is­tra­tional Phase III tri­al in the US and the EU.

Dot­mat­ics, a cloud-based sci­en­tif­ic R&D da­ta man­age­ment plat­form that was snapped up by In­sight­ful Sci­ence in March, has passed down the ti­tle of pres­i­dent to Mike Mc­K­ee, who will suc­ceed founder Stephen Gal­lagher. Mc­K­ee was most re­cent­ly EVP and gen­er­al man­ag­er of in­sid­er threat at Proof­point. Mc­K­ee has al­so held po­si­tions at Ob­serveIT and Rapid7 among oth­ers.

Michele Wales

Adap­tive Phage Ther­a­peu­tics has en­list­ed Michele Wales as chief le­gal of­fi­cer. Wales hails from In­House Patent Coun­sel, where she served as prin­ci­pal and founder. Pri­or to that, Wales had a 14-year stint at Hu­man Genome Sci­ences.

→ “Wnt” some HR ex­per­tise? Wnt path­way-fo­cused Sur­rozen, tak­ing part in the SPAC ma­nia through a $212 mil­lion re­verse merg­er with Con­so­nance Cap­i­tal Man­age­ment this spring, has se­lect­ed Liz Nguyen as VP and head of hu­man re­sources. Nguyen had been MyoKar­dia’s ex­ec­u­tive di­rec­tor, head of HR busi­ness part­ner­ing & in­ter­im HR site head af­ter Bris­tol My­ers’ de­ci­sion to pur­chase the com­pa­ny and she spent six years with MyoKar­dia over­all.

Kim Black­well

→ Once known as di­ag­nos­tic com­pa­ny Nov­el­lus, pre­ci­sion on­col­o­gy out­fit Fore Bio­ther­a­peu­tics keeps it in the short grass with Kim Black­well tee­ing it up as R&D/sci­ence chair along with Su­jit Ba­su as SVP of glob­al man­u­fac­tur­ing and tech­ni­cal op­er­a­tions. For­mer­ly VP of ear­ly phase on­col­o­gy and im­muno-on­col­o­gy at Eli Lil­ly, Black­well spent the last year as CMO and SVP, clin­i­cal on­col­o­gy de­vel­op­ment at Tem­pus Labs. As for Ba­su, he comes from Take­da by way of Shire and was most re­cent­ly the phar­ma gi­ant’s VP, phar­ma­ceu­ti­cal sci­ences, R&D.

Erik Atkisson

→ Mer­ck gave away lon­a­farnib to Pa­lo Al­to, CA-based Eiger Bio­Phar­ma­ceu­ti­cals in 2018, and by last No­vem­ber the FDA OK’d the drug for the ul­tra-rare con­di­tion prog­e­ria (Hutchin­son-Gil­ford prog­e­ria syn­drome). Eiger now brings in ex-Bio­Marin se­nior coun­sel Erik Atkisson as gen­er­al coun­sel and chief com­pli­ance of­fi­cer. Since 2019, Atkisson had tak­en on the roles of chief com­pli­ance of­fi­cer, le­gal coun­sel, and pri­va­cy of­fi­cer at Cy­to­ki­net­ics.

Lisa Ca­perel­li will take on the new­ly cre­at­ed VP of in­vestor re­la­tions po­si­tion at Ar­bu­tus. Be­fore join­ing the man­age­ment team at Ar­bu­tus — which spe­cial­izes in de­vel­op­ing a cure for peo­ple with HBV in­fec­tion — Ca­perel­li was as­so­ciate VP of in­vestor re­la­tions at Har­mo­ny Bio­sciences. She has al­so held po­si­tions in in­vestor re­la­tions at Mar­i­nus, Ad­vax­is, Poly­Medix and Windtree Ther­a­peu­tics.

→ DNA play­er Touch­light — which dou­bled its fundrais­ing round this year for a to­tal of $125 mil­lion — has added some new faces to its lead­er­ship team with the ap­point­ments of Robin Bod­i­coat (head of mar­ket­ing), Rhona McIn­tyre (head of sales for Eu­rope), and Julie Fos­ter (head of sales for North Amer­i­ca). Bod­i­coat pre­vi­ous­ly held roles at Quo­tient Sci­ences and Source Bio­Science. Mean­while, Fos­ter brings with her ex­pe­ri­ence from her time at Lon­za and Epis­tem, while McIn­tyre hails from Lon­za Bi­o­log­ics and Parex­el.

→ Scot­tish gam­ma delta T cell biotech TC Bio­pharm ap­point­ed Se­bas­t­ian Wan­less as its new se­nior clin­i­cal di­rec­tor. Wan­less joins TC Bio­Pharm af­ter leav­ing Bris­tol My­ers, where he spent 18 years and closed out his time there as VP of in­ter­con­ti­nen­tal re­search.

Joshua Brumm

Am­phista an­nounced that Joshua Brumm will re­place Satish Jin­dal as its new in­de­pen­dent chair­man. Brumm cur­rent­ly serves as pres­i­dent and CEO of Dyne Ther­a­peu­tics, and be­fore join­ing Dyne, he was COO and CFO of Kalei­do Bio­sciences. Am­phista, a UK-based pro­tein degra­da­tion biotech, de­buted last April and hauled in a $53 mil­lion Se­ries B round in March.

Aarvik Ther­a­peu­tics has brought on Richard Scheller, for­mer CSO and head of ther­a­peu­tics of 23andMe, as its board mem­ber and sci­en­tif­ic ad­vi­so­ry board chair. Pre­vi­ous­ly, Scheller was SVP of re­search and EVP of re­search and ear­ly de­vel­op­ment at Genen­tech. Scheller cur­rent­ly sits on the boards of Bridge­Bio, 23andMe, Alec­tor, DiCE Ther­a­peu­tics and Maze Ther­a­peu­tics.

In ad­di­tion to Scheller’s ap­point­ment, Aarvik has tapped Melis­sa Starovas­nik to be a part of its sci­en­tif­ic ad­vi­so­ry board. Starovas­nik spent near­ly three decades at Genen­tech, serv­ing in a va­ri­ety of roles such as VP, pro­tein sci­ences and VP, re­search op­er­a­tions and struc­tur­al bi­ol­o­gy. Starovas­nik al­so sits on the board of Twist Bio­science.

Aya Jakobovits

→ At the same time that the FDA grant­ed hu­man­i­tar­i­an use de­vice des­ig­na­tion to its treat­ment of Dandy Walk­er syn­drome, Bio­naut Labs has plucked up for­mer pres­i­dent and found­ing CEO Kite CEO Aya Jakobovits to be a part of their ad­vi­so­ry board. Un­til March 2018, Jakobovits served as pres­i­dent and CEO of Adicet Bio and pre­vi­ous­ly held roles at Agen­sys and Ab­genix.

→ In­tranasal vac­cines-fo­cused BlueWil­low Bi­o­log­ics has brought on three new hires to lead its sci­en­tif­ic ad­vi­so­ry board: Robin Isaacs (for­mer CMO of En­ta­sis Ther­a­peu­tics); Akiko Iwasa­ki (Yale pro­fes­sor in the de­part­ment of im­muno­bi­ol­o­gy and de­part­ment of mol­e­c­u­lar cel­lu­lar de­vel­op­men­tal bi­ol­o­gy); Steve Pro­jan (for­mer SVP of R&D in the in­fec­tious dis­eases & vac­cines in­no­v­a­tive med­i­cines unit at Med­Im­mune).

Lawrence Klein

→ Stan­ford spin­out Jasper Ther­a­peu­tics, which grabbed its tick­et to Nas­daq via SPAC re­verse merg­er in May, has ap­point­ed Lawrence Klein and Chris No­let to its board of di­rec­tors. Klein is the cur­rent COO of CRISPR Ther­a­peu­tics, while No­let was the for­mer West re­gion life sci­ences in­dus­try leader and part­ner at Ernst & Young.

Jae Park is the newest ad­di­tion to Al­lo­gene’s sci­en­tif­ic ad­vi­so­ry board that is chaired by Ton Schu­mach­er. Park is a hema­tol­o­gist-on­col­o­gist on the Leukemia Ser­vice at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter.

Teri Lox­am

→ Co­in­cid­ing with the de­par­tures of Fra­zier man­ag­ing part­ner Patrick Heron and Rob Hopfn­er of Piv­otal bioVen­ture Part­ners, An­nie Dra­peau and Teri Lox­am have joined the board of di­rec­tors at Vax­cyte. Dra­peau is chief peo­ple of­fi­cer at Toast, a pay­ment soft­ware com­pa­ny geared to­ward restau­rants, and Lox­am is CFO at SQZ Biotech­nolo­gies.

Iso­Plex­is, the Con­necti­cut biotech ze­ro­ing in on per­son­al­ized pro­tein “bar­codes” that filed for a $100 mil­lion IPO in Ju­ly, has a seat re­served for Ja­son My­ers on the board of di­rec­tors. My­ers is CEO of Genap­sys and the ex-CEO of ArcherDX, bought by In­vi­tae for $1.4 bil­lion in 2020.

Amy Mc­K­ee

→ North Car­oli­na biotech BioCryst has brought FDA vet­er­an and Parex­el VP Amy Mc­K­ee in­to its board of di­rec­tors. She joined Parex­el as VP of reg­u­la­to­ry con­sult­ing ser­vices in 2019 af­ter an 11-year ca­reer at the FDA, end­ing up as the deputy di­rec­tor for the On­col­o­gy Cen­ter of Ex­cel­lence.

Optib­ri­um, a de­vel­op­er of soft­ware for drug dis­cov­ery, has named Andy Black as non-ex­ec­u­tive chair of its board of di­rec­tors. Black is the co-founder and for­mer CEO of Ki­napse and cur­rent­ly serves as chair of Syg­na­ture Dis­cov­ery.

Re­Form Bi­o­log­ics has re­cruit­ed Roopom Baner­jee (for­mer pres­i­dent and CEO of Rain­dance Tech­nolo­gies), Kirsten Flow­ers (CCO for Ku­ra On­col­o­gy and for­mer SVP of com­mer­cial op­er­a­tions at Ar­ray), Stu­art Ran­dle (for­mer di­vi­sion pres­i­dent of Bax­ter Health­care) and Ed­ward Sul­li­van (com­pre­hen­sive busi­ness strate­gist and fi­nan­cial ex­pert) to be part of its board of di­rec­tors.

Paul Schloess­er al­so con­tributed to this edi­tion.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

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

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.