Mer­ck keeps it in the fam­i­ly as Robert Davis hands the CFO keys to Car­o­line Litch­field; Gilead los­es Di­ana Brainard, with vi­rol­o­gy ex­ec be­com­ing CEO of AlloVir

Car­o­line Litch­field

→ With Robert Davis prepar­ing to take over as Mer­ck’s CEO, the Big Phar­ma stayed in-house to choose a suc­ces­sor in the job he won’t hold for much longer. Car­o­line Litch­field, who’s served at Mer­ck since 1990 and has been trea­sur­er the past two years, will be­come CFO on April 1, the same day Davis as­sumes the role of pres­i­dent. Davis will then take the helm for Ken Fra­zier on Ju­ly 1.

In the four years be­fore her tenure as trea­sur­er, Litch­field led fi­nance for the Hu­man Health di­vi­sion, where Frank Clyburn just be­came pres­i­dent af­ter Mike Nal­ly’s de­par­ture last week as chief mar­ket­ing of­fi­cer.

Di­ana Brainard

End­points News fea­tured Di­ana Brainard in De­cem­ber as one of the women blaz­ing trails in bio­phar­ma when she spear­head­ed the ef­fort to au­tho­rize remde­sivir for treat­ing Covid-19. As of May 17, Brainard leaves Gilead be­hind af­ter lead­ing the vi­rol­o­gy ther­a­peu­tic area and will re­place David Hal­lal as CEO of AlloVir. Hal­lal will con­tin­ue in his ca­pac­i­ty as ex­ec­u­tive chair­man of the board. Brainard, a Mer­ck alum who first land­ed at Gilead in 2010 as a clin­i­cal re­search di­rec­tor, joined AlloVir’s board in 2019. She’s noth­ing if not can­did about tak­ing on a CEO job for the first time: “To be hon­est, I’m ter­ri­fied,” Brainard told our Kyle Blanken­ship. “It’s a brand new thing for me — but those but­ter­flies are part of the ap­peal of the job.”

Michael Amoroso

Michael Amoroso’s rapid as­cent through the ranks at Abeona is now com­plete with his pro­mo­tion to CEO. Peer Re­view has tracked Amoroso’s climb ever since he took on the role of chief com­mer­cial of­fi­cer last Ju­ly, and three short months lat­er, he be­came COO just af­ter João Sif­fert and four board mem­bers de­cid­ed to walk away. Amoroso had led com­mer­cial­iza­tion ef­forts for Yescar­ta at Kite be­fore mak­ing the change at Abeona, and be­fore Kite, he held sev­er­al mar­ket­ing posts at Cel­gene and was SVP, Amer­i­c­as for Ei­sai’s com­mer­cial on­col­o­gy busi­ness group.

In oth­er de­vel­op­ments, Thomp­son Hine part­ner Faith Charles and Hud­son Square Cap­i­tal pres­i­dent Mark Alvi­no are mak­ing their way to Abeona’s board of di­rec­tors.

Sven Zim­mer­mann will re­place No­var­tis and Roche vet Jean-Jacques Ga­raud as CEO of Paris-based In­otrem, mak­er of TREM-1 in­hibitor nan­gi­botide to treat sep­tic shock, on April 19. Ga­raud won’t stray from the com­pa­ny he co-found­ed, mak­ing the tran­si­tion to EVP, head of sci­en­tif­ic and med­ical af­fairs once Zim­mer­mann gets set­tled in. Be­fore get­ting his shot at lead­ing a biotech, Zim­mer­mann was CFO at Novim­mune and then left for the same po­si­tion at Metrio­Pharm af­ter the sale of ema­palum­ab to So­bi was com­plete in the sum­mer of 2019. Nan­gi­botide is al­so in Phase IIa stud­ies to com­bat se­vere Covid-19.

John Mulc­ahy

→ South San Fran­cis­co-based SiteOne Ther­a­peu­tics, which has part­nered with Am­gen on non-opi­oid pain ther­a­pies like its Naᵥ1.7 in­hibitor ST-2427, has giv­en sci­en­tif­ic co-founder John Mulc­ahy the bump to CEO. Out goes Stan Abel, the CEO at SiteOne since 2014 who will tran­si­tion to board chair­man. Mulc­ahy had been VP of re­search since the biotech’s 2012 launch in Boze­man, MT, and more specif­i­cal­ly he was project lead for the Am­gen col­lab­o­ra­tion.

Amzell BV has made some changes to its lead­er­ship team. Alan Har­ris has been named chair­man while Dario Car­rara has been pro­mot­ed to CEO. Har­ris is SVP in the Fer­ring Group’s R&D Man­age­ment and will con­tin­ue his role at Fer­ring. Mean­while, Car­rara for­mer­ly served as CSO of Amzell be­fore his bump up to CEO. Car­rara for­mer­ly served as gen­er­al man­ag­er of Fer­ring and was co-founder and head of R&D at Per­matec Phar­ma.

Mace Rothen­berg

Mace Rothen­berg be­gan 2021 by step­ping aside as Pfiz­er’s CMO, hand­ing the ba­ton to Stan­ford’s Ai­da Habtezion as the first jabs of the BioN­Tech-part­nered vac­cine were be­ing ad­min­is­tered. Af­ter 12 years over­all with Pfiz­er, Rothen­berg’s next move is a board ap­point­ment at Bar­bara We­ber’s can­cer biotech, Tan­go Ther­a­peu­tics. He’ll have com­pa­ny as Glob­al Blood Ther­a­peu­tics alum Les­ley Ann Cal­houn al­so gets start­ed as a mem­ber of Tan­go’s board. Cal­houn has been CFO at Ali­gos Ther­a­peu­tics since last sum­mer.

Karen Hale

→ Throw­ing their hat in­to the Covid-19 vac­cine ring by help­ing man­u­fac­ture mR­NA strag­gler Cure­Vac’s shot, No­var­tis has made Karen Hale chief le­gal of­fi­cer start­ing May 15, suc­ceed­ing Shan­non Klinger. Hale had de­vot­ed eight years to Ab­b­Vie, with the ma­jor­i­ty of her time as chief ethics & com­pli­ance of­fi­cer be­fore get­ting pro­mot­ed to VP, deputy gen­er­al coun­sel. Pri­or to her time at Ab­b­Vie, she spent 15 years in nu­mer­ous le­gal ca­pac­i­ties at Ab­bott.

→ Ef­fec­tive June 30, Fate Ther­a­peu­tics CSO Daniel Shoe­mak­er is re­tir­ing af­ter 12 years with the San Diego CAR-T play­er, in­clud­ing the last six as chief sci­en­tist. Chief R&D of­fi­cer Bob Valamehr will hold the fort on Fate’s pluripo­tent stem cell (iP­SC) prod­uct plat­form in his stead.

Rand Suther­land

Trans­late Bio — which had some big ques­tions raised about its mR­NA-based cys­tic fi­bro­sis drug last week — has reeled in Rand Suther­land as pres­i­dent. Suther­land comes aboard af­ter a sev­en-year stint at Sanofi Gen­zyme, where he most re­cent­ly served as glob­al head of med­ical af­fairs. Pri­or to that, Suther­land was a pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Col­orado and chief of pul­monary and crit­i­cal care med­i­cine at Na­tion­al Jew­ish Health in Den­ver.

Christo­pher Turn­er has left Blue­print Med­i­cines to be­come CMO of Nu­va­lent, the Deer­field-backed start­up that pulled off the tarp with a $50 mil­lion Se­ries A in Jan­u­ary with dual lead pro­grams in the ROK1 and ALK onco­genes. Turn­er led the charge on Gavre­to (from a part­ner­ship with Roche) as VP of clin­i­cal de­vel­op­ment at Blue­print Med­i­cines since 2018. He’s al­so been head of re­search at Ari­ad Phar­ma­ceu­ti­cals and VP of clin­i­cal sci­ence at Celldex Ther­a­peu­tics.

Jian Irish

→ Bay Area gene edit­ing out­fit Metageno­mi got a ma­jor boost when Leaps by Bay­er co-led a $65 mil­lion Se­ries A back in the fall. Now Jian Irish is along for the ride as COO. A 14-year Am­gen vet and for­mer bi­o­log­ics ex­ec at Sanofi, Irish comes to Metageno­mi af­ter serv­ing as SVP, glob­al head of man­u­fac­tur­ing at Kite, and ini­tial­ly she was the Gilead sub­sidiary’s SVP, sup­ply chain.

→ Big Phar­ma vet Bhavesh Ashar has got­ten the call to be chief com­mer­cial of­fi­cer of Bain-backed Pfiz­er spin­out Spring­Works Ther­a­peu­tics, which fo­cus­es on rare dis­eases and can­cer and has two ex-Pfiz­er drugs in its pipeline — nirogace­s­tat and mir­dame­tinib. Since 2017, Ashar had been SVP, gen­er­al man­ag­er of US on­col­o­gy for Bay­er, and al­so de­vot­ed 15 years to Sanofi Gen­zyme, both in the same role he filled at Bay­er and as VP, glob­al head of trans­plant.

At­ul Dan­dekar

→ Along with a guid­ed tour of the pipeline that End­points re­ceived on Tues­day from CEO Ja­son Colo­ma was the news that Maze Ther­a­peu­tics has brought in At­ul Dan­dekar as chief strat­e­gy of­fi­cer. Dan­dekar has been in the land of the phar­ma gi­ants for two decades, serv­ing 16 years at No­var­tis in a va­ri­ety of posts, in­clud­ing se­nior glob­al pro­gram head, neu­rol­o­gy. He re­cent­ly led the glob­al oph­thal­mol­o­gy busi­ness for Roche and Genen­tech, end­ing a sev­en-year run over­all to move on at Maze.

→ With No­vo Ven­tures and Abing­worth co-lead­ing the ef­fort to haul in $95 mil­lion for a Se­ries B, mi­to­chon­dr­i­al dis­ease-fo­cused Re­neo Phar­ma­ceu­ti­cals has hand­ed the CFO reins to Vi­neet Jin­dal. Be­fore ar­riv­ing at the San Diego-based biotech, Jin­dal was with Rea­ta Phar­ma­ceu­ti­cals as VP of strat­e­gy and VP of cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions. Re­neo’s lead can­di­date, REN001, tar­gets pri­ma­ry mi­to­chon­dr­i­al my­opathies, fat­ty acid ox­i­da­tion dis­or­ders and McAr­dle dis­ease.

Nathalie Laarakker

→ Dutch vac­cines com­pa­ny In­travacc has wel­comed Nathalie Laarakker as CFO. Laarak­er comes to In­travacc af­ter three years with Kite part­ner Gade­ta, where she was CFO and man­ag­ing di­rec­tor, and she’s al­so been head of fi­nance at Merus. In­travacc se­cured a $9.4 mil­lion con­tract from NI­AID last fall to de­vel­op a vac­cine for en­terovirus D68.

Mark De Rosch

→ Fol­low­ing an $80 mil­lion Se­ries E round for its eye can­cer ther­a­py AU-011 that pushed to­tal fund­ing to over $200 mil­lion, Elis­a­bet de los Pinos-led Au­ra Bio­sciences has brought Mark De Rosch in­to the fold as COO. De Rosch had been Epizyme’s chief reg­u­la­to­ry of­fi­cer and was SVP, reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance for Night­star Ther­a­peu­tics be­fore Bio­gen pur­chased it in 2019. Else­where, he was a reg­u­la­to­ry ex­ec at Ake­bia from 2014-18.

→ South San Fran­cis­co fi­brot­ic dis­ease biotech Blade Ther­a­peu­tics has named Jean-Frédéric Viret CFO. He hails from Co­herus Bio­Sciences, which just bought tori­pal­imab from Jun­shi for $150 mil­lion a month ago and where he held the same role since 2014. Viret has al­so been a CFO at xDx (now CareDx) and di­aDexus.

→ Chaired by Syn­cona chief in­vest­ment of­fi­cer Chris Hol­lowood, AAV gene ther­a­py play­er Swan­Bio has re­moved the in­ter­im tag from Mari­ta James and has ap­point­ed her as CFO. James had held the in­ter­im ti­tle since Feb­ru­ary 2020, and a cou­ple months af­ter she took on the role, Syn­cona led a $52 mil­lion Se­ries A round cen­tered on the biotech’s quest to treat adreno­myeloneu­ropa­thy (AMN) with lead drug SBT101.

Car­oli­na Gar­cia Ri­zo

James Wil­son-in­spired start­up Pas­sage Bio — which re­ceived a red light from the FDA last Au­gust for its first gene ther­a­py pro­gram — has bagged Eliseo Sali­nas as chief re­search & de­vel­op­ment of­fi­cer. Sali­nas hails from Aca­dia Phar­ma­ceu­ti­cals, where he served as CSO and SVP. Ad­di­tion­al­ly, Sali­nas brings with him ex­pe­ri­ence from Shire, Elan Phar­ma­ceu­ti­cals, Stem­Cell and New World Lab­o­ra­to­ries.

Im­muneer­ing has tapped Car­oli­na Gar­cia Ri­zo as CBO. Ri­zo comes from Just Bio­ther­a­peu­tics, where she al­so served as CBO. In ad­di­tion to Just, Ri­zo has served at Ther­mo Fish­er, Roche, Cepheid and MIT.

Jim­my Lai

→ A lit­tle more than a week af­ter a Se­ries B that to­taled $47 mil­lion, Son­ny Hsiao-led Ace­po­dia has se­lect­ed Jim­my Lai as CFO. Lai, who is well-versed in tak­ing Chi­na-based com­pa­nies pub­lic in the US, has quite a mix­ture of CFO ti­tles to his cred­it, in­clud­ing Chi­na On­line Ed­u­ca­tion Group, mo­bile gam­ing com­pa­ny Chukong Tech­nolo­gies and poly­sil­i­con mak­er Daqo New En­er­gy Corp.

Son­net Bio­Ther­a­peu­tics has added some new faces to its lead­er­ship team with the ap­point­ments of Richard Ken­ney as CMO and Manuel Da­fon­se­ca as head of clin­i­cal op­er­a­tions. Ken­ney comes from X-VAX Tech­nol­o­gy, where he most re­cent­ly served as chief de­vel­op­ment of­fi­cer. In ad­di­tion, Ken­ney brings to the ta­ble ex­pe­ri­ence from his times at Clin­Reg Bi­o­log­ics, Im­mune De­sign and Cru­cell Hol­land.

Mean­while, Da­fon­se­ca hops aboard from Mer­ck, where he most re­cent­ly served as di­rec­tor of glob­al clin­i­cal tri­al op­er­a­tions – on­col­o­gy. Pri­or to Mer­ck, Da­fon­se­ca was with Ipsen Bio­phar­ma­ceu­ti­cals, where he served as di­rec­tor of clin­i­cal op­er­a­tions.

Re­bus Biosys­tems has added two new hires to its lead­er­ship team. Neil Kennedy will serve as CCO while Scott Kothlow will serve as CFO. Pri­or to Re­bus, Kennedy was with Dove­tail Ge­nomics, Mil­li­pore and Ap­plied Biosys­tems among oth­ers. Mean­while, Kothlow hops aboard af­ter stints at So­ma­Log­ic, Sinop­sys Sur­gi­cal and Lab 79.

Zim­mer Bio­met has pro­mot­ed Ivan Tornos to the po­si­tion of COO. Tornos joined Zim­mer in No­vem­ber 2018 as group pres­i­dent, or­tho­pe­dics be­fore be­ing named group pres­i­dent, glob­al busi­ness­es and the Amer­i­c­as. Tornos joined Zim­mer from Bec­tone, Dick­in­son and Com­pa­ny, where he served as world­wide pres­i­dent of the glob­al urol­o­gy, med­ical and crit­i­cal care di­vi­sion. In ad­di­tion, Tornos served in roles at C.R. Bard, Co­vi­di­en In­ter­na­tion­al and John­son & John­son.

Earl Dou­glas

Earl Dou­glas has been named gen­er­al coun­sel at Ap­plied Mol­e­c­u­lar Trans­port, a South San Fran­cis­co biotech which joined the club of nine-fig­ure IPOs that grew to be par for the course in 2020. Dou­glas has been a le­gal con­sul­tant with Mesoblast and just wrapped a two-and-a-half-year run as gen­er­al coun­sel for Kiver­di.

David Paul­ing has been pro­mot­ed to gen­er­al coun­sel and Robert Kiss has sealed his own pro­mo­tion as SVP, process and an­a­lyt­i­cal de­vel­op­ment at Sutro Bio­phar­ma, which dis­closed pos­i­tive Phase I re­sults in De­cem­ber for the ovar­i­an can­cer drug STRO-002. Paul­ing first came on board as in­tel­lec­tu­al prop­er­ty coun­sel for Sutro in 2011, and Kiss is a 24-year Genen­tech vet who be­gan his tenure with Bill Newell’s team three years ago.

Alexan­der Kaoukhov

→ Irvine, CA-based cy­tokine ther­a­py play­er Bion­iz has tapped Alexan­dre Kaoukhov as SVP and head of clin­i­cal de­vel­op­ment. Kaoukhov, who most re­cent­ly was head of glob­al de­vel­op­ment at Almi­rall, al­so led der­ma­tol­ogy drug de­vel­op­ment as an as­so­ciate VP at Al­ler­gan. A Phase III study is on the dock­et for Bion­iz and its lead drug BNZ-1 in cu­ta­neous T cell lym­phoma.

→ Glob­al in­vest­ment bank Chardan has pulled David Lenchus in­to its ranks as man­ag­ing di­rec­tor and di­rec­tor of re­search. Pri­or to his new role, Lenchus was man­ag­ing di­rec­tor and di­rec­tor of re­search at BTIG. Ad­di­tion­al­ly, Lenchus held roles at Pali Cap­i­tal, Gorann and Co­lum­bia Artists Man­age­ment.

TIS­SI­UM has plucked up Thier­ry Dar­nis as VP of glob­al op­er­a­tions. Pre­vi­ous­ly, Dar­nis had a 12-year stint as plant man­ag­er for Medtron­ic sub­sidiary Sofradim Pro­duc­tion. Ad­di­tion­al­ly, Dar­nis served at Biom’UP and Af­flu­ent Med­ical.

Carl June

→ CAR-T pi­o­neer Carl June has tacked on an­oth­er ti­tle, and this time it’s chair­man of the im­muno-on­col­o­gy sci­en­tif­ic ad­vi­so­ry board at Er­ic Os­tertag-led Po­sei­da. Last fall, the FDA lift­ed its hold on Po­sei­da’s Phase I study of CAR-T ther­a­py P-PS­MA-101 in prostate can­cer af­ter a pa­tient death prompt­ed the halt.

→ Co-found­ed by Sarah Gilbert and Adri­an Hill — in­ven­tors of the As­traZeneca Covid-19 vac­cine that is suf­fer­ing from one pub­lic re­la­tions blun­der af­ter an­oth­er — Ox­ford spin­out Vac­citech has added Joseph Scheeren to the board of di­rec­tors. The for­mer Bay­er ex­ec suc­ceeds Vac­citech CSO Thomas Evans in the slot and just re­tired as pres­i­dent and CEO of Crit­i­cal Path In­sti­tute.

Mu­na Bhan­ji

→ If it seems like Mu­na Bhan­ji is tak­ing on quite a few board ap­point­ments late­ly, you’d be cor­rect: Last week she joined the board at Arde­lyx, and this time she heads to the board of di­rec­tors at Ve­r­a­cyte. A month ago, the long­time for­mer Mer­ck ex­ec al­so be­came a board mem­ber at Cy­to­ki­net­ics.

Pierre Legault, for­mer lead di­rec­tor at Urovant, has added an­oth­er board seat to his ré­sumé with his ap­point­ment as chair­man of the board of Sit­ryx. Cur­rent­ly, Legault serves as chair­man of the boards of Amolyt Phar­ma, Ar­tios Phar­ma, Bi­cy­cle Ther­a­peu­tics and Pox­el Phar­ma. In the past, Legault served as CEO of Pro­sid­ion and Eck­erd Phar­ma­cies.

Cathy Fried­man

Grail chair­per­son and Mor­gan Stan­ley alum Cathy Fried­man has been elect­ed to the board of di­rec­tors at Vi­vid­ion, now helmed by Jeff Hat­field and with a $135 mil­lion Se­ries C raise in the hop­per. Fried­man al­so has board seats at Lyell, Ra­dius Health and Seer.

Ganax­olone mak­er Mar­i­nus Phar­ma­ceu­ti­cals has re­served a spot at the board of di­rec­tors for Sara Nochur. The long­time chief reg­u­la­to­ry of­fi­cer at Al­ny­lam start­ed her new re­spon­si­bil­i­ties on John Maraganore’s crew as chief di­ver­si­ty, eq­ui­ty and in­clu­sion of­fi­cer in Jan­u­ary.

Nan­cy Stu­art

→ Com­ing off a Phase II win in di­a­bet­ic mac­u­lar ede­ma with its lead drug KVD900, KalVista has giv­en Nan­cy Stu­art a seat on the board of di­rec­tors. The Ver­tex and Am­gen alum has been COO at Con­cert Phar­ma­ceu­ti­cals since Oc­to­ber 2007.

→ Lon­don-list­ed Clin­i­gen — the com­pa­ny that snatched up the trou­bled IL-2 can­cer drug, Pro­leukin, sold by No­var­tis — has brought on Sharon Cur­ran as a new in­de­pen­dent non-ex­ec­u­tive di­rec­tor. Cur­rent­ly, Cur­ran serves as non-ex­ec­u­tive di­rec­tor of Cir­cas­sia and al­so serves on the board of Mor­phosys. Pre­vi­ous­ly, Cur­ran served at Ab­b­Vie, Ab­bott and Eli Lil­ly.

Kro­nos Bio has snatched up long­time Gilead vet Taiyin Yang to its board of di­rec­tors. Yang joined Gilead in 1993 and cur­rent­ly serves as EVP of phar­ma­ceu­ti­cal de­vel­op­ment and man­u­fac­tur­ing. Pri­or to her time at Gilead, Yang served at Syn­tex Cor­po­ra­tion. Fur­ther­more, Yang is a cur­rent board mem­ber of Ko­di­ak Sci­ences. In ad­di­tion to Yang’s ap­point­ment, Kro­nos has an­nounced that Jakob Loven has no­ti­fied the com­pa­ny that he will not stand for re-elec­tion at the com­pa­ny’s 2021 An­nu­al Meet­ing of Stock­hold­ers.

William Mez­zan­otte

Bel­lus Health has en­list­ed As­traZeneca vet William Mez­zan­otte for its board of di­rec­tors. Cur­rent­ly, Mez­zan­otte serves as head of re­search and de­vel­op­ment and CMO at CSL Behring. Pri­or to CSL, Mez­zan­otte was with Boehringer In­gel­heim. Mez­zan­otte spent over 15 years at As­traZeneca — with his last role be­ing head of in­flam­ma­tion, neu­ro­science and res­pi­ra­to­ry glob­al med­i­cines unit.

IMV has brought on Kyle Ku­valan­ka to its board of di­rec­tors. Ku­valan­ka is tak­ing over for Wayne Pisano who is re­tir­ing. Cur­rent­ly, Ku­valan­ka is CFO and COO of Goldfinch Bio. Pri­or to Goldfinch, Ku­valan­ka served in roles at Sy­ros Phar­ma­ceu­ti­cals, Blue­print Med­i­cines and Mil­len­ni­um.

→ South San Fran­cis­co-based Har­poon Ther­a­peu­tics has re­cruit­ed Alan Colow­ick to its board of di­rec­tors. A for­mer ex­ec­u­tive part­ner at Sofinno­va Ven­tures, Colow­ick is the ex-chair­man of Prin­cip­ia Bio­phar­ma and was an EVP at Cel­gene from 2010-17.

Kati­na Dor­ton

Kati­na Dor­ton — re­cent­ly ap­point­ed as CFO of NodTherahas joined the board of di­rec­tors at TScan, which just nabbed Bri­an Sil­ver as CFO a few weeks ago. Dor­ton is al­so on the boards of Ful­crum Ther­a­peu­tics and Pan­dion Ther­a­peu­tics.

Mis­sion Ther­a­peu­tics, a biotech that re­search­es se­lec­tive­ly in­hibit­ing deu­biq­ui­ty­lat­ing en­zymes (DUBs), has named Jonathan Hep­ple a non-ex­ec­u­tive di­rec­tor of its board of di­rec­tors. Hep­ple brings with him ex­pe­ri­ence from Roset­ta Cap­i­tal, where he is co-founder.

→ Gothen­burg, Swe­den-based Elicera Ther­a­peu­tics has re­cruit­ed Karin Hoogen­doorn to its board of di­rec­tors. Hoogen­doorn cur­rent­ly serves as a mem­ber of the In­ter­na­tion­al Ad­vi­so­ry Board of the Swedish Cen­tre for Ad­vanced Med­ical Prod­ucts (CAMP).

→ Aus­tralian biotech Provec­tus Al­gae has ap­point­ed Tim Lu to its board of di­rec­tors. Lu is the co-founder and CEO of Sen­ti Bio­sciences.

Cres­set has named David New­ble as non-ex­ec­u­tive di­rec­tor. Cur­rent­ly, New­ble is man­ag­ing di­rec­tor of SPT Labtech and for­mer­ly served as CEO of TAP Biosys­tems.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Voting in the 2020 election (AP Images)

The right to vote is fun­da­men­tal — a let­ter from biotech­nol­o­gy in­dus­try lead­ers

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We oppose all attempts to introduce laws that reduce the rights of US citizens to vote or that restrict them from exercising that right. The right to vote is fundamental to democracy. States that have enacted, or are proposing to enact, legislation to restrict voting are undermining our democracy and posing a threat to our nation. As leaders of the life sciences industry, we stand for what we believe is right for our country, our enterprises, our employees and those who benefit from our work. We join the first groups of business leaders who have challenged these laws and will continue to make our collective voices heard on this matter.

Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Anand Shah (FDA)

For­mer head of FDA’s med­ical and sci­en­tif­ic af­fairs on Covid: ‘FDA has nev­er been test­ed like this’

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Launched by MIT grads, a small start­up gets $20M to back a ro­bot­ics rev­o­lu­tion in cell ther­a­py man­u­fac­tur­ing

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.

Barbara Weber, Tango Therapeutics CEO (Tango)

It takes two to Tan­go: The biotech us­ing CRISPR to dis­cov­er new can­cer gene tar­gets rides a $353M SPAC deal to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.

Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.

Kristin Fortney, BioAge Labs CEO

An­ti-ag­ing biotech up­start plucks a drug from Am­gen's dis­card pile, piv­ot­ing from heart fail­ure to mus­cle con­di­tions

Back in April 2019, Amgen quietly shut down a Phase I trial for a drug named AMG 986. There was no safety concern; the molecule just didn’t hit the mark on helping the small band of heart failure patients who received it.

A small biotech, though, believes it would stand a chance in the burgeoning anti-aging field.

BioAge Labs has licensed AMG 986 — now renamed BGE-105 — with plans to parlay the existing IND into a quick Phase I trial teasing out the pharmacodynamic effects and set the stage for mid-stage tests focused on acute muscle indications.