Gone away are the blue­bird ex­ecs as COO, CMO both leave the nest; Mike Nal­ly is lat­est ma­jor fig­ure to move on from Mer­ck

Joanne Smith-Far­rell

→ As blue­bird bio’s reg­u­la­to­ry con­cerns swell yet again by press­ing the pause but­ton for Lenti­Glo­bin a month ago, Joanne Smith-Far­rell won’t be around to see how the saga plays out with the FDA. Smith-Far­rell has tak­en the helm at Long­wood-backed B cell biotech Be Bio­phar­ma, which launched last Oc­to­ber with a $52 mil­lion Se­ries A round. She was pre­vi­ous­ly blue­bird’s COO and busi­ness unit head, on­col­o­gy, and she first came to Nick Leschly’s team as CBO in 2017 af­ter her Big Phar­ma ex­pe­ri­ence in busi­ness de­vel­op­ment with Mer­ck and Pfiz­er. Smith-Far­rell tells our Kyle Blanken­ship that her de­ci­sion to be­come CEO at Be Bio wasn’t re­lat­ed to the de­ci­sion to split blue­bird in­to two com­pa­nies in Jan­u­ary.

Else­where, Rick Mor­gan has de­cid­ed not to be part of the Jim Mullen Ex­pe­ri­ence at Ed­i­tas Med­i­cine af­ter join­ing Be Bio as CSO. Mor­gan, a blue­bird vet in his own right, had been the SVP of im­muno­genet­ics at Ed­i­tas since 2018.

→ Smith-Far­rell isn’t the on­ly blue­bird staffer that’s get­ting out of Dodge. CMO David David­son an­nounced his in­tent to leave blue­bird af­ter nine years on the job, ef­fec­tive April 16. The Gen­zyme vet will stay on as a con­sul­tant un­til his suc­ces­sor is found. While the sun part­ed from the clouds for blue­bird this week with pos­i­tive da­ta for its Loren­zo’s Oil dis­ease pro­gram, the Lenti­Glo­bin dra­ma and the sus­pen­sion of mar­ket­ing for Zyn­te­glo still rep­re­sent a stormy pat­tern at the biotech.

Frank Clyburn

Roger Perl­mut­ter sure ini­ti­at­ed a chang­ing of the guard at Mer­ck. Af­ter the R&D chief an­nounced he would hang it up, CEO Ken Fra­zier fol­lowed suit by plan­ning a June 30 de­par­ture. Mike Nal­ly, chief mar­ket­ing of­fi­cer for the Hu­man Health di­vi­sion, was on an in­ter­nal short list of can­di­dates to re­place Fra­zier. But with Robert Davis wait­ing in the wings as CEO, Nal­ly is on his way out too af­ter hold­ing nu­mer­ous gigs at the phar­ma gi­ant since 2003 be­fore be­com­ing the chief mar­ket­ing ex­ec two years ago. Frank Clyburn, who joined Mer­ck in 2008 and was chief com­mer­cial of­fi­cer, Hu­man Health, has been giv­en the ti­tle of pres­i­dent, Hu­man Health.

One oth­er note on Perl­mut­ter: Shang­hai-based CBC Group just named him as a sci­ence part­ner and a mem­ber of the sci­en­tif­ic ad­vi­so­ry board.

→ Jux­ta­posed with the pos­i­tive Phase III da­ta that were re­leased in the SHORE­LINE study for de­pres­sion drug zu­ra­nolone, Sage COO Mike Cloo­nan wants to set out on his own as a CEO (des­ti­na­tion un­known) and bids adieu on May 3. The MOUN­TAIN study for zu­ra­nolone failed in late 2019, gut­ting the stock. And Cloo­nan, an ex-Bio­gen com­mer­cial ex­ec who be­gan as Sage’s CBO in 2017, tran­si­tioned to COO af­ter a re­struc­tur­ing that re­sult­ed in more than half the work­force fac­ing the chop­ping block in April 2020. Three months ago, Bar­ry Greene stepped in to helm Sage, while ex-CEO Jeff Jonas took over as chief in­for­ma­tion of­fi­cer.

Lori Ma­comber

Frank Zhang was re­leased on bail last month, but he’s a man with­out a com­pa­ny now that Ying Huang has tak­en over as Leg­end’s CEO, and the Chi­nese biotech con­tin­ues life af­ter Zhang with Lori Ma­comber get­ting pro­mot­ed to VP, fi­nance. Since 2019, Ma­comber had been Leg­end’s VP of sup­ply chain fi­nance and con­troller, and she al­so brings sev­en years of fi­nan­cial ex­pe­ri­ence from Eli Lil­ly. The move comes two months af­ter Leg­end made Li­da Pacaud VP of clin­i­cal de­vel­op­ment af­ter wrap­ping up her tenure at No­var­tis On­col­o­gy as glob­al pro­gram clin­i­cal head, ex­ec­u­tive med­ical di­rec­tor of the cell & gene ther­a­py unit.

→ Co-found­ed by David Liu and fresh off the ac­qui­si­tion of Geor­gia Tech spin­out Guide Ther­a­peu­tics, base edit­ing biotech Beam Ther­a­peu­tics has named Amy Si­mon CMO. Si­mon had been with Al­ny­lam since 2010, start­ing as a clin­i­cal re­searcher and then mov­ing up to VP of clin­i­cal de­vel­op­ment, a ti­tle she had held for the past year. She was the lead clin­i­cian for givosir­an, mar­ket­ed as Givlaari af­ter the FDA ap­proved the drug in 2019 for acute he­pat­ic por­phyr­ia.

Aron Knicker­bock­er

→ For­mer Five Prime Ther­a­peu­tics pres­i­dent and CEO Aron Knicker­bock­er has tak­en the helm of Au­los Bio­science as CEO. Pri­or to his new role, Knicker­bock­er was co-founder, found­ing CEO and chair­man of Rayze­Bio. Pri­or to Rayze­Bio and Five Prime, Knicker­bock­er spent over eight years at Genen­tech.

Chris Garabe­di­an’s Per­cep­tive Xon­toge­ny Fund led the way on the Se­ries A last sum­mer, and now Steve Altschuler-chaired eye dis­ease biotech As­cle­piX out of Bal­ti­more has hand­ed the pres­i­dent and CEO reins to Robert Dempsey. Bel­licum founder Kevin Slaw­in had been in­ter­im CEO be­fore the ap­point­ment. Dempsey, who had helmed oph­thalmic com­pa­ny TearClear, was glob­al head of oph­thal­mol­o­gy at Shire and was at the fore­front of Take­da’s 2019 sale of Xi­idra to No­var­tis in an up to $5.3 bil­lion deal.

Mark Rus

→ Shire alum Mark Rus has be­come CEO of Boston-based Delix Ther­a­peu­tics, which is aimed at CNS dis­or­ders and us­es tech­nol­o­gy from David Ol­son’s lab at UC-Davis to de­vel­op “psy­choplas­to­gens,” or mol­e­cules that can pro­mote neu­ro­plas­tic­i­ty. Rus just served as an en­tre­pre­neur-in-res­i­dence and ad­vi­sor for At­las Ven­ture and logged 13 years at Shire un­til the Take­da buy­out, the last four of those years as group VP of neu­ro­science.

Nordic Nanovec­tor has reeled in Pe­ter Braun as CEO. Braun joins the com­pa­ny with three decades of ex­pe­ri­ence from Roche, where he served as SVP, head of ac­cess strat­e­gy, health pol­i­cy & com­mu­ni­ca­tions. In ad­di­tion to Roche, Braun served at Bio­four­mis as CCO.

→ There’s a new sher­iff in town at Swedish im­muno-on­col­o­gy out­fit Al­li­ga­tor Bio­science, with Søren Bre­gen­holt tak­ing com­mand as CEO af­ter helm­ing UK-based Macrophage Phar­ma since 2019. Pri­or to his first CEO job, Bre­gen­holt held cor­po­rate VP posts for eight years each at No­vo Nordisk and Sym­phogen. Bre­gen­holt suc­ceeds Per Nor­lén start­ing June 1, and in the mean­time, COO Ma­lin Carls­son will fill the in­ter­im CEO slot.

Syl­vain Celanire

→ Bel­gium-based Au­gus­tine Ther­a­peu­tics has se­lect­ed Syl­vain Celanire as its CEO. Celanire jump­start­ed his ca­reer at UCB New Med­i­cine be­fore hop­ping aboard Ad­dex Ther­a­peu­tics. In ad­di­tion, Celanire is the co-founder and CEO of Prag­ma Ther­a­peu­tics.

Yi Lar­son has joined Per­cep­tive start­up Lian­Bio, a “best-in-class sourc­ing and de­vel­op­ment en­gine” in Chi­na that launched last Au­gust, as CFO. A for­mer man­ag­ing di­rec­tor of health­care in­vest­ment bank­ing at Gold­man Sachs, Lar­son just com­plet­ed her first turn as a CFO with Turn­ing Point Ther­a­peu­tics. A few months af­ter con­tribut­ing to Lian­Bio’s de­but round, Pfiz­er forked over an ad­di­tion­al $70 mil­lion in a col­lab­o­ra­tion built around in-li­cens­ing and co-de­vel­op­ing new ther­a­pies.

→ While the coun­try fills out NCAA Tour­na­ment brack­ets, Ele­don Phar­ma­ceu­ti­cals is fill­ing out its lead­er­ship team with Jeff Born­stein as CMO and Paul Lit­tle as CFO. Born­stein, a Bio­gen and Gilead alum, comes to Ele­don from Take­da, where he was the Japan­ese phar­ma’s VP and head of clin­i­cal sci­ences, gas­troen­terol­o­gy. Lit­tle is a long­time Al­ler­gan ex­ec in fi­nance and com­mer­cial op­er­a­tions who had pre­vi­ous­ly been CFO and trea­sur­er of Sien­tra. Ele­don, a biotech out of Irvine, CA, tar­gets the CD40L path­way to de­vel­op drugs for those with ALS, au­toim­mune dis­eases and or­gan or cell trans­plant re­cip­i­ents.

David Huang

→ Pitts­burgh-based biotech Pep­ti­log­ics, which fo­cus­es on pep­tide drug de­sign and de­vel­op­ment — and scored a $35.4 mil­lion Se­ries B that was boost­ed by Pe­ter Thielhas tapped David Huang as SVP and CMO. Huang is a long­time at­tend­ing physi­cian with the De­part­ment of Vet­er­ans Af­fairs and has been a CMO be­fore with Con­tra­Fect, Mo­tif Bio, and X-Bi­otix Phar­ma­ceu­ti­cals.

Pep­ti­log­ics has made a cou­ple oth­er ap­point­ments with Nick Ny­s­trom as SVP, com­put­ing and da­ta, and Nicholas Pachu­da as SVP, port­fo­lio strat­e­gy and de­vel­op­ment. Ny­s­trom spent 28 years with the Pitts­burgh Su­per­com­put­ing Cen­ter, de­part­ing as chief sci­en­tist, while Pachu­da hails from J&J’s or­tho­pe­dic fran­chise, DePuy Syn­thes, serv­ing as world­wide VP of ex­ter­nal in­no­va­tion and en­abling tech­nolo­gies.

Christo­pher Rec­knor is get­ting pro­mot­ed to COO at Cy­to­Dyn, a week af­ter CEO Nad­er Pourhas­san cranked up the spin ma­chine to ex­plain how leron­limab miss­ing the mark on its pri­ma­ry end­point was a source of op­ti­mism. Rec­knor, who joined Cy­to­Dyn as VP of clin­i­cal de­vel­op­ment in Au­gust 2020, has al­so been a prin­ci­pal in­ves­ti­ga­tor for such Big Phar­mas as As­traZeneca, Eli Lil­ly and Am­gen in more than 100 clin­i­cal tri­als.

Manu Chakravarthy

→ Chalk­ing up $47 mil­lion in new fund­ing to tar­get meta­bol­ic dis­eases us­ing in­cretin re­cep­tor ag­o­nists, Berke­ley, CA-based Car­mot Ther­a­peu­tics has wel­comed Manu Chakravarthy as CMO and EVP of R&D. Chakravarthy, whose in­volve­ment in Big Phar­ma R&D be­gan at Mer­ck, had pre­vi­ous­ly been CMO of Ax­cel­la Health. Be­fore Ax­cel­la, he was Eli Lil­ly’s VP and glob­al head of ex­ter­nal R&D and in­no­va­tion strat­e­gy in di­a­betes and car­dio­vas­cu­lar re­search.

Io­vance makes their sec­ond C-suite hire in three months, with Ig­or Bilin­sky jump­ing on board as COO (back in De­cem­ber, Jean Marc Bellemin was ap­point­ed CFO at the Cal­i­for­nia cell ther­a­py biotech). Bilin­sky had most re­cent­ly been CBO at Onc­ter­nal Ther­a­peu­tics, and he’s been a CEO be­fore at An­dro­clus Ther­a­peu­tics, which closed up shop in 2007. Bilin­sky’s pre­vi­ous COO ex­pe­ri­ence was with Am­pliPhi Bio­sciences be­fore his short stay at Onc­ter­nal.

Andy Mey­er

→ T cell en­gager biotech Janux — join­ing forces on a $1 bil­lion pact with Mer­ck in one of Roger Perl­mut­ter’s part­ing deals — has brought on Andy Mey­er as CBO. Mey­er was Ever­core’s man­ag­ing di­rec­tor in life sci­ences in­vest­ment bank­ing and spent near­ly six years there af­ter his time at Bank of Amer­i­ca. A cou­ple weeks ago, Janux gath­ered up $56 mil­lion in a Se­ries A raise that was spurred by the Mer­ck deal.

Ed­ward Smith has signed on to Ver­santbacked bis­pe­cif­ic gam­ma-delta T cell en­gager (or bsTCEs) biotech La­va Ther­a­peu­tics to be­come its CFO. Be­fore head­ing to the Dutch out­fit, which just made Kapil Dhin­gra chair­man of the board last month, Smith had spent eight years as CFO of Mar­i­nus Phar­ma­ceu­ti­cals, which read out pos­i­tive da­ta last fall with its lone drug that fo­cus­es on CD­KL5 de­fi­cien­cy dis­or­der.

Robert Wil­lette

Robert Wil­lette has tacked on the role of CSO at APIE Ther­a­peu­tics. Wil­lette joins the com­pa­ny from Com­plexa Ther­a­peu­tics and Im­mu­niMet Ther­a­peu­tics, where he served as in­ter­im CSO. Pri­or to that, Wil­lette had a 30-year long stint at GSK, where he most re­cent­ly served as VP and head of the com­pa­ny’s heart fail­ure and re­nal dis­cov­ery per­for­mance unit.

Lisa Deck­er has left Atre­ca to be­come CBO at Sil­i­con Val­ley-based IGM Bio­sciences, which — you guessed it — fo­cus­es on IgM an­ti­bod­ies and de­buted on Nas­daq in 2019 with a $175 mil­lion IPO. Be­fore her time as CBO at Atre­ca, she held var­i­ous ti­tles in 11 years at Nek­tar, with her fi­nal role be­ing VP, busi­ness de­vel­op­ment.

Miny­oung Kim

→ Shang­hai-based An­ten­gene made a few key hires last sum­mer, in­clud­ing CMO Don­ald Lung and med­ical af­fairs VP Dirk Hoen­e­mann. Now the hema­tol­ogy and on­col­o­gy play­er has wel­comed Miny­oung Kim as gen­er­al man­ag­er of An­ten­gene South Ko­rea. She had pre­vi­ous­ly been gen­er­al man­ag­er of Ipsen Ko­rea since 2015 and al­so brings mar­ket­ing ex­pe­ri­ence from Eli Lil­ly Ko­rea.

→ Spin­ning its wheels in Phase III of its Covid-19 vac­cine can­di­date while promis­ing to re­spond to the FDA’s clin­i­cal hold, In­ovio has re­cruit­ed Michael Cordera as EVP and gen­er­al coun­sel. Cordera, who had soared to EVP and gen­er­al coun­sel at Ea­gle Phar­ma­ceu­ti­cals, joined the biotech as its deputy gen­er­al coun­sel five years ago. In ad­di­tion to the reg­u­la­to­ry is­sues that be­set In­ovio, Joseph Kim’s bunch al­so squab­bled with its con­tract man­u­fac­tur­er, fil­ing suit against VGXI to get un­shack­led from the re­la­tion­ship.

Shaila­ja Ka­sib­hat­la

Bound­less Bio has named Shaila­ja Ka­sib­hat­la as VP, dis­cov­ery and trans­la­tion­al de­vel­op­ment. Pri­or to her new role, Ka­sib­hat­la was se­nior di­rec­tor of trans­la­tion­al de­vel­op­ment at Bris­tol My­ers Squibb. Be­fore that, she had an eight-year stint at No­var­tis and served at Mer­ck Re­search Labs.

→ Dig­i­tal health-fo­cused Well­doc has named Ma­ri­na Dorotheo its chief mar­ket­ing of­fi­cer. Dorotheo jumps aboard af­ter a 22-year stint at Ot­su­ka, most re­cent­ly serv­ing as head of com­mer­cial strat­e­gy and mar­ket­ing with­in Ot­su­ka’s Dig­i­tal Med­i­cine hub.

Rick Klaus­ner-chaired Lyell Im­munophar­ma — fo­cused on us­ing T cells to cure sol­id tu­mors — has en­list­ed Richard Sher­ry as SVP, TIL spe­cial­ist and clin­i­cal lead. Most re­cent­ly, Sher­ry served as re­search physi­cian and at­tend­ing sur­geon in the surgery branch at the NCI Cen­ter for Can­cer Re­search and the NCI Clin­i­cal Cen­ter. In ad­di­tion, he has held roles at the NIH, the NIH Sur­gi­cal Ad­min­is­tra­tive Com­mit­tee, the Saftey Mon­i­tor­ing Com­mit­tee for the Na­tion­al In­sti­tute of Neu­ro­log­ic Dis­or­ders and Stroke and as a melanoma ex­pert for the FDA’s Drug Ad­vi­so­ry Com­mit­tee.

Sue Hager

→ Ven­ture cap­i­tal fund Sec­tion 23 has added two new hires to its team with the ap­point­ments of Andy Har­ri­son as man­ag­ing part­ner and Sue Hager as chief in­vestor re­la­tions and com­mu­ni­ca­tions of­fi­cer. Har­ri­son hops aboard with lead­er­ship ex­pe­ri­ence from Al­pha­bet, Ver­i­ly Life Sci­ences and X (for­mer­ly GoogleX). Mean­while, Hager most re­cent­ly served at EQRx and Foun­da­tion Med­i­cine.

Ko­mo­do Health has re­cruit­ed Lau­rent Bride as chief tech­nol­o­gy of­fi­cer (CTO). Bride joins the group from soft­ware com­pa­ny Tal­end, where he al­so served as CTO.

→ San Diego-based on­col­o­gy biotech Ap­tose has a pair of new ex­ecs with George Melko (VP, reg­u­la­to­ry af­fairs) and Robert Kil­lion (VP, CMC). A reg­u­la­to­ry alum at As­traZeneca and In­cyte, Melko has re­cent­ly served as VP of reg­u­la­to­ry af­fairs at Tmu­ni­ty and Tes­sa Ther­a­peu­tics. Kil­lion lands this pro­mo­tion to a new­ly-cre­at­ed gig af­ter com­ing on­to the scene at Ap­tose last year. He’s held CMC po­si­tions at Roche/Genen­tech — where he spent near­ly two decades com­bined— and Gilead.

Matthew Pat­ter­son

→ Ex-Au­dentes chair­man and CEO Matthew Pat­ter­son has been named ex­ec­u­tive chair­man of the board at Remix Ther­a­peu­tics, the Cam­bridge, MA RNA pro­cess­ing biotech that hauled in $81 mil­lion for its De­cem­ber 2020 launch. Pat­ter­son has since moved in­to a strate­gic ad­vi­so­ry role with Au­dentes.

Lau­ra Shawver has a new board mem­ber at Seat­tle-based Sil­ver­back — a late en­trant in 2020’s IPO bo­nan­za — with the ad­di­tion of Re­pare Ther­a­peu­tics CMO Maria Koehler. The ex-CMO of Bi­cy­cle Ther­a­peu­tics was al­so an ex­ec with Pfiz­er On­col­o­gy from 2009-17.

Er­ic Dube

GSK vet and Tra­vere Ther­a­peu­tics CEO Er­ic Dube has joined the board of di­rec­tors at mi­to­chon­dr­i­al dis­ease-fo­cused Re­neo Phar­ma­ceu­ti­cals. In two years at the biotech, Dube has led the post-Mar­tin Shkre­li re­brand­ing of Retrophin, which be­came Tra­vere back in No­vem­ber.

→ For­mer Mer­ck CMO Michael Rosen­blatt is join­ing the board of di­rec­tors at PYC Ther­a­peu­tics, adding an­oth­er board seat to his ré­sumé. Rosen­blatt left his role at Mer­ck in 2016 to join Flag­ship Pi­o­neer­ing, where he now serves as a se­nior part­ner. Rosen­blatt cur­rent­ly sits on the boards of Ru­bius Ther­a­peu­tics, Cyg­nal Ther­a­peu­tics and Ohana Bio­sciences.

Alex­is Thomp­son

Sanofi de­liv­ered two sick­le-cell pro­grams from the Biover­a­tiv deal to Glob­al Blood Ther­a­peu­tics this week, and Ted Love’s crew has re­served a place for Alex­is Thomp­son on the board of di­rec­tors. A past pres­i­dent of the Amer­i­can So­ci­ety of Hema­tol­ogy, Thomp­son is head of the hema­tol­ogy sec­tion and di­rec­tor of the Com­pre­hen­sive Tha­lassemia Pro­gram at the Lurie Chil­dren’s Hos­pi­tal in Chica­go.

Mu­na Bhan­ji, who de­vot­ed more than 30 years to Mer­ck, has an­oth­er board ap­point­ment to her cred­it with Arde­lyx as Gor­don Ringold steps aside from the board. Bhan­ji, who capped her ca­reer at the phar­ma gi­ant as SVP, glob­al mar­ket ac­cess and pol­i­cy, al­so joined the board at Cy­to­ki­net­ics a month ago.

Ele­na Ridloff

→ Sev­er­al months af­ter adding Replimune’s Pamela Es­pos­i­to and Blue­print Med­i­cines CEO Jeff Al­bers to the board of di­rec­tors, Kymera Ther­a­peu­tics has made room for Ele­na Ridloff on the board as well. Ridloff joined Aca­dia as VP, in­vestor re­la­tions in 2018 and is cur­rent­ly CFO.

Treve­na is bring­ing Mar­vin John­son in­to the fold on the board of di­rec­tors, as found­ing CEO Max­ine Gowen and Julie McHugh both re­tire from the board. John­son re­tired from Mer­ck in 2018 as chief learn­ing of­fi­cer in the phar­ma gi­ant’s glob­al learn­ing and de­vel­op­ment de­part­ment.

José-Car­los Gutiér­rez Ramos

José-Car­los Gutiér­rez Ramos has locked in a seat on the board of di­rec­tors at Genen­tech im­muno-on­col­o­gy part­ner Bi­cy­cle Ther­a­peu­tics. The ex-CEO of Syn­log­ic and Reper­toire Im­mune Med­i­cines is now CSO at Dana­her.

→ Wait­ing out a par­tial clin­i­cal hold from the FDA on its head and neck squa­mous cell car­ci­no­ma study, ALX On­col­o­gy has elect­ed Sophia Ran­dolph to the board of di­rec­tors. The Pfiz­er and Mer­ck on­col­o­gy alum has been ALX’s CMO for near­ly five years.

→ Woburn, MA-based Re­Form Bi­o­log­ics has cho­sen Bar­bara Finck to be a part of its board of di­rec­tors. Cur­rent­ly, Finck serves as the act­ing CMO at Co­herus Bio­Sciences. Finck has al­so held roles at Im­munex and Eos Biotech­nol­o­gy among oth­ers.

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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Sajith Wickramasekara, Benchling via YouTube

Meet Bench­ling, the lat­est uni­corn seek­ing to rev­o­lu­tion­ize the way sci­en­tists do work with the help of the cloud

There’s another unicorn in biotech land, as Benchling and its leading R&D cloud platform pull in a $200 million Series E to help scientists accelerate drug development. In doing so, the company hit a lofty $4 billion valuation — nearly five times what it was worth around this time last year, according to Forbes.

Despite the fact that drug development is becoming significantly more complex, the industry continues to run on paper, emails and spreadsheets, co-founder and CEO Sajith Wickramasekara said in a video on Benchling’s website. The MIT grad sought to change that by creating software that allows scientists to better track, model and forecast their work.

Covid-19 roundup: No­vavax shakes up lead­er­ship with two pro­mo­tions and de­par­ture of CFO; Mod­er­na, No­vavax shots added to mix-and-match study in the UK

Novavax has had a busy month, filled with supply chain issues and manufacturing deals that have affected the rollout of its Covid-19 vaccine. Tuesday, the company announced updates to its leadership team.

CFO Greg Covino will step down from that role after just five months for personal reasons, the release said, but take on a new role as executive advisor. John Trizzino, current chief commercial officer and chief business officer, will take the CFO role over in the interim.

Amy­lyx to move for­ward with ALS pro­gram in Eu­rope, but FDA wants an­oth­er look; Hu­ma­cyte adds $50M in debt fi­nanc­ing

Amylyx is one of several companies looking to break through in the tough ALS field, and Wednesday they announced they’re moving forward with regulatory plans.

The Cambridge, MA-based biotech said they’re submitting a marketing application to the EMA for their AMX0035 program by the end of 2021. Wednesday’s news comes a few weeks after they revealed similar plans to move forward with Canadian health regulators by June 30.

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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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.