Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mal­lon

Mark Mal­lon steps aside at Iron­wood on March 12 af­ter close to two years at the helm, and he al­ready has a new change of scenery squared away. Be­gin­ning April 19, Mal­lon takes charge as CEO of can­cer-fo­cused ge­net­ic test mak­er NeoGe­nomics out of Fort My­ers, FL while his pre­de­ces­sor, Dou­glas VanOort, is re­tir­ing af­ter 12 years as NeoGe­nomics’ chair­man and CEO.

It’s a fresh start for Mal­lon af­ter what will amount to a tu­mul­tuous 23 months as Iron­wood’s chief ex­ec­u­tive. Last year was marked by tri­al fail­ures that spelled dou­ble trou­ble, leav­ing the Iron­wood cup­board bare: first, a Linzess re­for­mu­la­tion for ir­ri­ta­ble bow­el syn­drome with di­ar­rhea (IBS-D) in May, and then the drug IW-3718 for per­sis­tent acid re­flux in Sep­tem­ber. Af­ter IW-3718’s dis­con­tin­u­a­tion, Iron­wood chopped its staff by 35%. On Feb. 8, Mal­lon an­nounced his de­par­ture at Iron­wood, with pres­i­dent Tom Mc­Court get­ting bumped up to in­ter­im CEO.

Be­fore tak­ing on the CEO job, Mal­lon held a se­ries of roles over 24 years at As­traZeneca, in­clud­ing EVP of glob­al prod­uct and port­fo­lio strat­e­gy.

→ Not on­ly did In­sil­i­co an­nounce its in­tent to push their first drug can­di­date in­to the IND stage on Wednes­day, Alex Zha­voronkov has al­so lined up a new CSO to aid in the ef­fort with GSK alum Feng Ren climb­ing on board. Ren was with GSK for more than 11 years from 2007-18, tak­ing on a num­ber of chem­istry posts un­til he was se­lect­ed as head of chem­istry and di­rec­tor of Neu­rode­gen­er­a­tion DPU, the phar­ma gi­ant’s neu­ro­sciences R&D unit. Ren heads to In­sil­i­co af­ter his tenure at Chi­nese CRO Medicilon as SVP, head of chem­istry & bi­ol­o­gy. Zha­voronkov stayed mum on specifics for the pro­gram when he spoke with our Max Gel­man, but he did in­di­cate that it would fo­cus on id­io­path­ic pul­monary fi­bro­sis.

Taham­tan Ah­ma­di

J&J part­ner Gen­mab — which scored a break­through ther­a­py des­ig­na­tion with the phar­ma gi­ant al­most a year ago at this time with bis­pe­cif­ic JNJ-6372 for metasta­t­ic NSCLC — has pro­mot­ed Taham­tan Ah­ma­di to CMO, head of ex­per­i­men­tal med­i­cines, a brand new po­si­tion at the Dan­ish biotech. Ah­ma­di brought J&J ex­pe­ri­ence of his own be­fore his ar­rival at Gen­mab in 2017 as head of on­col­o­gy, spend­ing five years at Janssen in sev­er­al roles, no­tably VP, head of ex­per­i­men­tal med­i­cine and ear­ly de­vel­op­ment on­col­o­gy. Gen­mab re­port­ed a set­back in No­vem­ber, scrap­ping their pro­gram for the ADC enapotam­ab ve­dotin af­ter the da­ta yield­ed noth­ing to write home about.

Cyn­thia Pussi­nen

Spark Ther­a­peu­tics is con­tin­u­ing its hir­ing spree since Roche’s $4.3 bil­lion takeover, ap­point­ing Pfiz­er vet Cyn­thia Pussi­nen chief tech­nol­o­gy of­fi­cer. Pussi­nen, who held such ti­tles as glob­al head of sup­ply chain lo­gis­tics and head of strate­gic port­fo­lio man­age­ment dur­ing her 18 years with Pfiz­er, will lead Spark’s man­u­fac­tur­ing and tech­ni­cal op­er­a­tions for Lux­tur­na. She most re­cent­ly was Hon­ey­well’s glob­al VP and gen­er­al man­ag­er, life sci­ences and spe­cial­ty chem­i­cals. In ad­di­tion to Pussi­nen as CTO, Spark has brought in a new CMO, head of busi­ness de­vel­op­ment and chief strat­e­gy of­fi­cer in the last year.

Tal Zaks

→ In­clud­ed in Mod­er­na’s an­nu­al re­port yes­ter­day was a bit of a curve­ball: Tal Zaks is walk­ing away as CMO in Sep­tem­ber. What­ev­er Zaks does next, he is sure to be a hot com­mod­i­ty af­ter be­ing a key cog in Mod­er­na’s finest hour to date as the biotech pro­duces more of its Covid-19 mR­NA vac­cine, an im­pres­sive achieve­ment con­sid­er­ing they had no oth­er prod­ucts on the mar­ket be­fore the vac­cine’s au­tho­riza­tion in De­cem­ber. Zaks joined Stéphane Ban­cel’s team in March 2015 af­ter lead­ing Sanofi’s on­col­o­gy di­vi­sion. This is the sec­ond high-pro­file piece of lead­er­ship news at Mod­er­na in 2021 af­ter Corinne Le Goff, the ex-pres­i­dent of Am­gen’s US busi­ness or­ga­ni­za­tion, jumped on board as chief com­mer­cial of­fi­cer Jan. 19. Our Ja­son Mast has more per­spec­tive here.

Bri­an Sil­ver

→ Run­ning along­side Free­line’s ap­point­ment of new pres­i­dent and COO Michael Pari­ni was the news that CFO Bri­an Sil­ver was on his way out to pur­sue an­oth­er op­por­tu­ni­ty, an op­por­tu­ni­ty that came to light this week as the CSO of Har­vard spin­out TScan start­ing May 2. Co-found­ed by Long­wood’s Christoph West­phal, TScan joined forces last spring with the No­var­tis In­sti­tutes for Bio­Med­ical Re­search in a $30 mil­lion deal to de­vel­op a TCR im­muno-on­col­o­gy pro­gram, and then pulled in a $100 se­ries C round a month ago.

Sil­ver, who spent 15 years at Mor­gan Stan­ley and will re­main at Free­line as fi­nance chief and head of cor­po­rate de­vel­op­ment un­til April 30, was part­ner and head of biotech­nol­o­gy at Perel­la Wein­berg Part­ners be­fore jump­ing to Free­line in 2018.

Deb­o­rah Ger­aghty

→ A week af­ter tak­ing on a board ap­point­ment at Evelo Bio­sciences, John Hohnek­er has of­fi­cial­ly an­nounced his re­tire­ment at Anokion as Deb­o­rah Ger­aghty gets pro­mot­ed to pres­i­dent and CEO. Hohnek­er, who has Big Phar­ma ties with posts at No­var­tis and GSK, took the helm at the Swiss biotech in Jan­u­ary 2018 af­ter two and a half years as an R&D ex­ec with For­ma Ther­a­peu­tics. Ger­aghty kicked off her Anokion ca­reer as CBO in 2018, then be­came COO be­fore tak­ing com­mand of the top spot. She’s al­so been an ex­ec with Cy­dan, Di­men­sion Ther­a­peu­tics and Kanyos Bio.

Ad­di­tion­al­ly, Raj Man­chan­da has earned a pro­mo­tion of his own at Anokion, mov­ing his way up to chief de­vel­op­ment of­fi­cer. Man­chan­da, whose re­cent stops in­clude Fre­quen­cy Ther­a­peu­tics and Bio­gen, had pre­vi­ous­ly served as Anokion’s chief tech­ni­cal op­er­a­tions of­fi­cer.

→ For­mer CIA di­rec­tor John Bren­nan and 2004 De­mo­c­ra­t­ic pres­i­den­tial can­di­date Gen. Wes­ley Clark now com­prise half of the board of di­rec­tors at Im­mu­ni­ty­Bio, along with Chris­to­bel Se­lecky and Im­mu­ni­ty­Bio’s chair­man and CEO, Patrick Soon-Sh­iong. Im­mu­ni­ty­Bio merged with nat­ur­al killer play­er Nan­tK­west at the tail end of 2020 as Soon-Sh­iong’s “can­cer moon­shot” has fiz­zled af­ter sub­stan­tial hype.

Ken Takeshi­ta

Dai­ichi Sankyo has land­ed for­mer Kite ex­ec Ken Takeshi­ta as head of R&D at a mo­ment when the Japan­ese phar­ma is tout­ing more suc­cess­es with En­her­tu and adding a sixth ADC to their col­lec­tion. Takeshi­ta suc­ceeds Ju­nichi Ko­ga on April 1 af­ter Frank Neu­mann stepped in­to the role Takeshi­ta oc­cu­pied since De­cem­ber 2019. Takeshi­ta had a dozen-year tenure as an R&D ex­ec at Cel­gene, then fol­lowed that up with a two-year run as Sor­ren­to’s SVP of clin­i­cal R&D be­fore head­ing to Kite. Dai­ichi Sankyo and part­ner As­traZeneca notched its sec­ond ap­proval from the FDA for En­her­tu in Jan­u­ary, this time in gas­tric can­cer.

Stephen Squin­to

Alex­ion co-founder and Or­biMed ex­ec­u­tive part­ner Stephen Squin­to has re­signed from the board of di­rec­tors and from his post as in­ter­im head of R&D at Pas­sage Bio. Squin­to co-found­ed Pas­sage Bio with Jim Wil­son and Tachi Ya­ma­da, and he was in­ter­im CEO at the Philadel­phia-based gene ther­a­py start­up un­til last Jan­u­ary when Bruce Gold­smith took over. Pas­sage’s IND for PBGM01 to treat GM1 gan­gliosi­do­sis in in­fants got waved through by the FDA af­ter the agency de­layed the pro­gram in Au­gust. In the past year, Squin­to has been named chair­man of Genen­ta and vice chair­man of bioAffin­i­ty Tech­nolo­gies.

With space avail­able, Max­ine Gowen has there­fore signed on as a board mem­ber at Pas­sage. Gowen, the CEO of Tamuro Bio since Ju­ly 2019, al­so helmed Treve­na from 2007-18.

→ Keep­ing with the Alex­ion theme, Markus Pe­ters has tak­en on the top spot as CEO of New York-based Ae­vi­tas Ther­a­peu­tics, a sub­sidiary of Lind­say Rosen­wald-led Fortress Biotech. As head of glob­al mar­ket­ing, nephrol­o­gy & trans­plant at Alex­ion, Pe­ters was front and cen­ter in the launch of Soliris for atyp­i­cal he­molyt­ic ure­mic syn­drome. He comes to Ae­vi­tas af­ter serv­ing as COO of Gem­i­ni Ther­a­peu­tics and he has been chief com­mer­cial of­fi­cer for a short time at Ag­ilis Bio­ther­a­peu­tics.

Jer­ry Ca­cia

Jer­ry Ca­cia leaves Genen­tech and Roche be­hind af­ter 32 years in a num­ber of roles re­lat­ed to tech­ni­cal de­vel­op­ment, man­u­fac­tur­ing, and qual­i­ty con­trol to join South San Fran­cis­co gene edit­ing play­er Graphite Bio as chief tech­ni­cal of­fi­cer. Ca­cia had led glob­al tech­ni­cal de­vel­op­ment at Roche be­fore sign­ing on with Ver­sant-backed Graphite Bio, which de­buted with a $45 mil­lion launch round last Sep­tem­ber to fight sick­le cell dis­ease.

→ Mary­land-based Gly­coMimet­ics has pro­mot­ed Er­ic Feld­man to SVP and CMO. Feld­man suc­ceeds He­len Thack­ray — who served as SVP, clin­i­cal de­vel­op­ment and CMO — who has left the com­pa­ny to pur­sue an­oth­er op­por­tu­ni­ty. Feld­man pre­vi­ous­ly served as VP, glob­al clin­i­cal de­vel­op­ment. Pri­or to join­ing the com­pa­ny in 2019, Feld­man was CMO at Am­phive­na Ther­a­peu­tics. Pri­or to that he was at Seat­tle Ge­net­ics.

Sharon Town­son

Monte Rosa has me­thod­i­cal­ly pulled to­geth­er their ex­ec­u­tive team in the months since its $96 mil­lion Se­ries B round, and this week is no dif­fer­ent with Sharon Town­son get­ting pro­mot­ed to chief tech­nol­o­gy of­fi­cer. Town­son first came to Markus War­muth’s Boston biotech back in Ju­ly as VP, bio­mol­e­c­u­lar sci­ences from a brief stay at Kymera as ex­ec­u­tive di­rec­tor and head of plat­form bi­ol­o­gy. Else­where at Monte Rosa, Bridge­Bio’s COO in res­i­dence Chris­tine Siu has claimed a spot on the board of di­rec­tors, and Nir Lon­don of the Weiz­mann In­sti­tute of Sci­ence in Is­rael is now on the sci­en­tif­ic ad­vi­so­ry board.

→ The hits just keep on com­ing at In­ter­cept. Ac­cord­ing to an SEC fil­ing, CMO Ja­son Cam­pagna has fol­lowed ex-CEO Mark Pruzan­s­ki out the door and will ex­it stage left at In­ter­cept on March 5. The New York biotech has ab­sorbed a huge body blow from the FDA’s re­jec­tion of Ocali­va in the un­for­giv­ing NASH field, which has pro­vid­ed the back­drop for Pruzan­s­ki and Cam­pagna to bolt — while 170 oth­er staffers were on the chop­ping block as well. The limp­ing biotech has nonethe­less named Mesoblast COO Dag­mar Rosa-Bjorke­son to its board of di­rec­tors this week, ef­fec­tive April 1. The long­time No­var­tis vet, who had ex­ec­u­tive stints at Mallinck­rodt and Bax­al­ta, joined Mesoblast last sum­mer.

Jeff Aronin and his crew at Paragon Bio­sciences have a new CMO, ze­ro­ing in on Ab­b­Vie vet Jor­dan Dubow for the po­si­tion at the Chica­go in­cu­ba­tor. Dubow was clin­i­cal lead for lev­odopa/car­bidopa while he was at Ab­b­Vie, and af­ter his time at the phar­ma gi­ant he would serve as CMO at Marathon Phar­ma­ceu­ti­cals and, more re­cent­ly, Avadel Phar­ma­ceu­ti­cals.

Christo­pher DeRespino

→ With plans in the works to build an $80 mil­lion gene ther­a­py plant in the Re­search Tri­an­gle area, Ad­verum has tapped Big Phar­ma vet Christo­pher DeRespino as CBO. DeRespino hails from Am­gen, where he spent eight years and was re­cent­ly their ex­ec­u­tive di­rec­tor of busi­ness de­vel­op­ment. From 2008-13, he was Pfiz­er’s di­rec­tor of busi­ness de­vel­op­ment eval­u­a­tion and strat­e­gy.

Reed Tuck­son

Ad­di­tion­al­ly, Ad­verum has elect­ed Reed Tuck­son to the board of di­rec­tors. Tuck­son was EVP and chief of med­ical af­fairs and SVP of clin­i­cal af­fairs dur­ing his 13-year tenure at Unit­ed­Health Group.

→ Chicagoland biotech Clarus Ther­a­peu­tics, mak­er of testos­terone re­place­ment ther­a­py Jaten­zo, has re­cruit­ed Ric Pe­ter­son as CFO. This isn’t Pe­ter­son’s first rodeo in this ca­pac­i­ty, as he’s al­so filled the CFO role at Si­en­na Bio­phar­ma­ceu­ti­cals, Der­ma­vant and No­van, and was most re­cent­ly CFO at Botanix Phar­ma­ceu­ti­cals. Mean­while the man who Pe­ter­son re­places, Steve Bourne, is slid­ing in­to the role of chief ad­min­is­tra­tive of­fi­cer af­ter 17 years as CFO at Clarus.

→ Fo­cused on de­vel­op­ing off-the-shelf CAR-T ther­a­pies, St. Louis biotech Wu­gen has en­list­ed Jan David­son as CMO. David­son hails from Macro­Gen­ics, where since May 2016 the NIH alum had been se­nior di­rec­tor for clin­i­cal re­search.

Louisa Daniels

→ Pfiz­er alum Louisa Daniels has jumped over to Chris Gib­son’s team at Re­cur­sion — which is part­ner­ing with Bay­er on fi­brot­ic dis­eases — as chief le­gal of­fi­cer and gen­er­al coun­sel. Daniels lands at Re­cur­sion af­ter near­ly 13 years as the phar­ma gi­ant’s VP and as­sis­tant gen­er­al coun­sel from April 2008 to Jan­u­ary 2021. From May 2016 un­til her de­par­ture, she was Pfiz­er’s chief coun­sel of glob­al prod­uct de­vel­op­ment.

→ It hasn’t been a great big bed of ros­es at DBV Tech­nolo­gies af­ter the FDA swat­ted away its sec­ond peanut patch ap­pli­ca­tion and a sub­se­quent thin­ning of the herd that cost more than 200 jobs. The French biotech has thus se­lect­ed Michele Robert­son as chief le­gal of­fi­cer to help get its reg­u­la­to­ry house in or­der. Robert­son, an ex-Mer­ck at­tor­ney, has spent the last five years at Mallinck­rodt in a se­ries of roles, most re­cent­ly gen­er­al coun­sel, com­mer­cial op­er­a­tions and chief com­pli­ance of­fi­cer.

PYC Ther­a­peu­tics has pulled in Glenn Noron­ha as chief de­vel­op­ment of­fi­cer. Most re­cent­ly at Bridge­Bio, Noron­ha served as CSO for the oph­thal­mol­o­gy com­pa­nies For­ti­fy Ther­a­peu­tics and Reti­na­genix Ther­a­peu­tics. Pri­or to that, he was CSO of Clear­side Bio­med­ical and had gigs at Su­cam­po Phar­ma Amer­i­c­as, JW The­ri­ac Phar­ma­ceu­ti­cals, Al­con and Targe­Gen.

Javier Ro­driguez

Javier Ro­driguez has leaped to BioX­cel as chief le­gal of­fi­cer and cor­po­rate sec­re­tary. Ro­driguez was gen­er­al coun­sel at Reckitt Benckiser un­til it spun off In­di­v­ior, where he then be­came chief le­gal of­fi­cer from 2014-20. BioX­cel met its pri­ma­ry and sec­ondary end­points last month in a Phase Ib/II tri­al for ag­i­ta­tion in de­men­tia and Alzheimer’s dis­ease with its drug BX­CL501.

Nabri­va Ther­a­peu­tics has hauled in Daniel Dolan as CFO, suc­ceed­ing re­tir­ing CFO Gary Sender. Dolan comes aboard from Ra­dius Health, where he served as prin­ci­pal fi­nan­cial of­fi­cer. Pri­or to that, he held a 12-year stint at Shire Phar­ma­ceu­ti­cals.

→ Liège, Bel­gium-based Hy­loris Phar­ma­ceu­ti­cals has reeled in Thomas Ja­cob­sen as chief busi­ness de­vel­op­ment of­fi­cer, fol­low­ing the re­tire­ment of Ed Mal­oney. Ja­cob­sen co-found­ed Al­ter Phar­ma and has pre­vi­ous­ly served at Docphar­ma and Al­ter­no­va.

Alan Holmes

→ En­gi­tix has added two new faces to its lead­er­ship team: Alan Holmes as se­nior di­rec­tor, fi­bro­sis and John Prime as di­rec­tor, com­pu­ta­tion­al bi­ol­o­gy. Holmes hops aboard from UCB, where he served as di­rec­tor, drug tar­get iden­ti­fi­ca­tion. Pri­or to that, he was di­rec­tor with­in GSK’s pul­monary vas­cu­lar in­jury and fi­bro­sis DPU. Mean­while, Prime joins from Hori­zon Dis­cov­ery and has held stints at Med­Im­mune and Ku­DOS Phar­ma­ceu­ti­cals.

→ Emergex Vac­cines has snagged Robin Co­hen as busi­ness de­vel­op­ment di­rec­tor and Susi Os­borne as man­u­fac­tur­ing di­rec­tor. Co­hen comes along from J&J sub­sidiary Janssen-Cilag. On the oth­er hand, Os­borne joins the com­pa­ny from ADC Biotech­nol­o­gy and has pre­vi­ous ex­pe­ri­ence at Ipsen, GSK and No­var­tis.

Adam Din­er­man

→ Aro Bio­ther­a­peu­tics has bagged Adam Din­er­man as ex­ec­u­tive di­rec­tor, head of chem­istry, man­u­fac­tur­ing and con­trols (CMC) and Zhong­hao (John) Liu as VP, bi­ol­o­gy. Din­er­man joins with ex­pe­ri­ence from his times at J&J, Janssen R&D and Gen­zyme. Mean­while, Liu brings to the ta­ble ex­pe­ri­ence from NGM Bio­phar­ma­ceu­ti­cals and Metabolex.

→ Bri­an Faith has been en­list­ed as VP of com­mu­ni­ca­tions at City of Hope. Most re­cent­ly, Faith has served as VP of cor­po­rate com­mu­ni­ca­tions for Wal­greens. Faith’s pre­vi­ous ex­pe­ri­ence in­cludes stints at All­state, Fan­nie Mae and Wid­mey­er Com­mu­ni­ca­tions.

Pan­thera Biopart­ners has named Matt Coop­er as gen­er­al man­ag­er, on­col­o­gy. Coop­er comes from a back­ground run­ning gigs at DA­TA-CAN, the Na­tion­al Can­cer Re­search Net­work, and the NIHR Clin­i­cal Re­search Net­work.

→ Glob­al health re­search net­work TriNetX has made a slew of ap­point­ments to its board of di­rec­tors. These changes co­in­cide with the ac­qui­si­tion of a ma­jor­i­ty stake in the com­pa­ny by The Car­lyle Group in Oc­to­ber. Most no­tably, the com­pa­ny has snagged a big fish in the form of for­mer Pfiz­er CEO Ian Read as chair­man. In ad­di­tion to Read, the com­pa­ny has brought on Steve Wise, Joe Bress and Ash­ley Evans.

Wise is a man­ag­ing di­rec­tor and glob­al head of health­care at The Car­lyle Group, while Bress is a man­ag­ing di­rec­tor on the US buy­out team. Both are based in New York.

Evans is a man­ag­ing di­rec­tor in Car­lyle’s Tech­nol­o­gy, Me­dia and Tele­com group based in Men­lo Park.

Kapil Dhin­gra

Ver­sant-backed Dutch biotech La­va Ther­a­peu­tics has named Kapil Dhin­gra chair­man of the board. Dhin­gra, the ex-VP and head of on­col­o­gy clin­i­cal de­vel­op­ment at Roche, is a board mem­ber at Replimune, Five Prime, Au­to­lus Ther­a­peu­tics and Me­di­an Tech­nolo­gies.

James Sapirstein

→ Based in Palm Beach Coun­ty, FL and fo­cused on gas­troin­testi­nal dis­eases, Azur­Rx Bio­Phar­ma has tacked on an­oth­er ti­tle for pres­i­dent and CEO James Sapirstein: chair­man of the board. Sapirstein, the ex-Con­traVir CEO who has helmed Azur­Rx since Oc­to­ber 2019, suc­ceeds Ed­ward Borkows­ki as chair­man, while Borkows­ki will stay as lead in­de­pen­dent di­rec­tor.

Fishawack Health has named Deb­o­rah Keller as chair of its board of di­rec­tors. Keller is the for­mer CEO of Co­v­ance and is cur­rent­ly the di­rec­tor of West Phar­ma­ceu­ti­cal Ser­vices.

Mu­na Bhan­ji has signed on to the board of di­rec­tors at Cy­to­ki­net­ics, re­duced to be­ing a one-man band with ome­cam­tiv af­ter weak-sauce re­sults caused Am­gen to dis­solve their 14-year part­ner­ship in No­vem­ber. Bhan­ji de­vot­ed more than 30 years to Mer­ck, most re­cent­ly serv­ing as the phar­ma gi­ant’s SVP, glob­al mar­ket ac­cess and pol­i­cy.

Olivia Ware

→ Fol­low­ing the FDA’s de­fer­ral of a BLA for frown line treat­ment Dax­i­bot­u­linum­tox­i­nA, Re­vance is shoring up its board of di­rec­tors with Olivia Ware and Carey O’Con­nor Ko­la­ja. Ware is SVP and head of the Bru­ton ty­ro­sine ki­nase (BTK) in­hibitor fran­chise at Prin­cip­ia, while Ko­la­ja has been CEO of iden­ti­ty man­age­ment com­pa­ny AU10TIX since Oc­to­ber.

→ Im­muno-on­col­o­gy biotech CoIm­mune out of Durham, NC has elect­ed Ed Barac­chi­ni to the board of di­rec­tors. Barac­chi­ni’s most re­cent CBO gigs have been at Ima­go Bio­Sciences and Xen­cor.

Todd She­gog

Shed­ding the skin of Unum, the re­named Co­gent Bio­sciences has giv­en Todd She­gog a seat on its board of di­rec­tors. The for­mer CFO of Mil­len­ni­um and Syn­log­ic is cur­rent­ly the CFO at For­ma Ther­a­peu­tics, which un­veiled pos­i­tive Phase II da­ta last fall for its AML drug olu­tasi­denib.

Chris No­let is adding an­oth­er board seat to his ré­sumé with his ap­point­ment as chair of Am­brx‘s au­dit com­mit­tee. No­let cur­rent­ly sits on the boards of Viela Bio, Po­lar­i­tyTE and Re­vance — all as chair of the au­dit com­mit­tee. For­mer­ly, No­let was the for­mer West Re­gion life sci­ences in­dus­try leader & part­ner at EY.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.