No­vavax grabs an­oth­er CFO while Pat Cotro­neo re­tires from Fi­bro­Gen; Eli Lil­ly re­assem­bles key staff af­ter bio­med­i­cines unit split

Jim Kel­ly

→ The peren­ni­al Char­lie Brown of vac­cine de­vel­op­ment, No­vavax is grap­pling with Lucy’s knack for pulling the foot­ball away once again, this time with its Covid-19 vac­cine as the FDA pushed back an­oth­er bid for an EUA ear­li­er this month. In the mean­time, No­vavax has found Jim Kel­ly to re­place Greg Covi­no as CFO, leav­ing John Trizzi­no one less C-suite ti­tle to jug­gle. Kel­ly, the ex-CFO at Van­da Phar­ma­ceu­ti­cals, was just in this space in Oc­to­ber 2020 when he suc­ceed­ed Greg Patrick as CFO of Su­per­nus, and now he makes a quick change to a biotech that can’t seem to avoid tak­ing on Sisyphean qual­i­ties no mat­ter what it does.

Fur­ther­more, No­vavax has hired Nasir Egal away from Sanofi to be SVP of qual­i­ty as­sur­ance. Egal round­ed out near­ly 10 years at Sanofi by lead­ing glob­al qual­i­ty ex­ter­nal af­fairs, and be­fore that, he was re­spon­si­ble for qual­i­ty and com­pli­ance in sev­er­al re­gions for No­var­tis.

Pat Cotro­neo

→ Fi­nal­ly catch­ing a break with Eu­rope’s ap­proval of rox­adu­s­tat af­ter the FDA re­ject­ed it last week, Fi­bro­Gen is chang­ing CFOs, with Pat Cotro­neo re­tir­ing on La­bor Day to pave the way for Juan Gra­ham on Sept. 7. Thus ends a 20-year as­so­ci­a­tion with J&J for Gra­ham, the last two of those years as glob­al CFO / VP, fi­nance sup­ply chain. Cotro­neo had served as CFO since 2007 and will be CEO En­rique Con­ter­no’s ex­ec­u­tive ad­vi­sor un­til March 31, 2022. A month ago, CSO Per­cy Carter came on board the same week that an FDA ad­comm vot­ed against the ane­mia drug by wide mar­gins.

Anne White

→ Us­ing the Aduhelm af­fair to make the case for its own po­ten­tial Alzheimer’s com­peti­tor do­nanemab, Eli Lil­ly is caught up in the fer­vor and has split Lil­ly Bio­med­i­cines in­to Lil­ly Neu­ro­science and Lil­ly Im­munol­o­gy. Anne White, pres­i­dent of Lil­ly On­col­o­gy, will now be pres­i­dent of Lil­ly Neu­ro­science, while Loxo On­col­o­gy at Lil­ly CEO Jake van Naar­den will re­place her and be re­spon­si­ble for bring­ing Loxo and Lil­ly On­col­o­gy’s brands to­geth­er. Pa­trik Jöns­son, a Lil­ly staffer since 1990, has been ap­point­ed pres­i­dent of Lil­ly Im­munol­o­gy and will al­so con­tin­ue in his du­ties as SVP and pres­i­dent, Lil­ly USA and chief cus­tomer of­fi­cer.

Ad­di­tion­al­ly, Lil­ly In­ter­na­tion­al pres­i­dent Al­fon­so “Chi­to” Zu­lue­ta is re­tir­ing at the end of the year, with Lil­ly Bio­med­i­cines pres­i­dent Ilya Yuf­fa wait­ing to suc­ceed him. Zu­lue­ta has been with the phar­ma gi­ant since 1988, while Yuf­fa has de­vot­ed near­ly a quar­ter cen­tu­ry to Lil­ly. Our Kyle Blanken­ship has more on this cas­cade of changes.

Michael Pari­ni

Free­line Ther­a­peu­tics is plac­ing enough con­fi­dence in Michael Pari­ni on­ly five months in­to his tenure as pres­i­dent and COO to pro­mote him to CEO. There­sa Heg­gie leaves Free­line af­ter an 18-month run that was marked by the Lon­don biotech’s IPO in Au­gust 2020 and a two-year de­lay on a piv­otal tri­al for he­mo­phil­ia B can­di­date FLT180a six months lat­er be­cause of CMC is­sues. Be­fore Pari­ni climbed aboard on March 15, Pari­ni was EVP and chief ad­min­is­tra­tive, le­gal and busi­ness de­vel­op­ment of­fi­cer at Ver­tex.

Wolf­gang Brysch

→ There’s a pass­ing of the torch forth­com­ing at Swiss-based Metrio­Pharm — fo­cused on chron­ic in­flam­ma­to­ry dis­eases — as Thomas Christé­ly takes over the CEO job from Wolf­gang Brysch start­ing Oct. 1. Brysch, who co-found­ed Metrio­Pharm and has been chief ex­ec­u­tive since 2016, will set­tle in­to the dual roles of CSO and CMO. Christé­ly was man­ag­ing di­rec­tor and CFO of Ger­man HDV and HBV play­er MYR GmbH, which an­nounced its sale to Gilead in De­cem­ber for $1.7 bil­lion be­fore Gilead’s head of vi­rol­o­gy Di­ana Brainard jumped to AlloVir.

→ RNA pro­cess­ing biotech Remix Ther­a­peu­tics brought out the VIPs in its Se­ries A round as ARCH, Fore­site, The Col­umn Group and At­las all par­tic­i­pat­ed. Pres­i­dent and CSO Pe­ter Smith, an en­tre­pre­neur in res­i­dence at At­las, has been bumped up to pres­i­dent and CEO at Remix eight months af­ter its launch. For­mer­ly in the on­col­o­gy group at Mil­len­ni­um/Take­da, Smith was CSO at H3 Bio­med­i­cine be­fore co-found­ing Remix with At­las part­ner Kevin Bit­ter­man.

→ Un­like Fi­bro­Gen, My­ovant and Pfiz­er earned the FDA’s ap­proval with Myfem­bree for heavy men­stru­al bleed­ing as­so­ci­at­ed with uter­ine fi­broids in May, and on Sept. 7, My­ovant wel­comes Un­eek Mehra as chief fi­nan­cial and busi­ness of­fi­cer. Mehra, the CFO at PACT Phar­ma since Oc­to­ber 2019, spent 13 years with No­var­tis in a num­ber of ca­pac­i­ties, from CFO of the US in­te­grat­ed care and crit­i­cal care busi­ness units to glob­al head of port­fo­lio man­age­ment, li­cens­ing and M&A for the on­col­o­gy busi­ness. The Myfem­bree ap­proval was an ear­ly win for My­ovant CEO David Marek, who re­placed Lynn Seely at the start of 2021.

Richard Buck­ley

Richard Buck­ley has part­ed ways with As­traZeneca to be­come chief cor­po­rate af­fairs of­fi­cer at EQRx, one of many com­pa­nies get­ting in on the SPAC craze by re­verse merg­ing with CM Life Sci­ences III in a deal worth $1.8 bil­lion. To close out his 17 years at As­traZeneca, Buck­ley was Pas­cal So­ri­ot’s VP, glob­al cor­po­rate af­fairs, and has al­so served as Eli Lil­ly’s di­rec­tor of fed­er­al gov­ern­ment af­fairs. Mak­ing cheap­er drug prices their main ob­jec­tive, EQRx al­so made a CEO change when the SPAC deal was an­nounced, as pres­i­dent and COO Melanie Nal­licheri takes the top spot and Alex­is Borisy shifts to the role of chair­man on Sept. 1.

→ A sea of Yu­man­i­ty: There’s been no short­age of hir­ing at Yu­man­i­ty since it re­verse merged last sum­mer with Pro­teosta­sis Ther­a­peu­tics, and CFO Michael Wyz­ga con­tin­ues the trend. Wyz­ga, who was VP in the health­care in­vest­ment bank­ing group dur­ing his eight years at Need­ham & Com­pa­ny, joins the list of such new­com­ers as head of R&D Ajay Ver­ma and gen­er­al coun­sel Devin Smith.

Lin­da Couto

→ North Car­oli­na-based gene ther­a­py group At­se­na Ther­a­peu­tics, which land­ed a $55 mil­lion Se­ries A in De­cem­ber for clin­i­cal tri­als on oc­u­lar gene ther­a­py, has brought on Lin­da Couto as its new CSO. For­mer­ly the head of phar­ma­col­o­gy, tox­i­col­o­gy and oc­u­lar re­search at Spark Ther­a­peu­tics, Couto joins Spark co-founder Jen­nifer Well­man at At­se­na, who was named to the board of di­rec­tors last month.

→ Port­land-based start­up Spar­row Phar­ma­ceu­ti­cals, look­ing to cut down cor­ti­cos­teroid use with its lead can­di­date SPI-62, has tapped Frank Cz­er­wiec as CMO and Jamie MacPher­son as VP of reg­u­la­to­ry af­fairs and qual­i­ty. Af­ter 20 years with Ot­su­ka, Cz­er­wiec be­came CMO at Goldfinch Bio, a po­si­tion he had held since De­cem­ber 2018. And MacPher­son, the ex-di­rec­tor of reg­u­la­to­ry af­fairs at Alex­ion, has been a reg­u­la­to­ry ex­ec with Akcea the last four years. Or­biMed-backed Spar­row took flight in May with $50 mil­lion in Se­ries A fi­nanc­ing.

Ju­bi­lant Ther­a­peu­tics has re­cruit­ed Leila Al­land to its board of di­rec­tors and Je­re­my Bar­ton as strate­gic ad­vi­sor and in­ter­im CMO. Al­land cur­rent­ly serves as CMO of PMV Phar­ma­ceu­ti­cals and was pre­vi­ous­ly the CMO of Af­fimed and Tarve­da Ther­a­peu­tics. As for Bar­ton, he was pre­vi­ous­ly CMO at Bio­gen, eF­FEC­TOR Ther­a­peu­tics and Mi­rati Ther­a­peu­tics. In ad­di­tion to those stints, Bar­ton was head of ear­ly on­col­o­gy de­vel­op­ment at Pfiz­er.

Jeff Gulcher

→ Con­cur­rent with the Ge­nu­ity Sci­ence buy­out, Hi­ber­Cell has poached sev­er­al Ge­nu­ity em­ploy­ees: Chief tech­nol­o­gy of­fi­cer Tom Chit­ten­den has been with the com­pa­ny since 2015 and was once chief da­ta sci­ence of­fi­cer; Ge­nu­ity co-founder and CSO Jeff Gulcher be­comes CSO of ge­nomics; and chief in­for­mat­ics of­fi­cer Hákon Guðb­jarts­son is Gulcher’s long­time col­league from their days at de­CODE ge­net­ics and, be­fore it be­came Ge­nu­ity, NextCode Health. The $100 mil­lion all-stock deal comes af­ter Hi­ber­Cell’s $67.4 mil­lion Se­ries B raise in May, all part of the biotech’s quest to see how stress bi­ol­o­gy and in­nate im­mu­ni­ty con­tribute to can­cer re­cur­rence.

→ Im­munother­a­py start­up Im­mu­ni­tas Ther­a­peu­tics pro­mot­ed Aman­da Wag­n­er this week to CBO, cou­pled with Im­mu­ni­tas’ re­cent suc­cess in ob­tain­ing $58 mil­lion in Se­ries B fi­nanc­ing for their lead pro­gram, a CD161-block­ing an­ti­body. Wag­n­er was one of the ear­li­est em­ploy­ees when she joined Im­mu­ni­tas in Oc­to­ber 2019 as VP of strat­e­gy, one month be­fore they of­fi­cial­ly launched. Be­fore join­ing Im­mu­ni­tas, she was VP of cor­po­rate de­vel­op­ment at Q32 Bio af­ter leav­ing Con­cert Phar­ma­ceu­ti­cals, where she was VP of busi­ness de­vel­op­ment and prod­uct strat­e­gy for a decade.

Tushar Mis­ra

→ An­ti­body-drug con­ju­gate (ADC) biotech Mer­sana Ther­a­peu­tics re­cent­ly hired Tushar Mis­ra as their CMO, suc­ceed­ing the re­tir­ing Michael Kauf­man, who will stay for a tran­si­tion pe­ri­od that lasts un­til Sept. 10. A Take­da and Wave Life Sci­ences alum, Mis­ra was the for­mer head of man­u­fac­tur­ing at Flag­ship-backed Laronde, a biotech start­up led by Diego Mi­ralles that of­fi­cial­ly launched in May with a $50 mil­lion Se­ries A.

→ Go­ing pub­lic in Feb­ru­ary with the help of SPAC-ti­cian Ra­jiv Shuk­la in a $255 mil­lion deal, Lau­ra Nikla­son-led Hu­ma­cyte has locked in B.J. Scheesse­le as chief com­mer­cial of­fi­cer. Scheesse­le, a for­mer mar­ket­ing di­rec­tor at Life­Cell who stayed on at Al­ler­gan when Brent Saun­ders pur­chased the com­pa­ny in 2017, com­pletes a three-year stay as Quest Med­ical Imag­ing’s EVP of glob­al mar­ket­ing.

Caryn Parlavec­chio

→ Long­time No­var­tis vet Caryn Parlavec­chio has signed on as chief hu­man re­sources of­fi­cer at Cam­bridge, MA-based Schol­ar Rock, which just re­placed CEO Tony Kings­ley a cou­ple weeks ago with founder Nagesh Ma­han­thap­pa. Parlavec­chio rose to VP and glob­al HR head, on­col­o­gy and phar­ma de­vel­op­ment dur­ing her 19 years at No­var­tis, and for the last year she’s been chief hu­man re­sources of­fi­cer at Holy Name Med­ical Cen­ter in Tea­neck, NJ.

→ Chi­na-based bio­con­ju­gate de­vel­op­er GeneQuan­tum Health­care has se­lect­ed Kai­da Wu as CMO. His ex­pe­ri­ence reads like a ver­i­ta­ble who’s-who of phar­ma: more than five years as a sci­en­tist of dis­cov­ery med­i­cine at As­traZeneca; three years as an on­col­o­gy re­search in­ves­ti­ga­tor at Sanofi; an­oth­er three years at Janssen; and fi­nal­ly, the last four years at Cel­gene/Bris­tol My­ers Squibb, where he was re­cent­ly in­volved in hema­tol­ogy/on­col­o­gy and cell ther­a­py (HOCT) at the Mech­a­nisms of Can­cer Re­sis­tance The­mat­ic Re­search Cen­ter.

Cyn­thia Hu

→ Hear­ing loss biotech Deci­bel Ther­a­peu­tics — which fol­lowed its Se­ries D fi­nanc­ing with a nine-fig­ure IPO in Feb­ru­ary — has named Cyn­thia Hu chief le­gal of­fi­cer and cor­po­rate sec­re­tary. Hu joined CASI Phar­ma­ceu­ti­cals back in 2006 when it was known as En­treMed and was COO as well as VP, gen­er­al coun­sel and sec­re­tary. In June, ex-Ot­su­ka CEO William Car­son be­came chair­man of Deci­bel’s board.

→ This isn’t Evan Bal­lan­tyne’s first rodeo in the CFO seat as he hops aboard to take on the ti­tle at On­cX­er­na Ther­a­peu­tics. Bal­lan­tyne has served as the CFO of sev­er­al com­pa­nies, in­clud­ing Or­ches­tra Bio­med, Cerecin, Clin­i­cal Da­ta, Syn­thet­ic Bi­o­log­ics, Ave­dro and ZymeQuest.

Sarah Glass

→ Found­ed and chaired by CEO Stan­ley Crooke, the non-prof­it n-Lorem Foun­da­tion has brought in its first-ever chief de­vel­op­ment of­fi­cer with the ap­point­ment of Sarah Glass. Glass joins the com­pa­ny from Parex­el, where she served as glob­al head of rare dis­eases.

→ Am­s­ter­dam-based Lu­micks has en­list­ed Paul Wheel­er to be the com­pa­ny’s first CCO. Wheel­er brings with him ex­pe­ri­ence from his time at Lu­minex, Mer­ck, PRW Bio­science, Sin­gulex, Gy­ros, Ox­ford Im­munotec and Gua­va Tech­nolo­gies.

Vanes­sa Ri­breau

→ AI com­pa­ny Bench­Sci has wel­comed Vanes­sa Ri­breau as chief peo­ple of­fi­cer. Ri­breau was for­mer­ly the glob­al VP of peo­ple, places, and tech­nolo­gies at Alay­aCare. Ad­di­tion­al­ly, Bench­Sci has pulled out a seat for Boni­ta Stew­art on its board of di­rec­tors. Stew­art is a board part­ner at Google‘s ven­ture fund Gra­di­ent Ven­tures. Pri­or to that role, Stew­art spent 15 years at Google, most re­cent­ly serv­ing as their VP, glob­al part­ner­ships.

Re­cur­sion made every­one take no­tice with a gar­gan­tu­an $436 mil­lion IPO in April, and the Salt Lake City-based AI drug de­vel­op­er has now en­list­ed Jor­dan Chris­tensen as VP of en­gi­neer­ing. Since 2017, Chris­tensen has been VP of en­gi­neer­ing at ecobee, which spe­cial­izes in smart ther­mostats and oth­er home au­toma­tion tech­nol­o­gy.

→ All too ac­cus­tomed to FDA road­blocks with its Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py, Sol­id Bio has pegged Michael In­bar as VP of fi­nance. In­bar, a for­mer as­so­ciate di­rec­tor of SEC re­port­ing at Ac­celeron, has spent the last four years as VP, ac­count­ing and cor­po­rate con­troller at Sy­ros Phar­ma­ceu­ti­cals. Sol­id Bio has re­mained ac­tive on Peer Re­view this year since the pro­mo­tion of COO Joel Schnei­der with the ap­point­ment of a chief reg­u­la­to­ry of­fi­cer and SVP of clin­i­cal de­vel­op­ment, among oth­er new ex­ecs.

Angèle Ma­ki

Re­Code Ther­a­peu­tics, the ge­net­ic med­i­cines biotech backed by MPM and Or­biMed and led by for­mer Am­i­cus CSO David Lock­hart, has brought on Angèle Ma­ki as SVP of busi­ness de­vel­op­ment. Ma­ki hails from Eli Lil­ly, where she was the In­di­anapo­lis phar­ma’s VP, ven­ture sci­ence, cor­po­rate busi­ness de­vel­op­ment, and she al­so owns BD ex­pe­ri­ence at Genen­tech, 23andMe and Mer­ck.

Mary Cole­man has been named VP, head of in­vestor re­la­tions with Fir­dapse mak­er Cat­a­lyst Phar­ma­ceu­ti­cals out of the Mi­a­mi area. Cole­man, who just held the same ti­tle at BioX­cel, was VP, in­vestor re­la­tions and com­mu­ni­ca­tions for Ju­bi­lant Phar­ma­ceu­ti­cals and cov­ered sim­i­lar bases dur­ing her time as se­nior di­rec­tor at Savient Phar­ma­ceu­ti­cals from 2007-13.

Pre­mier Re­search has brought some new ex­ecs in­to the fold with the ap­point­ments of Sla­womir Wo­j­tow­icz-Pra­ga (VP, glob­al head of med­ical af­fairs), Ayesha Pan­dit (VP, med­ical on­col­o­gy strat­e­gy), and Ash­ley Her­rick (ex­ec­u­tive di­rec­tor, on­col­o­gy strat­e­gy). Wo­j­tow­icz-Pra­ga hops aboard with ex­pe­ri­ence from stints at Genen­tech/Roche, Talon Ther­a­peu­tics, Sankyo Phar­ma De­vel­op­ment, Aven­tis and Ther­adex. Mean­while, Pan­dit pre­vi­ous­ly served in roles at Ab­b­Vie, J&J and the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter. Last, but not least, Her­rick joins from MD An­der­son, where she served as se­nior clin­i­cal re­search pro­gram co­or­di­na­tor.

Mark Gold­berg

Mark Gold­berg is adding an­oth­er stint to his ré­sumé as non-ex­ec­u­tive di­rec­tor of can­cer im­munother­a­py-fo­cused Avac­ta. Gold­berg is a med­ical on­col­o­gist and hema­tol­o­gist on the fac­ul­ty of Brigham & Women’s Hos­pi­tal and Har­vard Med­ical School. Cur­rent­ly, Gold­berg sits on the board of di­rec­tors of Im­muno­Gen, Idera Phar­ma­ceu­ti­cals, Gly­coMimet­ics, Walden Bio­sciences and Blue­print Med­i­cines. In ad­di­tion, Gold­berg pre­vi­ous­ly served on the board of Au­dentes.

→ Backed by the Uni­ver­si­ty of Pitts­burgh Med­ical Cen­ter, T cell ther­a­py play­er Blue­Sphere Bio has made ex-Am­gen CFO Jonathan Pea­cock chair­man of the board. Pea­cock is al­so a board mem­ber at Gen­mab and UCB, and he’s the lead di­rec­tor at Avan­tor.

Sara Bon­stein

→ Equipped with a Se­ries C round to pro­pel its an­ti-CT­LA-4 an­ti­body and IL-2 ag­o­nist in­to the clin­ic, Xilio Ther­a­peu­tics has elect­ed Sara Bon­stein to the board of di­rec­tors. Cur­rent­ly the CFO at In­smed, Bon­stein was al­so CFO and COO at On­coSec from 2018-20.

Neil Ku­mar’s Bridge­Bio has a trio of new board mem­bers, with for­mer Scher­ing-Plough CEO and cur­rent War­burg Pin­cus part­ner Fred Has­san lead­ing the group. An­drea El­lis, the CFO of trans­porta­tion out­fit Lime, and for­mer AIG chief in­vest­ment of­fi­cer Dou­glas Dachille al­so have seats on the board.

Tama­ra Sey­mour has hopped on­to the board of di­rec­tors of Kem­Pharm. Sey­mour cur­rent­ly sits on the board of Arte­lo Bio­sciences and Kin­tara Ther­a­peu­tics. Pre­vi­ous­ly, Sey­mour has served as CFO of Sig­nal Ge­net­ics (now Virid­i­an Ther­a­peu­tics) and HemaQue­st Phar­ma­ceu­ti­cals.

Scott Gar­land

→ PACT Phar­ma CEO Scott Gar­land has joined the board of di­rec­tors at pe­di­atric can­cer biotech Day One Bio­phar­ma­ceu­ti­cals, which raised $160 mil­lion in an up­sized IPO this spring. The Mer­ck, Am­gen and Genen­tech vet al­so helmed Por­to­la from 2018 un­til Alex­ion’s 2020 ac­qui­si­tion.

Rekha Hem­ra­jani and Ja­son Colo­ma have been giv­en seats on the board of di­rec­tors at an­ti-ag­ing up­start BioAge Labs — a board that al­so in­cludes Vi­jay Pande. The ex-pres­i­dent and CEO of Ar­a­vive, Hem­ra­jani is on the boards of Max­Cyte and ALX On­col­o­gy, while Colo­ma has helmed Maze Ther­a­peu­tics since 2019.

David En­loe

Vi­ro­Cell Bi­o­log­ics has tapped Re­cro Phar­ma CEO David En­loe to be a part of its board of di­rec­tors. Pri­or to his cur­rent role, En­loe was pres­i­dent and CEO of Aji­nomo­to Bio-Phar­ma Ser­vices and head of Lon­za’s vi­ral ther­a­peu­tics busi­ness unit. In ad­di­tion to En­loe’s ap­point­ment, the com­pa­ny has al­so brought on CAR-T ex­pert Mar­tin Pule to its sci­en­tif­ic ad­vi­so­ry board.

→ Gas­troin­testi­nal dis­ease-fo­cused Azur­Rx Bio­Phar­ma has added BioDe­liv­ery Sci­ences EVP and CFO Ter­ry Coel­ho to the board of di­rec­tors. Coel­ho spent the back half of her sev­en years at No­var­tis as glob­al head of on­col­o­gy de­vel­op­ment fi­nance.

→ San Diego-based Oton­o­my has reeled in Jill Broad­foot to its board of di­rec­tors. Broad­foot cur­rent­ly serves as the CFO of aTyr Phar­ma and has pre­vi­ous­ly been the CFO of Emer­ald Health Phar­ma­ceu­ti­cals and Emer­ald Health Bio­ceu­ti­cals. Ad­di­tion­al­ly, she has held roles at GW Phar­ma­ceu­ti­cals and Vi­cal.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.