Boehringer In­gel­heim nabs new US pres­i­dent and CEO; As­traZeneca vet hops aboard No­vavax as CMO

Jean-Michel Boers

Jean-Michel Boers, who joined Boehringer In­gel­heim in 1998, is step­ping in as US pres­i­dent and CEO. He suc­ceeds Wolf­gang Baik­er, who is re­tir­ing af­ter 31 years with the com­pa­ny. Af­ter start­ing out at Boehringer In­gel­heim 22 years ago in Bel­gium as head of busi­ness in­for­ma­tion and sup­port, Boers has steadi­ly worked his way up the lad­der in more promi­nent lead­er­ship roles. He has led the US hu­man phar­ma busi­ness at the Ger­man drug­mak­er since Jan­u­ary 2017.

Baik­er took over from Paul Fonteyne in 2018 and pri­or to that had been Boehringer In­gel­heim’s SVP and the head of the bio­phar­ma busi­ness unit. His re­tire­ment is ef­fec­tive Ju­ly 31.

Vaxart, which was on the ini­tial 18-name short­list for Op­er­a­tion Warp Speed, is chang­ing CEOs as the South San Fran­cis­co biotech looks to pick up the pace on their oral tablet Covid-19 vac­cine can­di­date. An­drei Floroiu grabs hold of the reins, suc­ceed­ing Wouter La­tour, who had been CEO since 2011. La­tour will stay on as chair­man of the board. Be­fore tak­ing over at Vaxart, Floroiu was an ex­ec at Agenus and man­ag­ing di­rec­tor at Ex­i­go Cap­i­tal.

Lau­rent Fis­ch­er

→ Gene ther­a­py play­er Ad­verum, which re­cent­ly re­port­ed pos­i­tive in­ter­im da­ta for its Phase I tri­al, has brought on Lau­rent Fis­ch­er as CEO. Leone Pat­ter­son, who has served as CEO for four years, will be hand­ing the reins over and con­tin­ue serv­ing as the com­pa­ny’s pres­i­dent. Most re­cent­ly, Fis­ch­er served as SVP and head of the liv­er ther­a­peu­tic area at Al­ler­gan. Pre­vi­ous­ly, he served as chair­man and CEO of To­bi­ra Ther­a­peu­tics (ac­quired by Al­ler­gan in 2016) and has served in lead­er­ship roles at Jen­nerex, Aux­eris Ther­a­peu­tics and Ocera Ther­a­peu­tics.

→ Ex-Cel­gene CEO Bob Hug­in has added an­oth­er board ap­point­ment to his ré­sumé. Hug­in has joined Yale spin­out Bio­haven‘s board of di­rec­tors. Hug­in left Cel­gene in 2018 amongst ru­mors of him run­ning for Sen­ate in New Jer­sey. Hug­in jumped back in­to the in­dus­try in 2019, af­ter an un­suc­cess­ful run for Sen­ate, join­ing em­bat­tled Al­ler­gan‘s board of di­rec­tors.

Stéphane Ban­cel con­tin­ues to shore up the lead­er­ship team at Mod­er­na as the biotech jock­eys for po­si­tion on their Covid-19 vac­cine. Not long af­ter David Meline joined Mod­er­na as CFO, fel­low Am­gen vet Ray Jor­dan has as­sumed the role of chief cor­po­rate af­fairs of­fi­cer. From 2012-19, Jor­dan was Am­gen’s SVP, cor­po­rate af­fairs. The Big Phar­ma ex­pe­ri­ence is ex­ten­sive for Jor­dan, hav­ing been at J&J for 9 years and spent 17 years at Pfiz­er, round­ing out his tenure there as VP, com­mu­ni­ca­tions and in­for­ma­tion.

Fil­ip Dubovsky

→ Re­ceiv­ing $200 mil­lion worth of back­ing from RA Cap­i­tal this week for their Covid-19 vac­cine can­di­date, No­vavax is boost­ing its ex­ec­u­tive team by en­list­ing As­traZeneca vet Fil­ip Dubovsky as SVP and CMO, and Sil­via Tay­lor as SVP, in­vestor re­la­tions and cor­po­rate af­fairs. Dubovsky was As­traZeneca’s head of clin­i­cal en­gage­ment and pol­i­cy and deputy CMO for clin­i­cal af­fairs be­fore jump­ing to No­vavax. Tay­lor left Au­to­lus as VP of glob­al cor­po­rate af­fairs and com­mu­ni­ca­tions.

Sil­via Tay­lor

No­vavax has al­so added David Mott to their board of di­rec­tors. Mott hit the ex­it at New En­ter­prise As­so­ci­ates back in March and is chair­man of the board at Adap­ti­m­mune, Arde­lyx, Epizyme, Imara and Mer­sana.

Ju­lia Berret­ta has tak­en the helm as CEO at Mi­lan-based start­up Ep­silen Bio, a spin­off of the San Raf­faele Telethon In­sti­tute for Gene Ther­a­py (SR-Tiget). In ad­di­tion to lead­ing Ep­silen Bio, on the heels of clos­ing €2.3 mil­lion in fi­nanc­ing from Sofinno­va Part­ners, Berret­ta is CEO of Sofinno­va-backed Gene­spire. Berret­ta pre­vi­ous­ly moved through the ranks at Cel­lec­tis, round­ing out her tenure as VP, busi­ness de­vel­op­ment and strate­gic plan­ning. Ad­di­tion­al­ly, ex-Cel­lec­tis EVP and COO Math­ieu Si­mon will be chair­man of Ep­silen Bio’s board.

Nicole McK­night

→ Not on­ly is Am­abi­otics chang­ing its name, they’re chang­ing CEOs. What was for­mer­ly Am­abi­otics, whose mi­cro­bio­me-de­rived plat­form tar­gets dis­eases such as Parkin­son’s and Alzheimer’s, is now Stel­late Ther­a­peu­tics, with Nicole McK­night as the new CEO. She suc­ceeds Patrice Gar­nier, who led the biotech since 2015 and will con­tin­ue as chair­man and pres­i­dent. McK­night head­ed up the com­pa­ny’s New York of­fice be­fore tak­ing over ef­fec­tive May 18. Stel­late al­so named two peo­ple to their strate­gic ad­vi­so­ry board, Bernard Munos and Robert Schnei­der.

→ Ef­fec­tive Sept. 7, Thomas Loe­wold is jump­ing on board at API man­u­fac­tur­er Cam­brex as CEO and as a board mem­ber. For now, Cam­brex is led by an of­fice of the CEO that in­cludes chair­man Wayne Hewett. Loe­wold is cur­rent­ly pres­i­dent of the flex­i­bles di­vi­sion at pack­ag­ing man­u­fac­tur­er ProAm­pac. From 2012 to 2017, Loe­wold held nu­mer­ous po­si­tions at Ther­mo Fish­er Sci­en­tif­ic, even­tu­al­ly be­com­ing their chief com­mer­cial of­fi­cer.

Zomed­ica Phar­ma­ceu­ti­cals, a vet­eri­nary di­ag­nos­tic com­pa­ny, has named Robert Co­hen as in­ter­im CEO of the com­pa­ny. Co­hen takes over from Shameze Ram­pertab — act­ing in­ter­im CEO of the com­pa­ny — who will re­sume his du­ties as CFO. Co­hen joins the com­pa­ny af­ter serv­ing as pres­i­dent and CEO of Em­boMedics. Co­hen has pre­vi­ous­ly as­sumed lead­er­ship roles at Miro­ma­trix Med­ical and Tra­van­ti Phar­ma and jump­start­ed his ca­reer at Pfiz­er, where he spent a lit­tle over a decade.

Stephen Eck

→ Buoyed by can­cer drug da­ta un­veiled in AS­CO ab­stracts, par­tic­u­lar­ly in the HER2 space, Mary­land-based Macro­Gen­ics has wel­comed Stephen Eck as CMO and SVP, clin­i­cal de­vel­op­ment. The Pfiz­er and Eli Lil­ly vet had most re­cent­ly been CMO at Im­mat­ics US and pres­i­dent and CEO of Ar­a­vive Bi­o­log­ics. Pri­or to those roles, Eck was at Astel­las Phar­ma as VP and glob­al head of on­col­o­gy med­ical sci­ences.

→ Ef­fec­tive Ju­ly 6, Frank Sanders will be­come US pres­i­dent of pep­tide-based med­i­cine biotech Zealand Phar­ma. Sanders will lead from the Boston of­fice at Zealand, found­ed and based in Copen­hagen and con­tin­u­ing to make ac­qui­si­tions, such as the pur­chase of di­a­betes-fo­cused Va­ler­i­tas in Feb­ru­ary. Sanders was pre­vi­ous­ly the gen­er­al man­ag­er of the US com­mer­cial team at Sage Ther­a­peu­tics and al­so held po­si­tions at J&J and GSK.

→ With a lead prod­uct can­di­date be­ing pre­pared for clin­i­cal de­vel­op­ment to treat Duchenne and Beck­er mus­cu­lar dy­s­tro­phy, Col­orado-based Edge­wise Ther­a­peu­tics has re­cruit­ed Kirsten Gruis as their CMO. Gruis was the glob­al head of the neu­ro­mus­cu­lar fran­chise for Roche be­fore head­ing to Edge­wise. She was al­so the CMO at Ag­ilis Bio­ther­a­peu­tics and has al­so held lead­er­ship po­si­tions at WAVE Life Sci­ences, Al­ny­lam and Pfiz­er.

→ A cou­ple of staff moves are tak­ing place at pro­tein degra­da­tion spe­cial­ist Nurix Ther­a­peu­tics, which nabbed $120 mil­lion in fi­nanc­ing and is part­nered with Sanofi and Gilead. Michael Lotze moves in­to the role of chief cel­lu­lar ther­a­py of­fi­cer and Robert Brown is on board as VP of clin­i­cal de­vel­op­ment. A long­time pres­ence at the Uni­ver­si­ty of Pitts­burgh’s De­part­ment of Surgery, Lotze has pre­vi­ous­ly been the CSO at Io­vance (when it was then Li­on Biotech­nolo­gies) and VP of re­search at GSK. Be­fore Nurix, Brown had led cel­lu­lar ther­a­py de­vel­op­ment pro­grams at Al­lo­gene.

Am­baw Bel­lette

→ Cam­bridge, MA-based gene ther­a­py com­pa­ny Fer­Gene, the Fer­ring spin­out fo­cused on treat­ing blad­der can­cer, al­so has sev­er­al new faces. Am­baw Bel­lette, the new chief op­er­at­ing of­fi­cer, was the pres­i­dent of Pho­to­cure, al­so with a blad­der can­cer fo­cus. Vi­jay Kas­turi, who has been named VP of med­ical af­fairs, comes to Fer­Gene af­ter 4 ½ years at EMD Serono, where he even­tu­al­ly moved his way up to head of US med­ical af­fairs, on­col­o­gy. Fur­ther­more, blue­bird bio vet Pe­ter Ola­gun­ju is now Fer­Gene’s SVP of tech­ni­cal op­er­a­tions. Ola­gun­ju was blue­bird’s VP, glob­al pa­tient op­er­a­tions.

→ Af­ter cor­ralling a new CFO at the be­gin­ning of 2020, an­ti-in­fec­tive im­munother­a­py play­er Aridis Phar­ma­ceu­ti­cals is bring­ing in As­traZeneca vet Hasan Jafri as CMO. Paul Mendel­man had been in­ter­im CMO at Aridis since Oc­to­ber and will now be a se­nior med­ical ad­vi­sor. Jafri had been As­traZeneca’s se­nior med­ical di­rec­tor, clin­i­cal re­search and de­vel­op­ment, mi­cro­bial sci­ences, as well as the clin­i­cal head of the an­tibac­te­r­i­al mon­o­clon­al an­ti­bod­ies pro­gram.

Marie-Louise Fjäll­skog

Marie-Louise Fjäll­skog is head­ed to im­muno-on­col­o­gy play­er Sen­sei Bio­ther­a­peu­tics as their CMO. Fjäll­skog swings in­to Sen­sei af­ter a year as VP, clin­i­cal de­vel­op­ment at Merus. Pre­vi­ous stops in­clude In­fin­i­ty Phar­ma­ceu­ti­cals as VP, clin­i­cal de­vel­op­ment and the No­var­tis In­sti­tute for Bio­med­ical Re­search as clin­i­cal pro­gram leader, trans­la­tion­al clin­i­cal on­col­o­gy.

Mer­ck vet Christo­pher Dins­more has signed on at Nor­bert Bischof­berg­er-led Kro­nos Bio as their CSO. Be­fore get­ting start­ed at Kro­nos, Dins­more was an en­tre­pre­neur-in-res­i­dence at Third Rock Ven­tures. He was at For­ma Ther­a­peu­tics from 2013-19, most re­cent­ly as VP, head of chem­istry. Be­fore that, he spent 19 years at Mer­ck Re­search Lab­o­ra­to­ries, cul­mi­nat­ing in his tenure as ex­ec­u­tive di­rec­tor, dis­cov­ery chem­istry.

→ Rare dis­ease AI up­start Healx — which raised $56 mil­lion in Se­ries B fi­nanc­ing last Oc­to­ber — has ap­point­ed Meri Williams as chief tech­nol­o­gy of­fi­cer. Williams joins the com­pa­ny from chal­lenger bank Mon­zo and has had ex­pe­ri­ence serv­ing at Marks and Spencer and Proc­ter & Gam­ble.

Clin­ton Musil

→ Start­ing Ju­ly 1, Clin­ton Musil will be the CFO at Cat­a­lyst Bio­sciences, which is part­ner­ing with Bio­gen on a pre­clin­i­cal can­di­date for dry age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD). Musil was pre­vi­ous­ly the CBO at Per­son­alis and the VP of cor­po­rate de­vel­op­ment at AR­MO Bio­sciences, shep­herd­ing their IPO and $1.6 bil­lion sale to Eli Lil­ly.

→ At Ren­o­vaCare, a de­vel­op­er of au­tol­o­gous stem cell ther­a­pies, Robert Cook has been ap­point­ed CFO and board sec­re­tary, a week af­ter the com­pa­ny named Jo Ellen Schwein­le their CMO. Cook had held the CFO post at CorMedix and at a string of oth­er phar­mas pri­or to that such as BioBlast Phar­ma, Im­mune Phar­ma­ceu­ti­cals and Phar­mos Cor­po­ra­tion.

→ Di­a­betes-fo­cused med­ical de­vice com­pa­ny Big­foot Bio­med­ical has reeled in Eli Lil­ly vet Jim Mal­one as CMO. Dur­ing his 21-year stint at Eli Lil­ly, Mal­one, an en­docri­nol­o­gist, served in clin­i­cal re­search.

→ Stock­holm-based im­mune-on­col­o­gy biotech Al­li­ga­tor Bio­science has re­cruit­ed Marie Svens­son as CFO. She as­sumes her new role Sept. 1, and un­til then, An­dreas Jo­han­nes­son will con­tin­ue as in­ter­im CFO. Svens­son is cur­rent­ly CFO at In­Coax Net­works.

→ Mi­croR­NA biotech mi­Ra­gen Ther­a­peu­tics has en­list­ed Lee Rauch as COO. Rauch has held posts as CBO of Glob­al Blood Ther­a­peu­tics, in­ter­im CBO of Onyx Phar­ma­ceu­ti­cals and pres­i­dent and CEO of Nuon Ther­a­peu­tics among oth­ers.

Bay­er-part­nered Dew­point Ther­a­peu­tics is adding a pair of big-name phar­ma vets as it looks to make drugs tar­get­ing bio­mol­e­c­u­lar con­den­sates a re­al­i­ty. The Cam­bridge biotech will add for­mer Sanofi CEO Olivi­er Brandi­court and the head of Bay­er’s ven­ture arm, Jür­gen Eck­hardt, to its board. Though both MDs, the pair have held long ca­reers on the busi­ness side of the in­dus­try, which is where their in­sight will be need­ed most, said Dew­point CEO Amir Nashat.

→ New Haven, CT-based rare dis­ease phar­ma Rally­bio has se­lect­ed long­time Pfiz­er vet Jack­ie Schu­mach­er to lead glob­al reg­u­la­to­ry af­fairs. Schu­mach­er was VP of reg­u­la­to­ry and qual­i­ty at Lyn­dra Ther­a­peu­tics from 2017-19 af­ter leav­ing Pfiz­er, where she was in the chem­istry, man­u­fac­tur­ing, and con­trols (CMC) reg­u­la­to­ry or­ga­ni­za­tion.

Kia Mote­sharei

→ AI start­up BioX­cel Ther­a­peu­tics, tar­get­ing ther­a­pies in neu­ro­science and im­muno-on­col­o­gy, has locked in Will Kane as EVP and chief com­mer­cial of­fi­cer. Kane had been at Al­ler­gan since 2013 and was their SVP and head of the US gen­er­al med­i­cine busi­ness unit. He had al­so held po­si­tions at Pfiz­er and Sepra­cor (which is now Sunovion Phar­ma­ceu­ti­cals).

Io­n­is ma­jor­i­ty-owned spin­off Akcea has wel­comed Kia Mote­sharei as SVP of busi­ness de­vel­op­ment & cor­po­rate strat­e­gy. Mote­sharei hails from a 6-year stint at Mer­ck KGaA, where he most re­cent­ly served as VP and glob­al head of li­cens­ing and busi­ness de­vel­op­ment, neu­rol­o­gy & im­munol­o­gy. Pri­or to that, Mote­sharei served in roles at Dyax Corp (ac­quired by Shire and sub­se­quent­ly Take­da), Gen­fit and Ac­tivX.

Bao Truong

→ Chi­na-based rare dis­ease and on­col­o­gy phar­ma CAN­bridge, which com­plet­ed its $98 mil­lion Se­ries D fi­nanc­ing in Feb­ru­ary, is bring­ing Car­rie Ann Cook in­to the fold as SVP, glob­al head of busi­ness de­vel­op­ment. Cook is leav­ing Take­da, where she was se­nior di­rec­tor of the Cen­ter for Ex­ter­nal In­no­va­tion, Rare Dis­ease. Be­fore Take­da, she was the head of glob­al busi­ness de­vel­op­ment and li­cens­ing, MS, med­ical de­vices and glob­al health at EMD Serono.

David Luo

Jonathan Lim-led can­cer treat­ment start­up Eras­ca is mak­ing two new per­son­nel changes. The San Diego-based biotech has named Bao Truong VP of reg­u­la­to­ry af­fairs and David Luo VP of clin­i­cal re­search and op­er­a­tions. Truong and Luo are both vets of an­oth­er Lim com­pa­ny, Igny­ta. Truong had been head of reg­u­la­to­ry af­fairs there, while Luo was VP of clin­i­cal op­er­a­tions at Igny­ta at the same time. Truong was al­so head of reg­u­la­to­ry af­fairs at Ideaya Bio­sciences, while Luo has al­so been VP of clin­i­cal op­er­a­tions at Syn­thorx.

→ Hong Kong-based phar­ma­ceu­ti­cal group Ap­to­rum has en­list­ed Ki­ra Shein­er­man as se­nior strate­gic con­sul­tant — she will be based in New York. Shein­er­man is the co-founder, CEO and ex­ec­u­tive di­rec­tor of mol­e­c­u­lar di­ag­nos­tics com­pa­ny Di­amiR Bio­sciences.

Martha Man­ning has moved on to Mar­i­nus Phar­ma­ceu­ti­cals as VP, gen­er­al coun­sel and sec­re­tary. Man­ning comes to Mar­i­nus, which fo­cus­es on de­vel­op­ing ganax­olone to treat rare seizure dis­or­ders, from Achillion, where she was EVP, gen­er­al coun­sel and sec­re­tary. She al­so had a stint at San­doz as VP and gen­er­al coun­sel.

→ No stranger to chair­man­ships, Dan Lynch is now chair­man of the board at Waltham, MA-based Xilio Ther­a­peu­tics, which changed its name (from Akre­via) in March and raised a shade more than $100 mil­lion in a round led by Take­da to get their IL-2 and aCT­LA4 mAb pro­grams in­to the clin­ic. Lynch is al­so chair­man of the board at blue­bird bio, Blue­print Med­i­cines, Sur­face On­col­o­gy, Trans­late Bio and Spring­Works Ther­a­peu­tics.

→ Duchenne mus­cu­lar dy­s­tro­phy-fo­cused Sol­id Bio­sciences has ap­point­ed Ian Smith as chair­man of the board. The for­mer Ver­tex ex­ec, who was oust­ed last year for code of con­duct vi­o­la­tions, suc­ceeds Sol­id co-founder An­drey Zarur, who had been chair­man since 2013.

Bon­nie Bassler

→ You could say that Roy­al­ty Phar­ma has been kind of a big deal the past 3 weeks. Fresh off scor­ing a mo­men­tous $2.2 bil­lion IPO, Pablo Legor­re­ta’s drug roy­al­ty buy­er has named Bon­nie Bassler to their bord. Bassler, the chair of Prince­ton Uni­ver­si­ty’s mol­e­c­u­lar bi­ol­o­gy de­part­ment, has al­so sat on the board at Sanofi, Kalei­do Bio­sciences and Re­gen­eron.

→ In the midst of the remde­sivir hub­bub, Javier Ro­driguez has been elect­ed to Gilead’s board of di­rec­tors. Ro­driguez has spent 20 years at De­Vi­ta, which pro­vides health­care ser­vices to pa­tients with kid­ney dis­ease, and is cur­rent­ly their CEO.

→ Cal­ci­fi­ca­tion-fo­cused rare dis­ease up­start In­ozyme Phar­ma has tapped Doug Tre­co, for­mer CEO and co-founder of RA Phar­ma­ceu­ti­cals, as chair­man of the com­pa­ny’s board of di­rec­tors. Tre­co suc­ceeds re­tir­ing Joseph Sch­lessinger. In ad­di­tion, the Cam­bridge, MA-based com­pa­ny has wel­comed Bio­gen vet Lynne Sul­li­van as an in­de­pen­dent di­rec­tor.

→ San Diego-based Are­na Phar­ma­ceu­ti­cals has cho­sen Katharine Kno­bil to be on their board of di­rec­tors. Kno­bil, the cur­rent CMO and head of R&D at Kalei­do Bio­sciences, had al­so spent more than 20 years at GSK, most re­cent­ly as CMO.

Kavi­ta Pa­tel

Flag­ship‘s Sig­ilon, which re­cent­ly bagged $80 mil­lion, has wooed Kavi­ta Pa­tel to its board of di­rec­tors. Pa­tel is a prac­tic­ing physi­cian and served in the Oba­ma ad­min­is­tra­tion as di­rec­tor of pol­i­cy for the Of­fice of In­ter­gov­ern­men­tal Af­fairs and Pub­lic En­gage­ment in the White House.

→ Gene and cell ther­a­py start­up Abeona Ther­a­peu­tics has made some new ad­di­tions to its board of di­rec­tors with the ap­point­ments of George Mi­gausky and Paul Mann as in­de­pen­dent di­rec­tors. Mi­gausky pre­vi­ous­ly served as EVP and CFO of Dyax Corp, while Mann served as CFO at Po­lar­i­tyTE.

Con­tra­Fect, which was giv­en break­through des­ig­na­tion from the FDA for exe­ba­case to treat me­thi­cillin-re­sis­tant Staph au­reus (MR­SA), has made Lis­han Ak­log a mem­ber of their board of di­rec­tors. Ak­log, whose work as a car­diac sur­geon took him to Brigham and Women’s Hos­pi­tal, Mount Sinai Med­ical Cen­ter, and Har­vard Med­ical School, among oth­ers, is the co-founder, chair­man and CEO of PAVmed.

Er­ic Schmidt and Pe­ter Sven­nil­son are now pro­vid­ing their cap­i­tal mar­ket ex­per­tise to the board of di­rec­tors at Red­wood City, CA-based Rev­o­lu­tion Med­i­cines. Schmidt is the CFO at Al­lo­gene, while Sven­nil­son is the founder and man­ag­ing part­ner at The Col­umn Group.

→ French vac­cine de­vel­op­er Val­ne­va has ap­point­ed Jo­han­na Willem­i­na Pat­te­nier, for­mer gen­er­al man­ag­er of No­var­tis Vac­cines and Di­ag­nos­tics, and Sharon Eliz­a­beth Tet­low, founder and man­ag­ing part­ner of Potrero Hill Ad­vi­sors (PHA), to its su­per­vi­so­ry board.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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