Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Uzair Qadeer

Alex­ion has carved out a new po­si­tion for chief di­ver­si­ty of­fi­cer and filled it with an in­side pro­mo­tion.

Uzair Qadeer will now be re­spon­si­ble for their “di­ver­si­ty, in­clu­sion and be­long­ing” strat­e­gy, look­ing to re­shape the biotech’s cor­po­rate cul­ture. A vet­er­an of De­loitte and Bris­tol My­ers Squibb, Qadeer was work­ing on ex­ec­u­tive coach­ing and help­ing cre­ate the di­ver­si­ty pro­gram he now leads.

“At Alex­ion, we be­lieve that di­ver­si­ty is hav­ing a seat at the ta­ble, in­clu­sion is hav­ing a voice, and be­long­ing is hav­ing that voice be heard. Our work isn’t done un­til our em­ploy­ees and pa­tients can feel a true sense of be­long­ing,” Qadeer said. “Mag­ne­tiz­ing and in­cu­bat­ing di­verse tal­ent will al­low us to har­ness di­verse in­sights that fu­el in­no­va­tion and cre­ate val­ue for the pa­tients we serve. I am com­mit­ted to ac­ti­vat­ing this pur­pose­ful vi­sion.”

Yvonne Green­street

→ Af­ter a 17-year stint at Al­ny­lam, pres­i­dent Bar­ry Greene is leav­ing the RNAi biotech and hand­ing the reins over to COO Yvonne Green­street. Green­street, who was SVP of med­i­cines de­vel­op­ment at Pfiz­er and an SVP at Glax­o­SmithK­line be­fore join­ing Al­ny­lam in 2016, takes up the pres­i­dent post at a com­pa­ny fac­ing an im­por­tant and dif­fi­cult tran­si­tion. CEO John Maraganore has set am­bi­tious goals for the com­pa­ny, aim­ing to move them in­to a top 5 biotech in the next cou­ple years, along­side the likes of Am­gen and Re­gen­eron.

“Yvonne has got an in­cred­i­ble strate­gic mind; she’s in­cred­i­bly ef­fec­tive op­er­a­tional­ly,” Maraganore told End­point News’ Ja­son Mast. “With­out a doubt I think our fu­ture is in great hands.”

Mean­while, a search is on­go­ing at Al­ny­lam for a new chief com­mer­cial of­fi­cer.

→ Get­ting in the Covid-19 sweep­stakes with lenzilum­ab be­ing used in a com­bo with remde­sivir for NI­AID’s Big Ef­fect Tri­al, Cameron Dur­rantled Hu­mani­gen has al­so been re­vamp­ing its staff, this time with Tim­o­thy Mor­ris tak­ing over as COO and CFO. Con­cur­rent with the move, Mor­ris will step down from Burlingame, CA-based Hu­mani­gen’s board of di­rec­tors, of which he had been a mem­ber since 2016. Mor­ris leaves his CFO role at Io­vance and has held that role at a string of oth­er com­pa­nies, in­clud­ing Acel­Rx, Vivus and Quest­cor Phar­ma­ceu­ti­cals.

Else­where at Hu­mani­gen, Bob Atwill steps in to a new­ly-cre­at­ed role as head of the Asia-Pa­cif­ic re­gion. Cur­rent­ly a prin­ci­pal at cross-bor­der M&A provider Eaton Square with the same re­gion­al fo­cus, Atwill has been an ex­ec at such Aus­tralian com­pa­nies as Fit­genes and Ben­itec Bio­phar­ma.

Shree­r­am Arad­hye

→ Rid­ing high with its Phase I da­ta re­leased yes­ter­day from their Roche-part­nered RNAi pro­gram for hep B, Dicer­na has found a CMO to take the place of the re­tir­ing Ralf Rosskamp. No­var­tis vet Shree­r­am Arad­hye will be­come EVP and CMO on Sept. 8, while Rosskamp will hold a con­sult­ing role at least through June 2021. Arad­hye makes his way to Dicer­na af­ter be­ing chief de­vel­op­ment of­fi­cer at Ax­cel­la, and for 20 years he held nu­mer­ous ti­tles at No­var­tis and its glob­al af­fil­i­ates, no­tably as glob­al head of med­ical af­fairs and CMO, phar­ma­ceu­ti­cals.

→ No stranger to the C-suite, Paul High­am has tak­en the reins as CEO of Va­lo Ther­a­peu­tics, an im­munother­a­py play­er with of­fices in Ox­ford and Helsin­ki de­vel­op­ing can­cer treat­ments us­ing tu­mor anti­gen-coat­ed on­colyt­ic virus­es. High­am has al­so held the top spot at two Ger­man biotechs, Gly­co­tope and Im­mat­ics Biotech­nolo­gies. He got his start at Bay­er as GM, Swe­den and Den­mark, and then pro­ceed­ed to GSK as their VP, com­mer­cial de­vel­op­ment.

→ Buoyed by its $22 mil­lion Se­ries C round led by Boehringer In­gel­heim Ven­ture Fund, an­ti­body-drug con­ju­gate biotech NBE-Ther­a­peu­tics has a new CEO with Bertrand Damour now at the helm. His pre­de­ces­sor, founder Ulf Grawun­der, will slot him­self in­to the role of chief op­er­at­ing of­fi­cer and chief de­vel­op­ment of­fi­cer. His last CEO gig was at Syn­thena AG, where he was al­so chair­man, and he’s al­so been the top man at Gene­Prot, Mind­NRG and On­coEthix.

Mag­gie Chen

Mag­gie Chen is on board as CFO of Suzhou, Chi­na-based CD­MO CMAB Bio­phar­ma, fo­cused on pre­clin­i­cal and PhI/II clin­i­cal prod­ucts. Be­fore mak­ing the leap to CMAB, Chen had been VP and CFO at Fo­s­un, and pri­or to that, she was al­so CFO at Por­ton Phar­ma So­lu­tions.

→ Deep­en­ing its part­ner­ship with Pfiz­er a month ago with a $15 mil­lion round, Cam­bridge biotech Mis­sion Ther­a­peu­tics has made changes in its lead­er­ship with the pro­mo­tions of Paul Thomp­son to CSO and Nick Ed­munds to chief tech­no­log­i­cal of­fi­cer. An 11-year GSK vet, Thomp­son makes the jump af­ter 2 years as Mis­sion’s VP, clin­i­cal de­vel­op­ment. Ed­munds came from As­traZeneca in 2016, where he had been head of new modal­i­ties, drug safe­ty and me­tab­o­lism, and moves on up from his pre­vi­ous role at Mis­sion as VP, head of DUB (deu­biq­ui­ty­lat­ing en­zymes) dis­cov­ery.

Fang Ni

→ With the dis­tinc­tion of land­ing the first IPO in 2020 — set­ting the ta­ble for the crazi­ness to come in the midst of the pan­dem­ic — on­col­o­gy play­er Black Di­a­mond Ther­a­peu­tics has brought back found­ing CBO Fang Ni to fill the same ca­pac­i­ty.  He had been a prin­ci­pal at Ver­sant Ven­tures and a mem­ber of the in­vest­ment team, serv­ing as in­ter­im CBO at Monte Rosa Ther­a­peu­tics and Bright Peak Ther­a­peu­tics dur­ing that pe­ri­od. He’s al­so a Roche vet who was more re­cent­ly the di­rec­tor, glob­al on­col­o­gy busi­ness de­vel­op­ment & li­cens­ing with­in the Big Phar­ma’s part­ner­ing or­ga­ni­za­tion.

Ken­neth Kobayashi

→ When last we left Aslan Phar­ma­ceu­ti­cals, they were fac­ing the same up­hill bat­tle of tri­al de­lays that have been so per­va­sive dur­ing the pan­dem­ic, paus­ing re­cruit­ment for their study of ASLAN004 in mod­er­ate to se­vere atopic der­mati­tis. Sin­ga­pore-based Aslan has named Ken­neth Kobayashi CMO to con­tin­ue de­vel­op­ment of that lead pro­gram. Kobayashi heads to Aslan from Eli Lil­ly sub­sidiary Der­mi­ra, where he was their se­nior med­ical di­rec­tor. Pri­or to that, he was No­var­tis’ clin­i­cal de­vel­op­ment med­ical di­rec­tor in the im­munol­o­gy, he­pa­tol­ogy and der­ma­tol­ogy glob­al de­vel­op­ment unit.

WuXi Vac­cines — a joint ven­ture formed be­tween WuXi Bi­o­log­ics and Shang­hai-based Hile Bio-Tech­nol­o­gy — has snagged Jian Dong to helm the com­pa­ny as CEO. Dong hopped aboard WuXi Bi­o­log­ics in 2014 and pre­vi­ous­ly served in roles at Eli Lil­ly, Shang­hai Unit­ed Cell Biotech­nol­o­gy and Shen­zhen Kang­tai Bi­o­log­i­cal Prod­ucts.

Frank Zhang

→ Two months af­ter Yuan Xu steered Leg­end Biotech to a $424 mil­lion pub­lic de­but on the Nas­daq, founder and chair­man Frank Zhang is grab­bing the reins as CEO. In con­junc­tion with the move, Zhang is al­so step­ping down from the helm of Gen­Script — a po­si­tion he’s held for 18 years. Ac­cord­ing to a press re­lease, Xu stepped down for “per­son­al rea­sons.”

Cure­Vac, one of the key play­ers in the race to de­vel­op a new mR­NA vac­cine to fight Covid-19 has reshuf­fled the top spots in the ex­ec­u­tive suite. And they’ve brought on Ig­or Splaws­ki, a No­var­tis vet out of Har­vard to spear­head their work on mR­NA as CSO. Splaws­ki played a big role at the No­var­tis In­sti­tutes for Bi­o­log­i­cal Re­search un­der Jay Brad­ner, where he was an ex­ec­u­tive di­rec­tor and site head. Like Brad­ner, Splaws­ki was al­so a pro­fes­sor at Har­vard, where he worked on hu­man ge­net­ic and mol­e­c­u­lar bi­ol­o­gy stud­ies. He wrapped a 3-year stint at Har­vard in 2008.

Alan Smith

→ Ear gene ther­a­py com­pa­ny Ak­ou­os has tapped Alan Smith as chief tech­nol­o­gy of­fi­cer. In ad­di­tion, the com­pa­ny an­nounced that Saira Ra­masas­try — who’s al­so a board mem­ber of Vir and Sang­amo — has been ap­point­ed to its board of di­rec­tors as au­dit com­mit­tee chair, and board mem­ber Arthur Tzian­a­bos, the cur­rent CEO and pres­i­dent of Ho­mol­o­gy Med­i­cines, has been ap­point­ed chair­man of the board. Smith pre­vi­ous­ly served as EVP, tech­ni­cal op­er­a­tions at Bel­licum Phar­ma­ceu­ti­cals and has held ex­ec roles at Cog­nate Bioser­vices and Osiris Ther­a­peu­tics.

→ With a par­tic­u­lar fo­cus on di­a­bet­ic mac­u­lar ede­ma, Bel­gian bio­phar­ma Ox­u­ri­on NV has turned to Grace Chang to be their CMO. Cur­rent­ly an ad­junct clin­i­cal as­so­ciate pro­fes­sor in the oph­thal­mol­o­gy de­part­ment at USC’s Keck School of Med­i­cine, Chang used to be CMO at No­tal Vi­sion. She al­so led glob­al clin­i­cal de­vel­op­ment at for­mer No­var­tis sub­sidiary Al­con Lab­o­ra­to­ries.

Robert Zeldin

→ Part­ner­ing with J&J on their gene ther­a­py for x-linked re­tini­tis pig­men­tosa — and re­leas­ing promis­ing Phase I/II da­ta last month — MeiraGTx has snagged Robert Zeldin as CMO. Zeldin, a Mer­ck and No­var­tis vet, has pre­vi­ous­ly been CMO at sev­er­al biotechs in the last 5 years: Im­muno­vant, Ac­celeron and Abl­ynx.

→ GSK and Dai­ichi Sankyo vet Juan Car­los Jaramil­lo is mov­ing on to French vac­cine com­pa­ny Val­ne­va to take the CMO job, ef­fec­tive Oc­to­ber 1. His pre­de­ces­sor, Wolf­gang Ben­der, is re­tir­ing at the end of Oc­to­ber. Jaramil­lo had been with Dai­ichi Sankyo for 7 years, most re­cent­ly as SVP, head of glob­al mar­ket ac­cess & pric­ing. While at GSK, he was the act­ing head of clin­i­cal de­vel­op­ment and med­ical af­fairs vac­cines, Eu­rope.

Se­lec­ta Bio­sciences, which struck a li­cens­ing agree­ment in June to open up its im­mune tol­er­ance plat­form Imm­TOR to Sarep­ta, has re­cruit­ed Pe­ter Tra­ber as CMO. Tra­ber has helmed Galectin Ther­a­peu­tics as pres­i­dent and CEO, and has al­so spent time as their CMO in the crowd­ed but be­lea­guered NASH field. He was for­mer­ly CMO and SVP, clin­i­cal de­vel­op­ment & med­ical af­fairs with GSK and the pres­i­dent and CEO of the Bay­lor Col­lege of Med­i­cine.

Su­san­na High

Su­san­na High has been named chief op­er­at­ing of­fi­cer at Waltham, MA mus­cle dis­ease biotech Dyne Ther­a­peu­tics. She hails from blue­bird bio, where she filled the same role and guid­ed the ap­proval of Zyn­te­glo for trans­fu­sion-de­pen­dent be­ta tha­lassemia. High al­so held a num­ber of po­si­tions at Al­ny­lam, in­clud­ing SVP, strat­e­gy & busi­ness in­te­gra­tion, be­fore she left for blue­bird.

Backed by Mer­ck and Am­gen, Durham, NC-based RNA mod­u­la­tion biotech Ri­bometrix has tapped Bar­clay “Buck” Phillips as COO and CFO. Phillips is stay­ing in the Re­search Tri­an­gle area af­ter a stint at G1 Ther­a­peu­tics as their CFO, SVP of cor­po­rate de­vel­op­ment. He’s al­so led fi­nan­cial op­er­a­tions at No­vavax as SVP, CFO and trea­sur­er from 2013-17.

Enoch Kar­iu­ki

→ Fo­cused on re­cep­tor ty­ro­sine ki­nase-like or­phan re­cep­tor 1 (ROR) and chalk­ing up a $137 mil­lion Se­ries B round in Ju­ly, San Diego-based Velos­Bio has en­list­ed Enoch Kar­iu­ki to be their CFO. Kar­iu­ki skips over from an­oth­er San Diego biotech, Syn­thorx, where he was their SVP, cor­po­rate de­vel­op­ment. Pri­or to Syn­thorx, he was VP at H.I.G. Bio­Health Part­ners, the ded­i­cat­ed health­care in­vest­ment af­fil­i­ate of H.I.G. Cap­i­tal.

→ Stay­ing in San Diego, Kei­th Mar­shall has been ap­point­ed CFO of IBD-fo­cused Prometheus Bio­sciences. Mar­shall hails from Cona­tus Phar­ma­ceu­ti­cals, where he had been EVP, COO and CFO the last 3 years. Be­fore that, he was CFO and head of cor­po­rate de­vel­op­ment at Flag­ship Pi­o­neer­ing com­pa­ny Torque Ther­a­peu­tics (which merged with Co­gen Im­mune Med­i­cine to be­come Reper­toire Im­mune Med­i­cines).

→ More changes at San Diego biotechs abound as De­nis Dry­gin has signed on as CSO of mi­croR­NA play­er Reg­u­lus Ther­a­peu­tics, which forked over its lead drug to Sanofi in No­vem­ber 2018 af­ter sig­nif­i­cant down­siz­ing. Dry­gin co-found­ed and was VP of R&D at Pimera the last 7 years, and be­fore that, he spent 8 years at Cy­lene Phar­ma­ceu­ti­cals in nu­mer­ous posts, leav­ing in 2013 as VP, bi­ol­o­gy.

Nush­mia Khokhar

Nush­mia Khokhar has been pro­mot­ed to SVP, clin­i­cal de­vel­op­ment at Lon­don-based T cell pro­gram­ming bio­phar­ma Au­to­lus. Vi­jay Red­dy has al­so an­nounced he’s leav­ing Au­to­lus as CMO and re­turn­ing to the US. Khokhar was pre­vi­ous­ly the glob­al clin­i­cal leader for the dara­tu­mum­ab (Darza­lex) pro­gram at Janssen be­fore join­ing Au­to­lus as VP of clin­i­cal de­vel­op­ment in 2017. Al­so, Ac­celeron R&D chief Jay Back­strom has been elect­ed to Au­to­lus’ board of di­rec­tors.

→ Genome edit­ing vet TJ Cradick has been hand­ed the keys to the CSO car at CRISPR biotech Ex­ci­sion Bio­Ther­a­peu­tics. Cradick was head of genome edit­ing for more than 4 years at CRISPR Ther­a­peu­tics, and ear­ly in his ca­reer, he was a sci­en­tist in the zinc fin­ger nu­cle­ase de­sign & se­lec­tion group at Sang­amo.

Evo­lu­tion Re­search Group, a New Jer­sey-based net­work of clin­i­cal re­search sites, has cho­sen William Mar­tin to be CSO af­ter a near­ly 9-year run at Alk­er­mes in roles of in­creas­ing re­spon­si­bil­i­ty, capped by his year-long tenure as se­nior med­ical di­rec­tor, clin­i­cal de­vel­op­ment & med­ical af­fairs. He al­so spent time at Pfiz­er as as­so­ciate di­rec­tor, clin­i­cal re­search and pre­ci­sion med­i­cine.

James Craven

→ There are a few per­son­nel changes at CN Bio, a bio­engi­neer­ing com­pa­ny out of the UK fo­cused on sin­gle and mul­ti-or­gan mi­cro­phys­i­o­log­i­cal sys­tems (MPS). James Craven, CN Bio’s new chief com­mer­cial of­fi­cer, comes from Brooks Life Sci­ences, where he head­ed their mar­ket strat­e­gy and com­mer­cial de­liv­ery. Pfiz­er and Gen­Script vet Bri­an Man­ning is now the US head of sales af­ter be­ing se­nior di­rec­tor of busi­ness de­vel­op­ment at In­Sphero. Ad­di­tion­al­ly, Sarah Payne has been brought on as prod­uct mar­ket­ing man­ag­er.

→ With teplizum­ab gath­er­ing re­newed mo­men­tum thanks to sol­id June da­ta as a BLA awaits, Ash­leigh Palmer’s Proven­tion Bio has giv­en the new­ly-cre­at­ed role of chief le­gal of­fi­cer to Hei­dy Abreu King-Jones. She leaves Ax­cel­la, where she was SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. From 2013-18, King-Jones al­so filled sev­er­al po­si­tions in the le­gal de­part­ment at Sarep­ta.

Lance Ku­ra­ta

→ Speak­ing of le­gal ap­point­ments, Lance Ku­ra­ta has joined San Diego mR­NA play­er Arc­turus as chief le­gal of­fi­cer. Ku­ra­ta had pre­vi­ous­ly been a part­ner in the cor­po­rate group and mem­ber of the life sci­ences prac­tice group at Mintz.

→ AAV gene ther­a­py com­pa­ny AskBio has named Michael Kran­da as SVP, ther­a­peu­tic prac­tice leader. Pri­or to his new role, Kran­da served as se­nior di­rec­tor of busi­ness de­vel­op­ment at the Allen In­sti­tute. In ad­di­tion, Kran­da has held di­rec­tor roles at Im­munex (now Am­gen) and PTC Ther­a­peu­tics among oth­ers.

Jim Green­wood has be­come a se­nior ad­vi­sor at DLA Piper and will chair their Life Sci­ences, Health, Pol­i­cy and Reg­u­la­to­ry sub­group that was just cre­at­ed. Green­wood re­cent­ly com­plet­ed his 15-year tenure at the helm of BIO.

Cas­san­dra Mat­ney

→ CRO Pre­mier Re­search has wooed Cas­san­dra Mat­ney as se­nior med­ical di­rec­tor. Pri­or to hop­ping aboard the com­pa­ny, Mat­ney held po­si­tions at Astel­las, Janssen, In­cyte and Co­v­ance.

Lund­beck vet Mads Kro­n­berg has joined Dan­ish pep­tide-based med­i­cine biotech Zealand Phar­ma as their head of in­vestor re­la­tions & com­mu­ni­ca­tion. Be­fore mak­ing the jump to Zealand, Kro­n­berg spent more than 12 years at Lund­beck, work­ing his way up to se­nior di­rec­tor, head of cor­po­rate com­mu­ni­ca­tion.

→ A cou­ple months re­moved from the ap­point­ment of Ja­son O’Neill as CEO, im­munother­a­py-fo­cused Den­dreon has brought in Dar­lene Romine to be SVP of sales and mar­ket ac­cess as well as a mem­ber of the ex­ec­u­tive com­mit­tee. Romine has pre­vi­ous­ly held sim­i­lar posts at J&J, Bio­gen and Mallinck­rodt.

Jonathan Yu

→ Tar­get­ing hema­to­log­ic dis­eases, Disc Med­i­cine is giv­ing its staff a boost with Jonathan Yu com­ing in as SVP of cor­po­rate strat­e­gy and William Sav­age as VP of clin­i­cal de­vel­op­ment to help ad­vance their hep­cidin path­way mod­u­la­tor pipeline to­ward the clin­ic. Yu co-found­ed and was VP of cor­po­rate strat­e­gy, fi­nance and op­er­a­tions for Qpex Bio­phar­ma, while Sav­age, a Shire/Take­da vet, was se­nior med­ical di­rec­tor at Ma­gen­ta Ther­a­peu­tics.

Ellen For­est has got­ten the call to be chief hu­man re­sources of­fi­cer at Yu­man­i­ty Ther­a­peu­tics, which tar­gets neu­rode­gen­er­a­tive dis­eases. Pri­or to Cam­bridge, MA-based Yu­man­i­ty, For­est was SVP and head of hu­man cap­i­tal for Co­gen Im­mune Med­i­cine and VP, head of hu­man re­sources for Mer­ri­mack Phar­ma­ceu­ti­cals.

→ On­col­o­gy and in­flam­ma­to­ry dis­ease-fo­cused bio­phar­ma RAPT Ther­a­peu­tics has called up­on Phyl­lis Loud Gray to be VP of hu­man re­sources. Gray moves on from Sune­sis Phar­ma­ceu­ti­cals, where she was their se­nior di­rec­tor and head of hu­man re­sources.

→ Co-found­ed by Bob Langer and rais­ing $56 mil­lion in their May IPO, ENT-fo­cused Lyra Ther­a­peu­tics is bring­ing in Pamela Nel­son as SVP of reg­u­la­to­ry af­fairs. Nel­son, held the VP of reg­u­la­to­ry af­fairs post at Ave­dro pri­or to Lyra, start­ed her reg­u­la­to­ry ca­reer at Gen­zyme and Alk­er­mes.

Rich Hey­man

→ Less than a year af­ter pulling in an im­pres­sive $62 mil­lion Se­ries C round, PMV Phar­ma has named Rich Hey­man as chair­man of its board. Hey­man joins right as the Cran­bury, NJ-based com­pa­ny brought in $70 mil­lion from a Se­ries D fi­nanc­ing round. Hey­man comes to PMV af­ter found­ing the biotechs Aragon (ac­quired by J&J) and Ser­agon (ac­quired by Roche and Genen­tech), each of which sold for more than $1 bil­lion in the span of 12 months back in 2013 and 2014.

→ Ex-Pur­due CEO Mark Tim­ney has been named chair­man of the board at fi­bro­sis-fo­cused Blade Ther­a­peu­tics, suc­ceed­ing Luke Evnin, who was chair­man since its 2015 found­ing. Tim­ney al­so helmed and was a board mem­ber at The Med­i­cines Com­pa­ny.

Ted Love

Pablo Legor­re­ta’s Roy­al­ty Phar­ma, which made waves with its prodi­gious $2.2 bil­lion IPO in June, has added to its board of di­rec­tors with Glob­al Blood Ther­a­peu­tics pres­i­dent CEO Ted Love. MSCI chair­man and CEO Hen­ry Fer­nan­dez is al­so join­ing the board.

→ Buf­fa­lo-based Athenex has elect­ed Robert Spiegel to its board of di­rec­tors. Spiegel has held the CMO job at PTC Ther­a­peu­tics and Sch­ler­ing-Plough.

→ J&J vet Chris Ha­lyk is now on the board of di­rec­tors MediPharm Labs out of Toron­to. Ha­lyk spent 33 years at the phar­ma gi­ant un­til 2019, when he was pres­i­dent of Janssen (Cana­da).

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.