Vedan­ta Bio­sciences taps Big Phar­ma vet Jef­frey Sil­ber as CMO; Robert Doe­bele leaves be­hind teach­ing post at Col­orado to fo­cus on CSO job at Rain Ther­a­peu­tics

Jef­frey Sil­ber

→ A Big Phar­ma vet has joined Cam­bridge, MA up­start Vedan­ta Bio­sciences to help de­vel­op and ex­pand on its mi­cro­bio­me-de­rived bac­te­ria port­fo­lio.

Jef­frey Sil­ber signed on as CMO of Vedan­ta af­ter 4 years at EMD Serono as their SVP, glob­al clin­i­cal de­vel­op­ment. Sil­ber worked his way through the ranks at Mer­ck in the late 1990s, even­tu­al­ly be­com­ing their VP and ther­a­peu­tic area head, vac­cine clin­i­cal re­search. And af­ter 16 years at the phar­ma gi­ant, Sil­ber moved on to Ab­b­Vie to be their VP, strate­gic port­fo­lio de­vel­op­ment.

Else­where at Vedan­ta, Bio­gen and Se­qirus alum Nan­cy Chiu Wilk­er takes on the role of VP, le­gal.

Robert Doe­bele

→ Rolling along with $63 mil­lion in new fund­ing that was an­nounced a cou­ple weeks ago, Rain Ther­a­peu­tics of­fi­cial­ly named Robert Doe­bele CSO at Rain Ther­a­peu­tics — af­ter serv­ing as act­ing CSO since he co-found­ed the biotech in 2017. He tran­si­tions to EVP and CSO full-time, leav­ing his pro­fes­sor­ship at the Uni­ver­si­ty of Col­orado School of Med­i­cine. Doe­bele had been at CU since 2008 and al­so led the Tho­racic On­col­o­gy Re­search Ini­tia­tive at the Uni­ver­si­ty of Col­orado Can­cer Cen­ter.

→ Ex-Or­chard Ther­a­peu­tics CEO Mark Rothera is back lead­ing an­oth­er biotech, tak­ing over as pres­i­dent and CEO of Lon­don-based Si­lence Ther­a­peu­tics, which an­nounced its in­tent to list on Nas­daq back in May. Rothera left Or­chard in March af­ter hold­ing the top spot for more than 2½ years. Pri­or to Or­chard, he was chief com­mer­cial of­fi­cer at PTC Ther­a­peu­tics from 2013-17 and, for less than a year, was glob­al pres­i­dent of Aege­ri­on Phar­ma­ceu­ti­cals from 2012-13.

Dan Stan­er

→ Run­ning full throt­tle on a Phase III tri­al of its mR­NA-1273 Covid-19 vac­cine can­di­date, Mod­er­na has made Eli Lil­ly alum Dan Stan­er VP and gen­er­al man­ag­er in Switzer­land, the first sub­sidiary for the biotech out­side of North Amer­i­ca. Dur­ing al­most 19 years at Lil­ly, Stan­er held a range of mar­ket­ing and strate­gic posts, and left in 2019 as the phar­ma gi­ant’s area gen­er­al man­ag­er, Mid­dle East & Pak­istan re­gion. A Swiss na­tion­al, Stan­er was Lil­ly’s man­ag­ing di­rec­tor in Switzer­land from 2005-11.

Lewis Cant­ley’s metas­ta­tis-fo­cused start­up Volas­tra Ther­a­peu­tics has cho­sen ex-Sanofi and Pfiz­er on­col­o­gy ex­ec Charles Hugh-Jones as their CEO. Be­fore grab­bing the top spot here, Hugh-Jones had been CMO at Al­ler­gan, thus con­tin­u­ing the ex­o­dus af­ter the merg­er with Ab­b­Vie as Brent Saun­ders sets his sights on a $460 mil­lion SPAC. Hugh-Jones has al­so been an on­col­o­gy di­rec­tor at Scher­ing/Bay­er in the mid 2000s.

Lorence Kim

Third Rock has reeled in ex-Mod­er­na CFO Lorence Kim as a new ven­ture part­ner. Join­ing the team along­side Kim as ven­ture part­ners are David Kauf­man, who pre­vi­ous­ly served as CMO and head of trans­la­tion­al de­vel­op­ment at the Bill and Melin­da Gates Med­ical Re­search In­sti­tute; and An­drea van El­sas — who most re­cent­ly served as CSO at Aduro Biotech, which was re­cent­ly tak­en over in a re­verse merg­er af­ter years of set­backs in the clin­ic.

Lee Rauch

→ Mi­cro­cap mi­croR­NA play­er mi­Ra­gen‘s CEO William Mar­shall has re­signed, leav­ing COO Lee Rauch in charge as the new chief to over­see a “re­view of strate­gic al­ter­na­tives” — of­ten a sign that the board is ea­ger for a sale, al­though in-li­cens­ing and oth­er deals are al­so on the ta­ble. Mar­shall leaves in the midst of 44 job cuts and an R&D re­struc­tur­ing. Rauch, a biotech vet who joined just three months ago, and has a slew of ex­pe­ri­ence un­der her belt from po­si­tions at Glob­al Blood Ther­a­peu­tics, Onyx Phar­ma­ceu­ti­cals, Fortress Biotech and Nuon Ther­a­peu­tics among oth­ers.

→ At the same time as their of­fi­cial launch fol­low­ing a seed fundrais­ing round led by SV Health In­vestors and joined by Can­cer Re­search UK, Cellinta has tapped So­raya Bekkali as CEO. Bekkali hopped aboard the com­pa­ny af­ter a stint as CEO and di­rec­tor of the board of Syn­cona-backed Gy­ro­scope Ther­a­peu­tics. Pri­or to that, she was SVP CMO at Lyso­gene.

Leonard Blum

→ Mer­ck vet and ICOS com­mer­cial leader Leonard Blum has been named pres­i­dent and CEO of neu­ro­bi­ol­o­gy play­er XW­Phar­ma, which just com­plet­ed a $40 mil­lion Se­ries C. Blum held sev­er­al lead­er­ship roles at Mer­ck from 1987-2000, and from there, he helped bring Cialis to the mar­ket at ICOS while he was al­so their SVP, sales and mar­ket­ing, stick­ing around un­til its 2007 ac­qui­si­tion by Lil­ly. Blum, a for­mer US Army Spe­cial Forces of­fi­cer, was most re­cent­ly a con­sult­ing com­mer­cial ex­ec­u­tive at Madri­gal Phar­ma­ceu­ti­cals.

Rock­well Med­ical just found their pres­i­dent and CEO Rus­sell El­li­son in April, and now the iron de­fi­cien­cy-fo­cused metro De­troit phar­ma has an­oth­er Rus­sell to go with him as CFO and CBO: Rus­sell Skib­st­ed. He has been CFO at a num­ber of oth­er com­pa­nies, in­clud­ing his most re­cent posts at Bi­o­Time and its sub­sidiaries AgeX Ther­a­peu­tics, On­co­cyte and As­te­r­ias Bio­ther­a­peu­tics.

Fitzroy Dawkins

→ One of the many up­sized IPOs in the 2020 boom, hema­tol­ogy and on­col­o­gy play­er For­ma Ther­a­peu­tics has bol­stered its ex­ec­u­tive team with Fitzroy Dawkins as VP, clin­i­cal de­vel­op­ment and Ruth du Moulin as VP, med­ical af­fairs. Dawkins comes from In­cyte, where he was their ex­ec­u­tive di­rec­tor, on­col­o­gy drug de­vel­op­ment, while du Moulin hails from Take­da’s on­col­o­gy glob­al busi­ness unit in the role of VP, med­ical af­fairs and head of glob­al on­col­o­gy med­ical com­mu­ni­ca­tions.

→ Cam­bridge, MA syn­thet­ic bi­ol­o­gy play­er Syn­log­ic, which broke off a pact with Ab­b­Vie in May to de­vel­op an IBD treat­ment but is a fre­quent col­lab­o­ra­tor with Gink­go Bioworks, has re­cruit­ed David Ha­va as their CSO af­ter a brief run in the same role at Me­tera Phar­ma­ceu­ti­cals. Ha­va rose to CSO and led the R&D team dur­ing his 12 years at Pul­ma­trix, where he start­ed out as a se­nior sci­en­tist.

Michael Diem

→ Launched by Ver­sant’s Car­lo Riz­zu­to and CEO La­lo Flo­res, and chaired by Joe Jimenez, Philadel­phia-based Cen­tu­ry Ther­a­peu­tics has wel­comed Michael Diem as CBO. Be­fore head­ing to Cen­tu­ry, which de­vel­ops iP­SC-de­rived al­lo­gene­ic cell ther­a­pies to fight can­cer, Diem spent 3 years at Am­i­cus Ther­a­peu­tics as SVP and head of cor­po­rate and busi­ness de­vel­op­ment. He’s al­so held BD posts at As­traZeneca and GSK.

→ Cam­bridge, MA cell and gene ther­a­py biotech Ob­sid­i­an Ther­a­peu­tics has cor­ralled Jan ter Meulen as CSO. A Mer­ck alum who was their head of ba­sic vac­cine re­search, ter Meulen moves over to Ob­sid­i­an af­ter a 6-year stay as CSO of Im­mune De­sign, which would even­tu­al­ly be sold to Mer­ck for $300 mil­lion in ear­ly 2019.

→ Long­time Ra­dius Health CFO Nick Har­vey is mov­ing on to Adicet Bio in the same po­si­tion. Har­vey comes to the biotech, which de­vel­ops al­lo­gene­ic gam­ma delta T cell ther­a­pies with Re­gen­eron as a part­ner, af­ter his most re­cent CFO stint at Cen­trex­ion Ther­a­peu­tics. He was at Ra­dius Health from 2006-17 and led the com­pa­ny through its ini­tial IPO.

Rona An­halt

Alex­is Borisy‘s start­up EQRx has brought on a slew of new ex­ec hires. The ap­point­ments in­clude Rona An­halt as chief peo­ple of­fi­cer; Chris­t­ian An­toni as chief de­vel­op­ment of­fi­cer; Er­ic Hedrick as chief physi­cian ex­ec­u­tive; and Daniel Hoey as chief of tech­ni­cal op­er­a­tions. In ad­di­tion, for­mer chief ex­ec­u­tive of NICE An­drew Dil­lon hops aboard as an ad­vi­sor to the com­pa­ny. An­halt joins the com­pa­ny af­ter a stint as VP of hu­man re­sources at Cel­gene and ex­pe­ri­ence from No­var­tis. For­mer­ly, An­toni served at Sanofi and at LEO Phar­ma as SVP of glob­al de­vel­op­ment. Hedrick joins with roles from BeiGene, Epizyme, Genen­tech and Phar­ma­cyclics un­der his belt. Hoey, a Mer­ck vet, most re­cent­ly served at Te­va Phar­ma­ceu­ti­cals.

→ Scor­ing $110 mil­lion in fi­nanc­ing this sum­mer to fight CNS dis­eases with two drugs in Phase II, Mar­cio Souza-led Prax­is Pre­ci­sion Med­i­cines has se­lect­ed Nicole Swee­ny as CCO and Alyssa Wyant as SVP, reg­u­la­to­ry and qual­i­ty. A Gen­zyme and Shire alum, Swee­ny was pre­vi­ous­ly hered­i­tary an­gioede­ma fran­chise head and US gen­er­al man­ag­er at Take­da, while Wyant jumps to Prax­is af­ter her time as a reg­u­la­to­ry ex­ec at Ery­Del. Ad­di­tion­al­ly, Kin­nate chair­man Dean Mitchell has been named chair­man of Prax­is’ board.

Yann Maz­abraud

→ Af­ter David Meek­er took over as CEO in Ju­ly, Rhythm Phar­ma­ceu­ti­cals’ lat­est per­son­nel move in­volves Yann Maz­abraud as their EVP, head of in­ter­na­tion­al. An 18-year Sanofi Gen­zyme vet, Maz­abraud had been CCO and head of in­ter­na­tion­al at Tre­vi Ther­a­peu­tics be­fore jump­ing to Rhythm, which tar­gets rare ge­net­ic obe­si­ty dis­or­ders.

→ A lit­tle more than a year af­ter their lead drug crashed in a Phase IIb tri­al for mod­er­ate to se­vere hidradeni­tis sup­pu­ra­ti­va, In­flaRx has re­tooled the C-suite a bit with Thomas Taap­ken as CFO and the pro­mo­tion of Jor­dan Zwick as chief strat­e­gy of­fi­cer. Taap­ken was pre­vi­ous­ly ex­ec­u­tive chair­man at Bel­gian biotech Im­cyse, and from 2011-16 was the CEO and CFO of Epige­nomics. Zwick comes to In­flaRx fol­low­ing sev­er­al years as ex­ec­u­tive di­rec­tor, head of strat­e­gy and busi­ness de­vel­op­ment at Sal­ix Phar­ma­ceu­ti­cals.

Ed Rock

→ On­col­o­gy start­up Part­ner Ther­a­peu­tics an­nounced two changes in the C-suite with Ed Rock as CMO and co-founder De­ba­sish Roy­chowd­hury slip­ping in­to the role of CTO. A for­mer med­ical di­rec­tor at GSK, Rock rolls in­to PTx af­ter 3 years as VP of clin­i­cal re­search and clin­i­cal project leader at Macro­Gen­ics. Roy­chowd­hury helped launch Part­ner Ther­a­peu­tics in ear­ly 2018 with CEO Robert Mul­roy and has Big Phar­ma ex­pe­ri­ence with Eli Lil­ly, GSK and Sanofi.

→ Health tech com­pa­ny El­e­ment Sci­ence has named Zu­bin Eapen as CMO. Eapen, a prac­tic­ing car­di­ol­o­gist, comes to the com­pa­ny with ex­pe­ri­ence from ex­ec roles at The An­them Com­pa­niesCare­More Health sub­sidiary, Health­Core and Pat­tern Health Tech­nolo­gies.

Nad­er Youssef

→ Lu­ca Santarel­li’s start­up, Vec­tivBio — a spin­out of Ther­a­chon that launched in Jan­u­ary with $35 mil­lion in fi­nanc­ing — has snagged Nad­er Youssef as SVP and head of glob­al clin­i­cal de­vel­op­ment and med­ical af­fairs. Most re­cent­ly, Youssef served as VP of clin­i­cal de­vel­op­ment at Pas­sage Bio and CMO at Nu­trinia. In ad­di­tion, he’s held a role as ex­ec­u­tive di­rec­tor of GI glob­al clin­i­cal de­vel­op­ment and med­ical af­fairs for NPS Phar­ma­ceu­ti­cals (ac­quired by Shire in 2015).

MEI Phar­ma, which snapped up $100 mil­lion up­front from Ky­owa Kirin in April for PI3Kδ in­hibitor ME-401, has ap­point­ed Bri­an Powl as their SVP, mar­ket­ing. Powl logged 9 years at Cel­gene in a num­ber of mar­ket­ing roles, in­clud­ing VP, glob­al com­mer­cial CAR-T lead in his last 2 years, and he was al­so at No­var­tis On­col­o­gy from 2006-11.

Julie Car­retero

→ Flag­ship-backed and Sim­ba Gill-led Evelo Bio­sciences, which is test­ing their lead an­ti-in­flam­ma­to­ry drug EDP1815 as a Covid-19 treat­ment, has named No­var­tis vet Julie Car­retero chief peo­ple of­fi­cer. Car­retero spent 17 years at the Swiss phar­ma gi­ant, ris­ing to as­sis­tant di­rec­tor, hu­man re­sources. Her most re­cent post was at man­u­fac­tur­ing com­pa­ny FXI Cor­po­ra­tion as their chief hu­man re­sources of­fi­cer.

Voy­ager Ther­a­peu­tics, the com­pa­ny that Ab­b­Vie broke a neu­ro R&D pact with back in Au­gust, has wel­comed Michelle Quinn Smith as chief hu­man re­sources of­fi­cer. Smith joins the com­pa­ny with ex­pe­ri­ence from Flag­ship Pi­o­neer­ing, Take­da and Gen­zyme (lat­er Sanofi) un­der her belt. In ad­di­tion, Genen­tech vet Nan­cy Vi­tale will be join­ing the com­pa­ny as an in­de­pen­dent di­rec­tor to its board of di­rec­tors. Dur­ing her 13 year stint at Genen­tech, Vi­tale served as SVP and chief hu­man re­source of­fi­cer.

Kel­lie Sears

AskBio, an AAV gene ther­a­py out­fit in the Re­search Tri­an­gle area of North Car­oli­na, has called up­on Kel­lie Sears to be chief hu­man re­sources of­fi­cer. Af­ter a 13-year run at Pfiz­er in HR ser­vices, Sears had been at Al­ler­gan since 2012, where she was pro­mot­ed last year to SVP and chief hu­man re­sources of­fi­cer.

→ Tus­sling with heavy hit­ters like J&J/Ar­row­head, GSK/Io­n­is and Vir/Al­ny­lam in the RNAi game for hep B, Lex­ing­ton, MA-based Dicer­na has brought in Ling Zeng as their chief le­gal of­fi­cer and sec­re­tary. In keep­ing with the theme of No­var­tis vets, she heads to Dicer­na af­ter a 3-year spell as the Big Phar­ma’s deputy head of the le­gal M&A group.

An­tho­ny Wa­claws­ki

An­tho­ny Wa­claws­ki, who gave more than 35 years to Bris­tol My­ers Squibb in a num­ber of ca­pac­i­ties, has set­tled in as EVP, glob­al head of reg­u­la­to­ry af­fairs at Brain­Storm, an adult stem cell ther­a­py de­vel­op­er for ALS and oth­er neu­ro­ge­net­ic dis­eases. When Wa­claws­ki left BMS, he was the Big Phar­ma’s VP and head, reg­u­la­to­ry and phar­ma­ceu­ti­cal sci­ences, car­dio­vas­cu­lar, im­muno­sciences, fi­bro­sis, and ge­net­i­cal­ly-de­fined dis­eases.

Christo­pher Mor­ri­son has tak­en on the role of VP, process sci­ence at Cal­i­for­nia gene ther­a­py play­er Ad­verum Biotech­nolo­gies, which showed pos­i­tive Phase I da­ta for pa­tients with wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD) in May. Pri­or to Ad­verum, Mor­ri­son was se­nior di­rec­tor, bio­phar­ma­ceu­ti­cal de­vel­op­ment at ApicBio Ther­a­peu­tics and se­nior di­rec­tor, CMC op­er­a­tions at Gem­i­ni Ther­a­peu­tics.

Cristi­na Csim­ma

Cristi­na Csim­ma has be­come chair of the board of di­rec­tors at Finnish biotech Foren­do Phar­ma, whose lead pro­gram fo­cus­es on en­dometrio­sis. Csim­ma al­so chairs the board at Car­away Ther­a­peu­tics.

→ Pfiz­er vet Pol­ly Mur­phy has been added to the board of di­rec­tors at Jean Pierre Som­ma­dos­si-led Atea Phar­ma­ceu­ti­cals. Mur­phy has just been named CBO at Uro­Gen.

Ele­na Ridloff

Aca­dia Phar­ma­ceu­ti­cals EVP and CFO Ele­na Ridloff joins Kro­nos Bio as a mem­ber of their board of di­rec­tors and will chair the au­dit com­mit­tee. Else­where, Ridloff has been VP of in­vestor re­la­tions at Alex­ion.

→ Macro­Gen­ics chair­man Paulo Cos­ta has made his way to the board of di­rec­tors at in­fec­tious and in­flam­ma­to­ry dis­ease biotech CorMedix. The for­mer chair­man of Amylin Phar­ma­ceu­ti­cals was pres­i­dent of No­var­tis from 2005 un­til his re­tire­ment in 2008.

Lau­ra Hamill

Lau­ra Hamill has hopped on the board of di­rec­tors at Ac­celeron, armed with pos­i­tive da­ta that have boost­ed ex­ecs’ con­fi­dence in so­tater­cept. The Am­gen and Gilead vet is al­so a board mem­ber at Y-mAbs and Anap­tys­Bio.

Ve­r­alox Ther­a­peu­tics has named the CEO of Pal­la­dio Bio­sciences Alex Mar­tin as chair­man of its board of di­rec­tors. Mar­tin joins with ex­pe­ri­ence run­ning Realm Ther­a­peu­tics as CEO and stints at In­ter­cept Phar­ma­ceu­ti­cals, BioX­ell and No­var­tis.

Ar­a­vive has ush­ered Michael Rogers on­to its board of di­rec­tors. Rogers most re­cent­ly served as CFO at Aer­pio Phar­ma­ceu­ti­cals and has pre­vi­ous­ly served in roles at Acor­da Ther­a­peu­tics and In­de­vus Phar­ma­ceu­ti­cals (ac­quired by En­do Phar­ma­ceu­ti­cals) among oth­ers. He cur­rent­ly sits on the board of di­rec­tors for Ake­bia Ther­a­peu­tics.

Natasha Gior­dano has been elect­ed to the board of di­rec­tors at Bed­min­ster, NJ-based Mati­nas Bio­Phar­ma, with its lead an­ti-fun­gal can­di­date MAT2203 in a Phase II study. Gior­dano has helmed PLx Phar­ma since Jan­u­ary 2016.

John Hous­ton

→ Mary­land-based im­muno-on­col­o­gy biotech NextCure has wel­comed John Hous­ton to their board of di­rec­tors. The Bris­tol My­ers Squibb vet has been pres­i­dent and CEO of Arv­inas since 2017.

F-star Ther­a­peu­tics CEO Eliot Forster gets a seat at the board of di­rec­tors with Im­mat­ics. The Ger­man T cell im­munother­a­py play­er merged with blank check com­pa­ny Arya Ven­tures and se­cured $252 mil­lion in fund­ing.

Bud Brigham

→ Austin im­muno-on­col­o­gy out­fit Perseus Hold­ings has an­nounced the ad­di­tion of Ben “Bud” Brigham to their board of di­rec­tors. Brigham is al­so chair­man of Brigham Ex­plo­ration, An­them Ven­tures, Brigham Min­er­als and At­las Sand.

Cy­dan co-founder and CEO Chris Adams has jumped on the board of di­rec­tors at Avice­da Ther­a­peu­tics, which is de­vel­op­ing gly­co-im­mune ther­a­peu­tics (GITs). Nan­cy Thoma­son, EVP and CFO of HAP In­vest­ment Group, is al­so new to the board.

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.