Al­ny­lam bids adieu to 2020 — and hel­lo to a slate of new ex­ecs; No­vavax taps Rick Crow­ley as COO

John Maraganore is clos­ing out the year with a surge of new hires at Al­ny­lam just a month af­ter lumasir­an notched an FDA ap­proval for pri­ma­ry hy­per­ox­aluria type 1 (PH1). Tol­ga Tan­guler, who takes on the role of chief com­mer­cial of­fi­cer, has Big Phar­ma ex­pe­ri­ence at Pfiz­er, tack­ling mul­ti­ple po­si­tions and ris­ing to pres­i­dent of their North Amer­i­ca rare dis­ease unit. For the last 2 years, Tan­guler was SVP and head of US for Alex­ion.

Kasha Witkos

Else­where at Al­ny­lam, Kasha Witkos is now SVP and head of Cana­da, Eu­rope, Mid­dle East and Africa (CE­MEA). Witkos was a com­mer­cial ex­ec at Shire, and af­ter the buy­out, she even­tu­al­ly be­came Take­da’s glob­al rare im­munol­o­gy fran­chise head. Salil Pa­tel, get­ting sit­u­at­ed as Al­ny­lam’s SVP and head of med­ical af­fairs, spent 14 years at Bris­tol My­ers Squibb, spend­ing time as head of med­ical for the phar­ma gi­ant’s on­col­o­gy busi­ness and wrap­ping up his tenure as VP, head of search and clin­i­cal col­lab­o­ra­tions.

Fi­nal­ly, Ag­niesz­ka Gal­lagher joins Al­ny­lam as chief ethics and com­pli­ance of­fi­cer af­ter 3 years as gen­er­al coun­sel, chief com­pli­ance of­fi­cer and sec­re­tary for Vi­iV Health­care.

Rick Crow­ley

Lag­ging be­hind Pfiz­er/BioN­Tech and Mod­er­na in the Covid-19 vac­cine race, No­vavax has re­cruit­ed Rick Crow­ley as COO in a year teem­ing with per­son­nel moves at the biotech. Back in June, No­vavax had tasked Ben Machielse with CMC re­spon­si­bil­i­ties, but qual­i­ty, man­u­fac­tur­ing, sup­ply chain and reg­u­la­to­ry af­fairs op­er­a­tions now shift to Crow­ley’s desk — leav­ing Machielse as sole­ly an ex­ec­u­tive ad­vi­sor to CEO Stan­ley Er­ck. Crow­ley makes the switch to No­vavax from TerSera Phar­ma­ceu­ti­cals, where he was EVP, tech­ni­cal op­er­a­tions, and his pre­vi­ous COO ex­pe­ri­ence was with Savient Phar­ma­ceu­ti­cals from 2013-14.

Joe Jimenez and Per­ry Karsen have hooked on to the board of di­rec­tors at Ver­sant-backed gene edit­ing play­er Graphite Bio, which emerged with a $45 mil­lion Se­ries A in Sep­tem­ber. Jimenez and Adi­tum Bio part­ner Mark Fish­man just got their mitts on an an­ti-in­flam­ma­to­ry Nrf2 drug from vTv Ther­a­peu­tics for their third com­pa­ny, An­teris Bio, which fo­cus­es on re­nal dis­ease. Karsen, the chair­man of Jounce and a board mem­ber at In­tel­lia un­til Dec. 31, was CEO of Cel­gene’s cel­lu­lar ther­a­peu­tics di­vi­sion and al­so their COO.

Erin Whit­ney

→ Co-CEOs Josh Co­hen and Justin Klee over at Amy­lyx have brought on three more mem­bers of their team with Erin Whit­ney, head of glob­al clin­i­cal op­er­a­tions; Shau­na Hor­vath, head of glob­al mar­ket­ing; and Kei­th White, head of glob­al mar­ket ac­cess. Be­fore join­ing Amy­lyx, which boast­ed pos­i­tive da­ta for its Phase II/III ALS tri­al in Sep­tem­ber, Whit­ney was blue­bird bio’s di­rec­tor of clin­i­cal de­vel­op­ment op­er­a­tions for their sick­le cell pro­gram. Be­fore that, she was in­volved in the Pompe dis­ease pro­gram at Gen­zyme.

As for the two oth­er ap­point­ments, Hor­vath had been a con­sul­tant for Amy­lyx for the last year and she pre­vi­ous­ly held mul­ti­ple ti­tles at Cam­bridge Bio­Mar­ket­ing, in­clud­ing head of op­er­a­tions. Fi­nal­ly, White is a 14-year Genen­tech vet who left his post at Cor­bus Phar­ma­ceu­ti­cals as VP, glob­al mar­ket ac­cess and pric­ing.

An­drew Guggen­hime

An­drew Guggen­hime has been pro­mot­ed to pres­i­dent and CFO of Vax­cyte, the vac­cine play­er that used to be SutroVax un­til its May re­brand­ing. That same month, Guggen­hime was named CBO and CFO of Vax­cyte, which then threw its hat in the very crowd­ed IPO ring in June by rais­ing just a shade un­der $250 mil­lion. Guggen­hime’s oth­er CFO stops in­clude six years at Der­mi­ra (which Eli Lil­ly bought for $1.1 bil­lion) as well as Car­dioDx and Cal­is­to­ga Phar­ma­ceu­ti­cals.

→ Big Phar­ma alum Dol­ca Thomas has punched her tick­et to La Jol­la, CA-based Equi­l­li­um, which is de­vel­op­ing itolizum­ab to treat dis­eases like aGVHD, lu­pus/lu­pus nephri­tis and un­con­trolled asth­ma. She will be the biotech’s EVP of R&D as well as their CMO. The for­mer di­rec­tor of glob­al clin­i­cal de­vel­op­ment in im­munol­o­gy at Bris­tol My­ers Squibb, Thomas was al­so VP of clin­i­cal de­vel­op­ment and clin­i­cal im­munophe­no­typ­ing at Pfiz­er and VP and glob­al head of trans­la­tion­al med­i­cine for im­munol­o­gy, in­flam­ma­tion, and in­fec­tious dis­ease at Roche. She spent the last 2 years as CMO at Prin­cip­ia.

An­jeza Gji­no

→ A Phase II tri­al for sick­le cell dis­ease went bust in Oc­to­ber at Pe­ter Hecht’s spin­off Cy­cle­ri­on. Nonethe­less, two pro­mo­tions have been hand­ed out to Cheryl Gault (COO) and An­jeza Gji­no (CFO) at the Cam­bridge, MA com­pa­ny. Gault had been Cy­cle­ri­on’s SVP and head of strat­e­gy and cor­po­rate de­vel­op­ment since the spring and was pre­vi­ous­ly at an­oth­er place Hecht helmed, Iron­wood, for eight years. As a re­sult, cur­rent CFO Bill Huyett will be strate­gic ad­vi­sor to the com­pa­ny ef­fec­tive Jan. 1. Gji­no is an­oth­er Iron­wood alum who was bumped up at Cy­cle­ri­on from her role as VP, fi­nance and cor­po­rate sec­re­tary.

Mean­while, Po­laris Part­ners man­ag­ing di­rec­tor Amy Schul­man an­nounced her in­ten­tion to step aside from Cy­cle­ri­on’s board of di­rec­tors.

Ce­cil­ia Jones

Log­icBio has tacked on an­oth­er C-suite change with Bio­gen alum Ce­cil­ia Jones as CFO af­ter Mar­i­ana Nacht came on the scene as CSO and Kyle Chi­ang was pro­mot­ed to COO in No­vem­ber. Jones has been with Bio­gen for 10 years in a num­ber of fi­nan­cial roles and is their VP for R&D, world­wide med­ical and busi­ness de­vel­op­ment fi­nance un­til she takes over at Log­icBio on Jan. 11.

RA Cap­i­tal-backed rare dis­ease out­fit CAN­bridge Phar­ma­ceu­ti­cals, which kicked off 2020 with a $98 Se­ries D raise, has made Justin Lu gen­er­al man­ag­er of Chi­na, putting him in charge of com­mer­cial op­er­a­tions in Shang­hai. Lu, who has held sales man­age­ment po­si­tions at Bay­er in Shang­hai and No­var­tis in the Bei­jing of­fice, was Take­da Phar­ma­ceu­ti­cal Chi­na’s head of he­mo­phil­ia and rare dis­ease.

Denelle Wayn­ick

→ Rare dis­ease phar­ma San­iona, based in Copen­hagen and Boston, has been busy piec­ing to­geth­er its lead­er­ship ros­ter in 2020, and this week is no dif­fer­ent with Denelle Wayn­ick as chief le­gal of­fi­cer and Kyle Har­ald­sen as chief tech­ni­cal op­er­a­tions of­fi­cer. If it seems like Wayn­ick was just in this space, you’re very per­cep­tive: Wayn­ick is mov­ing on to San­iona af­ter she just took the gen­er­al coun­sel job at MyoKar­dia in Ju­ly. Bris­tol My­ers bought out MyoKar­dia a cou­ple of months af­ter she ar­rived. She al­so has a seat at Zo­genix’s board of di­rec­tors, which was an­nounced in Sep­tem­ber. Har­ald­sen heads to San­iona af­ter his tenure at AM­AG Phar­ma­ceu­ti­cals as VP of tech­ni­cal op­er­a­tions and project man­age­ment. Ear­li­er this year, San­iona broke in a new CEO, CFO, chief com­mu­ni­ca­tions of­fi­cer and chief hu­man re­sources of­fi­cer.

→ Backed by Flag­ship Pi­o­neer­ing, chaired by David Ep­stein and en­cour­aged by da­ta from their Phase Ib atopic der­mati­tis tri­al, Cam­bridge, MA biotech Evelo Bio­sciences has tapped Jonathan Zung as chief de­vel­op­ment of­fi­cer. Zung had been pres­i­dent of spon­sor and CRO pro­grams at WCG Clin­i­cal pri­or to his ar­rival at Sim­ba Gill-led Evelo. Zung’s al­so been a clin­i­cal op­er­a­tions ex­ec at Bris­tol My­ers Squibb and UCB as well as a glob­al R&D di­rec­tor at Pfiz­er from 1991-2001.

Du­ane Barnes

→ Stock­holm-based So­bi, which splashed $250 mil­lion up­front along with $915 mil­lion in mile­stones for sys­temic C3 ther­a­py pegc­eta­coplan from Apel­lis a cou­ple months ago, has ap­point­ed Du­ane Barnes as their head of North Amer­i­ca. Barnes, the pres­i­dent and head of op­er­a­tions at UCB and based out of At­lanta, will start in Jan­u­ary. He was al­so Am­gen’s VP & gen­er­al man­ag­er, US val­ue and ac­cess.

→ Long­time Bris­tol My­ers Squibb vet Chris Sti­j­nen has been named chief com­mer­cial of­fi­cer at Swiss-based Re­lief Ther­a­peu­tics, a biotech that has seen its share price sky­rock­et by 38,000% this year as they con­tin­ue work on RLF-100 for res­pi­ra­to­ry fail­ure at­trib­uted to se­vere Covid-19. Sti­j­nen’s last du­ties at BMS were cen­tered on Chi­na as the phar­ma gi­ant’s VP, prod­uct & port­fo­lio strat­e­gy and in­ter­im head, com­mer­cial strat­e­gy and ca­pa­bil­i­ties in Shang­hai.

→ UK-based biotech fund Abing­worth has pro­mot­ed Bali Mu­ralid­har to man­ag­ing part­ner. Mu­ralid­har joined the com­pa­ny last April and cur­rent­ly sits on the boards of Re­neo Phar­ma­ceu­ti­cals, Nu­Cana, Spruce Bio­sciences and Ex­i­cure.

→ The folks at Q32 Bio, who se­cured a $60 mil­lion Se­ries B to tar­get the IL-7R path­way, have a new chair­man of the board in Mark Iwic­ki, re­plac­ing co-founder David Grayzel. Iwic­ki has helmed Kala Phar­ma­ceu­ti­cals since 2015.

Na­tal­ie Holles

Al­lakos has reeled in Au­dentes Ther­a­peu­tics CEO and pres­i­dent Na­tal­ie Holles to its board of di­rec­tors.  Pri­or to Au­dentes, Holles held roles at Hy­pe­r­i­on Ther­a­peu­tics, KAI Phar­ma­ceu­ti­cals and Genen­tech.

J&J vet Denice Tor­res has been added to the board of di­rec­tors at CNS-fo­cused Karuna Ther­a­peu­tics. Tor­res was at J&J from 2005-17, round­ing out her time at the Big Phar­ma as chief strat­e­gy and busi­ness trans­for­ma­tion of­fi­cer for their med­ical de­vice di­vi­sion.

Denice Tor­res

Mani Mo­hin­dru has been elect­ed to the board of di­rec­tors at Cy­tomX, which is part­ner­ing on bis­pecifics with Astel­las in an $80 mil­lion deal. The for­mer CEO of CereX­is, Mo­hin­dru al­so served as CFO and chief strat­e­gy of­fi­cer at Cara Ther­a­peu­tics from 2017-19.

→ San Diego cell and gene ther­a­py play­er Po­sei­da Ther­a­peu­tics has wel­comed Luke Corn­ing to their board of di­rec­tors. Corn­ing start­ed out at Gold­man Sachs and leads the cred­it team at Pent­wa­ter Cap­i­tal Man­age­ment.

→ Ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health has made Tony Bourne in­de­pen­dent non-ex­ec­u­tive di­rec­tor of its board. Bourne cur­rent­ly serves as chair of CW+. Pre­vi­ous­ly, he was chief ex­ec­u­tive of the British Med­ical As­so­ci­a­tion.

→ Lon­don-based VC shop 4BIO Cap­i­tal, which has made some high pro­file ex­its from com­pa­nies such as Or­chard and Seres, has ap­point­ed Akiko Iwasa­ki to its Sci­en­tif­ic Ad­vi­so­ry Board. Iwasa­ki is the Walde­mar Von Zed­witz pro­fes­sor in the de­part­ment of im­munol­o­gy and a pro­fes­sor in the de­part­ment of mol­e­c­u­lar, cel­lu­lar and de­vel­op­men­tal bi­ol­o­gy at Yale Uni­ver­si­ty.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.