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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.