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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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