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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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