Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

Va­lerie Ode­gard

→ Ac­com­pa­ny­ing the news that they just scored an $85 mil­lion Se­ries C round, Lau­ra Shawver-led Sil­ver­back Ther­a­peu­tics has pro­mot­ed two ex­ecs, with Va­lerie Ode­gard adding pres­i­dent to her CSO du­ties and Nao­mi Hun­der mov­ing to CMO. A No­vo Nordisk alum, Ode­gard has been with the Seat­tle-based biotech since 2016 and the CSO the last 2 years. Be­fore Sil­ver­back, she was VP of re­search at Juno Ther­a­peu­tics.

Hun­der came to Sil­ver­back in ear­ly 2019 as their SVP, clin­i­cal R&D af­ter near­ly 2 years as VP, clin­i­cal de­vel­op­ment and med­ical af­fairs at Ac­er­ta Phar­ma. She al­so held mul­ti­ple lead­er­ship posts over a 6 ½-year pe­ri­od at Seat­tle Ge­net­ics.

→ Af­ter just 49 days in­to his new role at the helm of Leg­end Biotech, Frank Zhang has been forced to hand the ti­tle back. The for­mer Gen­Script CEO — a role he held for 18 years — is un­der house ar­rest in Chi­na as part of a cus­toms in­ves­ti­ga­tion in­volv­ing Gen­Script, the par­ent com­pa­ny of Leg­end. While he re­mains the chair­man, CFO Ying Huang has been tapped to dou­ble as in­ter­im CEO. As of now, there’s no way to tell how or when the whole mat­ter will be re­solved.

Philippe Lopes-Fer­nan­des

→ Ef­fec­tive Oct 1, Ipsen is bring­ing on Philippe Lopes-Fer­nan­des as their EVP and CBO af­ter David Loew bolt­ed from Sanofi to be­come their CEO in May. Be­fore mak­ing the tran­si­tion to Ipsen, Lopes-Fer­nan­des held nu­mer­ous roles at Mer­ck KGaA, even­tu­al­ly work­ing his way up to SVP, glob­al head of busi­ness de­vel­op­ment and al­liance man­age­ment.

 

→ Af­ter re­cent­ly bag­ging $60 mil­lion in a Se­ries B raise, Bob Nelsenbacked and mR­NA-fo­cused Nut­crack­er Ther­a­peu­tics has reeled in Mad­ha­van Bal­achan­dran as COO. Pre­vi­ous­ly, Bal­achan­dran served as EVP of op­er­a­tions at Am­gen. In ad­di­tion to his new role at Nut­crack­er, Bal­achan­dran will con­tin­ue to serve as di­rec­tor of Catal­ent, uniQure, A2 Bio­ther­a­peu­tics and the Ste­vana­to Group.

Eliz­a­beth Cz­erepak

→ With two FDA break­through des­ig­na­tions in their hip pock­et for plinab­u­lin in the US and Chi­na, New York im­muno-on­col­o­gy play­er Be­yond­Spring has brought on Eliz­a­beth Cz­erepak as CFO. Cz­erepak, who has made the bank­ing rounds at Bear Stearns and JP Mor­gan, has Big Phar­ma ex­pe­ri­ence with Mer­ck and Roche dat­ing back to the 1980s and has been CFO on sev­er­al oc­ca­sions, most re­cent­ly with Genevant Sci­ences (where she was al­so CBO) and else­where at Al­tim­mune and Is­ar­na Ther­a­peu­tics.

Be­yond­Spring has al­so made Ed­ward Liu CFO of their pro­tein degra­da­tion sub­sidiary Seed Ther­a­peu­tics. Liu will re­tain his CFO post at Be­yond­Spring, Chi­na.

John Gay, who start­ed out with Mor­risville, NC-based No­van two years ago, has been pro­mot­ed to CFO. Since Jan­u­ary 2019, Gay had been VP, fi­nance and cor­po­rate con­troller for the biotech, whose mol­lus­cum con­ta­gio­sum drug SB206 sput­tered in a late-stage tri­al at the start of this year — be­fore Kel­ly Mar­tin re­tired from the com­pa­ny in Feb­ru­ary. Ad­di­tion­al­ly at No­van, for­mer Owens & Mi­nor CEO, CFO and COO James Bier­man has been elect­ed to the board of di­rec­tors.

An­tho­ny Coyle

Reper­toire Im­mune Med­i­cines, a Flag­ship biotech that is the prod­uct of the merg­er of Co­gen Im­mune Med­i­cines and Torque Ther­a­peu­tics, has tapped An­tho­ny Coyle to be their pres­i­dent of R&D. The co-found­ing CEO of Pan­dion, Coyle al­so spent 7 years as SVP and CSO at Pfiz­er, where he launched the phar­ma gi­ant’s Cen­ters for Ther­a­peu­tic In­no­va­tion.

Resh­ma Rang­wala is join­ing Ar­a­vive as CMO. Rang­wala is bring­ing along ex­pe­ri­ence from her pre­vi­ous roles as VP, med­ical at Gen­mab and ex­ec­u­tive clin­i­cal di­rec­tor at Mer­ck.

Michael Os­tra­ch

Michael Os­tra­ch, the SVP, CFO and CBO at Dy­navax, has in­formed the biotech about his planned re­tire­ment in 2021. Os­tra­ch has been with the hep B vac­cine de­vel­op­er since 2006 and has in­di­cat­ed he would stay on as an ad­vis­er if Dy­navax hap­pens to se­lect a CFO be­fore March 31, 2021. Dy­navax doesn’t plan to fill the CBO slot when Os­tra­ch re­tires.

Else­where at Dy­navax, Pe­ter Par­adiso has been waved in as a mem­ber of their board of di­rec­tors. Par­adiso moved in­to a new chap­ter with Par­adiso Bi­o­log­ics Con­sult­ing af­ter re­tir­ing from Pfiz­er in 2012 as VP, new busi­ness and sci­en­tif­ic af­fairs for Pfiz­er Vac­cines.

Noah Clauser start­ed out at Boston-based Cataba­sis Phar­ma­ceu­ti­cals in April 2011 as the biotech’s con­troller. Nine years lat­er, he’s their CFO af­ter 3 years as VP, fi­nance. Be­fore join­ing Cataba­sis, whose lead can­di­date edasa­lonex­ent is in Phase III to treat Duchenne mus­cu­lar dy­s­tro­phy, Clauser was an ac­count­ing man­ag­er at Im­press Soft­ware.

Elis­a­beth Lei­der­man

Elis­a­beth Lei­der­man has ac­cept­ed the CFO role at Deci­bel Ther­a­peu­tics, which saw a chang­ing of the guard at CEO in Jan­u­ary when Lau­rence Reid suc­ceed­ed Steve Holtz­man. Be­fore mov­ing to Deci­bel, a col­lab­o­ra­tor with Re­gen­eron that fo­cus­es on hear­ing loss and bal­ance dis­or­ders, Lei­der­man was CBO and cor­po­rate sec­re­tary at Com­plexa and be­fore that, she was Fortress Biotech’s SVP, head of cor­po­rate de­vel­op­ment.

→ Bio­phar­ma­ceu­ti­cals com­pa­ny Bio­con has named Anu­pam Jin­dal as its new CFO. Jin­dal hops aboard af­ter a 22-year stint at the Vedan­ta Group of com­pa­nies, where he held the po­si­tion of group CFO at Ster­lite Tech­nolo­gies.

→ Liq­uid biop­sy out­fit Ini­va­ta, a Cam­bridge spin­out with a lab in the Re­search Tri­an­gle, has tapped Pe­ter Collins as CBO. Collins, a for­mer VP and head of di­ag­nos­tics at GSK, had been at Guardiant Health as their VP of bio­phar­ma BD. His last CBO gig was at Your­gene Health, a po­si­tion he held from 2014-19.

Bec­ki Mori­son

→ Eli Lil­ly alum Bec­ki Mori­son has joined Leo Phar­ma, which just of­floaded their pso­ri­a­sis as­set LP0058 for $200 mil­lion to fel­low Dan­ish com­pa­ny Union Ther­a­peu­tics in Ju­ly, as EVP, glob­al ther­a­peu­tic & val­ue strat­e­gy. Mori­son spent more than 18 years at Lil­ly in an as­sort­ment of posts, leav­ing the Big Phar­ma as their VP, im­munol­o­gy. She moved up to that po­si­tion in Jan­u­ary 2019 af­ter a spell as pres­i­dent and gen­er­al man­ag­er, UK, Ire­land and Nordics.

No­var­tis and Roche vet Fed­eri­co Bolog­nani is mak­ing the tran­si­tion to Ax­i­al Ther­a­peu­tics, fo­cused on CNS-re­lat­ed and gut-de­rived dis­eases, as their VP and head of clin­i­cal sci­ence, ef­fec­tive Nov 2. Bolog­nani has had the same ti­tle at Vec­tivBio and Ther­a­chon the last cou­ple years, and dur­ing his time at Roche from 2013-18, he was the phar­ma gi­ant’s trans­la­tion­al med­i­cine leader as well as bio­mark­er and ex­per­i­men­tal med­i­cine leader.

→ Ital­ian biotech Dom­pé Far­ma­ceu­ti­ci has pro­mot­ed Ash­ley Kline to glob­al biotech head, and she will al­so con­tin­ue in her two oth­er po­si­tions: gen­er­al man­ag­er of Dom­pé US and sec­re­tary of the US af­fil­i­ate’s board of di­rec­tors. Kline, who joined the com­pa­ny in Ju­ly 2018, was at Genen­tech from 2009-14, specif­i­cal­ly with the Lu­cen­tis team as group prod­uct man­ag­er, fran­chise op­er­a­tions. She was al­so a se­nior di­rec­tor at San­ten from 2016-18.

Ken­non Broad­hurst

→ With ex­pan­sive Big Phar­ma ties, Ken­non Broad­hurst has been named VP of glob­al mar­ket­ing at BioAg­i­lytix Labs. Broad­hurst, who has held lead­er­ship po­si­tions at Ab­bott, No­var­tis, Mer­ck and Bris­tol My­ers Squibb, re­cent­ly spent more than 5 years at Am­gen, in­clud­ing as their glob­al mar­ket­ing lead for on­col­o­gy and hema­tol­ogy biosim­i­lars. But be­fore head­ing to BioAg­i­lytix, a bio­an­a­lyt­i­cal test­ing lab­o­ra­to­ry fo­cus­ing on large mol­e­cule bio­analy­sis, Broad­hurst was man­ag­ing part­ner at the Bil­go­la Group.

→ Ear­li­er this month, Austin-based gene ther­a­py biotech Gen­prex named William Gan­non VP of reg­u­la­to­ry af­fairs. Now they have an­oth­er new ex­ec in the mix as Thomas Gal­lagher steps up to the plate as SVP of in­tel­lec­tu­al prop­er­ty and li­cens­ing. Gal­lagher, who was pre­vi­ous­ly a prin­ci­pal at the Fe­nagh Group, spent near­ly 20 years at Im­Clone Sys­tems, the vast ma­jor­i­ty of it han­dling in­tel­lec­tu­al prop­er­ty. He has al­so been SVP of in­tel­lec­tu­al prop­er­ty and li­cens­ing at Kad­mon from 2010-16.

Char­lotte Turnier

No­vadis­cov­ery, an in sil­i­co clin­i­cal tri­als com­pa­ny based in Ly­on, France, has two new ex­ecs with Jim Bosley as SVP, mod­el­ing and sim­u­la­tion and Char­lotte Turnier as SVP, sales and mar­ket­ing. A for­mer re­search en­gi­neer at DuPont, Bosley found­ed pre­dic­tive mod­el­ing con­sul­tan­cy Cler­mont, Bosley in 2012. Turnier comes from Icon, the Irish CRO, where she was ex­ec­u­tive di­rec­tor of busi­ness de­vel­op­ment, Eu­rope. From 2012-17, she was al­so a se­nior di­rec­tor in BD at IQVIA.

ERS Ge­nomics — formed to pro­vide broad ac­cess to the foun­da­tion­al CRISPR/Cas9 in­tel­lec­tu­al prop­er­ty — has made the ad­di­tion of Michael Arciero as VP of in­tel­lec­tu­al prop­er­ty and com­mer­cial de­vel­op­ment. Arciero brings ex­pe­ri­ence from his pre­vi­ous role as di­rec­tor of tech­nol­o­gy com­mer­cial­iza­tion and new ven­tures for the USC Stevens Cen­ter for In­no­va­tion.

Ka­trin Ru­pal­la

4D Phar­ma, a small biotech based in Leeds, UK which Mer­ck signed a pact with last Oc­to­ber, has brought on Ka­trin Ru­pal­la as an in­de­pen­dent non-ex­ec­u­tive di­rec­tor. Ru­pal­la brings with her ex­pe­ri­ence from her pre­vi­ous roles at Mer­ck, Roche, Cel­gene and Bris­tol My­ers Squibb — where she served as VP head R&D Chi­na and glob­al de­vel­op­ment team leader for Op­di­vo/Yer­voy in Chi­na, and then VP, head on­col­o­gy glob­al reg­u­la­to­ry sci­ences.

→ South San Fran­cis­co biotech Sur­rozen has pulled in David Wood­house to its board of di­rec­tors. Wood­house hails from NGM Bio­phar­ma­ceu­ti­cals, where he cur­rent­ly serves as CEO and di­rec­tor.

Both Re­vi­tope On­col­o­gy and The­olyt­ics have wel­comed Carsten Rein­hardt to their re­spec­tive boards of di­rec­tors. Rein­hardt, the man­ag­ing di­rec­tor and chief de­vel­op­ment of­fi­cer at Im­mat­ics, has been at the fore­front of bis­pe­cif­ic T cell ther­a­py.

Denelle Wayn­ick

Zo­genix, which has a Ju­ly FDA ap­proval in hand with Fin­tepla for seizures as­so­ci­at­ed with Dravet syn­drome, has three new mem­bers of their board. Denelle Wayn­ick just start­ed at MyoKar­dia this sum­mer as gen­er­al coun­sel and cor­po­rate sec­re­tary; Car­o­line Loewy is al­so on the board of di­rec­tors at Phase­Bio Phar­ma­ceu­ti­cals, Ap­tose Bio­sciences and CymaBay; and Mary Stutts is SVP of cor­po­rate re­la­tions at Sum­i­to­vant Bio­phar­ma.

CymaBay chair­man Robert Wills has been added to the board of di­rec­tors at Mile­stone Phar­ma­ceu­ti­cals, which tar­gets car­dio­vas­cu­lar dis­eases. Wills logged more than 25 years at J&J, where he was their VP, al­liance man­age­ment. Mile­stone has al­so elect­ed for­mer Op­ti­vara CEO Lisa Giles to the board.

Tom Finn

→ Cincin­nati im­munother­a­py out­fit Eikonok­lastes has locked in long­time Proc­ter & Gam­ble ex­ec Tom Finn for their board of di­rec­tors. Finn re­tired this sum­mer as pres­i­dent of P&G Glob­al Per­son­al Health Care and had been with P&G since 1984.

Zio­pharm On­col­o­gy con­tin­ues to shift its board of di­rec­tors with Kevin Buchi af­ter ap­point­ing James Huang in Ju­ly. Con­se­quent­ly, new Dicer­na CFO Doug Pagán has re­signed from the board. Buchi is the for­mer CEO of Cephalon, Tetralog­ic Phar­ma­ceu­ti­cals and Biospecifics Tech­nolo­gies.

Melanie Lev­eridge

→ The Eu­ro­pean Lab­o­ra­to­ry Re­search & In­no­va­tion Group (EL­RIG) UK, has elect­ed Melanie Lev­eridge as chair. Lev­eridge has been with the non-prof­it since 2017 and is cur­rent­ly head of screen­ing, pro­fil­ing and mech­a­nis­tic bi­ol­o­gy UK, and glob­al com­pound man­age­ment at GSK.

Pri­vate eq­ui­ty firm Ar­se­nal Cap­i­tal Part­ners has tapped Richard Eglen as a se­nior ad­vi­sor to its health­care team. Eglen’s pre­vi­ous stints in­clude roles at Roche, PerkinElmer, Dis­cov­erX and most re­cent­ly as ex­ec­u­tive of­fi­cer, VP and gen­er­al man­ag­er of Corn­ing.

→ Med­ical de­vice com­pa­ny Crea­vo Med­ical Tech­nolo­gies has ap­point­ed Mar­tin Frost as chair­man of the board of di­rec­tors. Frost takes over from Robert Barr. Frost co-found­ed CMR Sur­gi­cal and for­mer­ly served as the com­pa­ny’s CEO and has al­so served in roles at Sagen­tia.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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Lit­tle Zosano takes an­oth­er beat­ing as the FDA slaps down their ap­pli­ca­tion for a mi­graine patch

Zosano $ZSAN has officially come up short in its bid to develop a migraine patch.

The FDA rejected the company’s application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta, Zosano said Wednesday morning, issuing a CRL for the microneedle patch. Regulators cited inconsistent exposure levels across multiple clinical trials as the main reason for the thumbs down.

Investors did not take too kindly to the news, with Zosano shares plunking down around 25%. The company is requesting a Type A meeting to “provide clarity on the next steps for the program,” CEO Steven Lo said in a statement.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.

Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.