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.

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.

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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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.

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.