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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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