Lau­ra Shawver on why she came back af­ter an $88M wind­fall; Mor­phoSys taps Am­gen vet as CCO

Lau­ra Shawver

Lau­ra Shawver didn’t quite un­der­stand can­cer un­til she had it.

By that point, in 2006, she had al­ready been mak­ing on­col­o­gy drugs for over 15 years, a dyed-in-the-wool re­searcher who had ob­tained a PhD in phar­ma­col­o­gy be­fore re­train­ing her­self as a mol­e­c­u­lar bi­ol­o­gist in the heady pre-Dol­ly days of cloning. She knew all about tu­mors. She knew the genes that drove them and the drugs that halt­ed them. Her pre­vi­ous com­pa­ny, Sug­en, had se­quenced can­cers to de­vel­op suni­tinib, one of the first ki­nase in­hibitors.

”So I thought, oh, I’ll just go to get my tu­mor pro­filed,” Shawver told End­points News in an in­ter­view this week. “What I found out was that Lau­ra Shawver could get oth­er peo­ple’s tu­mors se­quenced, but Lau­ra Shawver the pa­tient — I couldn’t get my tu­mor pro­filed to save my soul. And that pissed me off.”

There was al­so a sec­ond rev­e­la­tion, one marked per­haps less by anger than by a sort of trag­ic clar­i­ty: Sud­den­ly, the year or so you could buy some­one with the drugs biotech was de­vel­op­ing didn’t seem as great a gift.

“I start­ed look­ing quite dif­fer­ent­ly at this, and said, ‘Wait a minute, these tar­get­ed agents — they don’t last that long,’” she said. “We don’t want to treat peo­ple for just 6 to 12 months, we want to pro­vide them cures.”

The can­cer would go — treat­ed with surgery and chemother­a­py, which she took while rais­ing a Se­ries C for her sec­ond ma­jor com­pa­ny, Phe­nomix — but the im­print would stay. Af­ter fi­nal­ly get­ting her tu­mor se­quenced by Ven­tana founder Thomas Gro­gan, Shawver found­ed Clear­i­ty, an or­ga­ni­za­tion ded­i­cat­ed to get­ting women ac­cess to tu­mor pro­fil­ing that can point to­ward treat­ments. And she be­came ob­sessed with im­muno-on­col­o­gy, a field that seemed to hold the promise to bring­ing pa­tients the clos­est thing to a cure.

Now, Shawver will get her first chance to run a biotech fo­cused square­ly on im­muno-on­col­o­gy. This week, af­ter the briefest of hia­tus­es from biotech, she was named CEO of Sil­ver­back Ther­a­peu­tics, the long-stealthy Or­biMed-found­ed Seat­tle can­cer start­up.

It’s a re­union of sorts for Shawver, who worked with Sil­ver­back founder and Or­biMed part­ner Pe­ter Thomp­son at her two pre­vi­ous com­pa­nies, Cleave Ther­a­peu­tics and Syn­thorx. The two had al­ready de­cid­ed, over din­ner one night while she was still at Syn­thorx, that they didn’t want this to be their last project to­geth­er. And sure enough, in Feb­ru­ary, less than 3 months af­ter Shawver ex­e­cut­ed a $2.5 bil­lion sale of Syn­thorx to Sanofi — a deal that land­ed her an $88 mil­lion wind­fall — she was land­ing in Seat­tle to meet the team Thomp­son had amassed.

Thomp­son, who served as CEO since found­ing the com­pa­ny in 2016, told End­points he want­ed some­one who could “push the en­ve­lope of sci­ence” for pa­tients while stick­ing to the facts. She praised Shawver as “frank and hon­est,” both as a men­tor and with the board.

“I know very suc­cess­ful folks in this in­dus­try who are very com­pelling sales peo­ple,” Thomp­son said. “And Lau­ra is a sci­en­tist. She is go­ing to tell you ex­act­ly what the da­ta shows and she won’t shy away from telling you what isn’t well known.”

Shawver is as fas­ci­nat­ed by the sci­ence as she is by any­thing else. “When has that been done be­fore? Oh not since the be­gin­ning of life,” she said of her days at Syn­thorx, a biotech built around the in­ven­tion of a new DNA base pair. Thomp­son point­ed out both of them had lived through the en­tire de­vel­op­ment of mod­ern can­cer ther­a­py, from high dose chemother­a­py to CAR-T. So she was par­tic­u­lar­ly in­ter­est­ed in Sil­ver­back, which is try­ing to take an­ti­body drug con­ju­gates — an idea first con­ceived in the ear­ly 2000s to de­liv­er chemother­a­py di­rect­ly to tu­mors — and use it to send the im­mune sys­tem di­rect­ly af­ter tu­mors.

Of course Shawver didn’t know when she vis­it­ed Seat­tle in Feb­ru­ary that the city was about to be­come the first US hotspot for Covid-19, and that soon af­ter, trav­el any­where would be­come un­ten­able and she would take over as CEO in dig­i­tal ab­sen­tia. But she said it’s been large­ly seam­less. The on­ly kinks were hav­ing to do a cou­ple in­tro­duc­tions and a cou­ple hires via Zoom. Much of the staff is now re­mote, al­though some lab work­ers still go in.

”It’s like be­ing a sci­en­tist,” Shawver said. “You do what you have to do.”

Even­tu­al­ly, though, Shawver will move up to Seat­tle. It will be the fifth time run­ning a biotech and it’ll be a choice. The $2.5 bil­lion Syn­thorx land­ed her a huge per­son­al for­tune. She could’ve tak­en it and lived out re­tire­ment on a beach in San Diego, where she’s spent much of her ca­reer.

In­stead, she’ll work to get their lead HER2-tar­get­ing drug in­to the clin­ic by year’s end. The goal is to treat sol­id tu­mors that have been re­sis­tant to im­munother­a­py thus far. Shawver said it wasn’t even a choice.

“For­get the wind­fall,” she said. “I just want­ed to do it again.” — Ja­son Mast


→ With the FDA giv­ing pri­or­i­ty re­view to its an­ti­body taf­a­sita­m­ab, Mor­phoSys has found a new chief com­mer­cial of­fi­cer. Roland Wan­del­er will step in­to the role ef­fec­tive May 5 and will be re­spon­si­ble for all com­mer­cial­iza­tion ac­tiv­i­ties world­wide. Be­fore Mor­phoSys, Wan­del­er held var­i­ous po­si­tions at Am­gen for al­most 15 years, most re­cent­ly as cor­po­rate VP and GM of Am­gen’s US Bone Health and Car­di­ol­o­gy Busi­ness Unit.

Rus­sell El­li­son

Rus­sell El­li­son has re­ceived the ba­ton at Rock­well Med­ical as pres­i­dent and CEO. El­li­son has sim­i­lar ex­pe­ri­ence at Prome­dior (CEO) and Bond Bio­sciences (pres­i­dent and CEO), and al­so spent time at Sanofi and Roche, both as CMO and VP, med­ical af­fairs. El­li­son suc­ceeds Stu­art Paul, who re­signed from the metro De­troit biotech af­ter re­plac­ing Robert Chioi­ni, who tried to un­fire him­self in 2018 be­fore reach­ing a set­tle­ment.

Jen­nifer Creel has left Cel­gene to be­come CFO of ADC Ther­a­peu­tics as the Swiss on­col­o­gy biotech works to­ward sub­mit­ting a BLA for its lead drug, lon­cas­tux­imab tesirine. Creel was at Cel­gene for more than a decade, most re­cent­ly as fran­chise CFO and cor­po­rate VP, glob­al fi­nance & busi­ness plan­ning. Oth­er stops where she held fi­nance po­si­tions in­clude Wat­son Phar­ma­ceu­ti­cals and Pfiz­er.

→ Fo­cused on the treat­ment of di­a­bet­ic and oth­er pe­riph­er­al neu­ropathies, Re­ge­na­cy Phar­ma­ceu­ti­cals has en­list­ed for­mer Mer­ck ex­ec David Michel­son as CMO. Pri­or to his new post, Michel­son served as CMO of Proclara Bio­sciences. Dur­ing his 11 year stint at Mer­ck, Michel­son was the neu­ro­science ther­a­peu­tic area head and VP for clin­i­cal de­vel­op­ment. Michel­son jump­start­ed his ca­reer at Eli Lil­ly.

Greg Guy­er

Bio­Marin, whose he­mo­phil­ia A gene ther­a­py val­rox has ob­tained pri­or­i­ty re­view al­beit with a steep price, has ap­point­ed Greg Guy­er to be chief tech­ni­cal of­fi­cer, EVP of glob­al man­u­fac­tur­ing and tech­ni­cal op­er­a­tions, ef­fec­tive May 4. He suc­ceeds Robert Baf­fi, who stays on full-time as a spe­cial ad­vi­sor to the chair­man and CEO for the rest of the year as he heads to­ward re­tire­ment. Pri­or to join­ing Bio­Marin, Guy­er had been SVP, op­er­a­tions at Bris­tol My­ers Squibb.

→ Af­ter snag­ging a $75.2 mil­lion IPO ear­ly last month, NEA-found­ed Imara has an­nounced that their CMO Willem Scheele will be hit­ting the ex­it. Scheele joined the com­pa­ny in March 2019. In ad­di­tion, SVP and CMO of Au­dentes Ther­a­peu­tics Ed­ward Con­ner has joined the com­pa­ny’s board of di­rec­tors.

Megan Bai­ley

Megan Bai­ley has been pro­mot­ed to CEO of Per­son­al Genome Di­ag­nos­tics (PGDx), suc­ceed­ing Dou­glas Ward. Bai­ley start­ed at PGDx, which fo­cus­es on can­cer ge­nomics, in 2018 as VP of mar­ket­ing and was even­tu­al­ly pro­mot­ed to chief com­mer­cial of­fi­cer. Be­fore her time at the Bal­ti­more-based PGDx, she had var­i­ous roles at Roche for more than 14 years.

Karen Smith

Emer­gent BioSo­lu­tions, called up­on by J&J to help pro­duce 1 bil­lion vac­cine dos­es by 2021 to com­bat Covid-19, has wel­comed Karen Smith as its CMO. She had pre­vi­ous­ly been CMO at Jazz Phar­ma­ceu­ti­cals and has most re­cent­ly been CEO of Mede­or Ther­a­peu­tics. Smith has made the rounds at nu­mer­ous play­ers, in­clud­ing Al­ler­gan, As­traZeneca and Bris­tol My­ers Squibb.

→ In­fec­tious dis­ease spe­cial­ist Yoav Golan is mov­ing his way up to Ap­pili Ther­a­peu­tics as CMO. Golan has been an at­tend­ing physi­cian in the Di­vi­sion of Ge­o­graph­ic Med­i­cine and In­fec­tious Dis­eases at Tufts Med­ical Cen­ter since 2002 and an as­so­ciate pro­fes­sor at Tufts Uni­ver­si­ty School of Med­i­cine. In oth­er ex­ec­u­tive roles, Golan was CEO of ExAr­ca Phar­ma­ceu­ti­cals and CSO of Pro­fil­i­ty.

Ser­e­na Hung

Arku­da Ther­a­peu­tics, which launched in No­vem­ber with a $44 mil­lion Se­ries A round, has ex­pand­ed its man­age­ment team with two new faces. Ser­e­na Hung has been named head of clin­i­cal de­vel­op­ment and Ray­mond Hurst will be VP of phar­ma­col­o­gy for Arku­da, which tar­gets neu­rode­gen­er­a­tive dis­eases. Hung makes the tran­si­tion to the Cam­bridge, MA-based start­up from WAVE Life Sci­ences, where she led clin­i­cal de­vel­op­ment for CNS pro­grams. Hurst heads to Arku­da from Con­cert Phar­ma­ceu­ti­cals, where he served as di­rec­tor of bi­ol­o­gy and phar­ma­col­o­gy.

Im­vax, the Philadel­phia biotech de­vel­op­ing IGV-001 to treat new­ly-di­ag­nosed glioblas­toma mul­ti­forme, has re­cruit­ed Mark Ex­ley as CSO af­ter bring­ing on John Furey as CEO last fall. Ex­ley comes to Im­vax from Agen­Tus Ther­a­peu­tics, where he was VP, cel­lu­lar im­munol­o­gy.

→ Cam­bridge, MA-based Reper­toire Im­mune Med­i­cines, a T cell-fo­cused Flag­ship Pi­o­neer­ing com­pa­ny, has added new mem­bers to the team. An­drea Di­Fabio joins Reper­toire as EVP, chief le­gal and cor­po­rate ad­min­is­tra­tion of­fi­cer; Tim Har­ris takes on the role of EVP, cor­po­rate de­vel­op­ment; and Lu­cia Celona is now EVP, chief hu­man re­sources of­fi­cer.

Gen­prex, an Austin-based gene ther­a­py biotech, has brought in Shan­non In­man as VP of glob­al clin­i­cal op­er­a­tions. No stranger to Texas, In­man comes to Gen­prex af­ter be­ing VP of glob­al clin­i­cal op­er­a­tions at Cell Med­ica (now Ku­ur Ther­a­peu­tics). She al­so was as­so­ciate di­rec­tor of clin­i­cal op­er­a­tions at Opexa Ther­a­peu­tics out of The Wood­lands, Texas.

Bi­cy­cle Ther­a­peu­tics, which an­nounced a $1.7 bil­lion im­muno-on­col­o­gy col­lab­o­ra­tion with Genen­tech in Feb­ru­ary, has se­lect­ed Za­far Qadir as its gen­er­al coun­sel. Be­fore join­ing Bi­cy­cle, Qadir was at UK’s Cell and Gene Ther­a­py Cat­a­pult as le­gal and busi­ness ad­vis­er. He al­so spent near­ly five years at Cell Med­ica and was their VP, le­gal coun­sel & com­pa­ny sec­re­tary.

Ra­jiv De Sil­va has been named chair­man of Co­vis Phar­ma‘s board of di­rec­tors. De Sil­va, the man­ag­ing part­ner of Asiri Ad­vi­sors, was the pres­i­dent, CEO and di­rec­tor at En­do In­ter­na­tion­al and the pres­i­dent of Valeant Phar­ma­ceu­ti­cals. Pri­or to that, he held sev­er­al po­si­tions at No­var­tis.

James McArthur

James McArthur, step­ping down from Imara’s board of di­rec­tors, has joined the board of di­rec­tors at T-Cure Bio­science, an im­muno-on­col­o­gy com­pa­ny in the Los An­ge­les area. The founder and one-time CEO of Imara, McArthur has al­so found­ed Cy­dan and rare dis­ease biotech Vtesse. The lat­est com­pa­ny McArthur has found­ed is Tibu­rio, which fo­cus­es on rare neu­roen­docrine dis­or­ders.

→ Buoyed by en­cour­ag­ing Phase III da­ta with its lead drug vo­closporin for the treat­ment of lu­pus nephri­tis, Au­rinia has ap­point­ed Tim Wal­bert to its board of di­rec­tors. Wal­bert has been pres­i­dent and CEO of Hori­zon Ther­a­peu­tics since 2008. He has al­so been pres­i­dent, CEO and di­rec­tor of IDM Phar­ma, which was ac­quired by Take­da, and the EVP of com­mer­cial op­er­a­tions at NeoPharm.

Ro­mesh Sub­ra­man­ian’s new biotech start­up, Dyne Ther­a­peu­tics, which is us­ing oligonu­cleotides to de­grade RNA re­spon­si­ble for dis­ease, has ap­point­ed David Lub­n­er to its board of di­rec­tors. Lub­n­er serves as the EVP and CFO of Ra Phar­ma (ac­quired by UCB).

Julie Ham­ble­ton

→ Cal­i­for­nia biotech Arch On­col­o­gy, fo­cused on an­ti-CD47 an­ti­body ther­a­pies with its lead can­di­date AO-176, has named Julie Ham­ble­ton to its board of di­rec­tors. Ham­ble­ton is the CMO at Ideaya Bio­sciences, and be­fore that, she was at Bris­tol My­ers Squibb as VP, head of US med­ical. She has al­so been EVP and CMO at Five Prime Ther­a­peu­tics.

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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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.

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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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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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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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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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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