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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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