Amy Bur­roughs to lead Cleave Ther­a­peu­tics; Cyn­thia Collins clinch­es Ed­i­tas CEO job amid his­toric CRISPR move

Amy Bur­roughs

→ Af­ter bag­ging $12 mil­lion to ad­vance its lead drug can­di­date CB-5339 — a (VCP)/p97 in­hibitor — through ear­ly clin­i­cal de­vel­op­ment, Cleave Ther­a­peu­tics is beef­ing up its ex­ec­u­tive team. Amy Bur­roughs will be lead­ing the helm as CEO while Scott Har­ris joins as COO. Bur­roughs was an ex­ec­u­tive-in-res­i­dence at 5AM Ven­tures, which led the re­cent fi­nanc­ing, where she al­so served as a strate­gic com­mer­cial ad­vi­sor to port­fo­lio com­pa­ny Cri­net­ics Phar­ma­ceu­ti­cals. Giv­en her ear­ly ex­pe­ri­ence with the team at Genen­tech and back­ground in life sci­ences con­sult­ing, Bur­roughs brings crit­i­cal per­spec­tives on “un­der­stand­ing mar­ket needs, build­ing part­ner­ships and at­tract­ing top-notch tal­ent,” said board chair­man and for­mer Cleave CEO Lau­ra Shawver.

Har­ris most re­cent­ly served at two Bridge­Bio sub­sidiaries, in­clud­ing as ex­ec­u­tive vice pres­i­dent, cor­po­rate de­vel­op­ment and op­er­a­tions at Navire Phar­ma. He’s had a stint as ex­ec­u­tive vice pres­i­dent of reg­u­la­to­ry af­fairs and tech­ni­cal op­er­a­tions at Ad­ynxx and honed his cross-func­tion­al acu­men across Corthera, Bio­Marin Phar­ma­ceu­ti­cal, At­ten­uon, Angstrom Phar­ma­ceu­ti­cal and Biosite.

Cyn­thia Collins

Sev­en months af­ter Ka­trine Bosley abrupt­ly stepped down from Ed­i­tas, Cyn­thia Collins has been con­firmed as the of­fi­cial pres­i­dent and CEO. Collins — a board mem­ber and for­mer CEO of Hu­man Longevi­ty — has presided over the re­cent ini­ti­a­tion of Ed­i­tas’ first hu­man tri­al, and will now con­tin­ue to steer the biotech along the his­toric CRISPR move. The dos­ing of ED­IT-101 (or AGN-151587, as their part­ners at Al­ler­gan, call it) would mark the first test of in vi­vo edit­ing us­ing CRISPR/Cas9 — more specif­i­cal­ly, to a ge­net­ic mu­ta­tion that caus­es a rare form of blind­ness known as Leber con­gen­i­tal amau­ro­sis 10 (LCA10). She will al­so work on “mov­ing clos­er to the clin­ic with ED­IT-301 for the treat­ment of sick­le cell dis­ease, ex­pand­ing our port­fo­lio through strate­gic busi­ness de­vel­op­ment, and build­ing our or­ga­ni­za­tion­al ca­pa­bil­i­ties to scale for growth,” Collins added in a state­ment.

Jay Shep­ard

Ar­a­vive CEO and pres­i­dent Jay Shep­ard will be step­ping down from his roles in the com­pa­ny “for fam­i­ly med­ical rea­sons.” The com­pa­ny’s board of di­rec­tors is com­menc­ing a search for his suc­ces­sor, and in the mean­time, Shep­ard plans to serve in his cur­rent role un­til a suc­ces­sor is ap­point­ed. Shep­ard’s de­par­ture comes as the com­pa­ny has ini­ti­at­ed the Phase 1b por­tion of a Phase 1b/2 clin­i­cal tri­al for their lead drug can­di­date, AVB-500 — an affin­i­ty de­coy pro­tein that tar­gets the GAS6-AXL sig­nal­ing path­way — com­bined with stan­dard of care ther­a­pies in pa­tients with plat­inum-re­sis­tant ovar­i­an can­cer. 

→ A Phase III ready Pal­la­dio Bio­sciences — with a lead drug, lix­i­vap­tan, lined up for poly­cys­tic kid­ney dis­ease — has picked Alex Mar­tin to lead their com­pa­ny as CEO. Mar­tin had the top job at Realm Ther­a­peu­tics be­fore its ac­qui­si­tion by ES­SA Phar­ma in Ju­ly and has held the COO role at In­ter­cept Phar­ma­ceu­ti­cals. He be­gan his ca­reer at SmithK­line Beecham and lat­er be­came vice pres­i­dent, busi­ness de­vel­op­ment & li­cens­ing at No­var­tis, grad­u­al­ly build­ing a fo­cus on BD, op­er­a­tions and fundrais­ing.

Mer­ck and Il­lu­mi­na-backed Ser­im­mune has brought on Noah Nass­er to over­see the com­mer­cial­iza­tion of its “im­mune in­tel­li­gence” tech­nol­o­gy plat­form map­ping the range of anti­gens stim­u­lat­ing im­mu­ni­ty. The new CEO, who hops over from the chief com­mer­cial of­fi­cer po­si­tion at Hu­man Longevity, sees “re­mark­able op­por­tu­ni­ties” in in­fec­tious dis­ease, on­col­o­gy and au­toim­mune dis­ease. Nass­er has led sim­i­lar func­tions at mul­ti­ple ge­net­ic test­ing com­pa­nies, in­clud­ing ones that were ul­ti­mate­ly ac­quired by Myr­i­ad Ge­net­ics and Il­lu­mi­na. Ser­im­mune’s founder, Patrick Daugh­er­ty, will con­tin­ue to act as the com­pa­ny’s CSO and board mem­ber. Il­lu­mi­na Ven­tures part­ner Bill Welch is join­ing the board of di­rec­tors.

Sud­ha Para­sur­a­man

Ri­bon Ther­a­peu­tics, the biotech backed by No­var­tis, Cel­gene and J&J to go af­ter new class­es of en­zyme fam­i­lies ac­ti­vat­ed un­der cel­lu­lar stress con­di­tions, has named Sud­ha Para­sur­a­man and Ed­ward “Tad” Stew­art its first-ever CMO and CBO, re­spec­tive­ly. Well versed in hema­tol­ogy, on­col­o­gy and pe­di­atrics, Para­sur­a­man held the same role at X4 Phar­ma­ceu­ti­cals and pri­or to that was VP, glob­al med­ical af­fairs at he­mo­phil­ia play­er uniQure. Her ca­reer has al­so tak­en her to No­var­tis and Mil­len­ni­um Phar­ma­ceu­ti­cals (now Take­da On­col­o­gy), as well as Har­vard Med­ical School, Chil­dren’s Hos­pi­tal of Boston, and Dana Far­ber Can­cer In­sti­tute. Stew­art, who spent over 15 years at Mer­ri­mack Phar­ma­ceu­ti­cals, was the pres­i­dent and CEO of Com­mense and CBO of Crescen­do

Bams Abi­la

Im­mod­u­lon — a UK biotech de­vel­op­ing im­mune-mod­u­lat­ing bac­te­r­i­al add-on can­cer ther­a­pies to check­point and chemo —  has se­lect­ed phar­ma vet Bams Abi­la as their CMO. Most re­cent­ly, Abi­la served as the CMO of Cmed and as the prin­ci­pal con­sul­tant at Clin­treq. His pre­vi­ous ex­pe­ri­ences in­clude lead­er­ship roles at Aven­tis, Pfiz­er, Astel­las, As­traZeneca and GSK. Abi­la was ap­point­ed as a vis­it­ing pro­fes­sor of bi­o­log­ics and ad­vanced ther­a­py drug de­vel­op­ment to the Fac­ul­ty of Life Sci­ences & Med­i­cine at King’s Col­lege Lon­don in 2015. He is a fel­low of the Fac­ul­ty of Phar­ma­ceu­ti­cal Med­i­cine of the Roy­al Col­lege of Physi­cians in the UK. 

→ The ma­chine learn­ing-dri­ven drug dis­cov­ery spe­cial­ists at Daphne Koller’s start­up in­sitro have wel­comed Mary Rozen­man to their ranks as CFO/CBO while tap­ping Kei­th James as SVP drug dis­cov­ery. Their ap­point­ments high­light the com­pa­ny’s com­mit­ment to not just iden­ti­fy nov­el tar­gets but to achieve its re­al goal of de­vel­op­ing nov­el, bet­ter ther­a­peu­tics faster while en­vi­sion­ing new types of col­lab­o­ra­tions. Rozen­man was the SVP of cor­po­rate de­vel­op­ment at Aim­mune Ther­a­peu­tics; be­fore that she learned the ins and outs of biotech in­vest­ments and fi­nanc­ing as a VP at Lon­gi­tude Cap­i­tal and a ju­nior part­ner at McK­in­sey & Com­pa­ny. James, a Pfiz­er vet with mul­ti­ple clin­i­cal can­di­dates to his name, was the pres­i­dent of the Fer­ring Re­search In­sti­tute and a vis­it­ing in­ves­ti­ga­tor at The Scripps Re­search In­sti­tute

→ With its lead prod­uct can­di­date for re­frac­to­ry angi­na now in the clin­ic, Xy­lo­Cor Ther­a­peu­tics has re­cruit­ed Rick­ey Rein­hardt as their CMO. Hav­ing led the Eu­ro­pean ap­proval for GSK’s Strimvel­lis and di­rect­ed clin­i­cal R&D at Re­genxbio, Rein­hardt will now ap­ply his ex­per­tise in gene ther­a­py to the car­dio­vas­cu­lar niche. Most re­cent­ly he was CMO at Comet Ther­a­peu­tics, where he chan­neled his deep ex­pe­ri­ence in me­tab­o­lism.

Ajim Tam­boli Rodin

→ Synap­tic-fo­cused biotech Rodin Ther­a­peu­tics has ap­point­ed Ajim Tam­boli as CFO. A long­time health­care in­vestor, Tam­boli comes on board af­ter a stint at Asym­me­try Cap­i­tal Man­age­ment. He was an an­a­lyst at Lehman Broth­ers, Cred­it Su­isse and Lazard Fr­eres, with a num­ber of IPOs and fol­low-on of­fer­ings un­der his belt, be­fore found­ing En­durant Cap­i­tal Man­age­ment.

→ Just a few weeks af­ter tak­ing his $1.1 mil­lion sev­er­ance check from Gilead, John McHutchi­son has re-emerged as the new CEO of As­sem­bly Bio­sciences, which has seen its share price swoon as in­vestors lost con­fi­dence in its abil­i­ty to com­pete with Gilead with its ex­per­i­men­tal he­pati­tis B drug. McHutchi­son will be join­ing Steven J. Knox in the new job. Knox left as head of clin­i­cal de­vel­op­ment at Gilead, where he al­so played a big role in the de­vel­op­ment of the hep B drug Vem­lidy, to join As­sem­bly in the same role. 

Josh Bilenker didn’t just gain a per­son­al wind­fall by sell­ing Loxo to Eli Lil­ly for $8.1 bil­lion. He got a new, if tem­po­rary, job out of the deal as well. Bilenker will now head on­col­o­gy re­search and ear­ly phase de­vel­op­ment as they look for a re­place­ment for Levi Gar­raway, now head­ed off in pur­suit of “oth­er op­por­tu­ni­ties.” In ad­di­tion, Long­time BD chief Dar­ren Car­roll is head­ed to re­tire­ment af­ter 22 years at the phar­ma gi­ant. Heather Wasser­man has been pro­mot­ed to vice pres­i­dent of cor­po­rate busi­ness de­vel­op­ment, with re­spon­si­bil­i­ty for busi­ness de­vel­op­ment trans­ac­tions, emerg­ing tech­nolo­gies and in­no­va­tion, and ven­ture cap­i­tal, SVP/trea­sur­er Phil John­son will be in charge of M&A and Frank Cun­ning­ham has been pro­mot­ed to se­nior vice pres­i­dent of man­aged health­care ser­vices.

Teri Lox­am

→ Cell ther­a­py play­er SQZ Biotech has wooed se­nior Mer­ck ex­ec Teri Lox­am to be­come its CFO. The phar­ma gi­ant said that Lox­am, who’s been man­ag­ing in­vestor re­la­tions and glob­al com­mu­ni­ca­tions, “will be missed per­son­al­ly and pro­fes­sion­al­ly.” Pe­ter Dan­nen­baum has been pro­mot­ed to fill her shoes.

Ve­r­avas — a med­ical di­ag­nos­tic com­pa­ny fo­cused on bi­otin — has tapped Car­roll Street­man Jr to head the com­pa­ny as CEO. Dur­ing his 45-year ca­reer in the in­dus­try, Street­man has been in man­age­ment po­si­tions at med­ical ser­vices com­pa­ny Full Spec­trum Be­hav­ior Analy­sis, Di­a­Sorin, CSHC Con­sul­tants and HCA Health­care Cor­po­ra­tion. It was at Di­a­Sorin that he first worked with Ve­r­avas’ CSO, Josh Sol­do.

→ As Or­thofix Med­ical CEO Brad Ma­son steps in­to re­tire­ment, he’s pass­ing the ba­ton to sea­soned med­ical de­vice ex­ec Jon Ser­bousek. Aside from lead­ing the whole mus­cu­loskele­tal op­er­a­tion, Ser­bousek has al­so been named pres­i­dent of the spine unit.

Jon Ser­bousek

Aprea Ther­a­peu­tics, a can­cer biotech with head­quar­ters in both Boston and Stock­holm, has ap­point­ed Scott Coiante as the com­pa­ny’s se­nior vice pres­i­dent and CFO, join­ing from Ag­ile Ther­a­peu­tics where he held the same roles. Pri­or to his time at Ag­ile, Coiante served as the vice pres­i­dent of fi­nance and trea­sur­er at Medarex be­fore its ac­qui­si­tion in 2009 by Bris­tol My­ers Squibb.

Emalex Bio­sciences has en­list­ed At­ul Ma­h­ablesh­warkar on their mis­sion to de­vel­op ecopi­pam for pe­di­atric Tourette Syn­drome and child­hood-on­set flu­en­cy dis­or­der. As SVP of drug de­vel­op­ment, Ma­h­ablesh­warkar is tasked with every­thing from clin­i­cal af­fairs, phar­ma­covig­i­lance, reg­u­la­to­ry mat­ters to qual­i­ty as­sur­ance. The new role will draw on both his train­ing in psy­chi­a­try and years of de­vel­op­ment ex­pe­ri­ence ac­crued at Take­da, Black­Thorn and most re­cent­ly Re­vance.

No­vo Nordisk vet Lars Green is switch­ing ship af­ter 27 years to take charge of fi­nance, IT, le­gal and in­vestors re­la­tions as CFO of Novozyme — the en­zyme shop split off from the No­vo con­glom­er­ate al­most two decades ago. In his last role at the Dan­ish in­sulin mak­er, he head­ed up busi­ness ser­vices and com­pli­ance af­ter a stint lead­ing fi­nance and op­er­a­tions. In con­junc­tion with his ap­point­ment, he’s re­sign­ing from Novozyme’s board, where he’s served as a di­rec­tor since 2014.

Col­in God­dard Hi­ber­Cell

Christoph Rentsch has re­signed from the CFO post at Swiss spe­cial­ty phar­ma San­thera. Rentsch, whose ca­reer has spanned Cred­it Su­isse, Lon­za, Roche and Polyphor, was cred­it­ed for sev­er­al cor­po­rate fi­nance trans­ac­tions at San­thera, which has been on a bumpy ride with its Duchenne mus­cu­lar dy­s­tro­phy drug.

→ Lead­ing can­cer im­munother­a­py pi­o­neer Alan Ko­r­man, who is cred­it­ed for his work at BMS and Medarex that led to the de­vel­op­ment of two of the first ap­proved can­cer im­munother­a­py drugs, ip­il­i­mum­ab (an­ti-CLTA-4) and nivolum­ab (an­ti-PD-1) and their com­bi­na­tion, has joined the sci­en­tif­ic ad­vi­so­ry board of Drag­on­fly Ther­a­peu­tics

Steven Gillis Hi­ber­Cell

→ New York-based Hi­ber­Cell has ap­point­ed ex-OSI Phar­ma CEO Col­in God­dard to the board of di­rec­tors. God­dard will serve un­der new­ly mint­ed chair­man Steven Gillis, a man­ag­ing di­rec­tor at Arch who is prob­a­bly best known as founder of Im­munex.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.