Ovid ex­ec Yaron Wer­ber cross­es back to Cowen; Saqib Is­lam pro­mot­ed to Spring­Work­s' first CEO slot

Yaron Wer­ber

→ While a num­ber of an­a­lysts have been seen mi­grat­ing to the front lines of biotech, Yaron Wer­ber is mov­ing in the op­po­site di­rec­tion. Af­ter ro­tat­ing through a cou­ple of roles at rare dis­ease biotech Ovid Ther­a­peu­tics  and help­ing put to­geth­er its $75 mil­lion IPO $OVID — he’s head­ed back to Wall Street.

The for­mer Cit­i­group an­a­lyst is land­ing at Cowen as a man­ag­ing di­rec­tor and se­nior mem­ber of its biotech team, at a time in­vest­ment banks are pay­ing big dol­lars to scoop pop­u­lar biotech boost­ers from each oth­er.

“We are thrilled to wel­come Yaron back to eq­ui­ty re­search and back to Cowen, where he be­gan his im­pres­sive ca­reer in biotech. As a trained med­ical doc­tor, re­spect­ed pub­lic com­pa­ny CFO and a proven sell-side an­a­lyst, Yaron is an out­stand­ing ad­di­tion to Cowen’s lead­ing health­care and biotech re­search team,” said Cowen CEO Jef­frey Solomon in a state­ment.

Wer­ber, who first joined Ovid as CFO in 2015, has since added CBO and trea­sur­er to his ti­tle in ad­di­tion to a stint as sec­re­tary.

Spring­Works Ther­a­peu­tics will be cel­e­brat­ing its one-year an­niver­sary with their first per­ma­nent CEO in place. Tak­ing the helm is Saqib Is­lam, an ex-Mod­er­na ex­ec who’s been over­see­ing fi­nance and busi­ness de­vel­op­ment since the biotech spun out with four rare dis­ease as­sets from Pfiz­er. He will join the board of di­rec­tors, work­ing with ex­ec­u­tive chair­man Dan Lynch, and lead the charge for find­ing more promis­ing clin­i­cal-stage drugs from oth­er in­dus­try play­ers to grow their pipeline, which cur­rent­ly fea­tures lead pro­grams in desmoid tu­mors and neu­rofi­bro­mato­sis type 1. Spring­Works has al­so just en­tered a pact with BeiGene to test its MEK in­hibitor in com­bi­na­tion with the Bei­jing-based biotech’s RAF dimer in­hibitor to tar­get ad­vanced sol­id tu­mors with RAS mu­ta­tions.  

Lisa Ric­cia­r­di

→ As Suono Bio en­ters a new phase of its busi­ness marked by a new strate­gic in­vest­ment from Fu­ji­film, Carl Schoell­ham­mer is step­ping aside from the CEO role to make room for Lisa Ric­cia­r­di. Schoell­ham­mer, who helped found the com­pa­ny along­side MIT’s Robert Langer, Gio­van­ni Tra­ver­so of Brigham and Women’s Hos­pi­tal and Po­laris part­ner Amy Schul­man, will re­main as COO. A Pfiz­er vet with stints at Es­sex Wood­lands Health Ven­tures, Ex­press Scripts and Foun­da­tion Med­i­cine, Ric­cia­r­di is tasked with steer­ing Suono’s for­mu­la­tion-in­de­pen­dent de­liv­ery tech to the clin­ic.

David Schenkein’s long run as Agios CEO — grow­ing the com­pa­ny from his leg­endary blank sheet of pa­per to a high pro­file pub­lic biotech with close to 500 staffers, two ap­proved drugs on the mar­ket and more ad­vanc­ing in the pipeline — is com­ing to an end. In five months Schenkein is pass­ing the reins of the Cam­bridge, MA-based com­pa­ny $AGIO to Jack­ie Fouse, the ex-Cel­gene ex­ec who went on to run one of Vivek Ra­maswamy’s biotechs for a short stint. Af­ter Fouse jumped on the Agios board late last year, he says, reg­u­lar dis­cus­sions with the board about a tran­si­tion plan be­gan to gel. And “it be­came clear that Jack­ie had an in­ter­est in that role.” At Ra­maswamy’s Der­ma­vant, Fouse was in charge of grow­ing the Phoenix, AZ-based start­up. Af­ter she takes the new job at Agios Feb­ru­ary 1, she’ll be ex­pect­ed to con­tin­ue to build on Schenkein’s vi­sion for the com­pa­ny, look­ing to keep build­ing a sci­ence-dri­ven, re­search-ori­ent­ed bio­phar­ma along the lines of Genen­tech. Frank Tor­ti, who re­cent­ly joined Roivant as Vant In­vest­ment Chair, will step in as Der­ma­vant’s board chair­man.

→ Five months af­ter Third Rock part­ner Ab­bie Cel­niker of­fi­cial­ly launched Rheos Med­i­cines with an aim at be­com­ing a leader in im­munome­tab­o­lism, the start­up has wooed a top Roche sci­en­tist to the helm. San­jay Keswani has been named CEO at the Cam­bridge, MA-based com­pa­ny, join­ing a large mi­gra­tion of top ex­ec­u­tives leav­ing Big Phar­ma for the fast-grow­ing start-up crowd. He had been a se­nior vice pres­i­dent and glob­al head of the neu­ro­science, oph­thal­mol­o­gy and rare dis­eases unit for Roche’s pRED or­ga­ni­za­tion, based in Basel. Be­fore that he had a broad port­fo­lio at Bris­tol-My­ers Squibb, with ear­li­er gigs at Eli Lil­ly and Am­gen.

David Goren

→ Is­rael’s Vax­il has tapped Big Phar­ma vet David Goren to suc­ceed se­r­i­al en­tre­pre­neur Isaac Maresky as CEO. Goren first moved from New York to es­tab­lish and grow Pfiz­er’s Is­raeli com­mer­cial pres­ence. He stayed on to serve as gen­er­al man­ag­er in the coun­try for As­traZeneca and has re­cent­ly start­ed his own bou­tique con­sult­ing firm called Epi­one Strat­e­gy.

Found­ed on a plat­form de­vel­oped by Weiz­mann In­sti­tute sci­en­tists, Vax­il’s lead as­set is an or­phan drug des­ig­nat­ed im­munother­a­py that tar­gets a neoanti­gen known as MUC1. Hav­ing com­plet­ed a Phase I/II tri­al in mul­ti­ple myelo­ma, the biotech is look­ing to test Im­mucin in Phase II for ad­di­tion­al sol­id tu­mor in­di­ca­tions.

Gos­samer Bio has re­cruit­ed in­dus­try vet Luisa Salter-Cid to lead re­search and pre­clin­i­cal de­vel­op­ment ef­forts for its fledg­ling op­er­a­tion that’s mov­ing “at light speed,” ac­cord­ing to founder Fa­heem Has­nain. The new CSO jumps from a 13-year run at the im­munol­o­gy unit of Bris­tol-My­ers Squibb, where her path crossed with Gos­samer Bio CEO Sheila Gu­jrathi. She will be re­spon­si­ble for trans­lat­ing some of the pre­clin­i­cal pro­grams that Has­nain and Gu­jrathi have been busy snap­ping up, many of which re­main tight­ly un­der wraps. But one thing we know for cer­tain is that the biotech will have plen­ty of cash — $330 mil­lion at last count — to see them through.

Gin­na La­port

Gin­na La­port is tak­ing up her first CMO job since leav­ing acad­e­mia at Ver­sant-backed Tem­pest Ther­a­peu­tics as the biotech eyes its first clin­i­cal tri­als in 2019. A for­mer mem­ber of the FDA’s on­co­log­ic drugs ad­vi­so­ry com­mit­tee, La­port is ex­pect­ed to lever­age both her ex­per­tise in hema­tol­ogy/on­col­o­gy and re­cent ex­pe­ri­ence man­ag­ing clin­i­cal de­vel­op­ment at Corvus Phar­ma to ad­vance Tem­pest’s im­muno-on­col­o­gy as­sets in­clud­ing TPST-1120, a PPARα block­er de­signed to in­flame the tu­mor mi­croen­vi­ron­ment and ac­ti­vates im­por­tant tu­mor‐killing im­mune cells (the for­mer lead as­set, an IDO in­hibitor, ap­pears to have been dropped). Join­ing her in the C-suite will be Ali­cia Lev­ey, who’s been pro­mot­ed to chief busi­ness of­fi­cer from a VP po­si­tion.

→ The cell ther­a­py ex­perts at Tmu­ni­ty have brought in an ex­pe­ri­enced ex­ec to man­age the biotech’s fi­nan­cial op­er­a­tions, con­nect with the fi­nan­cial mar­kets and over­see IT and oth­er day-to-day tasks. Graeme Bell comes to the EVP and CFO af­ter serv­ing in the same roles at Ana­cor Phar­ma and In­tel­lia fol­low­ing a 20-year ca­reer at Mer­ck. CEO Us­man “Oz” Azam has this to say about his ap­point­ment: “Graeme’s ex­ten­sive knowl­edge in fi­nance and proven suc­cess in deal-mak­ing will be a tremen­dous as­set to Tmu­ni­ty as we con­tin­ue to cre­ate and pur­sue strate­gic busi­ness op­por­tu­ni­ties that align with our vi­sion” — to use CRISPR gene edit­ing tech to mod­i­fy im­mune cells.

→ Back in busi­ness af­ter a spell in lim­bo, Iron­shore Phar­ma­ceu­ti­cals has re­cruit­ed Scott Evan­ge­lista to lead the com­mer­cial roll­out of its AD­HD drug as pres­i­dent and COO. Ex­ecs like Evan­ge­lista’s years of ex­pe­ri­ence pro­vid­ing com­mer­cial­iza­tion sup­port at what is now IQVIA, which he will now use to launch Jor­nay, a ver­sion of a gener­ic stim­u­lant with a de­layed-re­lease tech that Iron­shore hopes will dis­tin­guish it from the crowd..

Hu­bert Chen

→ Days af­ter an­nounc­ing his de­par­ture from Pfenex, Hu­bert Chen is show­ing up as the new chief med­ical of­fi­cer at fel­low San Diego biotech Metacrine. The new job will take Chen back to his roots in en­docrinol­o­gy while lean­ing on the clin­i­cal de­vel­op­ment skills he’s built over the years with treat­ments for he­pati­tis, fi­bro­sis, and in­flam­ma­to­ry dis­ease at places like Aileron, Reg­u­lus, Amylin and Am­gen.

→ Af­ter eight years in the CSO seat at Amipo Phar­ma $AMPE, David Bar-Or says “the time is right” to re­tire. Though the lit­tle biotech’s BLA for Am­pi­on, its drug for os­teoarthri­tis in the knee, was spurned by from the FDA weeks ago, Bar-Or notes that prepa­ra­tion for an­oth­er fil­ing is on­go­ing. While stay­ing on Am­pio’s board of di­rec­tors and sci­en­tif­ic ad­vi­so­ry board, he will turn his at­ten­tion to some projects in trau­ma re­search at the Swedish Med­ical Cen­ter.

Ra­dius Health, the Waltham, MA-based biotech best known for its fierce os­teo­poro­sis ri­val­ry with Am­gen, has ap­point­ed can­cer ex­pert Charles Mor­ris to guide its ex­pan­sion in­to on­col­o­gy. As CMO, he will shep­herd all clin­i­cal, reg­u­la­to­ry and med­ical af­fairs for the com­pa­ny. “I be­lieve elaces­trant is unique­ly po­si­tioned to po­ten­tial­ly ad­dress un­met needs in the treat­ment of hor­mon­al breast can­cer,” said Mor­ris, who’s run a num­ber of ear­ly-stage pro­grams at Al­los Ther­a­peu­tics, Im­muno­Gen and most re­cent­ly PsiOxus Ther­a­peu­tics. “I have al­ready had the chance to re­view and pro­vide in­put to op­ti­mize elaces­trant’s clin­i­cal de­vel­op­ment plan and look for­ward to ini­ti­at­ing our Phase 3 study in the fourth quar­ter of this year.”

→ With the com­bo of its lead drug PEGPH20 with Abrax­ane near­ing Phase III, Halozyme $HA­LO has poached long­time Bris­tol-My­ers Squibb ex­ec Ben­jamin Hick­ey to be its chief com­mer­cial of­fi­cer. Hick­ey, who’s been man­ag­ing the phar­ma gi­ant’s UK and Ire­land op­er­a­tions in re­cent years, is join­ing the San Diego biotech’s com­mer­cial unit at ground ze­ro, with a broad man­date to build the sales, mar­ket­ing and mar­ket ac­cess teams.

→ Brain­Storm Cell Ther­a­peu­tics $BCLI has ap­point­ed No­var­tis vet Ar­turo Araya as chief com­mer­cial of­fi­cer. Araya had been glob­al head of com­mer­cial of No­var­tis’ Cell and Gene Ther­a­pies Unit and has been on the board at Brain­storm since Feb­ru­ary of last year.

→ Still in search for a CEO to re­place William Lis, Por­to­la will now be look­ing for a new chief com­mer­cial and busi­ness of­fi­cer as well. Tao Fu re­signed, ef­fec­tive lat­er this month, just as the biotech is be­gin­ning to roll out its blood thin­ner an­ti­dote An­dexxa and an­ti­co­ag­u­lant Bevyxxa. CFO Mar­di Di­er, who’s al­ready shoul­der­ing half of the in­ter­im pres­i­dent role,  will lead the com­mer­cial ac­tiv­i­ties in the in­ter­im.

John Na­son just got a pro­mo­tion at gener­ics gi­ant Te­va to head up its API unit, which de­vel­ops, man­u­fac­tures and mar­kets bulk API for both third-par­ty clients and the com­pa­ny it­self, as well as its bi­o­log­ics op­er­a­tions. Na­son held sim­i­lar roles for Bris­tol-My­ers Squibb and No­var­tis in Ire­land be­fore join­ing the Is­raeli com­pa­ny in 2015.

Welling­ton Sun

→ Fol­low­ing a decades-long ca­reer in gov­ern­ment agen­cies — capped by 10 years di­rect­ing the FDA’s di­vi­sion of vac­cines and re­lat­ed prod­uct ap­pli­ca­tions — Welling­ton Sun is mov­ing to the oth­er side of the ta­ble, tak­ing a job at biotech uni­corn Mod­er­na as head of vac­cine strat­e­gy and reg­u­la­to­ry af­fairs. His in­fec­tious dis­ease spe­cial­ty is es­pe­cial­ly ap­peal­ing to Mod­er­na as nine of its 21 de­vel­op­ment can­di­dates — sev­en out of the 10 in clin­i­cal de­vel­op­ment — fall in the field.

Mer­ck vet John Hunter is the new CSO at SiteOne Ther­a­peu­tics, a de­vel­op­er of non-opi­oid pain ther­a­pies. While his re­cent role in­volves car­dio-re­nal re­search, he has a back­ground in neu­ro­science and has led dis­cov­ery re­search in the area for both Scher­ing-Plough and Roche.  

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.
SpringWorks

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.