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.  

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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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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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Florian Brand (L) and Srinivas Rao (ATAI)

Psy­che­del­ic biotech ATAI hopes to ex­pand port­fo­lio through re­search part­ner­ship with Mass Gen­er­al

Psychedelics have made a comeback for mental health research, with companies like startup biotech ATAI Life Sciences raising millions and earning the backing of prominent investors like Peter Thiel, but there’s a hole at the heart of the resurgence: Researchers still don’t fully understand how they work.

A new partnership between ATAI and world-renowned Mass General Hospital hopes to change that.

Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant located in Wrexham, Wales that is packing the Oxford/AstraZeneca Covid-19 vaccine into vials was surrounded by a bomb squad after officials called police to report a suspicious package.

The alert caused a partial evacuation of the plant, the BBC was among those to report Wednesday. The owner of the plant, British drugmaker Wockhardt UK, said it was cooperating with local authorities and that there were no reports of any injuries.