E-Scape Bio in­stalls per­ma­nent CEO Julie Anne Smith; Fa­ther pass­es reins to son at Al­le­gro Oph­thalmics

→ A year af­ter E-Scape Bio leapt out of stealth mode with some strong back­ing, the San Fran­cis­co up­start is ready to put its work in neu­rode­gen­er­a­tion to a clin­i­cal test. Lead­ing that charge will be Julie Anne Smith, who’s been ap­point­ed to suc­ceed Or­bimed part­ner Leon Chen as CEO. A two-time chief ex­ec­u­tive and biotech vet­er­an, Smith brings ex­pe­ri­ence in small mol­e­cule ther­a­pies and lyso­so­mal stor­age dis­or­ders from her re­cent stints at Nure­dis and Rap­tor Phar­ma. That re­sume checks all the right box­es for E-Scape: While the com­pa­ny launched with a heavy fo­cus on a ge­net­ic ap­proach to tack­ling Alzheimer’s, it has since put that project on the back­burn­er in fa­vor of an S1P5 pro­gram from Ab­b­Vie, which is slat­ed for the clin­ic in 2019.

→ Af­ter build­ing Al­le­gro Oph­thalmics from scratch over the past sev­en years, Ham­par Kara­geoz­ian de­cid­ed it’s time pres­i­dent and CMO Vick­en Kara­geoz­ian — al­so his son — steps up for the CEO role. Kara­geoz­ian Sr. will move to the ex­ec­u­tive chair­man po­si­tion, re­spon­si­ble for strat­e­gy with an eye on dis­cov­ery and R&D, while the new CEO preps the com­pa­ny for Phase III tri­als of lead drug risute­ganib in di­a­bet­ic mac­u­lar ede­ma. An oph­thalmic sur­geon by train­ing, Vick­en Kara­geoz­ian had pre­vi­ous­ly co-found­ed two oph­thal­mol­o­gy biotechs based on ther­a­peu­tics he co-in­vent­ed.

→ Over the last 11 years, Ed­ward Hu has been COO, CFO and chief in­vest­ment of­fi­cer at WuXi AppTec. Now he’s been named co-CEO, with a spe­cial re­spon­si­bil­i­ty for small mol­e­cule drug dis­cov­ery, de­vel­op­ment, man­u­fac­tur­ing ser­vices, drug and med­ical de­vice test­ing ser­vices, plus some. He’s re­tain­ing his CFO re­spon­si­bil­i­ties for now un­til a re­place­ment is se­lect­ed. And Hu will con­tin­ue to re­port to com­pa­ny founder Ge Li, who’s been chiefly re­spon­si­ble for the rapid growth of the big Chi­na-based com­pa­ny.

→ Ven­ture cap­i­tal­ist James Kuo sees po­ten­tial in On­co­Track­er’s bio­mark­er test­ing busi­ness — so much so that he left his 11-year role as man­ag­ing di­rec­tor of Athena Bioven­tures to pur­sue the CEO job there. “While the ini­tial fo­cus will be on build­ing a prof­itable busi­ness in the rapid­ly grow­ing mul­ti­ple myelo­ma mar­ket, we in­tend to serve a broad­er can­cer pop­u­la­tion by in­te­grat­ing nov­el im­mune ther­a­pies with com­pan­ion di­ag­nos­tics,” he said of the com­pa­ny. Bor­row­ing from his stints at Syn­thet­ic Bi­o­log­ics and Pfiz­er, he plans to ex­pand the West Hol­ly­wood, CA com­pa­ny through li­cens­ing deals like the one it had with Juno Ther­a­peu­tics.

→ Gaithers­burg, MD-based Sen­sei Bio­ther­a­peu­tics has named Ildiko Csi­ki as its chief med­ical of­fi­cer. Csi­ki most re­cent­ly worked as vice pres­i­dent of im­muno-on­col­o­gy clin­i­cal de­vel­op­ment at In­ovio Phar­ma­ceu­ti­cals. Ear­li­er she worked as clin­i­cal de­vel­op­ment lead for Mer­ck‘s Keytru­da pro­gram. Re­port­ing to John Celebi — pres­i­dent and CEO since May — her first project will in­volve mov­ing for­ward the Phase I can­cer vac­cine SNS-301.

→ Bone heal­ing spe­cial­ist Kuros Bio­sciences has ap­point­ed Pas­cal Longlade to re­place re­tired CMO Vir­ginia Jamieson. Work­ing out of the Swiss biotech’s Nether­lands site, Longlade in­her­its a pipeline of bone graft sub­sti­tute prod­ucts and surgery sealants. He has moved be­tween phar­ma, biotech and med­ical de­vice com­pa­nies, most re­cent­ly over­see­ing med­ical and reg­u­la­to­ry af­fairs for France’s D&A Phar­ma.

→ Achillion $ACHN is on a hir­ing spree un­der new CEO Joseph Tru­itt. Just a week af­ter bring­ing Leerink banker An­tho­ny Gib­ney on as chief busi­ness of­fi­cer, the biotech has scooped Steven Ze­lenkofske from uniQure to be its chief med­ical of­fi­cer. Switch­ing his fo­cus from gene ther­a­pies to com­ple­ment in­hibitors for rare dis­eases, Ze­lenkofske will lead a clin­i­cal de­vel­op­ment team along­side new VPs Lau­ra Bar­row and Marc Uk­nis. His reg­u­la­to­ry ex­pe­ri­ence will be key as Achillion hus­tles along its Phase II pro­grams and pre­pare for reg­is­tra­tional tri­als, Tru­itt said.

Ran­dall Sze has been pro­mot­ed to CFO at Athenex, tak­ing over the fi­nance and ac­count­ing de­part­ment while con­tin­u­ing to spear­head cor­po­rate de­vel­op­ment ac­tiv­i­ties. While Sze on­ly joined the com­pa­ny late last year, he’s known CEO John­son Lau and the man­age­ment team since steer­ing Athenex’s IPO $AT­NX as the lead ex­e­cu­tion banker.

Michael Garone has re­signed from Im­munomedics $IM­MU af­ter a two-year CFO run that fea­tured a brief gig as in­ter­im CEO. Chief busi­ness of­fi­cer Us­ama Ma­lik will step in to shoul­der the fi­nan­cial du­ties, while con­troller William Frick­er has been named prin­ci­pal ac­count­ing of­fi­cer. The com­pa­ny em­pha­sized that his de­par­ture “is not the re­sult of any dis­agree­ment with the com­pa­ny,” its lead­er­ship or op­er­a­tions, and not­ed that Garone will stay on as VP of fi­nance for tran­si­tion un­til May 2019, ex­act­ly one year af­ter Im­munomedics sub­mit­ted a BLA for its an­ti­body-drug con­ju­gate.

→ San Diego-based Cidara Ther­a­peu­tics $CDTX has lost CFO Matthew On­aitis to med­ical de­vice com­pa­ny Main­stay Med­ical. Jef­frey Stein, the CEO, and Brady John­son, di­rec­tor of fi­nance and con­troller, are split­ting up his re­spon­si­bil­i­ties in the in­ter­im.

Bio­gen vet Anne Marie de Jonge Schuer­mans is jump­ing to So­bi to head its tech­ni­cal op­er­a­tions — a new union of the man­u­fac­tur­ing, bi­o­log­i­cal de­vel­op­ment & sup­ply chain and en­vi­ron­ment & safe­ty units. The Swedish rare dis­ease com­pa­ny likes her skills in “putting process­es and sys­tems in place, and of dri­ving trans­for­ma­tion in cross-func­tion­al and cross-cul­tur­al set­tings.” She starts in Oc­to­ber.

→ As Si­mon Bed­son re­tires from the in­ter­na­tion­al com­mer­cial op­er­a­tions at Ver­tex $VRTX, the com­pa­ny has re­cruit­ed Lu­dovic Fe­naux from Bris­tol-My­ers Squibb to take his place in its Lon­don head­quar­ters. Fe­naux, who’s al­so worked at As­traZeneca and Glax­o­SmithK­line, joins Ver­tex amid some tough fights it’s hav­ing with sin­gle Eu­ro­pean pay­ers over cov­er­ing its cys­tic fi­bro­sis drugs.

Aerie Phar­ma­ceu­ti­cals $AERI has tapped Jef­frey White to join its R&D team as di­rec­tor, tox­i­col­o­gy and phar­ma­co­ki­net­ics. He joins from a sim­i­lar po­si­tion at Al­con, the eye care busi­ness No­var­tis is look­ing to spin out.

→ As ApoGen Biotech­nolo­gies goes pub­lic with its ex­pand­ed Se­ries A — with $11 mil­lion from the cor­po­rate ven­ture arms of Mer­ck KGaA, Ab­b­Vie, Eli Lil­ly, J&J and WuXi AppTec — it’s al­so an­nounc­ing the ap­point­ment of two new ex­ecs. Stephen Gwalt­ney, for­mer­ly of Glob­al Blood Ther­a­peu­tics and Take­da, is the new VP of chem­istry; Pe­ter de Vries joins from Fred Hutchin­son Can­cer Re­search Cen­ter to take on the se­nior di­rec­tor of bi­ol­o­gy po­si­tion. ApoGen is de­vel­op­ing ther­a­peu­tics to tack­le re­sis­tance to can­cer drugs.

→ CEO Per­ci­val Bar­ret­to-Ko is still build­ing out his ex­ec team at Astel­las, with two new pro­mo­tions this week. Ro­dri­go Fer­nan­dez, pre­vi­ous­ly ex­ec­u­tive di­rec­tor of Astel­las’ in­ter­na­tion­al busi­ness, is now VP, Latin Amer­i­ca, play­ing a su­per­vi­so­ry role across all coun­tries in the re­gion. Shon­telle Dod­son has been tapped SVP, health sys­tems, tasked with a slate of re­spon­si­bil­i­ties across pric­ing and mar­ket ac­cess.

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.