Great Danes: Two Nordic biotechs name their chief ex­ec­u­tives; Ax­el Hoos bids adieu to Glax­o­SmithK­line, be­comes CEO of small on­col­o­gy play­er

Ben­ny Sorensen

Don’t let the short week de­ceive you. Peer Re­view has a lot to get to:

→ When our Nicole De­Feud­is pro­filed new Co­di­ak CMO Jen­nifer Whel­er, she al­so wrote that Ben­ny Sorensen would be tak­ing on the role of SVP of strate­gic projects af­ter head­ing up clin­i­cal de­vel­op­ment. That didn’t last long.

We’ve learned that Sorensen has re­signed to lead Dan­ish biotech Hemab Ther­a­peu­tics as CEO. Backed by No­vo Hold­ings, Hemab is a three-year-old com­pa­ny that de­vel­ops bis­pe­cif­ic an­ti­bod­ies for rare bleed­ing dis­or­ders that had been helmed by co-founder Jo­han Faber. Sorensen, an Al­ny­lam vet, will still be con­nect­ed to Co­di­ak as a mem­ber of the sci­en­tif­ic ad­vi­so­ry board and a clin­i­cal con­sul­tant.

→ We’re stay­ing in Den­mark as Michael Pehl has been named CEO at Ad­cen­do, fo­cused on AD­Cs and equipped with the largest Se­ries A round for a biotech in the land of Bor­gen. As CEO of Ger­man CAR-T play­er GEMoaB, Pehl helped join forces with Black­stone and CRISPR big­wig In­tel­lia to launch a new CAR-T biotech in late June. Black­stone plunked down $250 mil­lion on the in­vest­ment. Pehl, the ex-pres­i­dent and CEO of Im­munomedics, was pres­i­dent of on­col­o­gy (among oth­er po­si­tions) dur­ing his tenure with Cel­gene from 2006-17.

Ax­el Hoos

Glax­o­SmithK­line is los­ing its on­col­o­gy head as Ax­el Hoos hits the ex­it to man the ship at stealthy biotech Scor­pi­on Ther­a­peu­tics as CEO. Dur­ing his nine-year gig with the UK phar­ma gi­ant, Hoos over­saw a long-await­ed turn­around at GSK on­col­o­gy af­ter the com­pa­ny opt­ed to of­fload its en­tire late on­col­o­gy pipeline to Swiss drug­mak­er No­var­tis in March 2015. Most re­cent­ly, Hoos served as GSK’s SVP, R&D gov­er­nance chair and ther­a­peu­tic area head on­col­o­gy.

Christo­pher Gior­dano

→ We have a suc­ces­sion plan in place at Tenax Ther­a­peu­tics in the Re­search Tri­an­gle, as Christo­pher Gior­dano grabs the top spot and An­tho­ny Di­Ton­no re­tires as CEO. Gior­dano of­fi­cial­ly takes over at Tenax on Ju­ly 14 af­ter more than a dozen years with IQVIA, three of those as pres­i­dent of IQVIA Biotech. Di­Ton­no had led the com­pa­ny since June 1, 2018 and had been on the board of di­rec­tors since 2011. Tenax has hit its share of tur­bu­lence in the past — af­ter lead can­di­date lev­osi­men­dan tum­bled bad­ly in Phase III in ear­ly 2017, giv­ing its stock a thrash­ing, then-CEO John Kel­ley re­signed a cou­ple months lat­er. Con­cur­rent with the Gior­dano news, Tenax is un­load­ing $10 mil­lion in stocks to an in­vestor not iden­ti­fied in the re­lease.

→ Hop­ing to get back in the good graces of in­vestors in the Duchenne sweep­stakes, Ilan Gan­ot has lined up three new ex­ecs at Sol­id Bio­sciences a month af­ter adding chief reg­u­la­to­ry of­fi­cer Iman Bar­ilero to the staff. Up first, Rox­ana Don­isa Dreghi­ci leaves Roche to take on the role of SVP, clin­i­cal de­vel­op­ment for Sol­id Bio. Don­isa Greghi­ci was the Swiss phar­ma’s glob­al de­vel­op­ment lead/as­so­ciate group med­ical di­rec­tor, neu­ro­science.

Al­so at Sol­id Bio, Amer­i­can Ex­press vet Caitlin Lowie (VP, com­mu­ni­ca­tions & IR) hits the scene af­ter her time at Stal­largenes Greer as se­nior di­rec­tor, com­mu­ni­ca­tions and strate­gic growth ini­tia­tives. And Al­i­son Kessler (VP, le­gal cor­po­rate & IP), for­mer­ly glob­al head of patents for No­var­tis’ over-the-counter busi­ness, was briefly chief le­gal of­fi­cer with Cosette Phar­ma­ceu­ti­cals.

Lou Ar­cu­di

Lou Ar­cu­di took over for Mil­len­do co-founder Ju­lia Owens as CEO af­ter a Phase I im­plo­sion of NK3R an­tag­o­nist MLE-301 left an emp­ty cup­board and the op­tion of a sale on the ta­ble. A merg­er with Tem­pest Ther­a­peu­tics has since closed, and Ar­cu­di is mov­ing on to Amolyt Phar­ma — a mak­er of pep­tides for en­docrine and meta­bol­ic dis­eases — as CFO. Ar­cu­di, a Gen­zyme fi­nance alum, was CFO and SVP of op­er­a­tions dur­ing his 11 years at Idera Phar­ma­ceu­ti­cals. Pri­or to Idera, he served as Pep­ti­m­mune’s VP of fi­nance and ad­min­is­tra­tion.

That’s not all: Amolyt has added Janssen alum and Ix­altis chief de­vel­op­ment of­fi­cer Elis­a­beth Svan­berg to the board of di­rec­tors along with long­time Am­gen ex­ec James Hind­man.

→ CRISPR up­start Lo­can­abio, helmed by Jim Burns and awash with cash from a $100 mil­lion Se­ries B, has re­cruit­ed John Leonard as CSO and Ed­ward Con­ner as CMO. Leonard (not to be con­fused with the In­tel­lia CEO) makes the switch from CRISPR Ther­a­peu­tics, where he led hema­tol­ogy and in vi­vo re­search and trans­la­tion, and he al­so was head of meta­bol­ic and neu­ro­mus­cu­lar re­search in Sanofi Gen­zyme’s rare dis­ease unit. Mean­while, Con­ner ex­its Au­dentes (now Astel­las Gene Ther­a­pies) af­ter his tenure as CMO and has held that same ti­tle be­fore with Sang­amo. He was pre­vi­ous­ly VP of glob­al clin­i­cal de­vel­op­ment at Ul­tragenyx be­fore his run of C-suite ap­point­ments.

Sarah Lu

BioShin, the Bio­haven sub­sidiary in Shang­hai that hit pay dirt back in Sep­tem­ber with a $60 mil­lion round led by Or­biMed, has bol­stered its lead­er­ship with CMO Sarah Lu and chief com­mer­cial of­fi­cer Mary Ma. Lu is a 13-year UCB vet and for­mer clin­i­cal de­vel­op­ment ex­ec at Sim­cere who was re­cent­ly SVP, pres­i­dent of glob­al de­vel­op­ment for Shang­hai Green Val­ley. Ma tack­les the CCO role af­ter a string of Big Phar­ma stops in Chi­na in­clud­ing Eli Lil­ly, Ab­b­Vie and — just be­fore this move to BioShin — Mer­ck, where she was a VP and led the hos­pi­tal spe­cial­ty care busi­ness unit.

Caren Dear­dorf

→ Sev­er­al weeks af­ter los­ing CMO and head of R&D John Davis for “fam­i­ly rea­sons,” Ma­gen­ta Ther­a­peu­tics is re­load­ing in an­oth­er po­si­tion as Caren Dear­dorf takes the chief com­mer­cial of­fi­cer job. Dear­dorf, who was pre­vi­ous­ly CCO at Ohana Bio­sciences, closed out her eight years at Bio­gen in 2019 as VP, glob­al prod­uct de­vel­op­ment & com­mer­cial­iza­tion lead for Spin­raza and the SMA port­fo­lio.

In a re­lat­ed de­vel­op­ment, ex-Ma­gen­ta chief op­er­at­ing and fi­nan­cial of­fi­cer Ja­son Ryan is now on the board of di­rec­tors at Se­ma4, which merged with the Cas­din Cap­i­tal SPAC named CM Life Sci­ences in Feb­ru­ary.

→ Part­ner­ing with Co­herus on the an­ti-PD-1 tori­pal­imab, Jun­shi Bio­sciences has se­lect­ed Wei Qian as chief com­mer­cial of­fi­cer. Qian spent the last five years as a VP at Roche Chi­na and the pre­vi­ous 10 play­ing a bevy of po­si­tions at As­traZeneca in Chi­na, in­clud­ing VP of the GAA busi­ness unit (gas­troin­testi­nal sys­tem, anes­the­sia and an­ti-in­fec­tion). Jun­shi and Co­herus un­veiled da­ta at last month’s AS­CO for na­sopha­ryn­geal can­cer that nudges tori­pal­imab in­to the con­ver­sa­tion in a crowd­ed PD-1/L-1 space.

Nikhil Goel

Sean Mc­Clain’s Ab­sci filed for an IPO last week, shoot­ing for the $100 mil­lion fig­ure that’s be­come a pop­u­lar place­hold­er. A slight styl­is­tic change to the com­pa­ny name isn’t the on­ly oth­er move Ab­sci has made, with Nikhil Goel step­ping in as CBO and Sarah Ko­r­man as gen­er­al coun­sel. Goel jumps over to the pro­tein print­ing biotech based in Wash­ing­ton state af­ter five years at Cred­it Su­isse and was a di­rec­tor in the M&A busi­ness. Af­ter a stint as head of in­tel­lec­tu­al prop­er­ty for fi­nal drug prod­ucts at Am­gen, Ko­r­man then be­came Neu­vo­gen’s gen­er­al coun­sel and cor­po­rate sec­re­tary in 2019.

Out­look Ther­a­peu­tics has nabbed Rus­sell Tre­nary as the com­pa­ny’s pres­i­dent and CEO, suc­ceed­ing Lawrence Keny­on who will con­tin­ue to serve as CFO. Tre­nary joins the com­pa­ny from In­n­Fo­cus, where he served as pres­i­dent and CEO in a sev­en-year stint be­fore its ac­qui­si­tion by San­ten Phar­ma­ceu­ti­cal. Be­fore that, Tre­nary was pres­i­dent and CEO of glob­al med­ical de­vice com­pa­ny G&H Or­tho­don­tics and served in a va­ri­ety of roles at Sun­rise Tech­nolo­gies, Vi­daMed and Al­ler­gan.

Sabine Dauge­lat

→ With the ra­dio­phar­ma­ceu­ti­cals field siz­zling, Ger­many-based ITM is bring­ing in Sabine Dauge­lat as COO af­ter nab­bing $109 mil­lion in loan fi­nanc­ing back in April. Dauge­lat, once the se­nior glob­al pro­gram team di­rec­tor at San­doz, ends her two-year as­so­ci­a­tion with Pieris Phar­ma­ceu­ti­cals as ex­ec­u­tive di­rec­tor, head of project lead­er­ship. Rayze­Bio and Ak­tis are among the oth­er play­ers who have joined the ra­dio­phar­ma band­wag­on just in the past year.

Rob Brain­in

→ As Marc Sta­p­ley takes up the CEO man­tle from Bon­nie An­der­son, Ve­r­a­cyte has locked in two oth­er ex­ecs with EVP and CBO Rob Brain­in and SVP and chief in­for­ma­tion of­fi­cer Bill Zondler. Brain­in, the erst­while CEO of Ge­nu­ity Sci­ence, was once VP and gen­er­al man­ag­er of Il­lu­mi­na’s life sci­ences and ap­plied ge­nomics busi­ness. Fleet­ing­ly the con­sult­ing CIO at Ax­o­vant, Zondler comes to Ve­r­a­cyte from an­oth­er CIO post at Bio­ther­a­nos­tics.

David He­witt has signed on as CMO of Bay Area non-opi­oid pain man­age­ment biotech Al­lay Ther­a­peu­tics, which made its de­but in May with ster­ling Phase I pain re­lief da­ta that showed they “were on to some­thing that pre­cip­i­tat­ed the com­ing-out par­ty,” as CEO Adam Gri­d­ley told End­points News. He­witt, the ex-Sy­neos Health CMO who broke in­to bio­phar­ma at J&J and then mi­grat­ed to the neu­rol­o­gy group at Mer­ck, is the for­mer SVP of clin­i­cal de­vel­op­ment for both Nu­ra Bio and Karuna Ther­a­peu­tics.

Adam Cut­ler

Q32 Bio — the Cam­bridge, MA biotech where CMO Ja­son Cam­pagna land­ed af­ter his time at In­ter­cept — has locked in Adam Cut­ler as CFO. Cut­ler makes the switch af­ter al­most four years in the same post at Austin-based Mol­e­c­u­lar Tem­plates, which struck an I/O deal in Feb­ru­ary with Bris­tol My­ers Squibb worth $70 mil­lion up­front. Be­fore jump­ing to that CFO spot, he was SVP of cor­po­rate af­fairs at Ar­bu­tus. Mak­ing the most progress thus far at Q32 Bio is an an­ti-IL-7Ra an­ti­body in Phase I dubbed ADX-914.

Bio­phytis isn’t one of the flashier com­pa­nies to go pub­lic in 2021; nev­er­the­less, the French biotech did price its IPO at $16.75 mil­lion af­ter with­draw­ing its first try, and its lead drug for sar­cope­nia is al­so in Phase II/III for Covid-19 pa­tients with pneu­mo­nia. This week Bio­phytis has fleshed out its C-suite with Jean Mar­i­ani as CMO and Benoit Canolle as CBO. Mar­i­ani, the di­rec­tor of L’In­sti­tut de la Longévité, is al­so pro­fes­sor emer­i­tus at Sor­bonne Uni­ver­si­ty. When his 11-year run at Sanofi drew to a close in 2015, Canolle was project man­ag­er for the im­muno-in­flam­ma­tion de­vel­op­ment fran­chise. For the last year, he’s been Pierre Fab­re’s head of cor­po­rate med­ical port­fo­lio & project di­rec­tion.

Just one more thing, as Colum­bo liked to say: Claude Al­lary is in line to re­place Jean Franchi on Bio­phytis’ board of di­rec­tors.

Tina Bea­mon

→ San Diego can­cer biotech MEI Phar­macol­lab­o­rat­ing with Ky­owa Kirin on PI3Kδ in­hibitor zan­delis­ibhas ap­point­ed Tina Bea­mon chief com­pli­ance of­fi­cer. Bea­mon, who just filled the same role at Karyopharm, has al­so been Alex­ion’s ex­ec­u­tive di­rec­tor of com­pli­ance and ethics. Be­fore Alex­ion, she brought her le­gal ex­pe­ri­ence to Boehringer In­gel­heim as the Ger­man phar­ma’s se­nior coun­sel in the US on­col­o­gy busi­ness unit.

→ Copen­hagen-based IO Biotech has en­list­ed Kei­th Ven­dola as CFO. Ven­dola brings to the ta­ble ex­pe­ri­ence from his times at Re­zo­lute, Co­herus, Eiger Bio­Phar­ma­ceu­ti­cals and Thresh­old Phar­ma­ceu­ti­cals (now Mol­e­c­u­lar Tem­plates).

Jisoo Park

Melin­ta Ther­a­peu­tics makes Peer Re­view for the sec­ond week in a row as the an­tibi­otics mak­er brings in Jisoo Park as head of busi­ness de­vel­op­ment, M&A and strat­e­gy. A vet­er­an of JP Mor­gan’s glob­al health­care team, Park was pre­vi­ous­ly VP of busi­ness de­vel­op­ment and M&A at Co­vis Phar­ma. This marks the sec­ond hire in as many weeks for Melin­ta as the com­pa­ny re­moved the in­ter­im tag from CFO Su­san Blum.

El­e­var Ther­a­peu­tics is adding some fresh faces to its lead­er­ship team with the ap­point­ments of Mau­reen Con­lan as CMO, Julie Boisvert as VP, reg­u­la­to­ry af­fairs and Do­minick Di­Pao­lo as VP, qual­i­ty as­sur­ance. Con­lan comes to the Salt Lake City-based com­pa­ny from Ra­dius Health; Boisvert hops aboard from BeiGene USA, where she served as se­nior di­rec­tor in reg­u­la­to­ry af­fairs; while Di­Pao­lo joins from qual­i­ty and com­pli­ance con­sul­tan­cy firm Qual­i­ty by De­sign.

Preethi Sun­daram

→ Hav­ing bat­tled it out in court over the ap­proval of ri­val Ja­cobus’ LEMS drug — a bat­tle that was ul­ti­mate­ly lostCat­a­lyst Phar­ma­ceu­ti­cals has tapped Preethi Sun­daram as chief prod­uct de­vel­op­ment of­fi­cer. Sun­daram comes to Cat­a­lyst af­ter an as­sort­ment of R&D and med­ical af­fairs roles in 16 years at Sanofi, rang­ing from glob­al project head in mul­ti­ple ther­a­peu­tic ar­eas to her lat­est re­spon­si­bil­i­ties as glob­al head of med­ical op­er­a­tions, gen­er­al med­i­cines busi­ness unit.

→ Austin, TX-based Ae­glea Bio­Ther­a­peu­tics has named Jonathan Alspaugh as CFO. Alspaugh makes the jump from Ever­core, where he most re­cent­ly served as a man­ag­ing di­rec­tor in the firm’s cor­po­rate ad­vi­so­ry busi­ness. Pri­or to that, Alspaugh was with Bar­clays Cap­i­tal.

Robert Mill­ham

CATO SMS, a glob­al provider of clin­i­cal re­search so­lu­tions, has bagged Robert Mill­ham as pres­i­dent of clin­i­cal tri­al op­er­a­tions. Mill­ham had a 17-year stint at Pfiz­er, where he led and con­tributed to the de­vel­op­ment of com­pounds against mul­ti­ple in­di­ca­tions of can­cer, in­clud­ing lung, breast, col­orec­tal and ovar­i­an. He was al­so the COO of Odonate Ther­a­peu­tics, SVP at Sy­neos Health and VP of strate­gic al­liances for Caris Life Sci­ences.

→ Peer Re­view reg­u­lar jCyte’s lead­er­ship keeps on grow­ing with chief de­vel­op­ment of­fi­cer and long­time Glax­o­SmithK­line ex­ec Adri­an Mor­ris. From 1997-2012, Mor­ris served in a num­ber of ca­pac­i­ties at the phar­ma gi­ant rang­ing from VP, glob­al com­mer­cial strat­e­gy in the res­pi­ra­to­ry pipeline to VP, di­ag­nos­tics busi­ness unit and Pan­dem­ic Cen­tre of Ex­cel­lence. Since he left GSK, Mor­ris had been man­ag­ing di­rec­tor at Phar­ma­co Con­sult­ing. For those scor­ing at home, jCyte has added a CFO, chief com­mer­cial of­fi­cer, gen­er­al coun­sel and oth­er ex­ecs in clin­i­cal de­vel­op­ment and med­ical af­fairs along with Mor­ris since Shan­non Blalock was pro­mot­ed to CEO in Feb­ru­ary.

Mark Alt­mey­er

Mark Alt­mey­er has been named chair­man of Dutch-based AM-Phar­ma’s su­per­vi­so­ry board. The Bris­tol My­ers, Ot­su­ka and Ax­o­vant vet was pres­i­dent and CEO of Arvelle be­fore An­geli­ni pur­chased it to ring in 2021 with a near­ly $1 bil­lion price tag.

Morn­ing­side Group co-founder Ger­ald Chan has added an­oth­er chair­man­ship, this time at Cog­ni­to Ther­a­peu­tics, which showed pos­i­tive Phase II da­ta with its lead dig­i­tal prod­uct for Alzheimer’s. Chan is al­so chair­man at Apel­lis and Stealth Bio­ther­a­peu­tics.

Lin­da Bain

→ Co­di­ak CFO Lin­da Bain is hop­ping on­to the board of di­rec­tors at VBI Vac­cines. Pri­or to her role at Co­di­ak, Bain was CFO at Ad­verum Biotech­nolo­gies; VP, fi­nance, busi­ness op­er­a­tions, and trea­sur­er at blue­bird bio; and held roles at Gen­zyme. In ad­di­tion to her new seat, Bain sits on the boards of Au­to­lus Ther­a­peu­tics and Arv­inas.

On­coRe­sponse has re­cruit­ed Cy­tomX pres­i­dent, CEO and chair­man Sean Mc­Carthy as an in­de­pen­dent di­rec­tor of its board. Mc­Carthy joined Cy­tomX in 2010 as CBO and has served as CEO since 2011. Pri­or to that role, Mc­Carthy was with Pap­pas Ven­tures, SGX Phar­ma­ceu­ti­cals and Mil­len­ni­um Phar­ma­ceu­ti­cals.

Jan Hill­son

→ Au­toim­mune and neu­rode­gen­er­a­tive dis­ease biotech Ele­don Phar­ma­ceu­ti­cals has elect­ed Jan Hill­son to the board of di­rec­tors. Hill­son, the SVP of clin­i­cal de­vel­op­ment at Alpine Im­mune Sci­ences, was once SVP of drug de­vel­op­ment for Chemo­Cen­tryx.

Chaired by Brent Saun­ders and with new CMO David Tanz­er join­ing the fray, the folks at eye dis­ease biotech OcuTer­ra have en­list­ed Richard Lind­strom and Sheri Rowen for their sci­en­tif­ic ad­vi­so­ry board. The founder of Min­neso­ta Eye Con­sul­tants, Lind­strom is an ad­junct pro­fes­sor emer­i­tus at the Uni­ver­si­ty of Min­neso­ta’s oph­thal­mol­o­gy de­part­ment. Rowen, a LASIK sur­geon in New­port Beach, CA, found­ed Mer­cy Med­ical Cen­ter’s oph­thal­mol­o­gy de­part­ment in Bal­ti­more 25 years ago.

Chimeric Ther­a­peu­tics has plucked up George Matcham as a non-ex­ec­u­tive di­rec­tor of its board. Matcham is a Cel­gene vet and was part of the com­pa­ny from its ear­ly days in 1988 to his re­tire­ment in 2018 — serv­ing as COO of Cel­gene Cel­lu­lar Ther­a­peu­tics and SVP of CAR-T CMC de­vel­op­ment. Matcham pre­vi­ous­ly sat on the board of In­stil Bio as an ad­vi­sor.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.