‘Nat­ur­al evo­lu­tion’: Caris­ma’s sci­en­tif­ic co-founder moves in­to the CSO post; Vas Narasimhan en­lists Ron­ny Gal to help with No­var­tis re­vamp

Michael Klichin­sky

When Michael Klichin­sky was work­ing with the famed Penn re­searchers Carl June and Saar Gill as a grad stu­dent, he didn’t pic­ture a C-suite ti­tle in his fu­ture. But af­ter co-found­ing a biotech with Gill in 2016 to go af­ter a new can­cer de­stroy­ing fron­tier in drug de­vel­op­ment, that start­ed to change.

“It was such a cool idea, and when we first thought it up, our ini­tial goal was, ‘Wow, what if we could re­al­ly make these cells eat any­thing we want to?’” Klichin­sky told End­points News about his re­search that helped found the CAR macrophage tech­nol­o­gy be­hind Caris­ma Ther­a­peu­tics.

Af­ter found­ing the start­up, it took about two years for Klichin­sky to leap full-time in­to the biotech. He climbed from VP of dis­cov­ery to SVP of re­search and has since es­ca­lat­ed an­oth­er rung of the lad­der to CSO. From that perch, he’ll head up the trans­la­tion­al sci­ences team, lead a Mod­er­na part­ner­ship on can­cer cell ther­a­pies and build out the ear­ly clin­i­cal work at the 75-em­ploy­ee biotech. His in­creased re­spon­si­bil­i­ties at Caris­ma are part of a “nat­ur­al evo­lu­tion,” the ear­ly-30s ex­ec­u­tive said.

With the C-suite hat placed firm­ly on his head in re­cent weeks, the 2021 End­points 20 un­der 40 hon­oree is ready to help the Philly-area biotech mold in­to its vi­sion as an “en­gi­neered myeloid cell com­pa­ny,” not just a “CAR macrophage com­pa­ny,” Klichin­sky said.

The com­pa­ny’s first CAR-M ther­a­py en­tered hu­man stud­ies last year and a da­ta read­out from the first co­hort is slat­ed for AS­CO this June, Klichin­sky said. That “Tro­jan horse idea,” as the ex­ec­u­tive pre­vi­ous­ly char­ac­ter­ized to End­points, has blos­somed in­to a plat­form and is now among a pipeline of oth­er ef­forts, in­clud­ing dis­cov­ery work on CAR mono­cytes, which are the pre­cur­sor to the macrophage, the new­ly-mint­ed CSO said.

“[B]y en­gi­neer­ing cells at the mono­cyte stage, we have the po­ten­tial to short­en our cell man­u­fac­tur­ing from a week to a sin­gle day,” he said.

On­col­o­gy isn’t the on­ly area, ei­ther. Dis­cov­ery work across liv­er fi­bro­sis and Alzheimer’s dis­ease are start­ing to sprout up. “Macrophages in the ab­sence of tu­mors ac­cu­mu­late in the liv­er,” the CSO ex­plained. And for the neu­rode­gen­er­a­tive dis­ease, Caris­ma is work­ing with Gill’s Penn lab to look at en­gi­neer­ing cells to tar­get be­ta amy­loid and oth­er pro­tein ag­gre­gates that are thought to trig­ger the mem­o­ry rob­bing dis­or­der.

Add CRISPR gene edit­ing to the hop­per, a col­lab­o­ra­tion to test a Caris­ma as­set with Mer­ck’s Keytru­da in a clin­i­cal tri­al next year and oth­er tie-ups, like No­var­tis sign­ing on to man­u­fac­ture the biotech’s CAR-Ms.

The new CSO will al­so play a big part in Caris­ma’s work with Mod­er­na on in vi­vo cell ther­a­pies for can­cer, po­ten­tial­ly com­pris­ing as many as 12 pro­grams.

Kyle LaHu­cik

Ron­ny Gal

Ron­ny Gal will forego his work as an an­a­lyst, join­ing No­var­tis “no lat­er than Au­gust 1” in the new­ly cre­at­ed role of chief strat­e­gy & growth of­fi­cer. The in­dus­try watch­er for 17 years at Bern­stein is a crown jew­el in CEO Vas Narasimhan’s re­or­ga­ni­za­tion plan, where­by Gal will be tasked with seek­ing M&A op­por­tu­ni­ties val­ued at less than $2 bil­lion and help­ing the com­pa­ny gain trac­tion in the US mar­ket. Narasimhan’s over­haul will af­fect thou­sands of staffers, al­ready re­sult­ing in the dis­missals of CMO John Tsai, head of on­col­o­gy Su­sanne Schaf­fert and pres­i­dent of cus­tomer & tech­nol­o­gy so­lu­tions Robert Wel­tevre­den.

Gal’s move brings to mind Biren Amin, who left Jef­feries af­ter near­ly a decade to take the CFO job at can­cer up­start Im­muneer­ing in April 2021.

Arpa Garay

→ When Mer­ck an­nounced the Aug. 1 re­turn of Joseph Ro­manel­li to take charge of the Hu­man Health in­ter­na­tion­al busi­ness, it com­plet­ed a three-pronged ap­proach to re­place Frank Clyburn: Jan­nie Oost­huizen would lead Hu­man Health US while Arpa Garay would han­dle Hu­man Health glob­al mar­ket­ing re­spon­si­bil­i­ties. It turns out that Garay won’t be around to see that lead­er­ship struc­ture through.

Garay will in­stead be pack­ing up for Mod­er­na, re­plac­ing Corinne Le Goff as chief com­mer­cial of­fi­cer on May 31. With Mod­er­na ex­plod­ing in­to a house­hold name, com­mer­cial­iza­tion ef­forts are un­der a greater mi­cro­scope for its Covid-19 vac­cine, which hasn’t been read­i­ly avail­able for low-in­come coun­tries com­pared with the Pfiz­er and J&J jabs.

→ As Nek­tar sounds taps on be­m­peg, wash­ing away the high hopes they once had for IL-2 af­ter late-stage flops with Bris­tol My­ers Squibb’s Op­di­vo, the job cuts run deep. Nek­tar will jet­ti­son ap­prox­i­mate­ly 70% of its work­force, and the C-suite isn’t ex­empt. CMO Dim­it­ry Nuyten and chief com­mer­cial of­fi­cer John North­cott will walk out the door, while head of im­munol­o­gy Bri­an Kotzin gears up to re­place Nuyten. Nek­tar’s fu­ture now hinges on two oth­er can­di­dates in the pipeline, NK­TR-358 and NK­TR-255.

Joel Schnei­der

→ The strate­gic re­or­ga­ni­za­tion trend has al­so reached Duchenne biotech Sol­id Bio­sciences, prun­ing its staff count by 35%. And at the end of May, Sol­id Bio will be say­ing good­bye to Joel Schnei­der, who start­ed out as a sci­ence an­a­lyst in 2014 and rose to COO last year. The press re­lease got in­ter­est­ing­ly spe­cif­ic about Schnei­der’s next steps, men­tion­ing that he will be­come CEO of a “pri­vate­ly held nov­el, vi­ral-based gene ther­a­py plat­form com­pa­ny.” In March 2021, Sol­id Bio did re­veal some SGT-001 da­ta that would os­ten­si­bly help the biotech re­bound from a bout of clin­i­cal holds, but in­vestors weren’t ex­act­ly unit­ed in their en­thu­si­asm.

Cameron Tur­tle

→ The hits just keep on com­ing for Bridge­Bio, which is lay­ing off an un­spec­i­fied num­ber of em­ploy­ees fol­low­ing dis­as­trous re­sults with its TTR amy­loi­do­sis drug aco­ramidis. And as Nicole De­Feud­is points out in her scoop this week, “The com­pa­ny’s cen­tral com­mer­cial team was sig­nif­i­cant­ly af­fect­ed.” Most no­tably, Cameron Tur­tle is out af­ter five years with Bridge­Bio and one year as chief strat­e­gy of­fi­cer. He’s al­so been CBO of Bridge­Bio sub­sidiary Ei­dos Ther­a­peu­tics.

Vlad Hogen­huis

→ Big Phar­ma vet Vlad Hogen­huis has tak­en the CEO job at Chimera Bio­engi­neer­ing, a South San Fran­cis­co biotech that’s been op­er­at­ing out of the spot­light since 2015 and de­vel­op­ing CAR-T ther­a­pies with its GOLD Plat­form tech­nol­o­gy. Hogen­huis filled sev­er­al po­si­tions in his 18 years at Mer­ck/MSD Chi­na, in­clud­ing chief mar­ket­ing of­fi­cer, be­fore mov­ing on to GSK in 2012. He would be­come SVP and glob­al fran­chise head, spe­cial­ty phar­ma­ceu­ti­cals at the UK phar­ma gi­ant be­fore his ap­point­ment as COO of rare dis­ease biotech Ul­tragenyx in 2018.

Cher­ry Thomas

→ Big Phar­ma vet Cher­ry Thomas has de­cid­ed to leave the Jen­nifer Doud­na CRISPR up­start Cari­bou Bio­sciences to take her first CMO gig at Cata­ma­ran Bio. Thomas joined Cari­bou as SVP of clin­i­cal de­vel­op­ment two years ago from Ar­ray Bio­Phar­ma, where she was VP, on­col­o­gy clin­i­cal de­vel­op­ment. Af­ter tour­ing through sev­er­al phar­ma gi­ants — GSK, No­var­tis and Bris­tol My­ers among them — she be­came part of the clin­i­cal de­vel­op­ment lead­er­ship at BeiGene and Jounce Ther­a­peu­tics. Spe­cial­iz­ing in off-the-shelf (CAR)-NK cell ther­a­pies, Cata­ma­ran has turned up enough in Peer Re­view since its No­vem­ber 2020 launch to earn re­wards points — and this is one of the biotech’s biggest hires yet.

An­na-Maria Deme­tri­ades

Cyrus Moza­yeni’s lead­er­ship team is com­ing in­to clear­er fo­cus as An­na-Maria Deme­tri­ades is named CMO of oc­u­lar gene ther­a­py play­er Vedere Bio II not long af­ter CFO Gi­na Con­syl­man’s ar­rival. As se­nior med­ical di­rec­tor for oph­thal­mol­o­gy clin­i­cal de­vel­op­ment at Genen­tech, Deme­tri­ades was the lead clin­i­cian for Eylea com­peti­tor Vabysmo, which snagged an ap­proval for di­a­bet­ic mac­u­lar ede­ma and wet age-re­lat­ed mac­u­lar de­gen­er­a­tion in Jan­u­ary.

Stephen From

Stephen From is mak­ing his way to the helm of Aruna Bio as CEO, suc­ceed­ing Skip Irv­ing, who has served in the in­ter­im. From joins the com­pa­ny af­ter a stint as CEO and chair­man of Eye­Gate Phar­ma­ceu­ti­cals. Ear­li­er in his ca­reer, From served at Bank of Amer­i­ca and Robert­son Stephens. Mean­while, Irv­ing will con­tin­ue to serve on the com­pa­ny’s board.

→ With a Bloomberg ar­ti­cle in­di­cat­ing a pos­si­ble sale of I-Mab af­ter CEO Joan Shen’s ex­it, the Chi­nese biotech has ap­point­ed Richard Yeh as COO and John Hayslip as CMO. Yeh re­cent­ly held the roles of CFO and head of strate­gic op­er­a­tions at Ab­bisko Ther­a­peu­tics, and he’s al­so been fi­nance chief for CStone Phar­ma­ceu­ti­cals. Hayslip, who just had a brief run at Nek­tar as VP of clin­i­cal de­vel­op­ment, is a nat­ur­al fit for I-Mab af­ter work­ing on lem­zopar­limab at Ab­b­Vie. The two com­pa­nies teamed up on the CD47 an­ti­body in a deal that saw Ab­b­Vie pay $180 mil­lion up­front for ex-Chi­na rights.

Lau­ra Clague

Lau­ra Clague is step­ping down as CFO of Tra­vere Ther­a­peu­tics in Au­gust as Chris Cline, the SVP of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions, pre­pares to take her place. Both Cline and Clague have served at Tre­vere since 2014, and when Cline takes over as fi­nance chief, Clague will then keep an ad­vi­so­ry role un­til 2023. The com­pa­ny dis­posed it­self of all traces to founder Mar­tin Shkre­li by re­brand­ing from Retrophin to Tra­vere in late 2020.

Doug Pagán

→ Co-found­ed by Stu­art Schreiber and pulling in a $50 mil­lion Se­ries B last sum­mer, Roche neu­rol­o­gy and im­munol­o­gy part­ner Jnana Ther­a­peu­tics has locked in Doug Pagán as CFO and COO. Pagán is set for dou­ble du­ty here af­ter near­ly two years as CFO of Dicer­na Phar­ma­ceu­ti­cals, which was sold to No­vo Nordisk for $3.3 bil­lion in No­vem­ber 2021. The for­mer fi­nance ex­ec at Ac­celeron al­so re­signed from the board at Zio­pharm On­col­o­gy (now Alaunos) in the ac­tivist at­tack mael­strom that was stoked by Wa­ter­Mill in 2020.

Su­san Lun­deen

→ In bounce­back mode with an or­phan drug des­ig­na­tion for BC­MA CAR-T AL­LO-605 af­ter the FDA lift­ed a clin­i­cal hold on its Al­lo­CAR T tri­als in Jan­u­ary, David Chang has wel­comed Su­san Lun­deen to Al­lo­gene as chief peo­ple of­fi­cer. Lun­deen has worked in HR since her days at Am­gen, and since 2016 she was chief hu­man re­sources of­fi­cer with Uni­ty Biotech­nol­o­gy. In the eight years be­fore Uni­ty, Lun­deen was SVP of hu­man re­sources at Kythera Bio­phar­ma­ceu­ti­cals un­til Al­ler­gan forked over $2.1 bil­lion to pur­chase the biotech in 2015.

Li­ong­Ho Chua

→ Af­ter nam­ing Nicholas Jack­son pres­i­dent of glob­al R&D in Feb­ru­ary, Joshua Liang-led Clover Bio­phar­ma­ceu­ti­cals has ap­point­ed Li­ong­Ho Chua as pres­i­dent of Greater Chi­na. Be­fore set­ting off for the Shang­hai vac­cine biotech, Chua was chief strat­e­gy of­fi­cer for AIM Vac­cine. The ex-Sanofi Pas­teur Chi­na GM has al­so spent time with Gilead as VP and gen­er­al man­ag­er, Asia com­mer­cial op­er­a­tions, and he’s al­so been coun­try man­ag­er for San­doz Chi­na.

Sean Mar­tin

→ The folks at San Diego pro­tein degra­da­tion biotech Bio­th­eryx may have stripped away the cap­i­tal­iza­tions in their com­pa­ny name, but they’ve gained a CFO. Jeff Car­avel­la worked in fi­nance at J&J for a decade and leaves Bar­bara We­ber’s team at Tan­go Ther­a­peu­tics, where he was VP, fi­nance. He’s al­so been se­nior fi­nance di­rec­tor for Charles Riv­er Lab­o­ra­to­ries and Ed­i­tas Med­i­cine, the gene edit­ing play­er where Sarep­ta’s Gilmore O’Neill just suc­ceed­ed Jim Mullen as CEO.

Gen­er­ate Bio­med­i­cines, the Flag­ship ma­chine learn­ing joint led by ex-Mer­ck chief mar­ket­ing of­fi­cer Mike Nal­ly, has picked up Sean Mar­tin as chief le­gal of­fi­cer and gen­er­al coun­sel. The one-time VP for com­mer­cial law and cor­po­rate law at Am­gen — which ponied up $50 mil­lion up­front in a Jan­u­ary deal with Gen­er­ate — Mar­tin spent the last five years as SVP and gen­er­al coun­sel with Bax­ter.

Dirk Gev­ers

Third Rock start­up Flare Ther­a­peu­tics, tak­ing aim at tran­scrip­tion fac­tors with an $82 mil­lion Se­ries A at its dis­pos­al, has re­cruit­ed Adri­an Jubb as CMO. The Genen­tech vet leaves 23andMe af­ter three years as head of clin­i­cal on­col­o­gy and neu­rol­o­gy. Jubb has been a CMO be­fore at Im­mune-Onc Ther­a­peu­tics af­ter lead­ing ear­ly de­vel­op­ment at Achao­gen.

→ Mi­cro­bio­me sci­ences com­pa­ny Seed Health is bring­ing aboard Dirk Gev­ers as CSO. Gev­ers hails from J&J’s Janssen Phar­ma­ceu­ti­cal Com­pa­nies, where he helped launched the Janssen Hu­man Mi­cro­bio­me In­sti­tute and served as glob­al head. Pri­or to his work with Janssen, Gev­ers was at the Broad In­sti­tute of MIT and Har­vard.

Stephanie Read

→ There are quite a few changes hap­pen­ing over at Toron­to-based High­land Ther­a­peu­tics. For starters, the com­pa­ny has locked in Stephanie Read as pres­i­dent and CEO of the com­pa­ny, tak­ing over for Ste­fan An­ton­s­son, who has been serv­ing in the in­ter­im. Read has spent the last 6.5 years with CSL as glob­al VP, cor­po­rate strat­e­gy and busi­ness de­vel­op­ment and 7.5 years with As­traZeneca/Med­Im­mune. Ear­li­er in her ca­reer, Read served in roles R&D and glob­al med­ical af­fairs at Shire.

Mean­while, An­ton­s­son (for­mer SVP of mar­ket­ing at Su­per­nus Phar­ma­ceu­ti­cals) will move back to his role as in­de­pen­dent di­rec­tor of the board. And, fi­nal­ly, join­ing him will be Scott My­ers (for­mer AM­AG Phar­ma­ceu­ti­cals CEO) as chair­man and Kevin Bain (cur­rent­ly chief cor­po­rate de­vel­op­ment of­fi­cer at Cell Re­search Cor­po­ra­tion and for­mer CFO of Alvo­gen and Alvotech) and Ildiko Mehes (SVP and gen­er­al coun­sel at Te­va Phar­ma­ceu­ti­cals) as in­de­pen­dent di­rec­tors.

Han Lim

Han Lim is jump­ing from one AI biotech for an­oth­er, tak­ing on the role of CBO at Morn­ing­side-backed Deep­Cure, which clinched a $40 mil­lion Se­ries A last fall. In 2019, Lim was pro­mot­ed from glob­al head of part­ner­ing to CBO at Atom­wise, which has built AI part­ner­ships with Eli Lil­ly, Bay­er and, more re­cent­ly, Bridge­Bio.

Si­mon Plyte

Sanofi bis­pe­cif­ic an­ti­body part­ner Bio­munex Phar­ma­ceu­ti­cals, a US-French biotech that re­cent­ly opened new lab­o­ra­to­ries in Paris, has ap­point­ed Si­mon Plyte as CSO and as a mem­ber of its sci­en­tif­ic ad­vi­so­ry board. Plyte, a vet­er­an of Boehringer In­gel­heim and Pfiz­er, most re­cent­ly served as VP, im­muno-on­col­o­gy at Merus.

→ Uni­ver­si­ty of Pitts­burgh spin­out Blue­Sphere Bio has pegged Robert Keefe as chief de­vel­op­ment of­fi­cer, dash­ing to the T-cell ther­a­py biotech af­ter a short stay at As­traZeneca. Since Oc­to­ber 2020, Keefe had served as the phar­ma gi­ant’s head of CMC cell ther­a­py de­vel­op­ment, and he’s al­so held posts at Lon­za, WuXi AppTec, Max­Cyte and Au­to­lus.

Lau­ra Mau­ri

Medtron­ic is sad­dling on Lau­ra Mau­ri as chief sci­en­tif­ic, med­ical and reg­u­la­to­ry of­fi­cer. Mau­ri joined the Dublin-based health­care tech com­pa­ny in Sep­tem­ber 2018 and be­came a mem­ber of the com­pa­ny’s ex­ec­u­tive com­mit­tee in Au­gust 2020. Pri­or to this, Mau­ri was an in­ter­ven­tion­al car­di­ol­o­gist at Brigham and Women’s Hos­pi­tal for 15 years.

Mainz Bio­med, a mol­e­c­u­lar ge­net­ics di­ag­nos­tic com­pa­ny, has named Darin Leigh as CCO. Leigh brings with him ex­pe­ri­ence from his times at Ab­bott, Lu­minex (VP of glob­al com­mer­cial op­er­a­tions), Metabolon and CDR Health (CCO).

Nimisha Sri­vas­ta­va

Twist Bio­science is shout­ing out a pair of pro­mo­tions: Tracey Mullen (SVP of op­er­a­tions) joined the DNA syn­the­sis out­fit as gen­er­al man­ag­er when it scooped up the com­pa­ny she helmed, the in vi­vo an­ti­body drug dis­cov­ery shop Ab­veris, in late No­vem­ber. Nimisha Sri­vas­ta­va (SVP of R&D), a Twist staffer since 2014 when she was a se­nior man­ag­er in sys­tems en­gi­neer­ing, had been VP of en­gi­neer­ing pri­or to her new post.

Gain­ing ex­tra com­pe­ti­tion with the re­cent launch of Emeryville, CA start­up Ansa Biotech­nolo­gies, Twist is al­so look­ing for a new COO af­ter the de­par­ture of Patrick Weiss, who cit­ed per­son­al rea­sons for his de­ci­sion to step down on April 21.

Nur­jana Bach­man

→ When in Rome, be­come the SVP, cor­po­rate de­vel­op­ment and strat­e­gy at ROME Ther­a­peu­tics. At least that’s what Nur­jana Bach­man has done at Rosana Kapeller’s re­peatome drug de­vel­op­er. Bach­man, the for­mer VP of bio­phar­ma and cor­po­rate al­liances at Foun­da­tion Med­i­cine, was al­so co-founder and CBO of Clar­i­tas Ge­nomics.

Son­al Gup­ta

Son­al Gup­ta has been ap­point­ed SVP and head of clin­i­cal de­vel­op­ment at Nat­ick, MA-based Affy­Im­mune Ther­a­peu­tics, a CAR-T biotech that raised $30 mil­lion in what was des­ig­nat­ed as a Se­ries A+ round last Oc­to­ber. Gup­ta was head of pre­clin­i­cal and clin­i­cal as­says at CRISPR Ther­a­peu­tics from 2016-19, and from there she be­came head of trans­la­tion­al re­search at Ru­bius Ther­a­peu­tics. She joins Affy­Im­mune from Avro­bio, where she was head of trans­la­tion­al med­i­cine.

Prog­en­i­ty, the com­pa­ny fo­cused on women’s health, gas­troin­testi­nal health and oral bio­ther­a­peu­tics, has tapped Paul Shabram as SVP, tech­ni­cal op­er­a­tions. Be­fore mak­ing his way to the San Diego-based com­pa­ny, Shabram formed Ven­tana Bio­Sciences Con­sult­ing and was VP of tech­ni­cal de­vel­op­ment at Emer­gent BioSo­lu­tions. Ear­li­er in his ca­reer, Shabram had stints at Pax­Vax, Scher­ing-Plough/Can­ji, Cy­tel and Ch­i­ron.

Deer­field-backed in­fec­tious dis­ease biotech Adap­tive Phage Ther­a­peu­tics has ap­point­ed Rob Casper as VP of clin­i­cal op­er­a­tions. Most re­cent­ly, Casper served as VP of clin­i­cal op­er­a­tions at Al­tim­mune and as se­nior di­rec­tor of clin­i­cal op­er­a­tions at Kolon Tis­sue­Gene. Tri­als are on­go­ing at APT to ex­am­ine pros­thet­ic joint in­fec­tion and di­a­bet­ic foot os­teomyelitis.

George Di­az

Tachi Ya­ma­da lega­cy up­start iECURE, a gene edit­ing biotech from chief sci­en­tif­ic ad­vi­sor Jim Wil­son at Penn, has in­stalled George Di­az as VP, ther­a­peu­tic area lead for urea cy­cle dis­or­ders. Di­az brings more than two decades of ex­pe­ri­ence from the Ic­ahn School of Med­i­cine at Mount Sinai — dur­ing his tenure, he was chief of the Di­vi­sion of Med­ical Ge­net­ics and a pro­fes­sor in both ge­net­ics & ge­nom­ic sci­ences and pe­di­atrics.

→ Syn­thet­ic lethal­i­ty shop Cyteir Ther­a­peu­tics, which joined Nas­daq at a blaz­ing-hot mo­ment for IPOs in 2021 that seems like light years ago, has brought on Adam Ve­ness as gen­er­al coun­sel. Ve­ness closed out his sev­en years at Ac­celeron as SVP, gen­er­al coun­sel and sec­re­tary be­fore the com­pa­ny caught Mer­ck’s eye last fall.

Paul Stof­fels

Gala­pa­gos CEO Paul Stof­fels has added chair­man to his list of ti­tles. The for­mer J&J lu­mi­nary took over this sub­stan­tial re­hab project on April 1 af­ter On­no van de Stolpe an­nounced his re­tire­ment last Au­gust. Gala­pa­gos, which fell from grace in a doomed part­ner­ship with Gilead, has al­so elect­ed ex-Sanofi CFO Jérôme Con­t­a­mine and Dan Bak­er to the board of di­rec­tors.

→ On May 1, Gen­nao Bio chief Stephen Squin­to will no longer be chair­man of Genen­ta Sci­ence, the Mi­lan gene ther­a­py biotech co-found­ed by Lui­gi Nal­di­ni. Genen­ta has nom­i­nat­ed ex-Aruna Bio CEO Mark Sir­go to re­place Squin­to, who will “pur­sue a new busi­ness op­por­tu­ni­ty,” ac­cord­ing to the re­lease.

Ang­ie You

Ken Song’s ra­dio­phar­ma start­up Rayze­Bio has added Ang­ie You to the board of di­rec­tors. You, the ex-CEO of Amu­nix, is a se­nior ad­vi­sor for Fra­zier Life Sci­ences, a strate­gic ad­vi­sor at Cas­din Cap­i­tal, and a board mem­ber at ORIC Phar­ma­ceu­ti­cals.

Frank Karbe has been grant­ed a seat on the board of di­rec­tors at New Jer­sey GI biotech Phath­om Phar­ma­ceu­ti­cals. The one-time fi­nance chief at Ex­elix­is was re­cent­ly the pres­i­dent and CFO at My­ovant, the com­pa­ny from the Vivek Ra­maswamy “vant” sta­ble part­ner­ing with Pfiz­er on Or­govyx and Myfem­bree.

Am­rit Ray

Kad­mon gene ther­a­py spin­out MeiraGTx has ush­ered in De­bra Yu to the board of di­rec­tors. The Pfiz­er alum is pres­i­dent and CBO of Per­cep­tive start­up Lian­Bio.

Grab­bing ex-US li­cens­ing rights to Re­gen­eron’s cho­les­terol dis­or­der drug Evkeeza, Ul­tragenyx has elect­ed Am­rit Ray to the board of di­rec­tors. Ray, the for­mer CMO for J&J’s Janssen, is cur­rent­ly the chief patent of­fi­cer at Nurtec mak­er Bio­haven.

IMV has se­lect­ed Michael Bai­ley from with­in its board to serve as chair­man, ef­fec­tive May 1. Bai­ley cur­rent­ly serves as pres­i­dent and CEO of Aveo On­col­o­gy and has sat on the board of IMV since 2020. Bai­ley start­ed out at Aveo as CCO in 2010, be­fore mov­ing on­to the role of CBO in 2013. Pri­or to his stint at Aveo, Bai­ley had roles at Syn­ta Phar­ma­ceu­ti­cals, Im­Clone Sys­tems and Genen­tech.

Jean Liu

Jean Liu will take a seat on the board of di­rec­tors at Eras­ca, the San Diego on­col­o­gy biotech that de­buted on Nas­daq with a hefty $300 mil­lion IPO last sum­mer. Liu cur­rent­ly serves as chief le­gal of­fi­cer at Seagen, and be­fore that, Liu was VP and gen­er­al coun­sel at Halozyme.

Com­pass Ther­a­peu­tics has point­ed the way for Ellen Chiniara and Mary Ann Gray to join its board of di­rec­tors. Chiniara was chief le­gal of­fi­cer of Alex­ion un­til the sale to As­traZeneca closed in Ju­ly 2021, while Gray — the pres­i­dent of Gray Strate­gic Ad­vi­sors — is a board mem­ber at Sarep­ta and Pal­isade Bio, among oth­ers.

→ At the same time that they pulled in an undis­closed amount of seed fi­nanc­ing, Ox­ford-based Mi­toRx Ther­a­peu­tics is bring­ing in Glyn Ed­wards as chair­man of the board. Ed­wards for­mer­ly served as CEO of Sum­mit Ther­a­peu­tics.

Derek Graf al­so con­tributed to this edi­tion.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.