Mov­ing on from Us­ama Ma­lik's in­sid­er trad­ing im­broglio, Fore re­sets at the top; Take­da spin­out turns to Neu­rana CEO to lead the way

Matthew Ros

→ The ouster of for­mer Im­munomedics ex­ec Us­ama Ma­lik cre­at­ed a CEO open­ing at Fore Bio­ther­a­peu­tics, which is tak­ing aim at BRAF mu­ta­tions fol­low­ing a re­brand last year. Matthew Ros has now stepped up to the tee box as CEO and a mem­ber of the board af­ter Ma­lik was em­broiled in an in­sid­er trad­ing scan­dal dur­ing his time at Im­munomedics that he chose to ad­dress in a rather cryp­tic LinkedIn post in De­cem­ber. A 17-year Bris­tol My­ers Squibb vet, Ros left Sanofi Gen­zyme in 2016 to be­come COO of Epizyme, where he had since been chief strat­e­gy and busi­ness of­fi­cer. Fore Bio, once known as di­ag­nos­tics com­pa­ny Nov­el­lus­Dx and chaired by for­mer Sanofi ex­ec Di­eter Weinand, is in a Phase I/IIa tri­al with its lead can­di­date FORE8394.

Brad Mar­gus

Brad Mar­gus is out as CEO of Take­da CNS spin­out Cere­vance, and Craig Thomp­son stands at the ready to take his place. Mar­gus will slide in­to the ex­ec­u­tive chair­man post at the end of this month and hand the reins to Thomp­son, the Pfiz­er and Mer­ck alum who got out of Dodge as chief ex­ec­u­tive of Neu­rana Phar­ma­ceu­ti­cals, where a re­cent Phase III bel­lyflop with tolperisone cast a bleak out­look on the com­pa­ny’s fu­ture. Be­fore his turn as Neu­rana’s chief, Thomp­son was pres­i­dent and CEO of An­thera Phar­ma­ceu­ti­cals and the COO at Tetraphase.

Christo­pher Sla­pak

Vor Bio CMO Christo­pher Sla­pak in­tends to re­tire with en­roll­ment in progress in its Phase I/IIa tri­al for acute myeloid leukemia pa­tients with high risk of re­lapse. The biotech from sci­en­tif­ic founder Sid­dhartha Mukher­jee is search­ing for can­di­dates to suc­ceed Sla­pak, the long­time Eli Lil­ly ex­ec who shed the in­ter­im med­ical chief la­bel at Vor in Ju­ly 2020. “Our plan has al­ways been for Dr. Sla­pak to build a team and in­fra­struc­ture to suc­cess­ful­ly ini­ti­ate the VBP101 clin­i­cal tri­al,” Vor chief Robert Ang said in a state­ment. “Now that we are ac­tive­ly re­cruit­ing with da­ta ex­pect­ed in the sec­ond half of 2022, we are mov­ing in­to an ex­e­cu­tion phase of the study. We have ex­pand­ed our clin­i­cal op­er­a­tions ca­pa­bil­i­ty and ex­per­tise to sup­port this ac­tiv­i­ty and now is a nat­ur­al time for this tran­si­tion.”

Joseph Ro­manel­li

→ Back in Feb­ru­ary, Mer­ck an­nounced that three peo­ple would re­place Frank Clyburn as the ex­ec left to serve as CEO at DuPont-ma­jor­i­ty owned In­ter­na­tion­al Fla­vors & Fra­grances (IFF). At the time, Mer­ck plucked up two ex­ecs from with­in, Arpa Garay (chief mar­ket­ing of­fi­cer, hu­man health) and Jan­nie Oost­huizen (pres­i­dent, Mer­ck Hu­man Health). And now, a for­mer Mer­ck ex­ec is com­ing back to take the third spot. Joseph Ro­manel­li was with Mer­ck for 25 years be­fore he took off less than a year ago to be­come CEO at Shang­hai-based Ji Xing Phar­ma­ceu­ti­cals. Dur­ing his time at Ji Xing, Ro­manel­li helped lead the com­pa­ny to ink its li­cens­ing deal with LENZ Ther­a­peu­tics for its two pres­by­opia can­di­dates.

Now, in his new role, Ro­manel­li will man­age Mer­ck’s $22 bil­lion in­ter­na­tion­al Hu­man Health busi­ness and a team of 14,000 staffers. All three ex­ecs will re­port di­rect­ly to CEO Robert Davis.

Mean­while, the found­ing CEO at Ji Xing, Pe­ter Fong, will be re­tak­ing the reins at the com­pa­ny af­ter Ro­manel­li’s de­par­ture.

Ken­neth At­tie

→ Things aren’t look­ing good over at Imara. So much so that the com­pa­ny is lay­ing off 83% of its staff at the end of this quar­ter — the com­pa­ny’s SVP and CMO Ken­neth At­tie among them — leav­ing Imara with a mea­ger 6 em­ploy­ees and a hunt for strate­gic op­tions to look at next steps. The axe fol­lows the Phase IIb flops ear­li­er this month. At­tie joined the com­pa­ny in Jan­u­ary 2021 af­ter more than a decade at Ac­celeron as VP, med­ical re­search.

Leonard Mazur

Citius Phar­ma­ceu­ti­cals is shak­ing things up at the top as the board has hand­ed Leonard Mazur the con­trols as CEO and chair­man. Start­ing May 1, My­ron Hol­u­bi­ak — Mazur’s pre­de­ces­sor and the for­mer pres­i­dent of Roche Lab­o­ra­to­ries — will be tran­si­tion­ing to ex­ec­u­tive vice chair­man of the board. Along with Hol­u­bi­ak, Mazur co-found­ed Leonard-Meron Bio­sciences, which merged with Citius in 2016. Mazur al­so found­ed and was CEO of Gen­e­sis Phar­ma­ceu­ti­cals.

Along with Mazur’s move, Jaime Bar­tushak will al­so be tak­ing on re­spon­si­bil­i­ties as CBO in ad­di­tion to his cur­rent CFO du­ties. Fi­nal­ly, Citius has wel­comed Michael McGuire — who de­vot­ed more than a quar­ter cen­tu­ry to Roche — as VP, pro­gram leader for an­ti-in­fec­tives. McGuire di­rect­ed the Tam­i­flu team at Roche Lab­o­ra­to­ries and joins the com­pa­ny from Melin­ta Ther­a­peu­tics, where he served as SVP com­mer­cial, gov­ern­ment af­fairs and cus­tomer en­gage­ment.

Humphrey Gard­ner

→ Ear­li­er this month, Har­bour Bio­Med en­trust­ed its CLDN18.2xCD3 bis­pe­cif­ic an­ti­body HBM7022 to As­traZeneca in a deal worth $25 mil­lion up­front, and the Shang­hai com­pa­ny has tapped Humphrey Gard­ner as CMO. The no­madic Gard­ner has held po­si­tions at nu­mer­ous com­pa­nies in the last decade, start­ing with As­traZeneca, where he was VP trans­la­tion­al med­i­cine, ear­ly clin­i­cal de­vel­op­ment. In that time pe­ri­od he’s al­so been SVP of clin­i­cal de­vel­op­ment at Karyopharm; chief, med­ical on­col­o­gy for Evelo Bio­sciences; CMO at Sil­i­con Ther­a­peu­tics; and a CMO in res­i­dence for Roivant.

Al­bert Sey­mour

Fac­ing a rocky road with its phenylke­tonuria gene ther­a­py that they’re try­ing to repave, Ho­mol­o­gy Med­i­cines has pro­mot­ed Al­bert Sey­mour to pres­i­dent of the com­pa­ny. Sey­mour, the chief sci­en­tist at Ho­mol­o­gy since 2016, was SVP and head of glob­al re­search and non­clin­i­cal de­vel­op­ment with Shire af­ter 13 years at Pfiz­er. The FDA put the clamps on Ho­mol­o­gy’s phenylke­tonuria tri­als in late Feb­ru­ary, with Bio­Marin run­ning in­to sim­i­lar reg­u­la­to­ry head­winds in this in­di­ca­tion a week ear­li­er.

→ The Maraganore Me­ter has resur­faced yet again as John Maraganore has been named a strate­gic ad­vi­sor at Sim­ba Gill’s Evelo Bio­sciences, along­side ex-MyoKar­dia CEO Tas­sos Gi­anakakos. A cou­ple weeks ago, we told you that the for­mer Al­ny­lam chief is on the verge of be­ing elect­ed to the board at Take­da, and Maraganore al­so racked up an­oth­er ad­vi­so­ry role at Treg biotech Aba­ta Ther­a­peu­tics.

Kel­ly Gold

→ Last sum­mer, Kel­ly Gold was pro­mot­ed to CBO and SVP of fi­nance at Camp4 Ther­a­peu­tics, the re­gR­NA biotech from Rick Young’s lab at the White­head In­sti­tute that net­ted a $45 mil­lion Se­ries A last sum­mer. This week, she proves that maybe all that glit­ters is gold, as she has been pro­mot­ed yet again, this time to CFO and SVP of fi­nance. Gold joined Camp4 in 2017 af­ter three years at Bio­gen.

→ In Michael Pari­ni’s first year as CEO of Free­line, the Lon­don biotech has notched a win in its ear­ly-stage Fab­ry dis­ease tri­al, while Pamela Foulds has suc­ceed­ed Julie Krop as CMO and Hen­ning Sten­nicke has as­sumed the role of chief sci­en­tist. This week Paul Schnei­der en­ters the fray as CFO af­ter a stint as SVP, fi­nance and op­er­a­tions with Exo Ther­a­peu­tics. Schnei­der, a for­mer fi­nance ex­ec at Aege­ri­on Phar­ma­ceu­ti­cals, was SVP, fi­nance dur­ing his three years at Case­bia Ther­a­peu­tics.

Venkat Yepuri

Chaired by ex-Gos­samer Bio CEO Sheila Gu­jrathi and mo­tor­ing along with a $111 mil­lion Se­ries B haul in Jan­u­ary, Cal­i­for­nia CAR-T play­er Imm­PACT Bio has ap­point­ed Venkat Yepuri as COO. Yepuri spent two decades at Am­gen, start­ing out as a glob­al strate­gic sourc­ing di­rec­tor in 2001 and ris­ing to VP, glob­al busi­ness so­lu­tions and chief pro­cure­ment of­fi­cer at the phar­ma gi­ant from 2017-21.

Math­ias Oelke

Math­ias Oelke has earned a pro­mo­tion to CSO at Nex­Im­mune, where Kristi Jones suc­ceed­ed Scott Carmer as CEO in late Feb­ru­ary. Oelke, a sci­en­tif­ic co-founder, was pre­vi­ous­ly SVP, pre­clin­i­cal im­munother­a­py and head of cell bi­ol­o­gy since 2017. Nex­Im­mune’s two lead as­sets— NEXI-001 for re­lapsed AML and NEXI-002 for mul­ti­ple myelo­ma — have ad­vanced to Phase I/II tri­als.

Venkat Ra­manan

Turn­stone Bi­o­log­ics, the Take­da vi­ral im­munother­a­py part­ner whose $80 mil­lion Se­ries D last sum­mer dwarfed its pre­vi­ous three rounds, is swing­ing the door open for Venkat Ra­manan as CFO and Joseph Camp­isi as gen­er­al coun­sel. Ra­manan held a hand­ful of fi­nance po­si­tions at Gilead and then piv­ot­ed to his lat­est stop at Seagen, where he would be pro­mot­ed to SVP of fi­nance. Camp­isi, the deputy gen­er­al coun­sel for a por­tion of his 16 years at Bris­tol My­ers, was re­cent­ly EVP, gen­er­al coun­sel and sec­re­tary with Scor­pi­on Ther­a­peu­tics.

Ras­mus Holm-Jor­gensen

Ras­mus Holm-Jor­gensen leads a huge cast that has ven­tured off to Acrivon Ther­a­peu­tics, Pe­ter Blume-Jensen’s bid to re­vive the old Eli Lil­ly drug prex­as­ert­ib (now known as ACR-368). Holm-Jor­gensen, Acrivon’s new CFO, spent 11 years at No­vo Nordisk and helped build Kiniksa from the ground up in 2015 as chief strat­e­gy and port­fo­lio of­fi­cer. Join­ing Holm-Jor­gensen are the fol­low­ing ex­ecs: Bruce Close (VP of qual­i­ty and com­pli­ance); James Dun­yak (VP of bio­sta­tis­tics); Joon Jung (VP and head of da­ta sci­ence); Crys­tal Mer­ca­do (glob­al head of HR); Thomas Ni­fong (head of clin­i­cal CDx op­er­a­tions); Sam Rua (VP of CDx reg­u­la­to­ry); and John van Duzer (VP of CMC).

Ehab El-Gabry

→ Roche vet Ehab El-Gabry has signed on as CMO of As­traZeneca spa­tial bi­ol­o­gy part­ner Akoya Bio­sciences, which has made sev­er­al ap­point­ments in the past year, in­clud­ing for­mer Park­er In­sti­tute for Can­cer Im­munother­a­py COO Fred­er­ic Pla. Be­fore tak­ing on this role, El-Gabry had been se­nior med­ical di­rec­tor for Per­son­al­ized Health Care So­lu­tions (PCHS) at Roche Tis­sue Di­ag­nos­tics.

Sarah Math­ieson

→ Fo­cused on he­pati­tis delta virus but boast­ing pos­i­tive re­sults with pegin­ter­fer­on lamb­da for Covid-19 last month, Eiger Bio­Phar­ma­ceu­ti­cals has scaled more lead­er­ship peaks to find chief tech­ni­cal of­fi­cer Chris Kurtz and SVP of cor­po­rate af­fairs Sarah Math­ieson. Kurtz left Gilead, where he was head of com­mer­cial API man­u­fac­tur­ing, to be­come EVP of tech­ni­cal op­er­a­tions at Cidara Ther­a­peu­tics in late 2020. Mean­while, Math­ieson — a 10-year GSK alum who was the Big Phar­ma’s glob­al head of R&D com­mu­ni­ca­tions and glob­al head of com­mu­ni­ca­tions and en­gage­ment for GSK Con­sumer Health­care — was re­cent­ly the EVP, cor­po­rate com­mu­ni­ca­tions, pa­tient ad­vo­ca­cy and en­gage­ment with Adamas Phar­ma­ceu­ti­cals.

Aaron Os­borne has been ap­point­ed CMO and chief de­vel­op­ment of­fi­cer at Nanoscope Ther­a­peu­tics, a Dal­las biotech de­vel­op­ing gene ther­a­pies for reti­nal dis­eases, join­ing Anil Lal­wani (VP of CMC and qual­i­ty) and Jared Stephens (VP of strat­e­gy and BD) as the newest ex­ecs. At Ad­verum, Os­borne most re­cent­ly served as CMO, and he has al­so held po­si­tions at Genen­tech, Al­con, No­var­tis and Bay­er.

Vir­ginia Casadas

→ Got­ta have Faeth: Thomas Strack is on board as CMO of Faeth Ther­a­peu­tics, while Vir­ginia Casadas joins the San Fran­cis­co-based squad as head of clin­i­cal op­er­a­tions. Strack had led clin­i­cal de­vel­op­ment at Mol­e­c­u­lar Tem­plates, and Casadas — a Pfiz­er and No­var­tis vet — is the ex-di­rec­tor, clin­i­cal op­er­a­tions at Vir Biotech­nol­o­gy. The sci­en­tif­ic co-founders at the AI-dri­ven can­cer me­tab­o­lism com­pa­ny in­clude Lewis Cant­ley, Sid Mukher­jee and Can­cer Re­search UK’s Karen Vous­den.

Tread­well Ther­a­peu­tics has brought on JD Mow­ery as COO. Mow­ery makes his way to the com­pa­ny with plen­ty of ex­pe­ri­ence un­der his belt from his times at Genen­tech, Lon­za, Juno/Cel­gene and AGC Bi­o­log­ics. Dur­ing his most re­cent stint at AGC, Mow­ery served as EVP, US op­er­a­tions.

→ Austin-based Maxwell Bio­sciences has ush­ered in Ed­ward Rud­nic as COO. Rud­nic was the founder, chair­man and CEO of Mid­dle­Brook Phar­ma­ceu­ti­cals and has pre­vi­ous ex­pe­ri­ence in stints at Shire, Vivre­on Bio­sciences, QRx Phar­ma, Union­Bridge Man­age­ment, Mer­ck and Bris­tol My­ers.

→ Just af­ter pulling in Dan Devine as CBO and gen­er­al coun­sel last week, Aussie biotech Vaxxas is now wel­com­ing aboard Scott Fry as COO. Fry hails from El­lume where he served as chief op­er­a­tions of­fi­cer and was re­spon­si­ble for the de­vel­op­ment and com­mer­cial­iza­tion of rapid tests for de­tect­ing dengue, in­fluen­za A, in­fluen­za B, group A strep­to­coc­cus, res­pi­ra­to­ry syn­cy­tial virus and Covid-19.

Lu­cas Vi­tale

→ A month re­moved from Sid­dhartha Ka­dia’s ap­point­ment as CEO, dig­i­tal cell bi­ol­o­gy play­er Berke­ley Lights has re­cruit­ed Lu­cas Vi­tale as chief hu­man re­sources of­fi­cer. Vi­tale just had a short stay as SVP of hu­man re­sources at Are­na Phar­ma­ceu­ti­cals, part of what Pfiz­er hopes is a con­tin­ued M&A blitz that re­cent­ly in­clud­ed the $525 mil­lion buy­out of Re­Vi­ral. He al­so climbed up the ranks to fin­ish his sev­en years at Nu­Va­sive as chief hu­man re­sources of­fi­cer.

→ An­oth­er Are­na vet has cho­sen a dif­fer­ent path: Patrick Mal­loy is now SVP, in­vestor re­la­tions and strate­gic com­mu­ni­ca­tions for Lu­ca Santarel­li at Vec­tivBio. Af­ter 16 years at Acte­lion, Mal­loy joined Are­na as se­nior di­rec­tor, glob­al mar­ket de­vel­op­ment for its PAH drug ra­linepag, earn­ing a pro­mo­tion to VP, in­vestor re­la­tions and strate­gic com­mu­ni­ca­tions.

Sami­ra Shaikhly

Third Rock-backed re­gen­er­a­tive play Am­bys Med­i­cines is bring­ing in a new duo to its lead­er­ship team with the ap­point­ments of Sami­ra Shaikhly as chief hu­man re­sources of­fi­cer and John McK­eon as VP of fi­nance. Shaikhly spent 15 years over at Gilead — cul­mi­nat­ing in her most re­cent role as glob­al head of hu­man re­sources, cor­po­rate func­tion — be­fore mak­ing her way to Am­bys. Mean­while, McK­eon hops aboard af­ter serv­ing as se­nior di­rec­tor of fi­nan­cial plan­ning and analy­sis at Al­lakos and has oth­er stints at Jaguar Health, Bio­Marin, Avinger and Genen­tech un­der his belt.

ProMIS Neu­ro­sciences has reeled in Lar­ry Alt­stiel as CMO. Alt­stiel tacks on this role to his cur­rent re­spon­si­bil­i­ties as part time CMO at Pin­teon Ther­a­peu­tics. Ear­li­er in his ca­reer, Alt­stiel served as VP and head of neu­ro­science clin­i­cal re­search at Pfiz­er.

→ Boul­der, CO-based Enve­da Bio­sciences has made room on its ex­ec team for Robert Buck­ley as chief peo­ple of­fi­cer. Buck­ley most re­cent­ly served as chief peo­ple of­fi­cer at Rain­Fo­cus and has pri­or ex­pe­ri­ence at Mi­no­va In­ter­na­tion­al, eBay, Gen­er­al Elec­tric and Thumb­tack.

Christo­pher Verni

Vig­il Neu­ro­science — which closed a $98 mil­lion IPO back in Jan­u­ary to fu­el its two ex-Am­gen TREM2 ag­o­nists — has wel­comed aboard Christo­pher Verni as gen­er­al coun­sel and Mary This­tle to its board of di­rec­tors. Verni most re­cent­ly served as SVP, gen­er­al coun­sel and chief in­tel­lec­tu­al prop­er­ty of­fi­cer at Sarep­ta Ther­a­peu­tics. Pri­or to that, Verni had gigs at ARI­AD Phar­ma­ceu­ti­cals, Gen­zyme and Pfiz­er.

Mean­while, this isn’t This­tle’s first board ap­point­ment as she sits on a num­ber of boards in­clud­ing Alaunos Ther­a­peu­tics, Ho­mol­o­gy Med­i­cines, En­tra­da Ther­a­peu­tics, En­terome and Co­coon Bio. This­tle cur­rent­ly serves as spe­cial ad­vi­sor at the Bill & Melin­da Gates Med­ical Re­search In­sti­tute and be­fore that, served as COO of Di­men­sion Ther­a­peu­tics. This­tle al­so has held roles at Ul­tragenyx, Cu­bist Phar­ma­ceu­ti­cals, PerkinElmer and Vi­a­cell.

Gabrielle Poiri­er

→ Com­pu­ta­tion­al chem­istry out­fit Nim­bus Ther­a­peu­tics has wel­comed two new ex­ecs while pro­mot­ing an­oth­er: VP of clin­i­cal de­vel­op­ment Bhaskar Sri­vas­ta­va, a vet­er­an of J&J’s Janssen, has been el­e­vat­ed to SVP. Gabrielle Poiri­er (VP, clin­i­cal op­er­a­tions) just held the same post at an­tibi­otics biotech En­ta­sis, and the for­mer clin­i­cal op­er­a­tions VP at Pro­teosta­sis Ther­a­peu­tics was al­so an as­so­ciate di­rec­tor at Iron­wood and Alex­ion. Zak Huang (VP, reg­u­la­to­ry af­fairs) spent 11 years be­fore mov­ing on to CSL Behring to be­come head of glob­al prod­uct reg­u­la­to­ry strat­e­gy and lat­er the head of Chi­na R&D.

François Bi­nette

Enochi­an Bio­Sciences has ap­point­ed François Bi­nette as EVP for R&D. Bi­nette, who once worked in re­gen­er­a­tive med­i­cine at J&J, most re­cent­ly served as SVP of prod­uct de­vel­op­ment at Lin­eage Cell Ther­a­peu­tics. Ear­li­er this month, the Los An­ge­les-based de­vel­op­er of cell ther­a­pies for HIV and can­cer brought on long­time Pfiz­er vet Greg Duczyn­s­ki as SVP for clin­i­cal op­er­a­tions.

Ka­te­ri­na Left­heris

→ In its first Peer Re­view ap­pear­ance since COO Niru­pa­ma Sub­ra­man­ian joined the team, Third Rock-backed Rheos Med­i­cines has lined up Ka­te­ri­na Left­heris as SVP of drug dis­cov­ery and Nabil Ud­din as VP of strat­e­gy and busi­ness de­vel­op­ment. Left­heris, a Bris­tol My­ers alum, com­pletes a near­ly five-year run as VP of chem­istry at Pli­ant Ther­a­peu­tics, while Ud­din has ex­it­ed the stage at Con­cert Phar­ma­ceu­ti­cals af­ter his time as VP of cor­po­rate de­vel­op­ment.

Ur­vashi Pa­tel

→ Gam­ma delta T cell out­fit IN8bio has two ap­point­ments that we didn’t get to dur­ing the short week last week: Ur­vashi Pa­tel has tak­en over as VP, reg­u­la­to­ry af­fairs, and Stacey Bilin­s­ki is the new VP, clin­i­cal op­er­a­tions. Pa­tel, who comes to IN8bio from her role as VP of reg­u­la­to­ry and qual­i­ty sys­tems at Wind­MIL Ther­a­peu­tics, al­so held po­si­tions at Janssen, Elan Phar­ma­ceu­ti­cals and Genen­tech. Bilin­s­ki most re­cent­ly served as glob­al se­nior di­rec­tor, op­er­a­tions at Tai­ho On­col­o­gy.

Su­san Flint

→ Alzheimer’s biotech Alzheon out of Fram­ing­ham, MA has di­aled up three new staffers: Su­san Flint (VP of clin­i­cal op­er­a­tions) al­so led clin­i­cal op­er­a­tions at Swedish biotech Wil­son Ther­a­peu­tics, which Alex­ion pur­chased for $855 mil­lion sev­er­al years ago; Patrick Kess­lak (VP of clin­i­cal de­vel­op­ment & med­ical af­fairs) is an Am­gen and Al­ler­gan vet who was re­cent­ly the se­nior di­rec­tor, clin­i­cal de­vel­op­ment for Re­vance Ther­a­peu­tics; and Er­wan de Nau­rois (VP of fi­nance) has left the role of se­nior di­rec­tor, fi­nan­cial plan­ning & analy­sis at Flag­ship Pi­o­neer­ing.

→ Boston-based Aileron Ther­a­peu­tics, whose lead pro­gram AL­RN-6924 fo­cus­es on p53-mu­tat­ed can­cers, has en­list­ed Christo­pher Zergebel as VP, pro­gram man­age­ment and clin­i­cal op­er­a­tions. So ends a long as­so­ci­a­tion with Tai­ho On­col­o­gy, where Zergebel was re­cent­ly VP, R&D ser­vices and VP, project man­age­ment.

Ashok Marín

→ With its lead bis­pe­cif­ic an­ti­body can­di­date ISB 1342 in Phase I for re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma, Glen­mark spin­out Ich­nos Sci­ences has se­lect­ed Ashok Marín as gen­er­al coun­sel. Marín held the role of chief le­gal of­fi­cer for four short months at Rafael Hold­ings af­ter a year-long stay at Gilead as as­so­ciate gen­er­al coun­sel. He’s al­so been Mallinck­rodt’s VP, com­pli­ance & chief pri­va­cy of­fi­cer.

Dirk Sauer, who re­tired last year af­ter 31 years at No­var­tis, has been added to the board of di­rec­tors at Bal­ti­more-based Gray­bug Vi­sion, suc­ceed­ing Ger­ard Ca­gle. From 2011-21, Sauer was in charge of No­var­tis’ oph­thal­mol­o­gy de­vel­op­ment unit.

John Scar­lett

Geron pres­i­dent and CEO John Scar­lett will re­tire from the board of di­rec­tors at South San Fran­cis­co can­cer biotech Cy­tomX when stock­hold­ers meet on June 15. Scar­lett had served on the board since June 2016.

→ US-Aus­tri­an im­munother­a­py biotech Hookipa Phar­ma has elect­ed Tim Reil­ly to the board of di­rec­tors. Af­ter an 18-year run at Bris­tol My­ers end­ed in 2021, Reil­ly made the leap to HotSpot Ther­a­peu­tics as their chief de­vel­op­ment of­fi­cer.

Roque­fort Ther­a­peu­tics is ush­er­ing in Si­mon Sin­clair as non-ex­ec­u­tive di­rec­tor to its board. Sin­clair has held a num­ber of roles at J&J and Mer­ck. Cur­rent­ly, Sin­clair serves as chief safe­ty of­fi­cer at Reckitt Benckiser Group.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

(Credit: Shutterstock)

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

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.