Brid­get Martell on tak­ing Yale spin­out 'to adult­hood'; Cul­li­nan On­col­o­gy CEO an­nounces res­ig­na­tion as Bris­tol My­ers hema­tol­ogy ex­ec is wel­comed aboard

Brid­get Martell

Brid­get Martell’s first clin­i­cal tri­al was an un­ortho­dox one.

Then a res­i­dent in in­ter­nal med­i­cine at Yale, she was giv­en an award to ex­plore a ca­reer in clin­i­cal re­search — which was how she wound up lead­ing a Phase I study for a ther­a­peu­tic co­caine vac­cine de­signed to help over­come ad­dic­tion. She end­ed up over­see­ing the tri­al from Pa­tient 1 to Pa­tient 110 and, in the end, the ear­ly tri­al was pos­i­tive.

“And so that’s when I re­al­ized that I need­ed to go to in­dus­try,” she said, “and un­der­stand how do you do this from start to fin­ish? How do you string those pearls?”

Thus be­gan a wind­ing, 20-year jour­ney that took her through every step on the prover­bial bench to bed­side jour­ney — cul­mi­nat­ing in the CEO of­fice at New Haven-based Ar­ti­zan Bio­sciences.

Uti­liz­ing a plat­form tech­nol­o­gy de­vel­oped by its Yale founders, the biotech has been scan­ning bac­te­r­i­al strains to pick out bad bac­te­ria and cook­ing up small mol­e­cules to tar­get them for both gas­troin­testi­nal and CNS dis­or­ders, an ap­proach it dubs “pre­ci­sion mi­cro­bio­me med­i­cine.” Ar­ti­zan is now “on track” to name its lead can­di­dates.

“I liken it to, you know, Jim­my took it out of in­fan­cy,” Martell said, re­fer­ring to for­mer CEO Jim­my Rosen. Now that Ar­ti­zan has grown in­to a tod­dler, “I have to take it to adult­hood.”

As a first-time CEO, she ex­pects to lever­age every as­pect of her wide-rang­ing back­ground for the new chal­lenge: the sci­en­tist who stud­ied mi­cro­bi­ol­o­gy and im­munol­o­gy; the in­ternist ex­posed to a whole ar­ray of dis­eases thrown at her; the clin­i­cal tri­al strate­gist with ex­pe­ri­ence at Pfiz­er, Ku­ra On­col­o­gy and bou­tique CRO RRD In­ter­na­tion­al; the biotech men­tor and ad­vi­sor she played while con­sult­ing for com­pa­nies and serv­ing as en­tre­pre­neur-in-res­i­dence at Yale’s Of­fice of Co­op­er­a­tive Re­search.

She will have help from a small team of 13 — an “amaz­ing team” whom she cites as a big fac­tor for the de­ci­sion to get in­to the trench­es — as Ar­ti­zan looks to es­tab­lish it­self in a bur­geon­ing field that’s grap­pled with its share of fail­ures.

“So we’re not ma­nip­u­lat­ing the mi­cro­bio­me, in terms of re­mov­ing or adding bugs or feed­ing bugs. What we’re do­ing is we’re ac­tu­al­ly af­fect­ing the fac­tors that are per­turb­ing the ul­ti­mate bal­ance in the GI tract and the in­flam­ma­tion,” she said. “Un­for­tu­nate­ly, some of the fail­ures are what I just spoke about, and that is, it’s com­plex, right? But, you know, if you start to chip away at what some of those mech­a­nisms are, hope­ful­ly we will start to have a broad­er un­der­stand­ing.”

Am­ber Tong

Nadim Ahmed

→ Co-found­ed by Patrick Baeuer­le — who was on our list of 20 in­flu­en­tial R&D ex­ecs in late Au­gust — Cul­li­nan On­col­o­gy end­ed up rais­ing $287.4 mil­lion in an IPO that helped get the prover­bial Nas­daq ball rolling in 2021. Now comes word that Owen Hugh­es has re­signed as CEO and Cul­li­nan has al­ready lined up Bris­tol My­ers Squibb’s Nadim Ahmed as his suc­ces­sor. Hugh­es, who slips in­to an ad­vi­so­ry role dur­ing the tran­si­tion, will no longer be on Cul­li­nan’s board of di­rec­tors.

Ahmed, who was with Glax­o­SmithK­line from 1992-2010, be­comes a chief ex­ec­u­tive here af­ter two years as EVP and pres­i­dent of hema­tol­ogy at Bris­tol My­ers. Af­ter GSK, he moved to Cel­gene, start­ing out as se­nior di­rec­tor, glob­al mar­ket­ing in the mul­ti­ple myelo­ma fran­chise and climb­ing up to pres­i­dent, glob­al hema­tol­ogy & on­col­o­gy be­fore the buy­out.

→ There’s some reshuf­fling tak­ing place at Sio Gene Ther­a­pies, which was once Ax­o­vant un­til the com­pa­ny shed its vant-ness last No­vem­ber. On Nov. 12, chief R&D of­fi­cer Gavin Cor­co­ran is hit­ting the road for “an op­por­tu­ni­ty with a pri­vate health­care tech­nol­o­gy com­pa­ny,” leav­ing pres­i­dent and CEO Pa­van Cheru­vu to han­dle Cor­co­ran’s re­spon­si­bil­i­ties hence­forth. Along with this news, Sio — whose gan­gliosi­do­sis pro­gram has shown promise in Phase I/II — is open­ing up search­es for a CMO and SVP of ear­ly de­vel­op­ment and sci­en­tif­ic af­fairs, both new po­si­tions.

Mace Rothen­berg

→ The ubiq­ui­tous Mace Rothen­berg has stacked up the ap­point­ments af­ter his re­tire­ment from Pfiz­er, and the drug gi­ant’s ex-CMO emerges once again as se­nior ad­vi­sor to CEO Paul Pe­ter Tak at Can­del Ther­a­peu­tics. In the last nine months, Rothen­berg has col­lect­ed board seats at Sur­rozen, Tan­go Ther­a­peu­tics, and Au­los Bio­science, and he’s joined the mis­sion ad­vi­so­ry board at EQRx. “Can­del is at the fore­front of one of the most ex­cit­ing ap­proach­es in can­cer im­munother­a­py,” Rothen­berg said in a state­ment. “I am ex­cit­ed by the op­por­tu­ni­ty to help Paul Pe­ter ad­vance the com­pa­ny’s promis­ing on­col­o­gy pipeline.”

Michelle Chen

→ CBO Michelle Chen is the lat­est ex­ec to join Alex Zha­voronkov’s squad at Al drug dis­cov­ery start­up In­sil­i­co fol­low­ing the ap­point­ment of CFO Ni­rav Jhaveri last month. Chen car­ries a busi­ness de­vel­op­ment back­ground from such big names as Roche, Mer­ck and Bio­Marin; fast for­ward to the present, and Chen makes her ex­it from WuXi Bi­o­log­ics, where she was SVP of cor­po­rate de­vel­op­ment and dis­cov­ery busi­ness de­vel­op­ment.

Brit­tany Bradrick

→ A year ago, Peer Re­view told you about Brit­tany Bradrick’s ar­rival at Vi­a­Cyte as CFO (lat­er be­com­ing COO as well), but Bradrick has left Vi­a­Cyte to ac­cept the CFO job at Or­biMed-backed Neurelis, whose lead drug Val­to­co (di­azepam nasal spray) was ap­proved by the FDA last year to treat seizures. Neurelis’ CFO since 2011, George Stu­art, will now jump to the COO post at Neurelis sub­sidiary Aegis Ther­a­peu­tics. Ad­di­tion­al­ly, ex-Five Prime EVP and CFO David Smith has claimed a seat on Neurelis’ board of di­rec­tors.

Lau­ra Genatossio

→ There’s a slate of pro­mo­tions at Urovant af­ter the FDA ap­proval of Gemte­sa in De­cem­ber 2020 and sub­se­quent da­ta in Sep­tem­ber that showed the over­ac­tive blad­der drug didn’t have a sta­tis­ti­cal­ly sig­nif­i­cant ef­fect on blood pres­sure or heart rate. And CEO Jim Robin­son is wel­com­ing a new ex­ec: Lau­ra Genatossio (SVP and gen­er­al man­ag­er, Eu­rope) is the lone new­bie who piv­ots to Urovant af­ter be­ing Sarep­ta’s VP and gen­er­al man­ag­er in the Eu­rope, Mid­dle East and Africa (EMEA) re­gion. As for the pro­mo­tions, Alana Dar­d­en Pow­ell gets el­e­vat­ed to VP, cor­po­rate com­mu­ni­ca­tions af­ter her year as ex­ec­u­tive di­rec­tor of busi­ness unit op­er­a­tions, com­mu­ni­ca­tions, and al­liance man­age­ment; Mark Niemaszek joined Urovant last year as VP of com­mer­cial op­er­a­tions and jumps to SVP, cor­po­rate plan­ning; and af­ter three years as VP, as­so­ciate gen­er­al coun­sel and head of in­tel­lec­tu­al prop­er­ty, Al­ler­gan vet Ted Chan scores the SVP ti­tle.

Ash Jayagopal

→ Raleigh, NC-based gene ther­a­py play­er Opus Ge­net­ics, the brain­child of Spark co-founder Jean Ben­nett that launched a month ago with a $19 mil­lion round, has picked up Ash Jayagopal as CSO and Joe Schachle as COO. Jayagopal con­cludes his two years as ex­ec­u­tive di­rec­tor of dis­cov­ery med­i­cine at Ko­di­ak Sci­ences, and be­fore that he was head of mol­e­c­u­lar phar­ma­col­o­gy and bio­mark­ers in oph­thal­mol­o­gy at Roche, which bought Spark in 2019. Schachle makes the tran­si­tion to Opus from his sec­ond stint at Gri­fols, where he was VP of glob­al com­mer­cial ser­vices & con­trol­ling and lat­er the VP of cus­tomer ex­pe­ri­ence en­able­ment.

Gregg Ny­berg

→ For­mer­ly the Mass­a­chu­setts Cen­ter for Ad­vanced Bi­o­log­i­cal In­no­va­tion and Man­u­fac­tur­ing (CABIM), Land­mark Bio has in­stalled Gregg Ny­berg as chief tech­nol­o­gy of­fi­cer and Michael Cov­ing­ton as chief qual­i­ty and reg­u­la­to­ry of­fi­cer. Ny­berg spent al­most 15 years at Am­gen, then moved on to Mer­ck in 2017 and was the as­so­ciate VP and head of bi­o­log­ics process de­vel­op­ment at Mer­ck Re­search Lab­o­ra­to­ries. Cov­ing­ton, who was with Am­gen from 1993-2003, has held con­sec­u­tive posts at No­var­tis Gene Ther­a­pies and Or­chard Ther­a­peu­tics as VP of reg­u­la­to­ry CMC.

Jen­nifer Di­a­mond

→ To the moun­tains we go, where Uni­ver­si­ty of Col­orado on­col­o­gy spin­out OnKure Ther­a­peu­tics has named fac­ul­ty mem­ber Jen­nifer Di­a­mond as CMO. Di­a­mond is an as­so­ciate pro­fes­sor of med­i­cine in the Di­vi­sion of Med­ical On­col­o­gy at CU’s An­schutz Med­ical Cam­pus, the same in­sti­tu­tion where Rain Ther­a­peu­ticsRobert Doe­bele has al­so taught. Led by Ar­ray Bio­Phar­ma co-founder Tony Pis­co­pio, OnKure raised a Se­ries B that to­taled $55 mil­lion in March.

Au­gust Allen

→ Stay­ing in Boul­der, Enve­da Bio­sciences has poached Au­gust Allen from Re­cur­sion, re­cruit­ing him as chief plat­form of­fi­cer. Allen, who be­gan as a re­search as­so­ciate at Re­cur­sion in 2016, rose to di­rec­tor of prod­uct man­age­ment be­fore Enve­da came call­ing. Enve­da, a biotech where ma­chine learn­ing and nat­ur­al bi­ol­o­gy com­min­gle and which teed up a $55 mil­lion Se­ries A in June, is led by CEO Viswa Col­lu­ru, a Re­cur­sion alum in his own right.

Va­lerie Jansen

Va­lerie Jansen has been pro­mot­ed to CMO at El­e­va­tion On­col­o­gy, the Shawn Le­land-helmed start­up that in­tro­duced it­self in Ju­ly 2020 and then pulled in a $65 mil­lion Se­ries B the fol­low­ing No­vem­ber. Jansen, who took over as VP of clin­i­cal de­vel­op­ment at El­e­va­tion back in April, pre­vi­ous­ly served as ex­ec­u­tive med­ical di­rec­tor at Mer­sana Ther­a­peu­tics and se­nior med­ical ad­vi­sor at Eli Lil­ly.

Gen­er­al At­lantic had top billing on a meaty $143 mil­lion Se­ries B round for Cin­Cor Phar­ma last week. The Cincin­nati biotech has now pegged Ma­son Free­man as EVP, clin­i­cal de­vel­op­ment, and lead­ing the pipeline is the al­dos­terone syn­thase in­hibitor CIN-107 from Roche. A long­time Mass­a­chu­setts Gen­er­al Hos­pi­tal vet who found­ed the fa­cil­i­ty’s Trans­la­tion­al Re­search Cen­ter, Free­man is a ven­ture part­ner at 5AM Ven­tures who has Big Phar­ma ex­pe­ri­ence at No­var­tis as head of the trans­la­tion­al med­i­cine pro­gram for car­dio­vas­cu­lar & meta­bol­ic dis­eases.

Su­san Schnei­der

→ Things are per­co­lat­ing on the lead­er­ship front at Ap­plied Ge­net­ic Tech­nolo­gies Cor­po­ra­tion with the ap­point­ments of CMO Su­san Schnei­der and VP of clin­i­cal op­er­a­tions Sarah DiS­al­va­tore. Schnei­der, the for­mer SVP of clin­i­cal de­vel­op­ment, oph­thal­mol­o­gy at Eloxx Phar­ma­ceu­ti­cals and then Ji Xing Phar­ma­ceu­ti­cals, is a Genen­tech and GSK vet who’s been VP and ther­a­peu­tic area head of glau­co­ma and reti­na with Al­ler­gan. Af­ter work­ing in clin­i­cal op­er­a­tions at Helsinn and Stem­line Ther­a­peu­tics, DiS­al­va­tore was re­cent­ly as­so­ciate VP of clin­i­cal op­er­a­tions for Rock­et Phar­ma­ceu­ti­cals. Her first day is Nov. 1, while Schnei­der starts on Nov. 8.

William Hod­der

→ Plac­ing an em­pha­sis on treat­ing dis­or­ders known as RA­Sopathies which are fu­eled by the ac­ti­va­tion of the Ras/Raf/MEK/ERK path­way, Penn­syl­va­nia-based NFlec­tion Ther­a­peu­tics has tapped William Hod­der as CEO and is bulk­ing up its lead­er­ship team with COO Gerd Kochen­do­er­fer, VP of clin­i­cal op­er­a­tions Patrice Hor­wath and SVP of glob­al reg­u­la­to­ry af­fairs & qual­i­ty as­sur­ance Lib­bie Mansell. Hod­der cap­tures the top spot here af­ter two years as CBO of Escient Phar­ma­ceu­ti­cals and he’s al­so been a cor­po­rate de­vel­op­ment ex­ec at Fi­bro­Gen and Pro­tag­o­nist Ther­a­peu­tics. Kochen­do­er­fer, a Fi­bro­Gen vet as well in drug de­vel­op­ment, was SVP and head of op­er­a­tions at Bridge­Bio’s Pelle­Pharm. A Medtron­ic alum, Hor­wath has been a clin­i­cal op­er­a­tions di­rec­tor at Ralexar Ther­a­peu­tics, while Mansell just wrapped up a brief tenure as AskBio’s SVP, reg­u­la­to­ry af­fairs.

→ Bethes­da, MD-based Gain Ther­a­peu­tics, which re­leased pos­i­tive re­sults from its in­duced pluripo­tent stem cell (iP­SC) study on Gauch­er and Parkin­son’s dis­ease last month, has ap­point­ed Matthias Alder as COO. Be­fore join­ing Gain, Alder was CBO at Au­to­lus Ther­a­peu­tics. He has al­so served as an EVP at Su­cam­po Phar­ma­ceu­ti­cals and Kuros Bio­sciences (for­mer­ly Cy­tos Biotech­nol­o­gy).

Philip Lam­bert

→ Backed by the Boehringer In­gel­heim Ven­ture Fund and tak­ing aim at ALS and fron­totem­po­ral de­men­tia with its lead as­set, San Diego neu­rode­gen­er­a­tive dis­ease biotech Li­bra Ther­a­peu­tics has brought in Philip Lam­bert as CSO. Be­fore join­ing Li­bra, which made its de­but last Sep­tem­ber with a $29 mil­lion Se­ries A haul, Lam­bert was the chief sci­en­tist at Cen­to­gene and has al­so been head of dis­cov­ery at Charles Riv­er Lab­o­ra­to­ries.

→ Ger­man-based Curexsys has plucked up Chris­t­ian Eck­ert as COO. Eck­ert makes his way to the ex­o­some-fo­cused com­pa­ny from Bris­tol My­ers, where he was re­spon­si­ble for GMP man­u­fac­tur­ing, amongst oth­er du­ties. Be­fore that, Eck­ert was with Medi­gene and Evotec.

Lori Gavrin has been ap­point­ed to the new­ly cre­at­ed po­si­tion of chief busi­ness and strat­e­gy of­fi­cer at NeuEx­cell Ther­a­peu­tics. Gavrin served most re­cent­ly as VP of cor­po­rate de­vel­op­ment at Tmu­ni­ty, and she’s al­so worked in lead­er­ship po­si­tions at Wyeth/Pfiz­er and GSK. Last month, Penn­syl­va­nia-based NeuEx­cell struck a man­u­fac­tur­ing deal with Fu­ji­film cen­ter­ing on its gene ther­a­py NXL-001 for is­chemic cor­ti­cal stroke.

Hai­jun Sun

→ Barcelona on­col­o­gy start­up ONA Ther­a­peu­tics has reached in­to the GSK tal­ent jar to pluck Hai­jun Sun as CSO. Af­ter three years at F-star — where he was VP of bi­o­log­i­cal prod­ucts — Sun spent a year with Tizona Ther­a­peu­tics as VP of an­ti­body de­vel­op­ment. He joined GSK in 2017 and was the phar­ma gi­ant’s head of an­ti­body phar­ma­col­o­gy be­fore land­ing his first C-suite job here at ONA, which launched last sum­mer with Bpifrance and Span­ish VC Ys­ios Cap­i­tal con­tribut­ing to the €30 mil­lion round. Ona has al­so giv­en its sci­en­tif­ic ad­vi­so­ry board a boost by nam­ing the fol­low­ing: Pamela Klein, Cé­dric Blan­pain, Sean Mor­ri­son, Josep Tabernero, Mark Thros­by and ONA sci­en­tif­ic co-founder Sal­vador Az­nar Ben­i­tah.

Katha­ri­na Staufer has signed on to be CMO at Swiss rare liv­er dis­ease biotech Ver­san­tis. Staufer comes to Ver­san­tis from In­sel­spi­tal — al­so known as the Uni­ver­si­ty Hos­pi­tal of Bern — where she was head of trans­plant med­i­cine. CEO Vince Forster dis­cussed the “un­de­liv­ery mech­a­nism” in Ver­san­tis’ plat­form with End­points News when the com­pa­ny nabbed Se­ries B fund­ing in Sep­tem­ber 2019.

Tere­sa Bair

Troy Wil­son’s Ku­ra On­col­o­gy has paved the way for Tere­sa Bair to be chief le­gal of­fi­cer. Bair spent six years at Athenex and since June 2020 she had tak­en on the roles of EVP, gen­er­al coun­sel and SVP, ad­min­is­tra­tion. Ku­ra’s menin in­hibitor KO-539 is now in Phase Ib for pa­tients with re­lapsed or re­frac­to­ry acute myeloid leukemia.

→ South San Fran­cis­co-based Novome Biotech­nolo­gies has re­cruit­ed Bill McLeod as CFO. McLeod most re­cent­ly served as a cor­po­rate fi­nance con­sul­tant to Sur­rozen. Pri­or to that, McLeod spent a decade at Stifel, where he served as co-head of eq­ui­ty cap­i­tal mar­kets. McLeod’s oth­er roles in­clude stints at JP Mor­gan and Bank of Amer­i­ca, among oth­ers.

Thomas Thomas

Alopexx has reeled in Thomas Thomas as CFO. Thomas joins the Cam­bridge, MA-based com­pa­ny with ex­pe­ri­ence from his roles at the Stup­s­ki Foun­da­tion (CEO from 2009-2010) and Genen­tech (cor­po­rate trea­sur­er from 2001-2006). Ad­di­tion­al­ly, Thomas serves as an in­de­pen­dent di­rec­tor on the board of Opi­ant Phar­ma­ceu­ti­cals.

→ Paris-based Pharnext has wel­comed some fresh faces to its man­age­ment team with the ap­point­ments of Raj Tho­ta (chief man­u­fac­tur­ing of­fi­cer and head of CMC) and Ab­hi­jit Pan­gu (head of reg­u­la­to­ry af­fairs). Ad­di­tion­al­ly, the com­pa­ny has pro­mot­ed Xavier Paoli to COO. Tho­ta comes to Pharnext from Fron­ti­da Bio­Pharm, where he served as VP, gen­er­al man­ag­er. Mean­while, Pan­gu joins with ex­pe­ri­ence from his times at Or­p­hazyme and Fer­ring among oth­ers. Last, but not least, Paoli joined Pharnext in 2014 as com­mer­cial­iza­tion strat­e­gy di­rec­tor. Pri­or to this stint, Paoli was with GSK, UCB and Alex­ion.

Alan Fu

IA­SO Bio­ther­a­peu­tics has brought on Alan Fu as CFO. Fu most re­cent­ly served as man­ag­ing di­rec­tor of Haitong In­ter­na­tion­al and di­rec­tor of Cit­i­group Glob­al Mar­kets. Ear­li­er in his ca­reer, Fu served at Rigel Phar­ma­ceu­ti­cals.

→ Boston-based X4 Phar­ma­ceu­ti­cals has me­thod­i­cal­ly as­sem­bled its lead­er­ship in the last year, whether it’s with new­com­ers (CSO Art Taveras and CMO Diego Ca­david) or pro­mo­tions (COO Mary DiB­i­ase). This time around, X4 has se­lect­ed Karolyn Park from Take­da as VP, US com­mer­cial. Park was se­nior di­rec­tor, US hema­tol­ogy port­fo­lio strat­e­gy In her lat­est role at Take­da, and she has ex­pe­ri­ence with Aduhelm be­fore its con­tro­ver­sial ap­proval as Bio­gen’s as­so­ciate di­rec­tor, glob­al ad­u­canum­ab com­mer­cial. In oth­er X4 de­vel­op­ments, Shire rare dis­ease vet Françoise de Craeck­er has joined the board of di­rec­tors.

Clay Sie­gall

Seagen CEO Clay Sie­gall has been named chair­man of the board at fel­low Seat­tle biotech Umo­ja Bio­phar­ma. The on­col­o­gy-fo­cused Umo­ja is flush with cash af­ter suc­ces­sive fi­nanc­ing rounds of $53 mil­lion and $210 mil­lion in No­vem­ber 2020 and June, re­spec­tive­ly.

Rachelle Jacques

→ Chaired by new Mi­rati CEO David Meek, the board of di­rec­tors at uniQure now in­cludes Rachelle Jacques. The com­pa­ny Jacques leads, En­zy­vant, just re­ceived FDA ap­proval last Mon­day with the one-time re­gen­er­a­tive ther­a­py Rethymic for ba­bies with con­gen­i­tal athymia.

→ Plung­ing down the Covid-19 leader­board af­ter the FDA re­ject­ed its lenzilum­ab EUA pitch, Hu­mani­gen is load­ing up on more board mem­bers. For­mer No­var­tis ex­ec John Hohnek­er jug­gles oth­er board seats at Bio­Th­eryX, Cyg­nal, Ar­a­vive, Evelo Bio­sciences and Tr­ishu­la Ther­a­peu­tics, and Fo­s­un vet Kevin Xie has been Gra­cell’s CFO since Ju­ly 2020.

→ Sarep­ta’s CMO and EVP of re­search and de­vel­op­ment Gilmore O’Neill is mak­ing his way on­to the board of di­rec­tors at Aptinyx. Pri­or to his cur­rent stint at Sarep­ta, O’Neill spent 15 years at Bio­gen, where he held roles in the de­vel­op­ment pro­grams for Alzheimer’s dis­ease, move­ment dis­or­ders, neu­rol­o­gy, mul­ti­ple scle­ro­sis, pain, neu­ro­mus­cu­lar dis­ease, gene and cell ther­a­py, and rare dis­eases.

Myr­tle Pot­ter

→ Duk­ing it out in the liq­uid biop­sy space with com­pa­nies like Caris and Thrive Ear­li­er De­tec­tion, Red­wood City, CA-based Guardant Health has elect­ed Myr­tle Pot­ter to the board of di­rec­tors. An ex-COO at Genen­tech, Pot­ter joined Roivant in 2018 and is cur­rent­ly CEO of Sum­i­to­vant Bio­phar­ma.

Zai Lab has made Scott Mor­ri­son a mem­ber of the board of di­rec­tors just a cou­ple weeks af­ter look­ing to file a BLA sub­mis­sion for the Macro­Gen­ics an­ti­body mar­ge­tux­imab in Chi­na. Mor­ri­son, who re­tired from Ernst & Young, is on the boards of Au­dentes, Corvus Phar­ma­ceu­ti­cals, Glob­al Blood Ther­a­peu­tics, Ideaya Bio­sciences and Ve­ra Ther­a­peu­tics.

Maria Fardis

Paul Wot­ten-led Ob­sid­i­an Ther­a­peu­tics is lean­ing on some­one fa­mil­iar with the TIL are­na by ap­point­ing Maria Fardis to the board of di­rec­tors. Back in May, Fardis re­signed as CEO of Io­vance al­most im­me­di­ate­ly af­ter the com­pa­ny said they’d have to de­lay the BLA fil­ing of their gene ther­a­py by at least an­oth­er year.

Look­ing to fight off cy­to­tox­ic T and NK cells, au­toim­mune dis­ease and can­cer biotech Abcuro has added Dar­lene Dep­tu­la-Hicks to the board of di­rec­tors. Since 2019, Dep­tu­la-Hicks has been CFO at F-star and is the for­mer CFO at Pieris.

→ CD­MO Biovec­tra has added two new faces to its board of di­rec­tors with the ap­point­ments of Gor­don Mc­Cauley (pres­i­dent and CEO of ad­Mare BioIn­no­va­tions) and Steven Klosk (for­mer CEO of Cam­brex Cor­po­ra­tion).

Derek Graf al­so con­tributed to this edi­tion.

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

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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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.”

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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.

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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.

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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.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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