Jane Gro­gan

→ Gene edit­ing play­er Graphite Bio notched a $150 mil­lion Se­ries B megaround to boost its to­tal to $195 mil­lion, and a month lat­er, Jane Gro­gan is mov­ing from an­oth­er start­up to be Graphite’s CSO. Gro­gan is leav­ing Ar­se­nal­Bio af­ter serv­ing as chief sci­en­tist since its launch in Oc­to­ber 2019. She was at Genen­tech from 2004-19, with her last five years as head of adap­tive tu­mor im­mu­ni­ty and prin­ci­pal sci­en­tist of can­cer im­munol­o­gy dis­cov­ery re­search.

Graphite Bio looks to set it­self apart in a sick­le cell field that al­ready con­sists of such names as Ver­tex/CRISPR, blue­bird bio and Glob­al Blood Ther­a­peu­tics — where Graphite CEO Josh Lehrer was once CMO — with its lead can­di­date GPH101.

Scott Holmes

→ Just a dream and the wind to car­ry him: Sail­ing takes Scott Holmes away to the CFO post at Cata­ma­ran Bio, the CAR-NK cell ther­a­py play­er with Alvin Shih now in place at the top spot. It re­unites the pair af­ter Shih cap­tained the boat at Dis­arm Ther­a­peu­tics be­fore Eli Lil­ly pur­chased the com­pa­ny for $135 mil­lion up­front, with Holmes as his CFO. Holmes al­so brings CFO ex­pe­ri­ence from Kiadis Phar­ma and Keryx Bio­phar­ma­ceu­ti­cals, where he en­gi­neered the merg­er with Ake­bia in 2018. Cata­ma­ran Bio made its de­but in No­vem­ber with a $42 mil­lion Se­ries A round.

→ San Fran­cis­co age-re­lat­ed dis­ease biotech Foun­tain Ther­a­peu­tics has tapped William Greene as CEO while he con­tin­ues to helm Icon­ic Ther­a­peu­tics, which he’s led since 2014. Greene, a for­mer MPM Cap­i­tal ven­ture part­ner who cut his teeth help­ing de­vel­op such drugs at Lu­cen­tis as a clin­i­cal sci­en­tist and epi­demi­ol­o­gist at Genen­tech, co-found­ed Pear Ther­a­peu­tics in 2013 with Corey Mc­Cann and Stephen Smith.

Al­i­son O’Neill

→ The C-suite is com­ing to­geth­er at Sur­face On­col­o­gy with the pro­mo­tions of Al­i­son O’Neill and Jes­si­ca Fees and the ar­rival of Hen­ry Rath. O’Neill, the new CMO, joined Sur­face in 2018 as VP of clin­i­cal de­vel­op­ment af­ter a cou­ple years in the same ca­pac­i­ty at Ra­dius Health, and she’s worked in Sanofi’s glob­al on­col­o­gy di­vi­sion as se­nior di­rec­tor. Fees takes the CFO job and has been with the biotech since 2014, mak­ing the leap from her for­mer role of SVP of fi­nance. Mean­while, Rath em­barks on his sec­ond CBO gig, leav­ing that po­si­tion at TScan. He’s an Am­gen vet who was SVP, cor­po­rate de­vel­op­ment at Seres from 2015-19.

Will Mc­Carthy

→ That’s all for the Gen­e­sis Ther­a­peu­tics CBO search as Will Mc­Carthy lands the job. Mc­Carthy piv­ots to the AI biotech, spun out of Stan­ford and led by CEO Evan Fein­berg, af­ter CBO stints at Gen­er­a­tion Bio and Igny­ta, which Roche snapped up for $1.7 bil­lion. Af­ter a short stay at Bio­gen, Mc­Carthy was with Halozyme from 2007-14 and then be­came VP, cor­po­rate de­vel­op­ment at Foun­da­tion Med­i­cine. Gen­e­sis Ther­a­peu­tics raked in a $52 mil­lion Se­ries A round back in De­cem­ber af­ter part­ner­ing with Genen­tech to uti­lize the AI ca­pa­bil­i­ties that help “get them pre­pared for clin­i­cal tri­als more quick­ly, and with a more op­ti­mal com­pound,” Fein­berg told End­points News.

→ Deb­o­rah As­cheim has signed on to be CMO at Stride­Bio, an AAV-based gene ther­a­py de­vel­op­er in the Re­search Tri­an­gle area. As­cheim’s pre­vi­ous CMO ex­pe­ri­ence was with Lin­da Mar­bán’s team at Capri­cor from 2015-19, and the ex-Ic­ahn School of Med­i­cine pro­fes­sor had been do­ing some in­de­pen­dent con­sult­ing work as pres­i­dent of d2a.

Bri­an Zhang

→ Af­ter mak­ing the ad­di­tion of Nicholas Des­jardins as CFO and cor­po­rate de­vel­op­ment of­fi­cer last week, Hi­malaya Ther­a­peu­tics has tapped Bri­an Zhang as CEO. Zhang comes from Roche, where he helped lead the de­vel­op­ment of Xeni­cal and the dis­cov­ery of Dorza­gli­atin, among oth­ers.

→ Men­lo Park, CA-based Co­hBar has pulled in Joseph Sar­ret to steer the helm of the com­pa­ny as CEO and di­rec­tor — suc­ceed­ing Steven En­gle. Sar­ret joins the mi­to­chon­dria-based ther­a­peu­tics com­pa­ny from Cori­um In­ter­na­tion­al, where he served as CBO. Sar­ret’s pre­vi­ous ex­pe­ri­ence in­cludes stints at So­lazyme, Sev­i­dent and Codex­is.

In ad­di­tion to Sar­ret’s ap­point­ment, Co­hBar has pro­mot­ed David Green­wood as chair­man of the board. Green­wood joined the board in April 2019.

Tere­sa McRoberts

→ Austin city lim­its: T cell ther­a­py-fo­cused Tri­umvi­ra out of Texas is shoring up its lead­er­ship team af­ter launch­ing last sum­mer with a $55 mil­lion round, nam­ing Tere­sa McRoberts CFO while pro­mot­ing An­dreas Bad­er to CSO and Jon Irvin to SVP of fi­nance. McRoberts leads the tri­umvi­rate with pre­vi­ous cred­its that in­clude Mor­gan Stan­ley and JP Mor­gan, and she comes to Tri­umvi­ra af­ter serv­ing as port­fo­lio man­ag­er, SVP and se­nior an­a­lyst at Al­ger Man­age­ment. Be­fore head­ing to Tri­umvi­ra in 2018 as SVP of R&D, Bad­er co-found­ed and was CEO of Or­ros Ther­a­peu­tics and was sci­en­tif­ic co-founder of Mir­na Ther­a­peu­tics. Irvin was al­so with Mir­na as CFO be­fore ar­riv­ing on the scene as VP of fi­nance for Tri­umvi­ra in 2018.

→ Trevor Hal­lam has been pro­mot­ed to pres­i­dent of re­search and CSO of Sutro Bio­phar­ma, which be­gan the dose-ex­pan­sion co­hort for its Phase I ovar­i­an can­cer study in Jan­u­ary. Hal­lam has his share of Big Phar­ma bona fides from As­traZeneca and Roche, and he’s been Sutro’s CSO since De­cem­ber 2010. Be­fore his Sutro tenure be­gan, he was EVP of R&D at Palatin Tech­nolo­gies.

Gra­ham Dempsey

→ Six months in­to the Paul Medeiros era, CNS-fo­cused Q-State Bio­sciences has hand­ed out a pro­mo­tion to Gra­ham Dempsey (CSO and head of R&D) while putting out the wel­come mat for CFO Chris Watt and gen­er­al coun­sel Jim Ja­cob­son. Dempsey came to Q-State out of Har­vard in 2014 as a se­nior sci­en­tist, climb­ing to SVP of R&D in short or­der. Ja­cob­son makes the switch af­ter be­ing Mer­ck KGaA’s se­nior at­tor­ney and chief US pri­va­cy coun­sel, with ex­pe­ri­ence that dates back to his par­tic­i­pa­tion in the health­care task force for the Clin­ton White House. Watt de­vot­ed more than 10 years to Bio­gen and then be­came SVP, head of fi­nance at Tetraphase un­til La Jol­la Phar­ma­ceu­ti­cal bought the com­pa­ny last sum­mer.

→ With its lead drug EDG-5506 geared to­ward Duchenne and Beck­er mus­cu­lar dy­s­tro­phy, Edge­wise Ther­a­peu­tics out of Boul­der, CO has called up­on Joanne Dono­van to be CMO, tak­ing over the po­si­tion briefly held by Kirsten Gruis. Dono­van is a 13-year Gen­zyme vet who was CMO and SVP, clin­i­cal de­vel­op­ment at Cataba­sis, where she spent 10 more years.

Vat­nak Vat-Ho

→ Pol­ish on­col­o­gy biotech Ryvu Ther­a­peu­tics has re­cruit­ed Vat­nak Vat-Ho as CBO. Be­fore tak­ing on his first CBO as­sign­ment at Ryvu — based in Krakow with se­lec­tive CDK8/CDK19 ki­nase in­hibitor RVU120 in its pipeline — Vat-Ho was Af­fimed’s VP of busi­ness de­vel­op­ment. And fur­ther back, he round­ed out his eight years at Pfiz­er as se­nior di­rec­tor/team lead, strat­e­gy, busi­ness de­vel­op­ment & al­liance.

→ Bev­er­ly Hills im­muno-on­col­o­gy biotech GT Bio­phar­ma has named Gre­go­ry Berk CMO while he re­signs from his board seat, mov­ing the Uni­ver­si­ty of Min­neso­ta’s Jef­frey Miller — the in­ven­tor of the TriKE tech­nol­o­gy plat­form that GT Bio­phar­ma uti­lizes — from con­sult­ing CMO to con­sult­ing CSO. Berk just com­plet­ed a fleet­ing stay as CMO of Celu­lar­i­ty and has al­so held the same ti­tle at Ve­rastem and Sideris Phar­ma­ceu­ti­cals.

→ Elas­trin Ther­a­peu­tics has wel­comed Pe­dro Quin­tana Diez to its lead­er­ship team as CMO. Quin­tana Diez jumps aboard from Sen­so­ry Sci­ences, where he al­so served as CMO. In ad­di­tion, Quin­tana Diez has held roles at Grunen­thal, Ab­b­Vie and Parin­Genix.

Ale­jan­dra Car­va­jal

→ An­ti­body-drug con­ju­gate (ADC) biotech Mer­sana Ther­a­peu­tics out of Cam­bridge, MA has brought on Ale­jan­dra Car­va­jal as SVP and chief le­gal of­fi­cer. Car­va­jal was pre­vi­ous­ly chief le­gal of­fi­cer, gen­er­al coun­sel & sec­re­tary at Mo­men­ta, nav­i­gat­ing the le­gal work dur­ing J&J’s $6.5 bil­lion buy­out. Ad­di­tion­al­ly, she held mul­ti­ple roles at Mil­len­ni­um and was the VP, gen­er­al coun­sel at Cerulean Phar­ma.

→ San Diego-based Shore­line Bio­sciences has named its co-founder William Sand­born as CMO. Sand­born was on the fac­ul­ty of the Mayo Clin­ic from 1993-2010. Af­ter that, he served as pro­fes­sor of med­i­cine, chief of the di­vi­sion of gas­troen­terol­o­gy and di­rec­tor of the In­flam­ma­to­ry Bow­el Dis­ease Cen­ter at the Uni­ver­si­ty of Cal­i­for­nia San Diego. He was a sci­en­tif­ic co-founder of San­tarus (ac­quired by Sal­ix Phar­ma­ceu­ti­cals, now Bausch Health). Cur­rent­ly, he serves on the SAB of Prometheus Bio­sciences.

Katie Laes­sig

→ A cou­ple weeks back, An­tios Ther­a­peu­tics chalked up a $96 mil­lion Se­ries B round, with CEO Greg Mayes in­di­cat­ing to End­points that they’re “go­ing to be pre­pared” for an IPO. An­tios has sub­se­quent­ly brought on Katie Laes­sig as SVP, glob­al reg­u­la­to­ry af­fairs and Karen Fusaro as SVP, clin­i­cal op­er­a­tions. A 16-year FDA alum, Laes­sig makes the switch to An­tios from her role of VP, ther­a­peu­tic strat­e­gy, strate­gic drug de­vel­op­ment at IQVIA. Fusaro’s Big Phar­ma in­volve­ment com­pris­es of glob­al clin­i­cal de­vel­op­ment at No­var­tis and glob­al clin­i­cal tri­als for HIV, mi­graine and oth­er can­di­dates at GSK, and more re­cent­ly she was VP, clin­i­cal and reg­u­la­to­ry op­er­a­tions at Melin­ta Ther­a­peu­tics.

Dirk Stevens

→ Dirk Stevens has tak­en on the role of SVP, qual­i­ty as­sur­ance and reg­u­la­to­ry af­fairs at MiMedx — look­ing to put a tu­mul­tuous past be­hind them — af­ter two years as VP, glob­al reg­u­la­to­ry af­fairs at Smith & Nephew. Stevens has al­so been a reg­u­la­to­ry ex­ec at Fre­se­nius Med­ical Care and served at J&J, Bax­ter Health­care and Co­vi­di­en.

→ Fre­mont, CA-based biotech Cytek Bio­sciences — which closed a $120 mil­lion Se­ries D round last No­vem­ber — has bagged Allen Poir­son as SVP of mar­ket­ing and cor­po­rate de­vel­op­ment. Poir­son hails from twoXAR Phar­ma­ceu­ti­cals, where he served as SVP of bio­phar­ma­ceu­ti­cal busi­ness de­vel­op­ment. Pri­or to that, he was CEO of Sony Biotech­nol­o­gy and Ac­cuim­age Di­ag­nos­tics.

Chris­tine Lind

→ Im­mu­nicum in­ter­im chair Chris­tine Lind has joined the NDA Group as VP of com­mer­cial. Most re­cent­ly, Lind served as strat­e­gy and busi­ness de­vel­op­ment ad­vi­sor at BioArc­tic AB. Pri­or to that, Lind was CEO of Medi­vir and had a decade-long stint at Mer­rill Lynch.

→ Aru­vant — Vivek Ra­maswamy’s sick­le cell Vant — has wel­comed Meghan Kel­ton as ex­ec­u­tive di­rec­tor of hu­man re­sources and Blair Clark-Schoeb as SVP of com­mu­ni­ca­tions. Kel­ton was a strate­gic HR leader at J&J and then moved on to No­var­tis Gene Ther­a­pies (pre­vi­ous­ly AveX­is) as peo­ple and or­ga­ni­za­tion head and HR site lead. Clark-Schoeb has been SVP, com­mu­ni­ca­tions at Zy­la Life Sci­ences, and ear­ly in her ca­reer she was se­nior di­rec­tor of cor­po­rate fi­nance for The Med­i­cines Com­pa­ny.

Philippe Dro

→ Philippe Dro has signed on to be a part­ner at Glenn Rock­man’s Ad­ju­vant Cap­i­tal. The chair­man of Scenic Biotech, Lu­ci­ole Med­ical and Lim­maT­e­ch Bi­o­log­ics, Dro was CBO of vac­cine de­vel­op­er Themis un­til it was sold to Mer­ck last year, and he al­so helmed Swiss-based Gly­co­V­axyn be­fore its 2015 ac­qui­si­tion by GSK for $190 mil­lion.

→ Mov­ing on from his Ver­tex crash-and-burn, the Ian Smith recla­ma­tion project has made its way to the board of di­rec­tors at Adri­an Gottschalk’s Foghorn Ther­a­peu­tics. Last sum­mer, Smith be­came chair­man at Sol­id Bio and he’s the ex­ec­u­tive chair­per­son at Vi­a­Cyte.

Mark Vel­le­ca

→ Mark Vel­le­ca has been named chair­man of the board at Tur­bine, a Hun­gar­i­an drug dis­cov­ery com­pa­ny us­ing a sim­u­la­tion-based ap­proach for its on­col­o­gy ther­a­pies. Vel­le­ca had been CEO of G1 Ther­a­peu­tics from 2014 un­til he hand­ed the ba­ton to Jack Bai­ley at the start of this year. On top of that, Gor­don Mills and Klaus Hoe­flich are now on Tur­bine’s sci­en­tif­ic ad­vi­so­ry board.

→ Af­ter reel­ing in for­mer Jef­feries an­a­lyst Biren Amin ear­li­er this month, Im­muneer­ing has now se­lect­ed Lau­rie Keat­ing to be a part of its board of di­rec­tors. Keat­ing cur­rent­ly serves as EVP and chief le­gal of­fi­cer of Al­ny­lam. This isn’t Keat­ing’s first board ap­point­ment, oc­cu­py­ing a seat on the board of Mass­Bio. Pri­or to Al­ny­lam, Keat­ing was with Mil­len­ni­um and Hy­dra Bio­sciences.

Su­san­nah Gray

→ Otel­lo Stam­pac­chia is no longer on the board of di­rec­tors at Mor­phic Ther­a­peu­tic, leav­ing the door open for Su­san­nah Gray to join. Gray re­tired from Roy­al­ty Phar­ma in 2019 af­ter 14 years as EVP and CFO. In oth­er Mor­phic board news, Vikas Goy­al won’t seek re­elec­tion when his term runs out at the Waltham, MA biotech.

→ Finch Ther­a­peu­tics — which scored $90 mil­lion to com­plete the fi­nal stretch for its oral mi­cro­bio­me ther­a­py last Sep­tem­ber — has en­list­ed for­mer Roche ex­ec Su­san Graf for its board of di­rec­tors. Cur­rent­ly, Graf serves as CEO of Aka­ma­ra Ther­a­peu­tics. Graf was al­so the for­mer CBO and prin­ci­pal fi­nan­cial of­fi­cer of Epizyme. Be­fore that, Graf was with NPS Phar­ma.

John Ko­co­nis

→ Sev­er­al months af­ter Alan Mendel­sohn took the CMO reins, der­ma­to­log­ic dis­ease-fo­cused Tim­ber Phar­ma­ceu­ti­cals has made its CEO John Ko­co­nis chair­man of the board. More­over, two board mem­bers have been as­signed new ti­tles: Ed­ward Sitar has been ap­point­ed lead in­de­pen­dent di­rec­tor, while David Co­hen chairs Tim­ber’s Sci­ence and Tech­nol­o­gy Com­mit­tee.

→ Akero Ther­a­peu­tics — which surged off of “un­prece­dent­ed” NASH da­ta last Ju­ly, just days af­ter a crush­ing re­jec­tion for In­ter­cept —  has opened a seat on its board for Yuan Xu as an in­de­pen­dent di­rec­tor. Xu brings with her ex­pe­ri­ence from her time as CEO of Leg­end Biotech, which reeled in a $424 mil­lion mon­ster IPO last year with her at the helm. Be­fore that, Xu was at Mer­ck’s bi­o­log­ics & vac­cines sub­di­vi­sion as well as man­u­fac­tur­ing groups for No­var­tis, Gilead and GSK.

James Sco­pa

→ Af­ter strik­ing a NASH deal with Mer­ck that could be val­ued at $458 mil­lion, South San Fran­cis­co liv­er dis­ease biotech Ali­gos Ther­a­peu­tics has made room for ex-MPM Cap­i­tal man­ag­ing di­rec­tor James Sco­pa on the board of di­rec­tors. Sco­pa claims board seats at sev­er­al oth­er com­pa­nies, in­clud­ing DiCE Mol­e­cules and Neu­ron23.

→ Emerg­ing from stealth mode, se­cur­ing an up­sized IPO and get­ting hit with a clin­i­cal hold all in a short pe­ri­od of time, Mar­cio Souza’s crew at Prax­is Pre­ci­sion Med­i­cines has its sec­ond new board mem­ber in as many weeks: Mass Gen­er­al Hos­pi­tal chief of neu­rol­o­gy Mer­it Cud­kow­icz. Re­tired Ver­tex and Mer­ck ex­ec Jef­frey Chodake­witz has like­wise head­ed to the board at Prax­is, which has ac­cept­ed the res­ig­na­tions of Black­stone’s Nick Galakatos and Ki­ran Red­dy, Prax­is’ co-founder and ex-CEO.

Vic­ki Vakiener

→ Try­ing to re­hab their im­age af­ter the Josh Hardy af­fair, Chimerix has re­served a seat for Vic­ki Vakiener on the board of di­rec­tors. Vakiener was pro­mot­ed to chief com­mer­cial of­fi­cer of Epizyme in Sep­tem­ber.

→ Mary Lynne Hed­ley is adding an­oth­er board seat to her ré­sumé with her new ap­point­ment at Helsinn. Most re­cent­ly, Hed­ley was di­rec­tor, pres­i­dent and COO at Tesaro. Pri­or to Tesaro, Hed­ley was with Abrax­is Bio­science, Ei­sai, MGI Phar­ma and ZY­COS. Hed­ley cur­rent­ly sits on the boards of Vee­va and Centes­sa Phar­ma­ceu­ti­cals.

Joanne Cur­ley

→ CNS biotech Vista­Gen has added Joanne Cur­ley to the board of di­rec­tors. Cur­ley, who was with Gilead for near­ly 15 years, was named chief de­vel­op­ment of­fi­cer at Ve­ra Ther­a­peu­tics last year.

→ Defini­GEN has ap­point­ed Ben Cons as chair­man of the board. Cons pre­vi­ous­ly held a 20-year stint at IQVIA and the as­so­ci­at­ed No­vaQue­st in­vest­ment fund. Cur­rent­ly, Cons is chair­man of Cas­tor EDC and Charn­wood Mol­e­c­u­lar, among oth­ers. Cons jump­start­ed his ca­reer at Bay­er­Scher­ing and GSK.

→ Er­rol de Souza has been elect­ed to the board of di­rec­tors at Cy­cle­ri­on Ther­a­peu­tics, which saw a Phase II flop with olin­ciguat for sick­le cell dis­ease last Oc­to­ber. The Neu­ro­crine founder and ex­ec­u­tive chair­man of Bio­nom­ics is on the boards of Roy­al­ty Phar­ma and Cat­a­lyst Bio­sciences.

→ Er­gomed has made the ad­di­tion of Llew Kelt­ner to its board of di­rec­tors, re­plac­ing Ian John­son. Kelt­ner brings ex­pe­ri­ence from his time as chair­man of Rap­tor Phar­ma­ceu­ti­cals and as a mem­ber of the board of Mannkind.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.