For­mer Spark ex­ec to lead a gene ther­a­py up­start of his own; Big Phar­ma mar­ket­ing vet named CEO of Swiss biotech

Joseph La Barge

Dave Green­wald’s days as act­ing CEO of Aper­tu­ra Gene Ther­a­py are over as Joseph La Barge steps in to lead the biotech, which just launched in April.

Peer Re­view had been won­der­ing about La Barge’s next land­ing spot since he left Spark at the end of 2021. In his eight-year stretch with the gene ther­a­py pi­o­neer, he be­gan as chief le­gal of­fi­cer and was lat­er pro­mot­ed to CBO in 2019, when Spark was sold to Roche for $4.3 bil­lion. Deer­field, where Green­wald is VP of busi­ness de­vel­op­ment, put up all the fi­nanc­ing for Aper­tu­ra’s $67 mil­lion Se­ries A.

Mar­tin Munte

→ Big Phar­ma vet Mar­tin Munte has been named CEO of Swiss biotech Vac­cen­tis, the mak­er of such ther­a­pies as Re­niale for non-metasta­t­ic re­nal cell car­ci­no­mas. Af­ter two years at Roche, Munte spent sev­en years in mar­ket­ing at As­traZeneca, then moved to Am­gen in 2009, where he stayed for the next 12 years. He held gen­er­al man­ag­er po­si­tions in Slo­va­kia and Turkey be­fore be­com­ing Am­gen’s ex­ter­nal ac­cess en­gage­ment lead, Eu­rope in 2019. Munte’s ap­point­ment fol­lows the ar­rival of three board mem­bers in May: Mar­cel Frei, Sub­ha­sis Roy and new chair­man Matthias Oer­tle.

Jen­nifer Schnei­der

→ Lon­don in­fec­tious dis­ease biotech Cen­tau­ri Ther­a­peu­tics, which pulled to­geth­er a $24 mil­lion Se­ries A with the help of Boehringer In­gel­heim and Evotec, has se­lect­ed Jen­nifer Schnei­der as CEO and He­len Bright as VP of R&D. Schnei­der is the for­mer ex­ec­u­tive of­fi­cer for the Glob­al An­tibi­ot­ic R&D Part­ner­ship (GARDP) North Amer­i­ca, while Bright — an ex-se­nior prin­ci­pal sci­en­tist at Pfiz­er and an As­traZeneca vet in vi­rol­o­gy and vac­cines dis­cov­ery — spent the last year as head of in­fec­tion bi­ol­o­gy at Med­i­cines Dis­cov­ery Cat­a­pult.

Gil Labrucherie

→ We filled you in on Gil Labrucherie’s de­par­ture from a tum­bling Nek­tar, and he’s turned up as CFO of Los An­ge­les-based Ace­lyrin, Shao-Lee Lin’s biotech that hit the jack­pot with a $250 mil­lion Se­ries B led by the folks at West­lake Vil­lage BioPart­ners. Labrucherie, who gets start­ed Ju­ly 18, joined Nek­tar in 2005 as SVP and gen­er­al coun­sel, and was pro­mot­ed to COO and CFO in May 2016. If you haven’t read them al­ready, End­points News’ Kyle LaHu­cik pro­filed Lin along with 14 oth­er LGBTQ bio­phar­ma lead­ers last month.

Chris Mora­bito

→ With Chris Mora­bito out as CMO of Ful­crum Ther­a­peu­tics, R&D chief and ex-Roche glob­al clin­i­cal de­vel­op­ment lead Ju­dith Dunn will mind the store un­til a suc­ces­sor is named. Mora­bito came to Ful­crum last year af­ter serv­ing in the same ca­pac­i­ty at Car­du­ri­on Ther­a­peu­tics. Ful­crum has pushed the one­time GSK drug losmapi­mod in­to Phase III for fa­cioscapu­lo­humer­al mus­cu­lar dy­s­tro­phy af­ter a Phase II bust in Au­gust 2020, and shares spiked a year lat­er when ear­ly da­ta for its sick­le cell pro­gram achieved sta­tis­ti­cal sig­nif­i­cance.

→ On Sept. 1, Her­bertSkipVir­gin will join in­com­ing Al­tos Labs chief Hal Bar­ron as CMO and head of the com­pa­ny’s Al­tos In­sti­tute of Med­i­cine. Vir­gin is skip­ping out on his CSO post at Vir Biotech­nol­o­gy to join Rick Klaus­ner’s new an­ti-ag­ing play, which boasts the likes of Frances Arnold and CRISPR pi­o­neer Jen­nifer Doud­na on the board. Pri­or to Vir, Vir­gin spent most of his ca­reer in acad­e­mia, serv­ing on the fac­ul­ty of Wash­ing­ton Uni­ver­si­ty School of Med­i­cine from 1990 to ear­ly 2019.

Su­mi Biswas

Spy­Biotech co-founder, pres­i­dent, CEO and CSO Su­mi Biswas has re­lin­quished one of her ti­tles, set­ting the stage for Mark Leucht­en­berg­er to take over as chief ex­ec­u­tive. Leucht­en­berg­er has led the charge at sev­er­al com­pa­nies, in­clud­ing CEO stints at Chi­as­ma, Rib-X Phar­ma­ceu­ti­cals (now Melin­ta) and Brook­lyn Im­munoTher­a­peu­tics. Un­der Biswas’ guid­ance, Spy­Biotech teamed up with the Serum In­sti­tute of In­dia on a Covid-19 vac­cine tri­al and net­ted a $32.5 mil­lion Se­ries A five months lat­er.

Amy Pe­ter­son

→ The hits just keep on com­ing at Cy­tomX as the biotech grap­ples with a Phase II dud from one of its lead drugs, praluzatam­ab rav­tan­sine, in breast can­cer. Sean Mc­Carthy’s crew is shrink­ing by 40% and the C-suite hasn’t been spared: Pres­i­dent and COO Amy Pe­ter­son, CFO Car­los Cam­poy and CMO Al­i­son Han­nah have all been shown the door. With the re­duced head­count, the South San Fran­cis­co biotech hopes to have enough cash on hand to last un­til 2025.

Jack­ie Fouse

Jack­ie Fouse will pass the ba­ton to Bri­an Goff at Agios on Aug. 8, end­ing a three-year run as chief ex­ec­u­tive that saw the com­pa­ny turn away from on­col­o­gy and rein­vent it­self as a rare dis­ease out­fit. Fouse re­ject­ed the no­tion of be­ing a CEO again in an in­ter­view with End­points News, but she’ll stay on as chair, while her pre­de­ces­sor and GV gen­er­al part­ner David Schenkein will keep his seat on the board af­ter two years as chair­man. Goff has plen­ty of Big Phar­ma cre­den­tials with 21 com­bined years of ser­vice at No­var­tis and J&J, and he’s al­so been chief com­mer­cial and glob­al op­er­a­tions of­fi­cer at Alex­ion from 2017-21.

Stephen Willard

→ Af­ter com­pa­ny shares took a nose­dive in May fol­low­ing news that its Covid-19 treat­ment had more deaths in the treat­ment group than place­bo co­hort in its NIH study and the res­ig­na­tions of its CFO and chief cor­po­rate of­fi­cer, NRx Phar­ma­ceu­ti­cals is try­ing to re­store some sem­blance of bal­ance to the com­pa­ny with the ap­point­ment of Stephen Willard as CEO. Willard as­sumes the reins from in­ter­im CEO Robert Besthof, who will re­turn to his du­ties as head of op­er­a­tions and CCO. No stranger to the CEO hat, Willard has served as chief ex­ec­u­tive at Cell­phire Ther­a­peu­tics and Flamel Tech­nolo­gies (now Avadel Phar­ma­ceu­ti­cals). Ear­li­er in his ca­reer, Willard was an as­so­ciate di­rec­tor at the FDIC.

→ To say it’s been a bumpy ride for Cy­to­Dyn would be an un­der­state­ment. Af­ter be­ing slapped with two clin­i­cal holds in March fol­low­ing an RTF and some stern warn­ings, the com­pa­ny has now ap­point­ed Cyrus Ar­man as pres­i­dent — who will even­tu­al­ly tran­si­tion to CEO in the next six months — in hopes of right­ing the ship. Ar­man takes over from in­ter­im pres­i­dent An­to­nio Migliarese, who will re­sume his du­ties as CFO. Ar­man comes aboard from Nim­ble Ther­a­peu­tics, where he served as CBO. Pri­or to that stint, Ar­man was with Neu­vo­gen (VP of cor­po­rate de­vel­op­ment and strat­e­gy) and Am­gen.

Alex­is Vandi­er

→ In Jan­u­ary, we shared that OSE Im­munother­a­peu­tics chair Do­minique Costan­ti­ni was pinch-hit­ting as CEO af­ter Alex­is Pey­roles’ de­par­ture, and this week Alex­is Vandi­er has stepped up to the plate as OSE’s per­ma­nent chief ex­ec. Vandi­er climbed through the ranks dur­ing his 12 years at Ipsen, get­ting el­e­vat­ed to VP – glob­al as­set lead, on­col­o­gy in ear­ly 2021. In Vandi­er’s string of posts at Ipsen, the new buy­er of Epizyme for $247 mil­lion, the 11-year Sanofi vet was gen­er­al man­ag­er of Ipsen France and SVP, glob­al con­sumer health­care strat­e­gy.

Mar­ty Moore

Frank Glavin has suc­ceed­ed co-founder Mar­ty Moore as CEO of Red­wood City, CA’s Meis­sa Vac­cines, while Moore be­comes the com­pa­ny’s CSO. Galvin was pre­vi­ous­ly the chief ex­ec­u­tive of Or­phan Tech­nolo­gies, which was sold to Mar­tin Shkre­li’s old com­pa­ny Tra­vere Ther­a­peu­tics for $90 mil­lion up­front when it was still Retrophin in Oc­to­ber 2020. Meis­sa is in a Phase Ic tri­al for its in­tranasal RSV vac­cine can­di­date MV-012-968 and al­so has an in­tranasal Covid-19 vac­cine hope­ful in Phase I.

Chan Lee

→ Star­ing at an FDA de­lay for tislelizum­ab with no hint of a resched­ule, BeiGene has made sev­er­al moves. Bat­ting lead­off, Chan Lee’s first day as gen­er­al coun­sel of BeiGene will be Mon­day as he takes over for Scott Samuels, who had been with the biotech for five years. Lee bids farewell to Sanofi af­ter his stint as North Amer­i­ca gen­er­al coun­sel, and from 2008-2016 he held mul­ti­ple le­gal posts at Pfiz­er, in­clud­ing SVP and chief coun­sel for the drug gi­ant’s In­no­v­a­tive Health glob­al busi­ness.

Ad­di­tion­al­ly, BeiGene has pro­mot­ed Shreya Jani to SVP, cor­po­rate af­fairs (ex-Greater Chi­na) and tapped Michael Schoen to lead US gov­ern­ment af­fairs & pub­lic pol­i­cy. Jani came on board as VP last June, and to round out 14 years at Pfiz­er in 2017, she was the Big Phar­ma’s VP, cor­po­rate af­fairs, vac­cines, on­col­o­gy and con­sumer health­care. Schoen will con­tin­ue to be CEO John Oyler’s chief of staff along with his du­ties as SVP of busi­ness op­er­a­tions.

Gil Efron

→ At Is­raeli on­col­o­gy play­er Pur­ple Biotech, there’s a new but fa­mil­iar face at the top. Gil Efron, the pres­i­dent and CFO for the last year and a Pur­ple Biotech ex­ec since 2018, has suc­ceed­ed Isaac Is­rael, who cit­ed per­son­al rea­sons for his ex­it. Pur­ple Biotech is test­ing its mon­o­clon­al an­ti­body CM24 as a com­bo ther­a­py with Bris­tol My­ers Squibb’s Op­di­vo.

→ Stay­ing in Lon­don, Karen Miller has signed on as CSO of Ix­a­ka, a cell and gene ther­a­py play­er tack­ling chron­ic limb-threat­en­ing is­chemia in Phase III. Miller comes to Ix­a­ka af­ter three years as SVP, pipeline re­search with Adap­ti­m­mune, and she was pre­vi­ous­ly the head of the im­munol­o­gy in­no­va­tion fund at GSK. The com­pa­ny once known as Rex­gen­ero lined up a $54 mil­lion (£40 mil­lion) haul in Jan­u­ary 2021.

Mic­ah Za­jic

→ Short­ly af­ter bring­ing in Marshelle Smith War­ren as CMO, cell ther­a­py out­fit SQZ Biotech­nolo­gies has bumped up Mor­gan Stan­ley alum Mic­ah Za­jic to CFO. Za­jic, the CBO at SQZ since Oc­to­ber 2020, served as se­nior di­rec­tor, cor­po­rate strat­e­gy with Alex­ion be­fore jump­ing to MeiraGTx as VP of cor­po­rate de­vel­op­ment from 2017-20. Dur­ing a flur­ry of sim­i­lar ap­point­ments at the dawn of 2022, ex-Al­ny­lam chief John Maraganore teamed up with SQZ as a strate­gic ad­vi­sor.

Su­san­nah Cantrell

→ One year to the day af­ter Brii Bio’s $320 mil­lion IPO on the Hong Kong ex­change, the biotech with HBV and HIV can­di­dates in the pipeline has ap­point­ed Su­san­nah Cantrell as CBO. Cantrell’s back­ground in­cludes stops at such ma­jor play­ers as GSK, Genen­tech and Gilead, where she was head of glob­al com­mer­cial strat­e­gy and mar­ket­ing on­col­o­gy. Since No­vem­ber 2020, she had filled the roles of CBO and lat­er COO at Sec­ond Genome.

Denise Det­tore

→ Good as Gold: Part of Mer­ck’s in­creas­ing in­ter­est in AI with a deal worth up to $610 mil­lion plus roy­al­ties, Ab­sci has en­list­ed Denise Det­tore as chief peo­ple of­fi­cer and Jack Gold as chief mar­ket­ing of­fi­cer. Fol­low­ing her time at Genen­tech and Jazz Phar­ma­ceu­ti­cals, Det­tore re­cent­ly took on the roles of VP, hu­man re­sources for North Amer­i­ca, Eu­rope and new mar­kets and co-glob­al head of hu­man re­sources at BeiGene. Gold had a long run in mar­ket­ing at Nike from 1997-2018, and then be­came chief mar­ket­ing of­fi­cer of Zymer­gen be­fore leav­ing in Jan­u­ary.

→ Now that we have AI on our minds, GSK part­ner PathAI has re­cruit­ed Bran­don El­dredge as CFO. He jumps to the AI pathol­o­gy up­start from Mass Gen­er­al Brigham, where he was chief clin­i­cal busi­ness of­fi­cer, and be­fore it re­brand­ed to Sy­neos Health, El­dredge served as SVP of cor­po­rate strat­e­gy and de­vel­op­ment at in­Ven­tiv Health. Al­though fi­nan­cial specifics were scant, PathAI and GSK are go­ing af­ter on­col­o­gy and NASH in a new pact that was an­nounced in April.

Saman­tha Vieira

→ With new CEO Stephen Yoo in place, An­jar­i­um Bio­sciences has fleshed out its C-suite with Saman­tha Vieira as COO and Nate Mas­sari as CBO. Vieira moves on to An­jar­i­um from Bio­gen, where she was glob­al prod­uct de­vel­op­ment and com­mer­cial lead, reti­nal gene ther­a­py af­ter the ill-fat­ed al­liance with Night­star. Mas­sari co-found­ed Rum­pus Ther­a­peu­tics and was EVP of rare dis­ease op­er­a­tions at Ay­tu Bio­Phar­ma be­fore the Swiss gene ther­a­py biotech came call­ing. An­jar­i­um as­sem­bled big-name in­vestors like Abing­worth and Pfiz­er for its $61 mil­lion Se­ries A in Sep­tem­ber 2021.

Lynette Her­scha

Lynette Her­scha has re­unit­ed with CEO Aman­da Wag­n­er as COO of I/O biotech Im­mu­ni­tas Ther­a­peu­tics, which is tar­get­ing CD161 with IMT-009. The pair worked at Con­cert Phar­ma­ceu­ti­cals — Her­scha as as­so­ciate gen­er­al coun­sel, Wag­n­er as VP, busi­ness de­vel­op­ment & prod­uct strat­e­gy — when the biotech inked a $250 mil­lion CF deal with Ver­tex in 2017. Since her days at Con­cert, Her­scha served as chief le­gal of­fi­cer and cor­po­rate sec­re­tary with Sol­id Bio and Sen­da Bio­sciences.

Deb­o­rah Tel­man

→ Af­ter a 17-year stint as gen­er­al coun­sel of Gilead, Brett Pletch­er is re­tir­ing, and Deb­o­rah Tel­man, who hops aboard from women’s health phar­ma and Mer­ck spin­out Organon, is tak­ing over. Tel­man served as gen­er­al coun­sel of Organon and has pre­vi­ous­ly held roles at Sor­ren­to Ther­a­peu­tics, John­son Con­trols and Ab­bott, among oth­ers.

→ Tak­ing an AI ap­proach to de­vel­op­ing can­cer drugs, Hous­ton’s Kiromic Bio­Phar­ma has el­e­vat­ed Leonar­do Mi­ran­dola to CSO. Mi­ran­dola has been part of the Kiromic crew since 2016, when he was ex­ec­u­tive di­rec­tor of R&D. He then rose to head of clin­i­cal trans­la­tion in 2020 and VP of R&D and clin­i­cal trans­la­tion a year lat­er. Kiromic’s stock has lost 96% of its val­ue since join­ing Nas­daq dur­ing the gold­en age of IPOs in 2020.

Nick Mord­winkin

→ South San Fran­cis­co-based Am­gen spin­out Kezar Life Sci­ences has locked in Nick Mord­winkin as CBO. Leav­ing Gilead af­ter near­ly a year as head of cor­po­rate de­vel­op­ment, in­flam­ma­tion and fi­bro­sis, Mord­winkin once held the role of se­nior di­rec­tor, head of cor­po­rate strat­e­gy at Ul­tragenyx. Kezar’s lead drug, ze­tomip­zomib, fell flat in a Phase II study for pa­tients with der­mato­myosi­tis and polymyosi­tis in May.

Gary Phillips

→ Swiss-based Anaveon, which raked in $119 mil­lion in the hunt for a bet­ter next-gen IL-2, has plucked up Gary Phillips as CBO. Phillips most re­cent­ly served as pres­i­dent and CEO of Or­phomed. Phillips has al­so served as EVP, chief strat­e­gy of­fi­cer, and pres­i­dent, au­toim­mune & rare dis­eases at Mallinck­rodt Phar­ma­ceu­ti­cals and had stints at Reckitt Benckiser Phar­ma­ceu­ti­cals, Bausch & Lomb, Mer­ck Serono, No­var­tis and Wyeth.

jCyte is mak­ing the rounds again in Peer Re­view, this time bring­ing in Stew­art Craig as chief tech­nol­o­gy of­fi­cer. Craig joins the New­port Beach, CA-based com­pa­ny from Ery­tech Phar­ma, where he served as chief tech­ni­cal of­fi­cer. Pri­or to that, Craig had gigs at Or­chard Ther­a­peu­tics (chief man­u­fac­tur­ing of­fi­cer), Sang­amo (SVP, tech­ni­cal op­er­a­tions), PT Cell Ther­a­py Ser­vices and Xcyte Ther­a­pies (COO).

Suzanne Fos­ter is join­ing the ranks of Beck­man Coul­ter Life Sci­ences as pres­i­dent, suc­ceed­ing Greg Milo­se­vich, who is mov­ing on to green­er pas­tures at Dana­her Cor­po­ra­tion. Fos­ter pre­vi­ous­ly served as pres­i­dent of health­care at Stan­ley Black & Deck­er and had a 10-year stint at Medtron­ic as gen­er­al man­ag­er of their ad­vanced en­er­gy busi­ness.

→ Pa­lo Al­to, CA-based Im­mune-Onc Ther­a­peu­tics has brought in Christo­pher Whit­more as CFO. Whit­more hails from No­table Labs, where he served in the same role. Be­fore that, Whit­more was VP of fi­nance and ad­min­is­tra­tion for Har­poon Ther­a­peu­tics. Whit­more al­so has ex­pe­ri­ence from stints at Im­mune De­sign, Acel­Rx Phar­ma­ceu­ti­cals, Sang­amo Ther­a­peu­tics and KP­MG.

Heather Hamel

In­Vi­vo Ther­a­peu­tics — which last made head­lines in 2017 af­ter re­port­ing a third pa­tient be­ing treat­ed with its spinal cord im­plant had died — has pro­mot­ed Heather Hamel to chief le­gal of­fi­cer and gen­er­al coun­sel. Hamel pre­vi­ous­ly served as the com­pa­ny’s VP of le­gal af­fairs and busi­ness de­vel­op­ment. Pri­or to join­ing In­Vi­vo, Hamel was with Eco­lab and PLR IP.

Ken­neth La­M­on­tagne

→ New York-based gam­ma delta T cell shop IN8bio has in­stalled Big Phar­ma alum Ken­neth La­M­on­tagne as SVP, busi­ness de­vel­op­ment. La­M­on­tagne had a nine-year run at No­var­tis that con­clud­ed as glob­al head of busi­ness in­sights, cell & gene ther­a­pies unit, and in Bris­tol My­ers’ busi­ness de­vel­op­ment lead­er­ship, he led the search & eval­u­a­tion team for the phar­ma gi­ant’s cell ther­a­py fran­chise. In April, La­M­on­tagne left his post as VP, busi­ness de­vel­op­ment with Ar­ti­san Bio.

Robert Glass­man has been named EVP, search & eval­u­a­tion of Ena­vate Sci­ences, a biotech in­vest­ment group from Pa­tient Square Cap­i­tal that kicked things off with $300 mil­lion in ear­ly May. The ex-vice chair­man of glob­al health care in­vest­ment bank­ing for Cred­it Su­isse, Glass­man had made a re­turn en­gage­ment to Or­biMed, spend­ing the last year and a half as a ven­ture part­ner in pub­lic eq­ui­ty.

San­dra Frithiof

→ Nev­er too late, we sup­pose: Swedish kid­ney dis­ease biotech Cal­lid­i­tas end­ed 2021 with a flour­ish by gain­ing ac­cel­er­at­ed ap­proval for Tarpeyo, a drug that cuts down pro­tein­uria in pa­tients with pri­ma­ry IgA nephropa­thy. Cal­lid­i­tas has al­so an­nounced a pair of moves that were cu­ri­ous­ly made a while ago. San­dra Frithiof has been head of hu­man re­sources since de­part­ing from Ram­berg Ad­vokater in May 2020, and ex-Good­win Proc­ter part­ner Jonathan Schur joined as group gen­er­al coun­sel in Oc­to­ber of that same year.

Philip Sut­ton

→ News from the land down un­der: Syd­ney-based an­tibi­otics biotech Rec­ce Phar­ma­ceu­ti­cals has ap­point­ed Philip Sut­ton as VP of trans­la­tion­al sci­ences. Sut­ton has worked with Rec­ce be­fore on its clin­i­cal ad­vi­so­ry com­mit­tee and as head of the H. py­lori de­vel­op­ment pro­gram, and for the last decade, Sut­ton led the mu­cos­al im­munol­o­gy group at Mur­doch Chil­dren’s Re­search In­sti­tute in Mel­bourne.

An­toine Yver

→ CRISPR start­up Spot­light Ther­a­peu­tics is look­ing to shine brighter by elect­ing En­her­tu lu­mi­nary An­toine Yver to the board of di­rec­tors. Yver, the cur­rent chair­man of de­vel­op­ment at Centes­sa, is a new board mem­ber at Sanofi — un­der­scor­ing the Big Phar­ma’s on­col­o­gy am­bi­tions — and was Dai­ichi Sankyo’s glob­al head of R&D from 2016-21.

Su­sanne Schaf­fert

→ In­dus­try vet Su­sanne Schaf­fert — who was cut out of a job at No­var­tis along with her col­league John Tsai as part of a ma­jor re­or­ga­ni­za­tion ef­fort at the phar­ma gi­ant — has hopped on­to the board of di­rec­tors of Ru­bius Ther­a­peu­tics right as Anne Pren­er is mak­ing her ex­it from the board. Schaf­fert spent the last 27 years at No­var­tis On­col­o­gy, cul­mi­nat­ing in her role as pres­i­dent. Ear­li­er in her ca­reer, Schaf­fert held a num­ber of roles with No­var­tis, in­clud­ing re­gion head, No­var­tis On­col­o­gy Eu­rope; head of in­vestor re­la­tions and glob­al fran­chise head for im­munol­o­gy and trans­plan­ta­tion.

Stephen Mayo

David Chang’s crew at Al­lo­gene has brought Xen­cor co-founder Stephen Mayo in­to the fold, open­ing up space for him on the board of di­rec­tors. Mayo holds board seats at Mer­ck and Sarep­ta, and has taught at Cal­tech for the last 30 years.

Lorence Kim

Third Rock ven­ture part­ner Lorence Kim has claimed a spot on the board of di­rec­tors at one of the VC’s star­tups, Rev­o­lu­tion Med­i­cines. Kim was with Gold­man Sachs for 14 years be­fore head­ing to Mod­er­na as CFO from 2014-20, and he’s a board mem­ber at Cowen, Flare Ther­a­peu­tics and Aba­ta Ther­a­peu­tics.

Nel­lo Main­olfi’s pro­tein degra­da­tion shop Kymera Ther­a­peu­tics has pulled up a chair for ex-Gates Foun­da­tion COO Leigh Mor­gan on the board of di­rec­tors. Mor­gan, the chief strat­e­gy and op­er­at­ing of­fi­cer for Nia Tero, is the for­mer glob­al head of hu­man re­sources for prod­uct de­vel­op­ment at Genen­tech.

Pam Stetkiewicz

→ We told you about Pam Stetkiewicz join­ing Ar­bor Biotech­nolo­gies last sum­mer as COO, and she’s just picked up a board seat at Im­muneID, an an­ti­body up­start from Long­wood and Har­vard’s Stephen Elledge. Stetkiewicz, a 13-year NI­BR vet­er­an and for­mer Ed­i­tas Med­i­cine ex­ec, left for Ar­bor af­ter a year as SVP, glob­al pro­gram leader at Flag­ship.

Struck down unan­i­mous­ly by an FDA ad­comm and hand­ed a CRL a cou­ple months lat­er for its All­port syn­drome drug bar­dox­olone methyl, Rea­ta has named 21-year Pfiz­er vet Steven Ry­der as a mem­ber of the board of di­rec­tors. The one-time Alex­ion chief de­vel­op­ment of­fi­cer has been CMO of Rally­bio for three years.

Georges Gemayel, the in­ter­im CEO of Gem­i­ni af­ter Ja­son Meyen­burg hit the eject but­ton in late Feb­ru­ary, has been ap­point­ed chair­man of Gly­co­Era’s board of di­rec­tors. Lu­ci­ole Med­ical CEO Philippe Dro and 5AM Ven­tures man­ag­ing part­ner Kush Par­mar have al­so earned seats on the board.

David Roth

James Cullem as­cend­ed to in­ter­im CEO at Al­lar­i­ty Ther­a­peu­tics a cou­ple weeks ago, and now he’s tak­en a seat on the board of di­rec­tors with co-founder Thomas Jensen, who shift­ed to the role of SVP of in­vestor re­la­tions. Sy­ros Phar­ma­ceu­ti­cals CMO David Roth has al­so joined Al­lar­i­ty’s board.

→ San Diego-based Plex­i­um, which has inked deals with heavy­weight play­ers such as Ab­b­Vie and Am­gen, has re­cruit­ed Bri­an Wong to its board of di­rec­tors. Wong is the pres­i­dent and CEO of RAPT Ther­a­peu­tics. Pri­or to his cur­rent role, Wong was with Five Prime (SVP, re­search and head of im­muno-on­col­o­gy), Roche (di­rec­tor in the in­flam­ma­tion dis­ease bi­ol­o­gy area), and Rigel Phar­ma­ceu­ti­cals.

Jill DeS­i­mone

→ Ex-Mer­ck US on­col­o­gy pres­i­dent Jill DeS­i­mone has been added to the board of di­rec­tors at Affi­ni-T Ther­a­peu­tics, which racked up a $175 mil­lion fi­nanc­ing round in March. DeS­i­mone joined the board at Prax­is Pre­ci­sion Med­i­cines a cou­ple months ago.

→ Pfiz­er and Te­va-part­nered Alvotech is adding four new mem­bers to its board of di­rec­tors with the ap­point­ments of Lisa Graver (CEO of Alvo­gen); Arni Hardar­son (part­ner at Az­tiq and for­mer deputy CEO of Alvo­gen); Lin­da Mc­Goldrick (chair­man and CEO of 2En­able­Heallth); and Ann Mer­chant (VP for Mor­phoSys).

Ben Machielse

→ At the same time it se­cured a seed fi­nanc­ing round to pur­sue the de­vel­op­ment of an ex-Sanofi mol­e­cule, Mosan­na Ther­a­peu­tics has elect­ed Ben Machielse as chair­man of the board. Machielse is the for­mer CEO of Vtessse and ex-COO of Omthera Phar­ma­ceu­ti­cals.

Effie Toz­zo

→ Mi­tochron­dria-dri­ven Co­hBar is tap­ping Effie Toz­zo as in­de­pen­dent di­rec­tor of its board. Cur­rent­ly, Toz­zo serves as CSO of Avi­lar Ther­a­peu­tics. Toz­zo’s ré­sumé al­so in­cludes stints at Cel­lar­i­ty (SVP, drug de­vel­op­ment), Mi­to­bridge (head of R&D and SVP, trans­la­tion­al sci­ences), Mer­ck, Roche, Bris­tol My­ers, Mil­len­ni­um, Ch­i­ron and Er­go­Science.

KAHR Med­ical, fo­cused on the de­vel­op­ment of bi-func­tion­al fu­sion pro­teins, has named Jen­nifer Mi­nai-Azary a mem­ber of its board of di­rec­tors. Mi­nai-Azary is the CFO of Con­text Ther­a­peu­tics and has pre­vi­ous­ly served in the same role at Mil­len­do Ther­a­peu­tics. Pri­or to those stints, Mi­nai-Azary was with Parex­el and Ernst & Young.

→ An­timi­cro­bial pro­teins-fo­cused com­pa­ny Lysan­do is pulling in Sang Jung Kim to its board of di­rec­tors. Kim joins Lysan­do with ex­pe­ri­ence from his cur­rent role as di­rec­tor of sales & mar­ket­ing at Am­ico­gen. Pri­or to Am­ico­gen, Kim was with Novozymes.

→ Ly­on, France-based Nosopharm is bring­ing in new faces to its su­per­vi­so­ry board with the ap­point­ment of Jacques Du­mas (CSO of Ar­rakis) as chair­man and new in­de­pen­dent mem­bers: Lau­rent Fraisse (for­mer Sanofi and Evotec alum), re­plac­ing Marie-Paule Richard; San­dra Du­bos (prin­ci­pal at Kreaxi and for­mer en­gi­neer at Sanofi-Aven­tis), re­plac­ing Gwe­nael Ha­mon; and Mar­tin Lau­ri­ot Pre­vost (co-founder of Ozyme).

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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