Lu­ba Green­wood takes the helm at Ko­jin Ther­a­peu­tics, steer­ing an all-fe­male C-suite; Alex­ion R&D chief packs up for change of scenery at VC firm

Lu­ba Green­wood

How rare is it to find a woman lead­ing a mi­cro- or small-cap biotech com­pa­ny? Ac­cord­ing to a re­cent sur­vey, it hap­pens less than 6% of the time. And all-fe­male C-suites? Al­most un­heard of.

But on Thurs­day, Ko­jin Ther­a­peu­tics of­fi­cial­ly tapped Lu­ba Green­wood as its first CEO, com­plet­ing an all-fe­male C-suite. All of the biotech’s se­nior sci­en­tists are women too, as is the sci­en­tif­ic co-founder. It’s a mo­ment that Green­wood al­ways be­lieved would come.

“I have al­ways had a pos­i­tive look that we will have women and mi­nori­ties in se­nior po­si­tions,” she told End­points News Thurs­day. “It’s won­der­ful.”

Look­ing back at her ca­reer, Green­wood would sep­a­rate her ex­pe­ri­ence in­to buck­ets. She dipped her toes in the in­dus­try in 2004 as an as­so­ciate at the law firm Wilmer­Hale, where she rep­re­sent­ed phar­ma­ceu­ti­cal, biotech and medtech com­pa­nies, among oth­ers. She’s al­ways been in­ter­est­ed in sci­ence — but it was while study­ing bi­ol­o­gy at Bran­deis that a pro­fes­sor en­cour­aged her to learn law.

She stayed at Wilmer­Hale for just over sev­en years, be­fore tran­si­tion­ing to Pfiz­er as se­nior coun­sel for M&A and cor­po­rate com­pli­ance. She would lat­er work at an­oth­er Big Phar­ma, Roche, as VP of glob­al M&A and busi­ness de­vel­op­ment, and at Google’s life sci­ences re­search com­pa­ny Ver­i­ly as head of strate­gic busi­ness de­vel­op­ment and cor­po­rate ven­tures.

She’s al­so dab­bled in small com­pa­nies, help­ing build star­tups in sev­er­al spaces, in­clud­ing im­munother­a­py, women’s health, ar­ti­fi­cial in­tel­li­gence, ma­chine learn­ing and mi­cro­bio­me. Most re­cent­ly, she was a man­ag­ing part­ner at the Dana-Far­ber Can­cer In­sti­tute’s ven­ture fund, Bin­ney Street Cap­i­tal, a ven­ture arm she found­ed to sup­port the de­vel­op­ment of treat­ments for in­cur­able can­cers.

“Ul­ti­mate­ly I re­al­ized that in­no­va­tion comes down to re­al­ly two things: re­al­ly amaz­ing sci­ence and re­al­ly amaz­ing peo­ple,” she said.

Ko­jin’s roots trace back to Vas­an­thi Viswanathan, who was work­ing as a post­doc in Har­vard bio­chemist Stu­art Schreiber’s lab when she demon­strat­ed a “vul­ner­a­bil­i­ty” in can­cer cells that don’t die af­ter treat­ment.

Most tar­get­ed can­cer drugs work by in­duc­ing can­cer cells to un­der­go apop­to­sis: a stan­dard, high­ly reg­u­lat­ed form of cel­lu­lar sui­cide. To sur­vive, some cells turn off that apop­to­sis pro­gram. But Viswanathan showed, by throw­ing thou­sands of mol­e­cules at hun­dreds of drug-re­sis­tant or se­mi-drug-re­sis­tant cell lines, that this pro­gram re­lies on the cell churn­ing out an abun­dance of fat­ty acids. And she showed that, in do­ing so, the cells be­come open to an­oth­er form of cell death: fer­rop­to­sis, where tox­ins build up and even­tu­al­ly kill the cell.

That work cul­mi­nat­ed in Ko­jin, and though it’s still in ear­ly stages, the start­up land­ed a $60 mil­lion Se­ries A back in June. Since then, it’s prob­a­bly dou­bled in size, Green­wood said.

What’s next for the se­r­i­al en­tre­pre­neur? Ce­ment­ing a pos­i­tive cul­ture at Ko­jin. That be­gins with a col­lab­o­ra­tive lay­out at the com­pa­ny’s new fa­cil­i­ty in Boston’s sea­port — for ex­am­ple, no one (not even the CEO) will have a des­ig­nat­ed of­fice.

“Hope­ful­ly you and I will speak in a year and we’ll be in con­sid­er­a­tion for one of the small best com­pa­nies to work for,” Green­wood said.

Nicole De­Feud­is

John Orloff

As­traZeneca sub Alex­ion ditched a Phase III study of Ul­tomiris in Au­gust that showed a “lack of ef­fi­ca­cy” for ALS af­ter the drug hit its pri­ma­ry end­point a month ear­li­er in Phase III for gen­er­al­ized myas­the­nia gravis. But that’s all in the past now for John Orloff, whose next act will be as a ven­ture part­ner for Agent Cap­i­tal, a life sci­ences in­vest­ment firm found­ed by Gee­ta Ve­muri. Orloff re­placed Mar­tin Mack­ay — the cur­rent CEO of Rally­bio — as Alex­ion’s R&D chief in 2017 af­ter hold­ing the same ti­tle at Bax­al­ta and Nov­e­l­ion Ther­a­peu­tics.

Af­ter his de­par­ture from Alex­ion, Orloff al­so clinched a spot on the board of di­rec­tors at Benev­o­len­tAI.

Ann Lee

→ The David Liu-found­ed gene edit­ing play­er Prime Med­i­cine, sin­gled out for this year’s End­points 11 and backed by big­wigs like ARCH’s Bob Nelsen and GV’s David Schenkein in a su­per­sized $315 mil­lion raise, has ap­point­ed Ann Lee as chief tech­ni­cal of­fi­cer. Lee’s ca­reer has been dot­ted with Big Phar­ma stops, most re­cent­ly at Bris­tol My­ers Squibb, where she was SVP and head of cell ther­a­py de­vel­op­ment and op­er­a­tions (CT­DO). Lee spent 14 years at Mer­ck Re­search Lab­o­ra­to­ries through the 1990s and ear­ly 2000s, and in 2005 she joined Genen­tech as VP of process R&D, lat­er tak­ing on the role of SVP and head of glob­al tech­ni­cal de­vel­op­ment at Roche.

Ri­ta Jain made a speedy ex­it with­in months of be­com­ing Im­muno­vant’s CMO in Jan­u­ary, but she’s a med­ical chief again at Chemo­cen­tryx, which just notched an ap­proval for its AN­CA-as­so­ci­at­ed vas­culi­tis drug Tavneos last week by a ra­zor-thin mar­gin. This ap­pears to be a no-brain­er for CEO Thomas Schall and his team: Jain knows Chemo­cen­tryx well as a mem­ber of the board of di­rec­tors with the com­pa­ny since March 2019. Be­fore her light­ning-quick stay at Im­muno­vant, Jain held the CMO post at Ake­bia Ther­a­peu­tics for two years and was Ab­b­Vie’s VP of men’s and women’s health and meta­bol­ic de­vel­op­ment.

Jo­han­na Mylet

Po­sei­da Ther­a­peu­tics, which bagged a $3.6 bil­lion non­vi­ral gene ther­a­py deal with Take­da ear­li­er this week, has made a slew of fresh pro­mo­tions to its lead­er­ship team with the ap­point­ments of Jo­han­na Mylet (CFO), De­von Shed­lock (CSO, cell ther­a­pies), Kristin Mar­tin (chief peo­ple and ad­min­is­tra­tion of­fi­cer), and Lisa Por­tale (SVP, reg­u­la­to­ry af­fairs). Mylet hopped aboard the Po­sei­da train in 2015 and most re­cent­ly served as SVP, fi­nance. Pri­or to her role with the San Diego-based com­pa­ny, Mylet was with HUYA Bio­science In­ter­na­tion­al and Grant Thorn­ton. Shed­lock most re­cent­ly served as Po­sei­da’s SVP of re­search & de­vel­op­ment. Shed­lock made his way to Po­sei­da af­ter stints at the Perel­man School of Med­i­cine and UPenn’s T-Cell En­gi­neer­ing Lab­o­ra­to­ry.

Kristin Mar­tin

Mean­while, Mar­tin for­mer­ly served as Po­sei­da’s chief hu­man re­sources of­fi­cer and was pre­vi­ous­ly VP of hu­man re­sources, fa­cil­i­ties and IT at Ardea Bio­sciences. Last, but not least, Por­tale jumped aboard Po­sei­da in ear­ly 2019 as the com­pa­ny’s VP, reg­u­la­to­ry af­fairs. Pri­or to that role, Por­tale was with Pfiz­er, Phe­nomix Cor­po­ra­tion, Neu­ro­crine Bio­sciences, Medtron­ic and Per­ri­go Com­pa­ny.

Paul Stof­fels

→ The shift in J&J’s lead­er­ship just got more seis­mic this week with the re­tire­ment of chief sci­en­tist Paul Stof­fels, who will step aside at the end of the year. Stof­fels — who’s al­so the vice chair­man of J&J’s ex­ec­u­tive com­mit­tee — was the CEO of Vir­co and chair­man of Ti­botec when J&J bought both com­pa­nies in 2002, and he’s been with the multi­na­tion­al ever since, get­ting el­e­vat­ed to CSO in 2012 and in­vig­o­rat­ing R&D there­after. Stof­fels would es­tab­lish John­son & John­son In­no­va­tion and John­son & John­son Glob­al Pub­lic Health to fur­ther ce­ment his lega­cy. The Stof­fels news comes af­ter CEO Alex Gorsky an­nounced his de­par­ture in Au­gust, pass­ing the ba­ton to Joaquin Du­a­to and tran­si­tion­ing to the ex­ec­u­tive chair­man post on Jan. 3.

Mary Beth Harler

IGM Bio­sciences has been busy with the cre­ation of some new busi­ness units to ex­pand on work ar­eas such as au­toim­mune dis­eases and in­fec­tious dis­eases. And with those new units, the Cal­i­for­nia-based com­pa­ny has snatched up a trio of ex­perts from Big Phar­ma to lead them. John Shiv­er, the for­mer SVP of vac­cine R&D at Sanofi Pas­teur, is join­ing IGM as chief strat­e­gy of­fi­cer of its in­fec­tious dis­ease unit. His col­league Tong-Ming Fu, who head­ed Sanofi Pas­teur’s vac­cine re­search in North Amer­i­ca, will take up the chief sci­en­tif­ic of­fi­cer spot. Mean­while, the IGM Au­toim­mu­ni­ty and In­flam­ma­tion de­part­ment will be head­ed up by Mary Beth Harler, most re­cent­ly head of im­munol­o­gy and fi­bro­sis de­vel­op­ment at Bris­tol My­ers Squibb.

Emile Nuwaysir, the for­mer CEO of Blue­Rock Ther­a­peu­tics, is step­ping in­to the CEO spot at En­so­ma — an am­bi­tious and well-backed start­up out of Fred Hutch and the Uni­ver­si­ty of Wash­ing­ton. In his new role, Nuwaysir will be tasked with mak­ing one of the old­est and most elu­sive goals in cell and gene ther­a­py a re­al­i­ty: re­pro­gram­ming blood cells with a sim­ple in­fu­sion, an ap­proach that could make CAR-T can­cer treat­ments and trans­for­ma­tive ther­a­pies for sick­le cell and oth­er rare blood dis­or­ders far safer, more scal­able and more ac­ces­si­ble. Nuwaysir brings with him ex­pe­ri­ence from his times at Nim­ble­Gen Sys­tems, Cel­lu­lar Dy­nam­ics In­ter­na­tion­al and In­ven­ra.

Mari Scheif­fele

Ipsen has named No­var­tis alum Mari Scheif­fele EVP and pres­i­dent, spe­cial­ty care in­ter­na­tion­al, and her first day with the French biotech is sched­uled for Nov. 1. Scheif­fele piv­ots to Ipsen af­ter spend­ing three years as the gen­er­al man­ag­er of UK & Ire­land at No­var­tis On­col­o­gy, and was al­so part of the lead­er­ship in the spe­cial­ty care busi­ness for No­var­tis Japan. In Au­gust, Ipsen strapped on the deal­mak­ing boots by col­lab­o­rat­ing with Ex­i­cure on neu­ro dis­eases—name­ly Hunt­ing­ton’s and An­gel­man syn­drome — for $20 mil­lion up­front.

Bren­dan Smith

→ On the heels of un­load­ing da­ta from its “off-the-shelf” CAR-T ther­a­py for pa­tients with B cell lym­phoma, CRISPR Ther­a­peu­tics is un­der­go­ing a CFO change with Michael Tom­sicek’s re­tire­ment af­ter four years at the Samarth Kulka­rni-led biotech. He’s suc­ceed­ed by Bren­dan Smith, ever-so-briefly the CFO at Trans­late Bio un­til Sanofi’s pur­chase of its part­ner for $3.2 bil­lion in Au­gust. Smith wrapped up six years at Pfiz­er in 2016 as VP, head of busi­ness op­er­a­tions for world­wide R&D be­fore join­ing Boston Con­sult­ing Group as a part­ner. Kulka­rni ex­pressed en­thu­si­asm about the safe­ty da­ta for CTX110 with our Ja­son Mast on Tues­day, but ques­tions re­main over dura­bil­i­ty.

There­sa Heah

Shankar Ra­maswamy’s gene ther­a­py joint Kriya Ther­a­peu­tics, which launched last year and las­soed a $100 mil­lion Se­ries B haul led by Jim Mom­tazee in Ju­ly, has wel­comed There­sa Heah as CMO and pres­i­dent of the new oph­thal­mol­o­gy di­vi­sion, Kriya Oph­thal­mol­o­gy. Heah, for­mer­ly the CMO at As­cle­piX and Ap­plied Ge­net­ic Tech­nolo­gies Cor­po­ra­tion, is a Sanofi and Al­ler­gan alum who al­so was glob­al strate­gic mar­ket­ing and tac­ti­cal brand plan lead for Eylea at Bay­er.

→ We have two pro­mo­tions at Waltham, MA-based Min­er­va Neu­ro­sciences af­ter the ar­rival of R&D chief Ra­mana Kuchib­hat­la, start­ing with CFO and CBO Ge­off Race get­ting the bump to pres­i­dent. A mem­ber of the Nes­san Berming­ham-chaired board at F-star, Race made the sprint to Min­er­va as CFO in 2014 and tacked on the CBO ti­tle in 2016. He was al­so the CEO at Funx­ion­al Ther­a­peu­tics be­fore its 2012 ac­qui­si­tion by Boehringer In­gel­heim. Next, the CFO role at Min­er­va is now in the hands of ex-chief ac­count­ing of­fi­cer Fred­er­ick Ahlholm, who al­so came on board in 2014 af­ter be­ing Amarin’s VP of fi­nance and chief ac­count­ing of­fi­cer.

Dymeka Har­ri­son

→ Fol­low­ing the ap­point­ments of CMO Mia Levy and chief bio­phar­ma busi­ness of­fi­cer San­ket Agraw­al this sum­mer, Roche’s Foun­da­tion Med­i­cine has se­lect­ed Dymeka Har­ri­son as chief com­mer­cial of­fi­cer. Be­fore her re­cent po­si­tion as the strate­gic mar­ket­ing head of Ab­bott Lab­o­ra­to­ries, Har­ri­son filled a string of sales roles at Ther­mo Fish­er, bio­Mérieux and Qi­a­gen. Foun­da­tion Med­i­cine’s head­quar­ters will move in­to a 16-sto­ry build­ing in Boston’s Sea­port Dis­trict that’s cur­rent­ly un­der con­struc­tion, with the space ex­pect­ed to be ready by 2023.

Ash­ley Hall has signed on to be chief de­vel­op­ment of­fi­cer at South­ern Cal­i­for­nia’s Re­neo Phar­ma­ceu­ti­cals, a mi­to­chon­dr­i­al dis­ease biotech that re­ceived a $95 mil­lion boost in a Se­ries B that No­vo Ven­tures and Abing­worth head­lined in De­cem­ber 2020. Ac­cord­ing to an SEC fil­ing, Hall changed roles from chief de­vel­op­ment of­fi­cer to chief reg­u­la­to­ry of­fi­cer at Es­pe­ri­on in June, but on­ly had the prover­bial cup of cof­fee at that post be­fore leav­ing for Re­neo. Ear­li­er, Hall was glob­al reg­u­la­to­ry lead, specif­i­cal­ly for PC­SK9 in­hibitor Repatha, with Am­gen.

Ja­son Haas

→ Fol­low­ing the ap­point­ment of chief com­mer­cial of­fi­cer Con­ley Chee in late Sep­tem­ber, Sy­ros has tapped Ja­son Haas as CFO. Be­fore his most re­cent turn as co-head of Amer­i­c­as, health­care in­vest­ment bank­ing for Bar­clays, Haas al­so led health­care in­vest­ment bank­ing for the Amer­i­c­as at Deutsche Bank. Sy­ros’ RARα ag­o­nist tamibarotene is in Phase II for acute myeloid leukemia (Phase II) and in Phase III for high­er-risk myelodys­plas­tic syn­drome.

→ Cit­ing per­son­al rea­sons, Noah Rosen­berg is on his way out as CMO of Tra­vere Ther­a­peu­tics, de­cid­ing in­stead on shift­ing to an ex­ec­u­tive ad­vi­sor role that will take ef­fect by the end of the year. Rosen­berg, who has been the med­ical chief since 2018, is a Pfiz­er and Sanofi vet in med­ical af­fairs who pre­vi­ous­ly owned the CMO ti­tle at Es­pe­ri­on. Re­mov­ing all ves­tiges of “Phar­ma Bro” Mar­tin Shkre­li by eras­ing the Retrophin name al­most a year ago, Tra­vere joined forces with Vi­for Phar­ma last month to com­mer­cial­ize its kid­ney drug sparsen­tan, a deal in which Vi­for shelled out $55 mil­lion up­front.

Mol­ly Painter

→ Speak­ing of Vi­for, Lee Hee­son (pres­i­dent, in­ter­na­tion­al) and Gre­go­ry Oakes (pres­i­dent, North Amer­i­ca) have al­so an­nounced their de­par­tures for per­son­al rea­sons, while Mol­ly Painter is about to ap­ply the first brush­strokes to her Vi­for can­vas as pres­i­dent, US start­ing Mon­day. Painter comes to Vi­for from Or­p­hazyme, where she held the same post as she will here, and af­ter three years at Shire she be­came VP, rare dis­ease at Take­da in 2019. Else­where, she’s had mar­ket­ing stints at Lund­beck and Bax­al­ta.

Patrick Walsh is jump­ing over to Im­mu­nic, which back in Feb­ru­ary had its lead drug fail to im­press in two sep­a­rate tri­als, as CBO. Walsh brings to the ta­ble ex­pe­ri­ence from his time at Ake­bia Ther­a­peu­tics, where he served as VP of busi­ness de­vel­op­ment. Pri­or to that stint, Walsh was in cor­po­rate de­vel­op­ment at AVEO On­col­o­gy.

Clin­ton Musil is head­ed for the ex­its at Cat­a­lyst Bio­sciences, an­nounc­ing his res­ig­na­tion as CFO of the South San Fran­cis­co biotech ef­fec­tive Oct. 29. We had him in this very space when he took the job on Ju­ly 1, 2020, and the search is on for a re­place­ment; mean­while, Cat­a­lyst con­troller Se­line Miller earns a pro­mo­tion to SVP, fi­nance and will al­so be in­ter­im chief fi­nan­cial and prin­ci­pal ac­count­ing of­fi­cer.

Tim­o­thy Hunt

Fil­ing for the $100 mil­lion IPO we’re so ac­cus­tomed to nowa­days, sol­id tu­mor-fo­cused Xilio Ther­a­peu­tics has in­stalled Tim­o­thy Hunt as chief cul­ture and cor­po­rate af­fairs of­fi­cer. From 2016-20, Hunt held the role of chief cor­po­rate af­fairs of­fi­cer at Ed­i­tas Med­i­cine, and he’s served as Cu­bist Phar­ma­ceu­ti­cals’ SVP of pub­lic af­fairs. Peer Re­view al­so notes that, af­ter get­ting pro­mot­ed to the po­si­tion in April, Ro­nan O’Ha­gan is out as Xilio’s CSO, ac­cord­ing to his LinkedIn page.

→ Raleigh, NC-based Rain­Bio, a gene ther­a­py play­er con­cen­trat­ing on corneal dis­eases, has named Gary Stern­berg its act­ing CEO. Stern­berg, the found­ing CEO of Star­gardt dis­ease-fo­cused Stargaz­er Phar­ma­ceu­ti­cals, is the ex-CBO at Eleven Bio­ther­a­peu­tics who was ther­a­peu­tic head of oph­thalmic med­ical af­fairs for a time at Genen­tech, tak­ing charge of US med­ical af­fairs for an­ti-VEGF block­buster Lu­cen­tis.

Blake Aftab

→ Climb­ing the ranks at al­lo­gene­ic gam­ma delta T cell ther­a­py play­er Adicet Bio, Blake Aftab has been pro­mot­ed to SVP and CSO. Aftab be­gan serv­ing as the biotech’s VP and head of re­search in April, and pri­or to his stint at Adicet, he was VP and head of pre­clin­i­cal sci­ence and trans­la­tion­al med­i­cine at Atara Bio­ther­a­peu­tics.

Amir Sho­jaei

→ With There­sa Heah set­ting off for Kriya and first-year CEO Robert Dempsey at the con­trols, Bal­ti­more-based eye dis­ease biotech As­cle­piX has now brought on Amir Sho­jaei as CSO and EVP, clin­i­cal de­vel­op­ment. Sho­jaei was Dempsey’s chief de­vel­op­ment of­fi­cer at TearClear and helmed eye-fo­cused TherOp­tix, which is now led by Au­ri­on Biotech founder Mon­ty Mon­toya. Pri­or to these po­si­tions, he was ther­a­peu­tic area head of oph­thal­mol­o­gy at Shire and Take­da.

→ San Diego-based Kite cell ther­a­py part­ner Shore­line Bio­sciences is bring­ing on Scott For­rest as CBO. Back in Jan­u­ary, we cov­ered his pro­mo­tion from CBO to CFO at Au­to­bahn Ther­a­peu­tics. For­rest, who co-found­ed ARCH-backed Black­Thorn Ther­a­peu­tics, has al­so served as COO and CFO at In­cep­tion Ther­a­peu­tics.

Jen­nifer Evans Stacey

Galera Ther­a­peu­tics out of Penn­syl­va­nia has a pair of new C-suit­ers, wel­com­ing chief com­mer­cial of­fi­cer Mark Bach­le­da and chief le­gal and com­pli­ance of­fi­cer Jen­nifer Evans Stacey. Bach­le­da played a key role in the launch­es of Breyanzi and Abec­ma at Bris­tol My­ers as VP & US busi­ness unit head for the CAR-T fran­chise. He’s al­so been VP of sales at Juno Ther­a­peu­tics and he end­ed his 15-year as­so­ci­a­tion with Am­gen in 2017 as the gen­er­al man­ag­er of Am­gen Czech Re­pub­lic. Evans Stacey moves on to Galera af­ter five years as the Wis­tar In­sti­tute’s VP, gen­er­al coun­sel, sec­re­tary and gov­ern­ment re­la­tions. Look­ing to tamp down the ef­fects of ra­di­a­tion, Galera’s lead drug ava­sopasem man­ganese is in Phase III for head and neck can­cer pa­tients with ra­dio­ther­a­py-in­duced se­vere oral mu­cosi­tis (SOM).

Gene Mack

Gene Mack has signed on to be CFO of Hous­ton neu­ro start­up Coya Ther­a­peu­tics, which launched in Feb­ru­ary with a noth­ing-too-fan­cy Se­ries A and the Treg re­search of Stan­ley Ap­pel to guide them. The CFO at On­coIm­mune be­fore Mer­ck pur­chased it in one of Roger Perl­mut­ter’s fi­nal deals, Mack was al­so the fi­nance lead at On­coIm­mune spin­out On­coC4.

Troels Koch

Eli Lil­ly’s saR­NA part­ner Mi­NA Ther­a­peu­tics has greet­ed a quar­tet of new ex­ecs, and tun­ing up first is SVP of chem­istry Troels Koch, the for­mer VP and head of re­search at Roche In­no­va­tion Cen­ter Copen­hagen. Next, Ju­lia Vas­sil­i­adou (VP, clin­i­cal op­er­a­tions) makes her way to Mi­NA af­ter 19 years with Glax­o­SmithK­line, where she re­cent­ly served as glob­al head of in-coun­try clin­i­cal op­er­a­tions. Al­so join­ing Robert Habib’s squad is Il­ian Tchakov, Mi­NA’s VP of clin­i­cal de­vel­op­ment who brings Big Phar­ma cre­den­tials from Lil­ly, Roche, As­traZeneca and was Ei­sai’s head of on­col­o­gy glob­al ear­ly clin­i­cal de­vel­op­ment. Last­ly, Kevin Fettes (VP, CMC and qual­i­ty op­er­a­tions) has been a VP in sim­i­lar ca­pac­i­ties with Gale­na and Dicer­na.

→ As Synair­gen gets in gear for reg­u­la­to­ry sub­mis­sions on SNG001, its in­haled in­ter­fer­on be­ta can­di­date to treat Covid-19, Roche vet Gareth Wal­ters is step­ping in as the UK com­pa­ny’s first chief reg­u­la­to­ry of­fi­cer. Dur­ing his sev­en years at Chugai Phar­ma­ceu­ti­cals, Wal­ters was head of Eu­ro­pean reg­u­la­to­ry af­fairs and, be­fore join­ing Synair­gen, glob­al reg­u­la­to­ry af­fairs head (re­search & ear­ly de­vel­op­ment).

Veit Schmelmer

→ Join­ing forces with J&J in a stem cell col­lab­o­ra­tion they hope can bear fruit in the treat­ment of acute myeloid leukemia, Vor Bio­phar­ma has paved the way for Veit Schmelmer to be SVP of pro­gram and al­liance man­age­ment. An 11-year vet in drug de­vel­op­ment at Take­da — name­ly En­tyvio — Schmelmer was pre­vi­ous­ly the project lead for MG­TA-145 at Ma­gen­ta, and from 2017-19 he was VP of port­fo­lio strat­e­gy for Mer­sana Ther­a­peu­tics.

Stef­fen Hell­mold has been ap­point­ed to the new­ly cre­at­ed role of SVP, busi­ness de­vel­op­ment, da­ta stor­age at San Fran­cis­co-based syn­bio spe­cial­ist Twist Bio­science. Be­fore join­ing Emi­ly Lep­roust‘s team at Twist, Hell­mold was VP of cor­po­rate strate­gic ini­tia­tives at West­ern Dig­i­tal. He al­so served as VP of mar­ket­ing at Ever­spin Tech­nolo­gies.

Sara Turken

→ With a study loom­ing to de­ter­mine if CRISPR gene edit­ing can cure HIV — earn­ing the FDA’s seal of ap­proval last month — Ex­ci­sion Bio­Ther­a­peu­tics has brought in three more staffers. Sara Turken (gen­er­al coun­sel) just closed out her three years at Rock­et Phar­ma­ceu­ti­cals as head of le­gal, com­pli­ance of­fi­cer & cor­po­rate sec­re­tary; Man­ish Anand (SVP, reg­u­la­to­ry af­fairs) has past reg­u­la­to­ry ex­pe­ri­ence from such com­pa­nies as Bio­Marin, Por­to­la and Cel­lec­tis, and since last sum­mer he had been AskBio’s VP of reg­u­la­to­ry af­fairs; and Robert Gun­ning (VP, con­troller) comes to Ex­ci­sion from his CFO post at No­var­tis sub Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, where he was al­so head of fi­nance trans­for­ma­tion.

→ As Vish Se­shadri pre­pares for his op­por­tu­ni­ty to take charge as CEO at Abeona, the gene and cell ther­a­py play­er has re­cruit­ed Jon Voss as VP, head of qual­i­ty. The erst­while EVP of glob­al qual­i­ty at Cel­lec­tis, a po­si­tion he held since 2019, Voss has al­so been a qual­i­ty con­trol ex­ec at Gen­er­a­tion Bio and Sarep­ta. The drug fur­thest along at Abeona is EB-101 for re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa.

John Tomtishen

→ Cell ther­a­py man­u­fac­tur­ing com­pa­ny and Po­sei­da part­ner Cel­lares has ap­point­ed John Tomtishen as VP of op­er­a­tions. Be­fore join­ing Cel­lares, Tomtishen was site man­ag­ing di­rec­tor of Leg­end Biotech’s cor­po­rate head­quar­ters. Cel­lares has nabbed a to­tal of $100 mil­lion in fund­ing, $82 mil­lion of that from a Se­ries B in May, for its Cell Shut­tle.

Ken Song’s Rayze­Bio, which snagged a nine-fig­ure Se­ries C round in June to bring its to­tal fund­ing to $258 mil­lion, has en­list­ed Genen­tech alum Roza­lyn Lit­tler as VP of reg­u­la­to­ry and qual­i­ty. Lit­tler al­so brings reg­u­la­to­ry ex­pe­ri­ence from Prometheus Lab­o­ra­to­ries, Heron Ther­a­peu­tics and Metacrine. One more Rayze­Bio note: Nek­tar SVP and ex­ec­u­tive clin­i­cal fel­low Mary Tagli­a­fer­ri now has a seat on a board of di­rec­tors that al­so in­cludes Ver­sant’s Jer­el Davis and ven­Bio’s Aaron Roys­ton.

Su­san Sil­ber­mann

→ Long­time Pfiz­er alum Su­san Sil­ber­mann has been elect­ed to the board of di­rec­tors at Per­cep­tive’s Lian­Bio a week af­ter Michael Humphries was named chief sci­en­tif­ic ad­vi­sor. Sil­ber­mann, who just re­tired from Pfiz­er (a move sev­er­al of her oth­er col­leagues have ei­ther made or in­tend to make), chaired the phar­ma gi­ant’s Covid-19 task force and had been glob­al pres­i­dent, emerg­ing mar­kets. In ad­di­tion, J&J vet Jesse Wu has al­so joined Lian­Bio’s board.

Intar­cia pres­i­dent and CEO Kurt Graves has been named ex­ec­u­tive chair­man of ion­ic liq­uids biotech i2O Ther­a­peu­tics. Graves, who has helmed and chaired Intar­cia since 2012, was al­so chair­man of the board at Ra­dius Health from 2011-20.

Kath­leen Tre­go­ning

→ Af­ter sign­ing a $125 mil­lion li­cens­ing agree­ment with Health­Care Roy­al­ty Part­ners last month, Spero Ther­a­peu­tics has added Kath­leen Tre­go­ning to its board of di­rec­tors. Tre­go­ning cur­rent­ly serves as the chief cor­po­rate af­fairs of­fi­cer at Cerev­el. Be­fore join­ing Cerev­el, she held the EVP of ex­ter­nal af­fairs po­si­tion at Sanofi.

Bob Dug­gan has turned to Ken Clark as the newest board mem­ber at Sum­mit Ther­a­peu­tics a few weeks af­ter the FDA raised ob­jec­tions to the pri­ma­ry end­point for its C. dif­fi­cile drug ri­dini­la­zole. Clark, who was be­hind the scenes of Ab­b­Vie’s $21 bil­lion deal to buy Dug­gan’s old com­pa­ny Phar­ma­cyclics, is a part­ner at Wil­son Son­si­ni Goodrich & Rosati.

Olivi­er Danos

→ Us­ing a gene ther­a­py ap­proach for eye dis­eases and top­ping off its Se­ries B fi­nanc­ing this sum­mer, French biotech Coave Ther­a­peu­tics — once known as Ho­ra­mahas added Olivi­er Danos and Fred­er­ic Chere­au to its board of di­rec­tors. Danos is the CSO at Re­genxbio, and Chere­au has been CEO at Log­icBio for the last five years.

Emi­ly Rollins is now a mem­ber of the board of di­rec­tors at Sci­ence 37, which is do­ing a SPAC dance af­ter merg­ing with LifeSci Ac­qui­si­tion II Corp. last week. Rollins, who will chair the au­dit com­mit­tee at Sci­ence 37, is an ex-au­dit and as­sur­ance part­ner at De­loitte.

→ The new va­cant seat on the su­per­vi­so­ry board at In­teR­NA Tech­nolo­gies has been se­cured by for­mer Aduro Biotech CSO An­drea van El­sas. Van El­sas suc­ceeds Mark Vaeck, who stepped down. Cur­rent­ly, van El­sas is a ven­ture part­ner with Third Rock Ven­tures and has pre­vi­ous­ly served in roles at Mer­ck, Organon and BioNovion.

Derek Graf al­so con­tributed to this edi­tion.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.