Ex-Take­da ex­ec hits the ground run­ning at the helm of rare dis­ease biotech — with 3 pri­or­i­ties off the bat; Sea­soned CEO jumps to ALS up­start

Tauhid Ali

Af­ter spend­ing years in the bio­phar­ma and rare dis­ease space, Tauhid Ali fi­nal­ly got the op­por­tu­ni­ty to ful­fill a per­son­al am­bi­tion: to co-found and cre­ate a biotech com­pa­ny in the rare dis­ease space. And he’s of­fi­cial­ly join­ing the transat­lantic biotech, which has per­son­nel in both the UK and the US, as CEO.

Af­ter the com­pa­ny was found­ed in the sec­ond half of 2021, Oak Hill Bio of­fi­cial­ly emerged from stealth in Feb­ru­ary with Take­da throw­ing its weight be­hind the biotech — by out-li­cens­ing Take­da as­sets and tak­ing an eq­ui­ty stake in the com­pa­ny. Take­da sent over some tal­ent to kick things off with a bang: CMO Vic­to­ria Niklas, most re­cent­ly glob­al pro­gram leader a Take­da as­set, now one of Oak Hill’s lead pro­grams, as well as Nor­man Bar­ton, the ex­ec be­hind the oth­er lead pro­gram at Oak Hill. Daniel Cur­ran, Take­da’s head of rare ge­net­ics and hema­tol­ogy ther­a­peu­tic area unit, al­so joined the board of di­rec­tors.

While the biotech is get­ting its feet off the ground, Ali has al­ready went ahead on some of the ground­work, start­ing with net­work­ing at the glob­al health­care con­fer­ence cur­rent­ly be­ing host­ed by RBC Cap­i­tal in NYC.

And in the mean­time, Ali sat down with End­points News.

Ali, orig­i­nal­ly from Scot­land, grew up with a sci­ence back­ground — his fa­ther was a physi­cian, and al­so grew up along­side peo­ple who suf­fered from dif­fer­ent chron­ic ill­ness­es.

“And I was just mo­ti­vat­ed to do some­thing in my life that I could look back on and say I was a part of a team — with a stress on team — that con­tributed to get­ting a ther­a­peu­tic to mar­ket and more im­por­tant­ly to pa­tients,” Ali said.

With that back­ground, Ali then went to uni­ver­si­ty, get­ting his mas­ter’s de­gree from the Welsh School of Phar­ma­cy and then go­ing on to get his PhD at Cardiff Uni­ver­si­ty, spe­cial­iz­ing in Parkin­son’s dis­ease. From there, it was pret­ty much noth­ing but rare dis­ease, work­ing with big com­pa­nies such as UCB, Ipsen, and Shire Phar­ma­ceu­ti­cals be­fore Shire got bought out by Take­da, where Ali even­tu­al­ly end­ed up spend­ing a few years.

While at Take­da, Ali found­ed a vir­tu­al rare dis­ease unit called TAKcel­er­a­tor, an in-house se­mi-au­tonomous ac­cel­er­a­tor. The goal, ac­cord­ing to Ali, was look­ing at sin­gle as­sets, and then take them through pre­clin­i­cal and ear­ly clin­i­cal stages. Af­ter that’s done, piv­ot to work­ing with VCs and spin out sin­gle-as­set biotechs with an em­pha­sis in rare dis­ease.

“It was a way to learn — one, about rare dis­ease drug de­vel­op­ment, pa­tient ad­vo­ca­cy, and al­so, in­ter­est­ing­ly, on op­er­a­tional ex­e­cu­tion. That was, how can we be more ag­ile and laser fo­cused in the way that we do R&D,” Ali added.

The biotech’s fo­cus so far (al­beit not very long yet) is rare dis­ease and neona­tal in­di­ca­tions — which could open the door for a sub­stan­tial share of the mar­ket in the US if the biotech is suc­cess­ful.

The biotech’s lead drug can­di­date, OHB-607, is a for­mer Shire drug that was de­signed to treat com­pli­ca­tions for ex­treme­ly preterm in­fants. The can­di­date is a re­com­bi­nant ver­sion of in­sulin-like growth fac­tor 1, which has been not­ed as a key dri­ver of fe­tal growth that the fe­tus pro­duces very lit­tle of un­til reach­ing 30 weeks.

Oak Hill not­ed that the drug showed a “sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment” in pre­vent­ing a se­vere form of a chron­ic lung dis­ease called bron­chopul­monary dys­pla­sia.

The most fa­mous neona­tal drug in the US, Mak­e­na, was ap­proved to re­duce the rate of pre­ma­ture births back in 2011 via ac­cel­er­at­ed ap­proval. While the drug is still avail­able, an FDA ad­vi­so­ry com­mit­tee vot­ed 9-7 to pull the ap­proval in 2019 in a still-on­go­ing, high­ly con­tro­ver­sial saga. The FDA will hold a meet­ing lat­er this year to re­view the ap­proval.

As for the com­pa­ny’s first steps, there’s ac­tu­al­ly three things Ali is fo­cus­ing on for now in both short term and the long term. First thing — ex­pand the team. The head­count at Oak Hill is cur­rent­ly about 13 em­ploy­ees, but Ali said it will go up to 15 in about a month. Sec­ond­ly is to ex­e­cute on the clin­i­cal pro­grams, which in­clude restart­ing a Phase IIb tri­al and start­ing up a brand new Phase II tri­al for its two lead, ex-Take­da drugs. And in the mean­time, raise more cap­i­tal for “key in­flec­tion points,” which in­clude clin­i­cal tri­als. Ac­cord­ing to Ali, those tri­als should have read­outs some­time in 2024.

— Paul Schloess­er

Kim Black­well

→ Eli Lil­ly vet Kim­ber­ly Black­well will take over as CEO at Zen­tal­is, where she has served as in­de­pen­dent di­rec­tor since 2020. Black­well was VP of ear­ly phase on­col­o­gy and im­muno-on­col­o­gy at Lil­ly, and she al­so served as CMO at Tem­pus. At Pfiz­er-part­nered Zen­tal­is, which con­cur­rent­ly raised $200 mil­lion, Black­well will look to ad­vance two of the biotech’s lead can­di­dates, Wee1 in­hibitor ZN-c3 and BCL-2 in­hibitor ZN-d5.

Clay Sie­gall

Fol­low­ing his ar­rest over al­le­ga­tions of do­mes­tic vi­o­lence, long­time Seagen CEO Clay Sie­gall re­signed from his post at the Wash­ing­ton-based biotech ear­li­er this week, as well as his board seats at Umo­ja Bio­phar­ma and Nurix Ther­a­peu­tics. Sie­gall was ar­rest­ed on April 23, and po­lice re­ports along with a sub­se­quent tem­po­rary re­strain­ing or­der de­scribed a pat­tern of abu­sive be­hav­ior. Sie­gall has de­nied the claims. Seagen launched its own in­ves­ti­ga­tion, al­though the biotech not­ed that Sie­gall’s de­par­ture was not dri­ven by find­ings from that ex­plo­ration. CMO Roger Dansey has stepped up as in­ter­im CEO while the com­pa­ny search­es for a per­ma­nent suc­ces­sor, and Fe­lix Bak­er is re­plac­ing Sie­gall as board chair.

ALS is one of the most dif­fi­cult dis­eases in drug de­vel­op­ment. Ear­li­er this year, Med­ical Ex­cel­lence Cap­i­tal joined forces with the non­prof­it Pro­ject ALS and lead­ing re­searchers at Co­lum­bia Uni­ver­si­ty to launch Pro­JenX, a biotech fo­cused on treat­ments for ALS and oth­er de­bil­i­tat­ing brain dis­eases. Now they’re tap­ping an ex­pert to build it up. Stan Abel is tak­ing the reins, af­ter leav­ing his post as CEO of SiteOne Ther­a­peu­tics. The long­time chief ex­ec­u­tive is known for guid­ing biotechs through Big Phar­ma ac­qui­si­tions: He was CEO at Corthera through its sale to No­var­tis, CFO of Cerexa through its sale to For­est Lab­o­ra­to­ries, and CFO of Penin­su­la through its sale to John­son & John­son. Now he’ll fo­cus on bring­ing Pro­JenX’s can­di­date pros­etin through a three-part Phase I tri­al in ALS.

Phuong Khanh Mor­row

Ef­fec­tive May 23rd, Phuong Khanh Mor­row will take over as CMO at CRISPR Ther­a­peu­tics. Mor­row most re­cent­ly served as VP and glob­al ther­a­peu­tic area head of hema­tol­ogy, GI on­col­o­gy, GU on­col­o­gy, and bone at Am­gen. She has al­so served as as­sis­tant pro­fes­sor, de­part­ment of breast med­ical on­col­o­gy at the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter.

Stacey Davis

→ Stacey Davis has joined tu­mor-se­lec­tive im­muno-on­col­o­gy biotech Xilio Ther­a­peu­tics as CBO. Davis most re­cent­ly served as VP, lung and im­muno-on­col­o­gy fran­chise, US on­col­o­gy at No­var­tis On­col­o­gy. She has al­so served as SVP and gen­er­al man­ag­er at Prominex as well as US im­munol­o­gy, head, com­mer­cial strat­e­gy, in­sights and op­er­a­tions at Janssen Biotech.

Ofer Go­nen

Ef­fec­tive June 30th, Ofer Go­nen will tran­si­tion from board mem­ber and CEO of Clal Biotech­nol­o­gy In­dus­tries to CEO of Medi­Wound. He will re­place cur­rent CEO Sharon Mal­ka, who will take a seat on the board of di­rec­tors. Be­fore join­ing Clal, Go­nen was gen­er­al man­ag­er of Bio­med­ical In­vest­ments, and the founder and man­ag­ing Part­ner at Arte Ven­ture Group.

Ryan Bleeks

Vi­siox Phar­ma has been rel­a­tive­ly qui­et since burst­ing on­to the eye ther­a­py scene with two lead can­di­dates li­censed from Sun Phar­ma Ad­vanced Re­search Com­pa­ny back in De­cem­ber. Now, the com­pa­ny says it’s ready to ap­proach the FDA this year — and it’s tap­ping a chief ex­ec­u­tive to lead the way. Ryan Bleeks is com­ing aboard to “to build a busi­ness for the fu­ture,” he said in an an­nounce­ment on Tues­day. Be­fore this, Bleeks was the VP of all things sales at RVL Phar­ma­ceu­ti­cals, where he helped launch the ac­quired ble­pharop­to­sis prod­uct Up­neeq. The new CEO is al­ready lin­ing up two NDA sub­mis­sions lat­er this year in the glau­co­ma and cataract surgery mar­kets.

Craig La­fer­rière

→ UK vac­cine out­fit iosBio has an­oth­er C-suite ex­ec in its ranks — just a month af­ter re­cruit­ing Ben War­riner, the for­mer fi­nance VP from fel­low UK-based Free­line Ther­a­peu­tics, to be its new chief fi­nan­cial of­fi­cer. This time, it went across the pond to Cana­da and brought Craig La­fer­rière on­board as its new chief de­vel­op­ment of­fi­cer. La­fer­rière, whose last stop was as a vac­cine de­sign con­sul­tant, had done stints at GSK and Pfiz­er Cana­da as a re­searcher, lat­er as a med­ical ad­vi­sor to Pfiz­er Cana­da’s vac­cine lead­er­ship team.

Daniel Marks

→ Cachex­ia physi­cian Daniel Marks has tak­en over as CMO at En­de­vi­ca Bio. He has worked out of Ore­gon Health & Sci­ence Uni­ver­si­ty in Port­land, OR for the last 2+ decades, work­ing his way up from a sci­en­tist and pe­di­atric en­docri­nol­o­gist to be­ing a man of many hats, such as se­nior as­so­ciate dean of re­search, the di­rec­tor of the Pa­pé Fam­i­ly Pe­di­atric Re­search In­sti­tute and di­rec­tor of the pa­tient re­silien­cy pro­gram for the Bren­den-Col­son Cen­ter for Pan­cre­at­ic Care. While at the uni­ver­si­ty, Marks was a se­nior con­sult­ing ad­vi­sor for the Bill & Melin­da Gates Foun­da­tion on its birth, growth & de­vel­op­ment team for 4.5 years and worked as a pe­di­atric en­docri­nol­o­gist at St. Luke’s Chil­dren’s Hos­pi­tal from 2009-2013.

Jo­han Baeck

→ Promon­to­ry Ther­a­peu­tics, a small mol­e­cule on­col­o­gy im­munother­a­py com­pa­ny, has ap­point­ed Jo­han Baeck as EVP and CMO. Baeck most re­cent­ly served as SVP, clin­i­cal de­vel­op­ment and med­ical af­fairs at Jounce Ther­a­peu­tics. By mov­ing in­to this po­si­tion, Baeck will re­place for­mer CMO Joseph O’Don­nell, who will now serve as se­nior med­ical di­rec­tor fo­cus­ing on pa­tient el­i­gi­bil­i­ty, en­roll­ment and clin­i­cal case man­age­ment.

Melanie Rol­li

→ Helsinn Group has a new group COO — Melanie Rol­li, who of­fi­cial­ly starts on June 1. A doc­tor by train­ing, she worked as a re­search fel­low at the Scripps Re­search In­sti­tute be­fore jump­ing on board with No­var­tis, where she spent more than a decade be­fore leav­ing as its glob­al head of med­ical safe­ty. Af­ter that, Rossi went on mul­ti­ple stints as biotech CEO for PIQUR Ther­a­peu­tics AG and AELIX Ther­a­peu­tics.

Kei­th Kendall

Af­ter falling on hard times amid the cur­rent bear mar­ket, Aque­s­tive Ther­a­peu­tics an­nounced that long­time CEO Kei­th Kendall is hit­ting the ex­it. While the com­pa­ny didn’t pro­vide a rea­son for the change, it not­ed that the move was “un­re­lat­ed to the Com­pa­ny’s strat­e­gy, op­er­a­tions, fi­nan­cial con­di­tion, re­port­ed fi­nan­cial re­sults, in­ter­nal con­trols or dis­clo­sure con­trols and pro­ce­dures.” COO Daniel Bar­ber is mov­ing up the ranks to re­place Kendall — and it looks like he’ll have his work cut out for him. The com­pa­ny’s stock $AQST is down more than 70% since the start of 2020, as the FDA con­tin­ues to weigh its once-re­ject­ed drug ap­pli­ca­tion for oral film to treat seizures. Bar­ber has been at Aque­s­tive since 2007, serv­ing in high-rank­ing po­si­tions such as SVP and chief strat­e­gy and de­vel­op­ment of­fi­cer over the past eight years.

Bruce Car

As End­points’ own Kyle LaHu­cik re­port­ed ear­li­er this week, Bruce Car will no longer serve as Agios‘ CSO. The long-time Bris­tol My­ers Squibb vet de­parts amid a round of lay­offs at Agios, as the com­pa­ny shifts to fo­cus on re­search and beef up its pipeline.

Just a month af­ter show­ing off its first clin­i­cal da­ta to in­vestor ap­plause, the CMO at NK cell ther­a­py spe­cial­ist Nkar­ta has de­cid­ed to re­sign. Kanya Ra­jangam — just shy of cross­ing the 3.5 year mark at the biotech — had done stints at Ex­elix­is, Onyx and Atara Bio­ther­a­peu­tics be­fore land­ing at the out­fit in 2018. The com­pa­ny said that Ra­jangam, whose res­ig­na­tion be­comes fi­nal on June 5, had de­cid­ed to re­sign to go over­see R&D at a yet-undis­closed biotech. In the mean­time, tak­ing her place is David Shook, a two-year vet­er­an at Nkar­ta with the new ti­tle of VP, clin­i­cal de­vel­op­ment.

Yung Chyung

As SMA out­fit Schol­ar Rock an­nounced ear­li­er this week that it laid off 25% of its staff, the com­pa­ny al­so re­vealed that CMO Yung Chyung has de­cid­ed to step down to ex­plore “new ca­reer op­por­tu­ni­ties,” ac­cord­ing to an SEC fil­ing. His last day is set for June 30 — while the biotech search­es for a re­place­ment in the mean­time. The Har­vard-trained doc­tor had spent time work­ing up the lad­der at Mass­a­chu­setts Gen­er­al Hos­pi­tal as a fel­low un­til he made the jump over to biotech in 2010 with Gen­zyme and Dyax be­fore join­ing Schol­ar Rock as CMO in 2016.

The man in charge at pen­ny stock play­er Adamis Phar­ma­ceu­ti­cals is now re­tired. Af­ter be­ing on the re­ceiv­ing end of two CRLs in a 12-month pe­ri­od be­fore get­ting an FDA ap­proval for its high-dose nalox­one in­jec­tion ZIMHI late last year, ex-CEO and pres­i­dent Den­nis Car­lo hand­ed over the keys of the biotech to David Mar­guglio, an Adamis co-founder who was the biotech’s chief busi­ness of­fi­cer since 2017. Mar­guglio had spent time in the fi­nan­cial sec­tor at Cit­i­group and Mer­rill Lynch be­fore join­ing Adamis in 2006 as VP, busi­ness de­vel­op­ment and board di­rec­tor.

Char­lottesville, VA-based Dif­fu­sion Phar­ma­ceu­ti­cals, which is try­ing to find ther­a­peu­tics to en­hance the body’s abil­i­ty to de­liv­er oxy­gen, has added to its C-suite. Raven Jaeger joined the com­pa­ny Thurs­day as its CRO. Jaeger will be re­spon­si­ble for the de­vel­op­ment and im­ple­men­ta­tion of reg­u­la­to­ry and re­lat­ed strate­gies to sup­port the de­vel­op­ment and com­mer­cial­iza­tion of Dif­fu­sion’s drug can­di­dates. Jaeger joins Dif­fu­sion from Bridge­Bio Phar­ma, where she was most re­cent­ly SVP for reg­u­la­to­ry af­fairs.

Emi­ly Doyle

Malvern, PA-based biotech Re­ac­tion Bi­ol­o­gy has made some moves at the top lev­el — bring­ing in two in­dus­try vet­er­ans in­to the C-suite. Alan Find­later has been ap­point­ed to the po­si­tion of CCO and Emi­ly Doyle to the po­si­tion of chief peo­ple of­fi­cer. Find­later, a 25+ year vet­er­an of the life sci­ences in­dus­try, will over­see Re­ac­tion’s BD op­er­a­tions, client ser­vices and sales func­tions. Pri­or to join­ing Re­ac­tion, Find­later was most re­cent­ly CCO of BioIVT, and he had pri­or ex­ec­u­tive or di­rec­to­r­i­al roles at Vi­um, Charles Riv­er Lab­o­ra­to­ries and WIL Re­search Lab­o­ra­to­ries.

Doyle is bring­ing more than 20 years ex­pe­ri­ence in­to her po­si­tion, with a back­ground in hu­man re­sources, or­ga­ni­za­tion­al de­vel­op­ment and tal­ent ac­qui­si­tion. She will be re­spon­si­ble for Re­ac­tion’s peo­ple strat­e­gy, in­clud­ing tal­ent ac­qui­si­tion, lead­er­ship de­vel­op­ment, com­pen­sa­tion, and di­ver­si­ty and in­clu­sion. Be­fore Re­ac­tion brought Doyle aboard, she was most re­cent­ly SVP, hu­man re­sources at Inzen Ther­a­peu­tics, and pre­vi­ous­ly served as Strong­bridge Bio­Phar­ma‘s chief HR of­fi­cer.

Dave Mor­ris

→ Va­lo‘s CMO Dave Mor­ris has been pro­mot­ed to pres­i­dent of ther­a­peu­tics and tech­nol­o­gy. Pri­or to serv­ing at Va­lo, Mor­ris was the CMO of En­ter­prise Ther­a­peu­tics and an op­er­at­ing part­ner of the No­var­tis Ven­ture Fund. He al­so served as glob­al head of clin­i­cal op­er­a­tions, an­a­lyt­ics, and re­gions  dur­ing his time at No­var­tis.

The man who once head­ed up Bris­tol My­ers’ glob­al phar­ma­ceu­ti­cals di­vi­sion back in the day — and snatched up board ap­point­ments like John Maraganore — stepped back for a bit in 2019. But it now looks like he is com­ing back. Don Hay­den, who com­mit­ted to be­ing CEO at Wind­MIL a few years back, ac­cept­ed a board po­si­tion on Wednes­day at Or­biMed’s TKI play in The­seus Phar­ma­ceu­ti­cals, sev­en months af­ter it went pub­lic and scored $160 mil­lion.  It’s his lat­est board ap­point­ment af­ter serv­ing on the board of mul­ti­ple com­pa­nies such as Ot­su­ka’s US sub­sidiary, RE­GENXBIO and Am­i­cus Ther­a­peu­tics.

John Per­ry

The GSK-backed de­vel­op­er of syn­thet­ic res­cue ther­a­pies, Adres­tia Ther­a­peu­tics, has named John Per­ry as its VP of hu­man ge­net­ics. Per­ry, an ex­pert in hu­man pop­u­la­tion ge­net­ics, is a pro­fes­sor at the Uni­ver­si­ty of Cam­bridge. His ex­per­tise will aim to com­ple­ment Adres­tia’s tech­nol­o­gy plat­form, pro­gress­ing a se­ries of ther­a­pies to treat dis­eases with a ge­net­ic com­po­nent.

Stephanos Ioan­ni­dis

A small mol­e­cule play­er out of CRISPR pi­o­neer David Liu’s lab is get­ting a new ex­ec­u­tive VP of drug dis­cov­ery as it con­tin­ues to push for­ward in what it be­lieves could be block­buster in­di­ca­tions. Stephanos Ioan­ni­dis is join­ing the team at Exo Ther­a­peu­tics. Ioan­ni­dis brings more than 20 years of ex­pe­ri­ence in neu­ro­science, on­col­o­gy and in­flam­ma­tion — the lat­ter two of which are big fo­cus­es for Exo — and a re­sume stacked with com­pa­nies such as H3 Bio­med­i­cine, FOR­MA Ther­a­peu­tics, and As­traZeneca. Be­fore join­ing Exo, Ioan­ni­dis was ex­ec­u­tive VP and head of dis­cov­ery at IFM Ther­a­peu­tics, where he led a group fo­cused on im­mune sys­tem ther­a­peu­tics.

Exo is al­so bring­ing on Cather­ine Scholz as se­nior VP of pro­gram man­age­ment. Scholz hails from H3 Bio­med­i­cines, but she’s al­so made stops at Ku­ra On­col­o­gy, EMD Serono, Mil­len­ni­um Phar­ma­ceu­ti­cals and Bay­er Scher­ing Phar­ma.

Cure­Duchenne has pro­mot­ed Lian­na Or­lan­do to VP of re­search and has added Bradley Hodges as part­ner of Cure­Duchenne Ven­tures. Or­lan­do start­ed at Cure­Duchenne in 2019 as se­nior di­rec­tor of re­search, while Hodges is the founder of Prothe­lia and has served as a dis­cov­ery con­sul­tant for Third Rock Ven­tures.

Gene­va-based women’s health biotech Ob­sE­va brings back An­nette Clan­cy as chair of the board. Clan­cy, an in­vestor with Sanofi-backed French VC Jeito, held the chair po­si­tion in 2013-2016 af­ter join­ing the board ear­li­er that year. A GSK vet­er­an, Clan­cy spent 30 years in the UK phar­ma’s BD di­vi­sion be­fore mov­ing more in­to the VC realm, which was ini­tial­ly as a se­nior ad­vi­sor to Fra­zier Health­care Ven­tures. She is al­so the chair of the board at ENYO Phar­ma. Clan­cy re­places Frank Ver­wiel, the for­mer pres­i­dent and CEO at Ap­tal­is Phar­ma who has stepped down from Ob­sE­va’s board and who cur­rent­ly has a board po­si­tion at In­tel­lia Ther­a­peu­tics.

David Fa­j­gen­baum

→ David Fa­j­gen­baum will join Crey­on Bio as com­pa­ny ad­vi­sor and board ob­serv­er. Fa­j­gen­baum is an as­sis­tant pro­fes­sor of trans­la­tion­al med­i­cine and hu­man ge­net­ics at the Perel­man School of Med­i­cine at the Uni­ver­si­ty of Penn­syl­va­nia and as­so­ciate di­rec­tor of pa­tient im­pact at the Penn Or­phan Dis­ease Cen­ter.

David John Jeans

→ David John Jeans has been ap­point­ed as a board of di­rec­tors of Sin­ga­pore-based His­toIn­dex, an ar­ti­fi­cial in­tel­li­gence dig­i­tal pathol­o­gy plat­form for fi­brot­ic dis­eases. Jeans has held se­nior lead­er­ship po­si­tions in ma­jor cor­po­ra­tions such as Smith & Nephew, Bris­tol My­ers Squibb, J&J and Amer­sham plc, which is now GE Health­care. He was pre­vi­ous­ly the chair­man of Cardiff Uni­ver­si­ty, deputy chief ex­ec­u­tive of the Med­ical Re­search Coun­cil, chaired the Trustee Board of MRC Tech­nol­o­gy and served as a trustee of the Fran­cis Crick In­sti­tute.

→ Mereo Bio­Phar­ma has ap­point­ed Ab­dul Mul­lick to its board of di­rec­tors. Mul­lick cur­rent­ly serves as pres­i­dent & CEO of Ky­owa Kirin In­ter­na­tion­al, a sub­sidiary of Japan-based Ky­owa Kirin Co. He has al­so served at No­var­tis as glob­al head of the di­a­betes fran­chise.

Karen Smith

→ Ta­laris Ther­a­peu­tics has added Karen Smith to its board of di­rec­tors. Smith cur­rent­ly serves as CMO at Novos­teo, and al­so sits on the board of Sang­amo Ther­a­peu­tics, Cap­stan Ther­a­peu­tics and Antares Phar­ma.

→ Lefei Sun has been ap­point­ed as non-ex­ec­u­tive di­rec­tor at HutchMed. Since 2018, Sun has served as man­ag­ing di­rec­tor and head of Chi­na health­care for Gen­er­al At­lantic.

Arun Oberoi

→ Physics-based dis­cov­ery unit Schrödinger ap­point­ed Arun Oberoi to its board of di­rec­tors ear­li­er this week. Oberoi, a for­mer soft­ware ex­ec­u­tive, held pre­vi­ous po­si­tions at Red Hat, the soft­ware group at IBM and once worked in IT gi­ant Hewlett Packard’s sales di­vi­sion.

→ Ezra Co­hen, the di­vi­sion chief of UC San Diego Health Hema­tol­ogy-On­col­o­gy and co-di­rec­tor of the San Diego Cen­ter for Pre­ci­sion Im­munother­a­py, has been ap­point­ed as the chair­man of the sci­en­tif­ic ad­vi­so­ry board at Pangea Bio­med.

Suke­tu Upad­hyay

A day af­ter an­nounc­ing that it’s ex­pand­ing its R&D op­er­a­tions in Boston, Ver­tex ap­point­ed Big Phar­ma vet­er­an Suke­tu Upad­hyay to its board of di­rec­tors. Upad­hyay is cur­rent­ly ex­ec­u­tive VP and CFO at the In­di­ana-based or­tho­pe­dic med­ical de­vice com­pa­ny Zim­mer Bio­met — but he’s pre­vi­ous­ly held sev­er­al high-rank­ing fi­nance and strat­e­gy roles at Bris­tol My­ers Squibb, En­do In­ter­na­tion­al, As­traZeneca and John­son & John­son.

Cor­rec­tion: A cor­rec­tion has been made to re­flect that Mak­e­na is still avail­able in the US, de­spite the FDA vot­ing 9-7 back in 2019 to pull it from the mar­ket. 

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.

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

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

John Evans, Beam Therapeutics CEO

Beam's base-edit­ed al­lo­gene­ic CAR-T gets FDA go-ahead af­ter four-month wait

The FDA wanted more information on four key areas before it would let Beam Therapeutics proceed with human testing for a cell therapy in a certain type of leukemia. It appears the biotech has answered the agency’s queries.

The US regulator cleared the base-edited, off-the-shelf CAR-T, Beam said Friday morning, lifting a hold from this summer. More details on specific next steps for the Phase I will come out next year, the Boston-area biotech said.

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