Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

Bain Cap­i­tal is de­ploy­ing one of its top in­vestors to Cerev­el Ther­a­peu­tics, steer­ing a $350 mil­lion-plus neu­ro play carved out of Pfiz­er. Or­ly Mis­han — a co-founder and prin­ci­pal of Bain’s life sci­ences unit — was in­volved in the part­ner­ship that birthed the biotech spin­out in the first place. As Cerev­el’s first chief busi­ness of­fi­cer, she is tasked with cor­po­rate de­vel­op­ment, pro­gram man­age­ment as well as tech­ni­cal op­er­a­tions. 

Cerev­el launched last Oc­to­ber af­ter Adam Kop­pel and Chris Gor­don at Bain spear­head­ed a deal to spin the neu­ro­sciences pro­grams Pfiz­er had aban­doned (along­side 300 staffers) out to a new, well-fund­ed com­pa­ny. Since then it’s been build­ing out its own team, fill­ing the lead­er­ship ranks with alum­ni of Sang­amo, Ot­su­ka and Mer­ck.

 “Cerev­el Ther­a­peu­tics is pur­pose-built to progress neu­ro­science ther­a­pies in a sus­tain­able way, and I look for­ward to work­ing with the team to ad­vance the sci­ence in­ter­nal­ly and through ex­ter­nal col­lab­o­ra­tions,” she said in a state­ment. Be­fore join­ing Bain, Mis­han spent more than a decade at the front­line of health­care busi­ness at Boston Sci­en­tif­ic and Bio­gen.

→ In the wake of Sil­la­Jen’s dev­as­tat­ing Phase III ter­mi­na­tion, chief busi­ness of­fi­cer He­le­na Chaye is jump­ing to an­oth­er on­colyt­ic virus com­pa­ny. She is now the CEO of West­ern On­colyt­ics, a Pitts­burgh biotech count­ing on the West­ern Re­serve strain of the vac­cinia virus to de­liv­er mul­ti­ple ways of trig­ger­ing an im­mune re­sponse. In the new job, she re­joins Stephen Thorne, co-founder and CSO, who al­so helped cre­ate Jen­nerex — the Sil­la­Jen pre­de­ces­sor where Chaye was an ear­ly ex­ec­u­tive. 

→ While their lead adeno­sine A2A re­cep­tor an­tag­o­nist pro­gram, EOS100850, is cur­rent­ly in a Phase I/Ib study, Gos­selies, Bel­gium and Cam­bridge, Mass­a­chu­setts-based iTeos Ther­a­peu­tics has an­nounced the ap­point­ment of Matthew Call as COO. Call served in the same role at En­do­cyte — ac­quired last year for $2.1 bil­lion by No­var­tis — where he was re­spon­si­ble for all busi­ness de­vel­op­ment and strate­gic trans­ac­tions. iTeos hopes that their sec­ond pro­gram, a ful­ly hu­man AD­CC-en­abling an­ti-TIG­IT an­ti­body (EOS884448), will en­ter the clin­ic in the sec­ond half of 2019. 

→ As it preps for a com­mer­cial piv­ot, Cir­cas­sia has wooed Pfiz­er vet Jonathan Emms to the new­ly cre­at­ed role of COO and nam­ing him a di­rec­tor while R&D chief Rod Hafn­er steps down from the board. Emms’ ex­pe­ri­ence lead­ing glob­al com­mer­cial ac­tiv­i­ties for Pfiz­er, as well as a stint with GSK, makes him well-po­si­tioned to over­see the British drug­mak­ers’ up­com­ing moves. Chief of all will be the US launch of Du­ak­lir, the COPD drug from As­traZeneca; there are al­so plans to es­tab­lish a new sales team in Chi­na and grow Cir­cas­sia’s pres­ence in Eu­rope. Mean­while, Hafn­er will shift his fo­cus to busi­ness de­vel­op­ment, sup­ply chain, med­ical af­fairs, reg­u­la­to­ry and qual­i­ty mat­ters.

→ Rare dis­ease play­er Strong­bridge Bio­phar­ma has reshuf­fled its C-suite, tap­ping Richard Kol­len­der as COO and pro­mot­ing CBO Robert Lutz to CFO. Kol­len­der, a long­time health­care in­vestor, was a board di­rec­tor. Lutz, a Shire vet, re­places Bri­an Davis as he heads off to oth­er op­por­tu­ni­ties.

Kath­leen Ford Ku­ra

→ Just a year af­ter re­cruit­ing Cel­gene/Re­cep­tos ex­ec John Far­nam to be COO, Ku­ra On­col­o­gy is bring­ing in Kath­leen Ford to fill his shoes. Ford al­so brings im­pres­sive phar­ma cre­den­tials, hav­ing most re­cent­ly head­ed glob­al clin­i­cal op­er­a­tions at Mer­ck KGaA’s Serono and pre­vi­ous­ly held sim­i­lar roles at Mil­len­ni­um and Alk­er­mes. Ku­ra sit­u­ates it­self in the nascent but pop­u­lar field of pre­ci­sion med­i­cine, tar­get­ing pa­tients with par­tic­u­lar ge­net­ic mu­ta­tions, with one reg­is­tra­tion-di­rect­ed study and more pipeline ex­pan­sion un­der­way.

→ For­mer For­est Labs CFO, Fran­cis (Frank) Perier, Jr, is join­ing Spring­Works Ther­a­peu­tics — which launched in the fall of 2017 with a whop­ping $103 mil­lion round and Pfiz­er $PFE as­sets — in the same ca­pac­i­ty. Pri­or to his role at For­est, Perier served as the vice pres­i­dent of fi­nance and op­er­a­tions plan­ning  – Amer­i­c­as Med­i­cines Group at Bris­tol My­ers Squibb. Pre­vi­ous­ly, he served as an ac­count­ing and au­dit­ing part­ner at De­loitte.

→ Amid an on­go­ing shift of its cen­ter of grav­i­ty to the US, Dai­ichi Sankyo has con­sol­i­dat­ed all hu­man re­sources func­tions and brought in Si­mon King to be the chief peo­ple of­fi­cer. King — who brings high-lev­el ex­pe­ri­ence from Bris­tol-My­ers Squibb and As­traZeneca at­tract­ing and man­ag­ing R&D tal­ent — will re­port di­rect­ly to Ko­ji Ogawa, head of the Japan­ese com­pa­ny’s US di­vi­sion. 

MJ MedTech sub­sidiary, Wuhan Gen­er­al Group $WUHN, is want­i­ng to be­come a ma­jor play­er in the US $166 bil­lion med­ical cannabid­i­ol space, as well as psilo­cy­bin and med­i­c­i­nal mush­room health sec­tor. To help with that, the com­pa­ny has ap­point­ed Hy­der Kho­ja — cannabi­noid & psy­che­del­ic med­i­cine sci­en­tist — as CSO. Pre­vi­ous­ly, Kho­ja was a re­search fac­ul­ty for Vir­ginia-Tech, Uni­ver­si­ty of Wyoming & Texas-Tech Uni­ver­si­ty’s Health Sci­ence Cen­ter. Kho­ja co-found­ed In­Med Phar­ma­ceu­ti­cals and di­rect­ed botan­i­cal drug re­search and de­vel­op­ment for their pre-clin­i­cal stage ther­a­pies in­to ap­pli­ca­tion and helped raise over $90 mil­lion for the ven­ture. 

Bi­olog-id — whose mis­sion is to en­sure safe de­liv­ery of health prod­ucts from donor to pa­tient with the help of their patent­ed smart stor­age kits — has slat­ed Om­ni­cell vet, Troy Hilsen­roth, to head the helm of their com­pa­ny as CEO. Hilsen­roth will be tak­ing over for cur­rent CEO, Pierre Par­ent, who will re­main as the com­pa­ny’s pres­i­dent. Pri­or to hop­ping on board, Hilsen­roth was the gen­er­al man­ag­er of the med­ica­tion ad­her­ence di­vi­sion at Om­ni­cell. 

→ Gear­ing up to­wards fur­ther de­vel­op­ing their on­go­ing piv­otal Phase III clin­i­cal, AGENT study of their drug can­di­date ar­foli­tixorin, Iso­fol Med­ical AB an­nounced the ap­point­ment of Roger Tell as CMO, in ad­di­tion to his cur­rent role as CSO. Cur­rent CMO, Karin Gan­löv will tran­si­tion to a new role of se­nior med­ical di­rec­tor, where she will fo­cus on safe­ty and reg­u­la­to­ry. Tell joined the com­pa­ny af­ter a stint at Aprea Ther­a­peu­tics as vice pres­i­dent of clin­i­cal de­vel­op­ment. Tell has served as an ad­vi­sor and on­col­o­gist at Eli Lil­ly, As­traZeneca and Mer­ck Serono

Car­o­line Dircks has been pro­mot­ed from SVP, R&D op­er­a­tions to COO at Bioa­sis Tech­nolo­gies — a com­pa­ny de­vel­op­ing the xB³ plat­form, tech­nol­o­gy for the de­liv­ery of ther­a­peu­tics across the blood-brain bar­ri­er (BBB) and the treat­ment of cen­tral ner­vous sys­tem (CNS) dis­or­ders. Dircks spent 13 years at Bris­tol My­ers Squibb in re­search and de­vel­op­ment op­er­a­tions — most re­cent­ly serv­ing as head of re­gion­al R&D op­er­a­tions and sched­ule man­age­ment. Pri­or to that, she had an 8-year stint at Vion Phar­ma­ceu­ti­cals.

 → Ape­ri­omics, a com­pa­ny fo­cused on iden­ti­fy­ing in­fec­tions, has added Alexan­der Va­len­cia, the for­mer mol­e­c­u­lar lab­o­ra­to­ry di­rec­tor at Cincin­nati Chil­dren’s Hos­pi­tal Med­ical Cen­ter and PerkinElmer Ge­nomics, to their team as CCO. In his new role, Va­len­cia will over­see clin­i­cal test de­vel­op­ment, val­i­da­tions, reg­u­la­to­ry af­fairs and op­er­a­tions on be­half of the com­pa­ny.

Now at the cen­ter of a storm of con­tro­ver­sy over its de­ci­sion to keep its knowl­edge of ma­nip­u­lat­ed da­ta hid­den from reg­u­la­tors dur­ing an FDA re­view, No­var­tis CEO Vas Narasimhan has found a long­time vet­er­an in the ranks to head the sci­en­tif­ic work un­der­way at AveX­is, as CSO, where the in­ci­dent oc­curred. Page Bouchard is tak­ing the place of the two top sci­en­tists at AveX­is — Bri­an Kas­par and his broth­er Al­lan Kas­par — who “have not been in­volved in any op­er­a­tions at AveX­is since ear­ly May 2019 and are no longer with the com­pa­ny.” There’s no word about why they left, but sev­er­al news re­ports sur­faced soon af­ter the state­ment was re­leased — in­clud­ing one from Meg Tir­rell at CN­BC — quot­ing sources at No­var­tis say­ing that the Kas­pars and sev­er­al oth­er sci­en­tists were ter­mi­nat­ed in con­nec­tion with the da­ta ma­nip­u­la­tion.

→ The slow-mov­ing over­haul of the lead­er­ship and strat­e­gy at GSK is tak­ing a fresh turn, and bring­ing an­oth­er woman to the top ranks of the in­dus­try. Glax­o­Smith

Kline said that US phar­ma­ceu­ti­cals pres­i­dent Jack Bai­ley “has de­cid­ed to step down” at the end of the year. And GSK CEO Em­ma Walm­s­ley has re­cruit­ed Mer­ck KGaA’s Maya Mar­tinez-Davis for the role. She’ll be work­ing with glob­al phar­ma chief Luke Miels, an As­traZeneca vet­er­an wooed to a se­nior spot short­ly af­ter Walm­s­ley made her move to the top at GSK. Cur­rent­ly the head of Latin Amer­i­ca and for­mer chief of glob­al on­col­o­gy at Mer­ck KGaA, Mar­tinez-Davis will fit in well with GSK’s com­mer­cial and R&D strat­e­gy in­volv­ing the de­vel­op­ment of new can­cer drugs. R&D chief Hal Bar­ron has made can­cer re­search a top pri­or­i­ty over the past year.

No­var­tis an­nounced that Fab­rice Chouraqui is step­ping down from his role as US phar­ma pres­i­dent and will be re­placed by Vic­tor Bul­to, who has cham­pi­oned Cosen­tyx in the US. In pick­ing Bul­to for the pro­mo­tion, No­var­tis is go­ing with a proven in-house ex­ec, cur­rent­ly in charge of the US im­munol­o­gy, he­pa­tol­ogy and der­ma­tol­ogy fran­chise. The 14-year No­var­tis ex­ec will be re­port­ing to Marie France Tschudin, who runs the glob­al phar­ma group at the Swiss gi­ant. Tschudin her­self is a re­cent ad­di­tion to the top team at No­var­tis. The for­mer pres­i­dent of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions came in a cou­ple of years ago when No­var­tis ac­quired the com­pa­ny and added ra­dio­phar­ma­ceu­ti­cals to its on­col­o­gy port­fo­lio. Bul­to start­ed as a se­nior brand man­ag­er at No­var­tis in 2005.

 → With the brief stint at Ac­celeron be­hind him, Robert Zeldin has found his next CMO role at Roivant’s new au­toim­mune-fo­cused off­shoot, Im­muno­vant. The ap­point­ment brings Zeldin back to his roots in im­munol­o­gy and lever­ages his more re­cent ex­pe­ri­ence with clin­i­cal de­vel­op­ment to ad­vance IMVT-1401, an an­ti­body that fa­cil­i­tates the degra­da­tion of path­o­gen­ic IgG. Brad­ford Mid­dlekauff, a Medarex alum and biotech vet, is al­so join­ing Pe­te Salz­mann’s team as gen­er­al coun­sel.

An­tho­ny Lem­bo Beth Is­rael Dea­coness

→ Hep B vac­cine mak­er, Dy­navax Tech­nolo­gies, has wel­comed Bain Cap­i­tal Life Sci­ences man­ag­ing di­rec­tor, An­drew Hack to its board of di­rec­tors. Hack pre­vi­ous­ly served as the CFO of Ed­i­tas Med­i­cine

Rit­ter Phar­ma­ceu­ti­cals — who is ex­pect­ing Phase III da­ta on its lead prod­uct can­di­date, RP-G28, for lac­tose in­tol­er­ance in Q4 Rit­ter Phar­ma­ceu­ti­cals — has ap­point­ed An­tho­ny Lem­bo to its med­ical ad­vi­so­ry board. Lem­bo is the di­rec­tor, GI motil­i­ty and func­tion­al bow­el dis­or­der cen­ter at Beth Is­rael Dea­coness Med­ical Cen­ter and is a pro­fes­sor of med­i­cine at Har­vard Med­ical School.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.