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.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.