Aim­mune signs Jayson Dal­las on to suc­ceed re­tir­ing CEO; Ed­uar­do Bra­vo leaves TiGenix in fi­nal chap­ter of Take­da buy­out

→ Ex-Ul­tragenyx com­mer­cial chief Jayson Dal­las is tak­ing the helm at Aim­mune Ther­a­peu­tics $AIMT — the com­pa­ny best known for its peanut al­ler­gy drug — well in time for a com­fort­able tran­si­tion with the out­go­ing CEO, Stephen Dil­ly. Dur­ing his three-year stint at Ul­tragenyx, Dal­las built up the com­mer­cial op­er­a­tions, in­clud­ing sales, mar­ket­ing, re­im­burse­ment and new prod­uct plan­ning, lead­ing up to the launch of the its first two rare dis­ease prod­ucts, which both won ap­proval last year. This marks his sec­ond job at a biotech, af­ter cut­ting his teeth at Pfiz­er, No­var­tis and then Roche/Genen­tech. He will now work on reg­u­la­to­ry fil­ings for AR101 with Dil­ly, who’s stay­ing on as a spe­cial ad­vis­er un­til the end of the year. Dil­ly an­nounced last No­vem­ber that he’s re­tir­ing to spend more time with fam­i­ly.

Rahul Bal­lal

→ Just ahead of a da­ta pre­sen­ta­tion, Cam­bridge, MA-based Imara has tapped sea­soned in­vestor/ex­ec Rahul Bal­lal as its new CEO. Hav­ing led the com­pa­ny to PhI­Ia stud­ies, founder James McArthur will now help steer strat­e­gy as a board di­rec­tor. Imara’s in­hibitor ap­proach to sick­le cell dis­ease has won the back­ing of New En­ter­prise As­so­ci­ates, Pfiz­er Ven­ture In­vest­ments and Bay City Cap­i­tal, among oth­ers. Chan­nelling his busi­ness de­vel­op­ment ex­pe­ri­ence at North­ern Bi­o­log­ics and Flex­ion Ther­a­peu­tics, as well as his VC back­ground from Ver­sant Ven­tures and No­var­tis Ven­ture Fund, Bal­lal is ex­pect­ed to ramp up the op­er­a­tions while push­ing its PDE9 in­hibitor IMR-687 through mid- and late-stage de­vel­op­ment.

Ed­uar­do Bra­vo

→ Giv­en the dra­ma and buzz sur­round­ing the $69 bil­lion Take­da/Shire union, it’s easy to for­get that Take­da has agreed to buy stem cell ther­a­py de­vel­op­er TiGenix, too, in the be­gin­ning of the year. But things are qui­et­ly pro­gress­ing, with news out this week that long­time CEO Ed­uar­do Bra­vo is of­fi­cial­ly de­part­ing. Take­da se­nior di­rec­tor Se­bas­t­ian Wehle will re­place him on the board, while run­ning the busi­ness on a day-to-day ba­sis with the help of CFO Clau­dia D’Au­gus­ta. For­mer­ly of Ny­comed, Wehle has been lead­ing the man­u­fac­tur­ing and sup­ply ac­tiv­i­ties for Alofisel, the Crohn’s dis­ease ther­a­py TiGenix de­vel­oped that earned a swift Eu­ro­pean ap­proval.

→ Af­ter a rocky sev­en-year ride, Pe­ter Tra­ber is bow­ing out as pres­i­dent, CEO and CMO of Galectin $GALT. While still tout­ing Phase III plans for its NASH drug, the com­pa­ny ac­knowl­edges that it’s con­sid­er­ing “strate­gic al­ter­na­tives.” The per­son over­see­ing all this will be Harold Shlevin, the COO who worked with Tra­ber for most of his tenure. Tra­ber joined the Nor­cross, GA-based com­pa­ny af­ter lead­ing Bay­lor Col­lege of Med­i­cine and Uni­ver­si­ty of Penn­syl­va­nia Med­ical School, look­ing for ad­vances in his fields of gas­troen­terol­o­gy and he­pa­tol­ogy. Yet up to the most re­cent PhI­Ib study, Galectin’s drug has not yield­ed any pos­i­tive re­sults.

Li­hua Yu

→ Hav­ing helped run H3 Bio­med­i­cine’s can­cer ge­nomics-based dis­cov­ery pro­grams since be­ing re­cruit­ed as chief da­ta sci­ences of­fi­cer in 2011, As­traZeneca vet Li­hua Yu has been el­e­vat­ed to the pres­i­dent seat. Her new role cov­ers the over­all sci­en­tif­ic and busi­ness di­rec­tion at the Ei­sai sub­sidiary, which now has three pre­clin­i­cal pro­grams in the pipeline.

Metabolon is ush­er­ing a new era in com­pa­ny his­to­ry as its found­ing CEO John Ryals re­tires, giv­ing way to Ro­han Hastie, who’s be­ing pro­mot­ed from the role of chief busi­ness of­fi­cer. Through his seat on the board, Ryals will con­tin­ue to push the Re­search Tri­an­gle Park, NC-based com­pa­ny to­wards ap­pli­ca­tions of its metabolomics plat­form in re­search, drug dis­cov­ery and de­vel­op­ment, di­ag­nos­tics and ther­a­py re­sponse.

→ Charg­ing on in the emer­gent field of mi­cro­bio­me drugs, Finch Ther­a­peu­tics has wel­comed two mem­bers to its C-suite. Ul­rich Thienel joins as CMO, over­see­ing clin­i­cal de­vel­op­ment for Finch’s two mi­cro­bio­ta plat­forms; new CFO Gre­go­ry Per­ry is re­spon­si­ble for fi­nan­cial and op­er­a­tional lead­er­ship. Both ex­ecs boast of a slate of bio­phar­ma roles on their re­sume: While Thienel may not be an ex­pert in the mi­cro­bio­me, he brings two decades of ex­pe­ri­ence fil­ing INDs, NDAs and BLAs for big phar­ma com­pa­nies in var­i­ous ther­a­peu­tic ar­eas; Per­ry cut his teeth at biotechs like Nov­e­l­ion Ther­a­peu­tics and Im­muno­Gen, no­tably or­ches­trat­ing sev­er­al IPOs. Take­da-part­nered Finch is start­ing with a Clostrid­i­um dif­fi­cile pro­gram — a pop­u­lar tar­get that’s at­tract­ed a num­ber of ri­vals.

Richard Ta­jak is step­ping down from the CFO role at Nan­tK­west, which has swift­ly ap­point­ed its chief ac­count­ing of­fi­cer and cor­po­rate con­troller Son­ja Nel­son to fill his shoes. The changeover at the cell ther­a­py com­pa­ny $NK comes on the same day that Patrick Soon-Sh­iong, the bil­lion­aire be­hind Nan­tK­west and its par­ent com­pa­ny Nant­works, an­nounced he’s seek­ing an IPO for a third spin­off called Nant — which will fo­cus on can­cer drugs. Ta­jak had been with the biotech for two years.

→ Gear­ing up for a sec­ond shot at ap­proval — and sub­se­quent launch — for its lead drug Fir­dapse, Cat­a­lyst Phar­ma­ceu­ti­cals $CPRX has tapped Lund­beck vet Daniel Bren­nan to be its chief com­mer­cial of­fi­cer. Ex­ecs of the Coral Gables, FL-based biotech like his ex­pe­ri­ence work­ing with or­phan, neu­ro­log­i­cal drugs, most re­cent­ly as COO at Edge Ther­a­peu­tics, tasked with pre-com­mer­cial­iza­tion ac­tiv­i­ties for Edge’s prod­uct. Cat­a­lyst had pre­vi­ous­ly been snubbed at the FDA on the ba­sis of an in­com­plete study; it’s hop­ing the new batch of da­ta, show­ing Fir­dapse’s ef­fect in treat­ing Lam­bert-Eaton myas­thenic syn­drome, will win them an ap­proval and put Bren­nan to work.

→ On the heels of an­nounc­ing its plans for a $100 mil­lion IPO, Au­to­lus has ap­point­ed Acte­lion vet An­drew Oak­ley as CFO and SVP. Be­fore join­ing the Lon­don-based biotech, which is con­sid­ered a fron­trun­ner in the race for next-gen CAR-Ts, Oak­ley held the same po­si­tion at So­sei for over a year.

→ Af­ter a year dou­bling as CBO and CFO at fresh­ly pub­lic Ar­cus Bio­sciences $RCUS, Jen­nifer Jar­rett is get­ting pro­mot­ed to the COO post (while re­main­ing as chief fi­nan­cial of­fi­cer). The new­ly cre­at­ed po­si­tion cov­ers a broad man­date: from fi­nance, in­vestor re­la­tions, cor­po­rate com­mu­ni­ca­tions, busi­ness and cor­po­rate de­vel­op­ment to strate­gic plan­ning and hu­man re­sources — all things that Jar­rett has got­ten in­volved in since join­ing the Hay­ward, CA-based com­pa­ny. A vet­er­an in­vest­ment banker, she made the jump to biotech fair­ly re­cent­ly at Medi­va­tion just be­fore Pfiz­er bought it out.

→ Man­u­fac­tur­ing ex­per­tise is cru­cial to any com­pa­ny se­ri­ous about T cell ther­a­pies, and Tri­umvi­ra Im­muno­log­ics is high­light­ing that through hir­ing Don­na Rill as chief tech­nol­o­gy of­fi­cer. Rill, who start­ed out man­ag­ing cell and gene ther­a­py labs in hos­pi­tals, is now ex­pect­ed to guide Tri­umvi­ra’s en­try in­to the clin­ic with her tech­nol­o­gy de­vel­op­ment and man­u­fac­tur­ing ex­pe­ri­ence. The biotech, which is head­quar­tered in Austin with re­search fa­cil­i­ties in On­tario, is hop­ing to com­mence Phase I/II stud­ies for a CD19 pro­gram in 2019.    

→ As Tai­wan’s JHL Biotech preps sev­er­al of its bi­o­log­ics for late-stage tri­als and em­braces the cap­i­tal mar­kets, it is bring­ing on new CFO El­lis Chu to help with re-list­ing and oth­er fundrais­ing ac­tiv­i­ties. A for­mer in­vest­ment banker jump­ing from VC mer­chant bank Ion Pa­cif­ic, Chu’s ap­point­ment comes a month af­ter JHL raised $106 mil­lion in a con­vert­ible bond is­suance, bring­ing its to­tal haul to $320 mil­lion.

→ A flur­ry of per­son­nel ac­tiv­i­ty is sweep­ing through au­toim­mune up­start Anokion, with Deb­o­rah Ger­aghty join­ing as CBO, co-founder Stephan Kon­tos be­ing pro­mot­ed from VP of re­search to CSO, and Tony Rosso­man­do re­cruit­ed as VP of tech­ni­cal op­er­a­tions. In Ger­aghty, CEO John Hohnek­er says, Anokion gets a sea­soned ex­ec at­tuned to pipeline de­vel­op­ment and strate­gic trans­ac­tions. Be­tween stints at In­fin­i­ty Phar­ma, Aileron and Di­men­sion as well as her found­ing role in an or­phan drug ac­cel­er­a­tor, Ger­aghty has dealt with most of the tasks now un­der her purview: busi­ness and cor­po­rate de­vel­op­ment, strate­gic plan­ning, pro­gram man­age­ment and com­mu­ni­ca­tions. Mean­while, Kon­tos takes over from Jeff Hubbell, who’s re­lin­quish­ing both his C-suite job and his board chair­man­ship, carv­ing out a place as chief sci­en­tif­ic ad­vis­er. Flex­ion CEO Michael Clay­man is step­ping in to lead.

→ Fol­low­ing a five-year run at the top of Bio­gen’s IT de­part­ment, Prakash Pan­di­an is head­ing up in­for­ma­tion sys­tems for con­tract re­search, de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion AM­RI. As chief in­for­ma­tion of­fi­cer, he will con­tin­ue what he’s been do­ing since start­ing at Mil­li­pore years ago: in­te­grat­ing busi­ness and tech­nolo­gies.

→ As Can­cer Ge­net­ics $CGI ex­plores ex­pand­ing its bio­phar­ma and dis­cov­ery busi­ness to com­ple­ment its di­ag­nos­tic base, it has hired Michael Mc­Cart­ney as chief com­mer­cial of­fi­cer, tasked al­so with over­see­ing BD ini­tia­tives. Mc­Cart­ney was CEO of an ear­ly-stage life sci­ence ser­vice provider called SciKon In­no­va­tion.

→ Un­der pres­sure from in­vestors over its lack­lus­ter per­for­mance, Al­ler­gan has now re­cruit­ed Ab­bott Lab­o­ra­to­ries’ for­mer EVP of fi­nance, Thomas Frey­man, to its board. Patrick O’Sul­li­van, mean­while, is on his way out as the com­pa­ny con­tin­ues with what it calls its “re­fresh­ment” process for the board.

→ Hav­ing proven her acu­men as gen­er­al man­ag­er of Take­da in Turkey, Gamze Yüce­land has been ap­point­ed to lead the fast-grow­ing Cana­di­an op­er­a­tion for the Japan­ese drug­mak­er. She will ini­tial­ly fo­cus on gas­troen­terol­o­gy and on­col­o­gy, the two core ther­a­peu­tic ar­eas Take­da has cir­cled for the re­gion.

→ In an ef­fort to “grow through strate­gic hires,” an­ti-ag­ing start­up resTOR­bio $TORC has poached Ker­ry Rus­sell from No­var­tis to be­come its VP of clin­i­cal de­vel­op­ment. Rus­sell will have broad au­thor­i­ty over the di­rec­tion and ex­e­cu­tion of the Boston-based com­pa­ny’s TORC1 in­hibitor pro­gram.

Ap­plied Ge­net­ic Tech­nolo­gies Cor­po­ra­tion $AGTC is boost­ing its clin­i­cal team with two new hires to ad­vance the rare dis­ease gene ther­a­pies it’s de­vel­op­ing. Lani­ta Scott — an alum of big name com­pa­nies like Genen­tech, Re­gen­eron and Al­ler­gan — will be VP of clin­i­cal re­search and med­ical af­fairs, while ex-Ver­tex staffer Karen Car­roll takes the ti­tle of VP, clin­i­cal de­vel­op­ment op­er­a­tions.

Matthew Beck is now VP of in­vestor re­la­tions at Cure­Vac, the Ger­man mR­NA ther­a­peu­tics biotech backed by the Gates Foun­da­tion.

Cy­tomX $CT­MX has re­cruit­ed Lloyd Row­land from Xen­cor as gen­er­al coun­sel.

→ Chi­nese CRO Shang­hai ChemPart­ner is bring­ing on Mer­ck vet Ming Liu as VP and head of bi­ol­o­gy and phar­ma­col­o­gy. l

→ Re­lieved of all his du­ties at TiGenix, Ed­uar­do Bra­vo is keep­ing busy as the new chair­man of Vivet Ther­a­peu­tics’ board, guid­ing the de­vel­op­ment of its gene ther­a­pies for rare meta­bol­ic dis­ease.

→ Now that the dust has set­tled on Juno’s sale, for­mer CSO Hyam Lev­it­sky is find­ing some time to sit on the board of Replim­mune, a Woburn, MA-based biotech work­ing on on­colyt­ic im­munother­a­pies.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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Maze in­ter­im chief Charles Hom­cy pass­es ba­ton to Ja­son Colo­ma; William Col­lier tapped as CEO of Ar­bu­tus

→ Four months in­to Maze Ther­a­peu­tics’ launch, Charles Hom­cy is pass­ing the start­up’s reins to an­oth­er Third Rock col­league. Ja­son Colo­ma, the cur­rent COO, is leav­ing his role at the VC firm to be­come full-time CEO on a mis­sion to trans­late ge­net­ic in­sights in­to new med­i­cines. Equipped with a whop­ping $191 mil­lion with sup­port from Arch, Maze’s big idea is to find and tar­get ge­net­ic mod­i­fiers that play a role in Mendelian dis­eases caused by an­oth­er gene. Colo­ma, a Roche/Genen­tech vet sea­soned in busi­ness de­vel­op­ment, was CBO at Corvus Phar­ma­ceu­ti­cals be­fore join­ing Third Rock in 2017.

Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Re­gen­eron/Sanofi's an­ti­body un­der­whelms in asth­ma study — shares of ri­val Anap­tys­Bio pay the price

Al­though ex­pec­ta­tions were mut­ed, Re­gen­eron $REGN and Sanofi’s $SNY ex­per­i­men­tal IL-33 an­ti­body has un­der­whelmed in a proof-of-con­cept mid-stage asth­ma tri­al. Al­though the drug sig­nif­i­cant­ly im­proved the loss of asth­ma con­trol and lung func­tion as a monother­a­py com­pared to a place­bo, its ef­fect was nei­ther su­pe­ri­or to the es­tab­lished Dupix­ent, nor of val­ue when com­bined with the IL-4/IL-13 treat­ment.