Mer­ck trig­gers a new round of lay­offs in R&D re­or­ga­ni­za­tion, push­ing more jobs in­to Cam­bridge, San Fran­cis­co

Mer­ck is con­firm­ing that it’s trig­gered a new round of lay­offs in its R&D group as it con­cen­trates and ex­pands its drug re­search work in two ma­jor biotech hubs, Cam­bridge, MA and San Fran­cis­co. The re­struc­tur­ing in­cludes adding a new lab in Cam­bridge, which will fo­cus on the fast-grow­ing mi­cro­bio­me field.

A spokesper­son for Mer­ck tells me:

“With­in Mer­ck Re­search Lab­o­ra­to­ries, we are mak­ing some or­ga­ni­za­tion­al changes with­in our dis­cov­ery, pre-clin­i­cal and ear­ly de­vel­op­ment area to en­able ear­li­er ac­cess to emerg­ing ex­ter­nal sci­ence and tech­nol­o­gy to aug­ment our lead­ing dis­cov­ery and de­vel­op­ment ca­pa­bil­i­ties. These changes in­clude in­creas­ing our in­vest­ment in ex­plorato­ry bi­ol­o­gy in ar­eas where bio­med­ical re­search is con­verg­ing, specif­i­cal­ly in Cam­bridge, Mass. and the San Fran­cis­co Bay area, Calif.  Un­for­tu­nate­ly, these changes will re­sult in work­force re­duc­tions at our Ke­nil­worth and Rah­way, N.J. sites and our North Wales, Pa. screen­ing fa­cil­i­ty as we shift re­sources and per­son­nel.

“Ad­di­tion­al­ly, here’s some back­ground on Cam­bridge and the San Fran­cis­co Bay area sites:

“We are ex­pand­ing MRL’s ear­ly dis­cov­ery re­search ca­pa­bil­i­ties by in­vest­ing in new lab­o­ra­to­ries at our Cam­bridge, Mass. site. Re­search will fo­cus on emerg­ing sci­ence, ag­nos­tic of ther­a­peu­tic area. Ini­tial ex­plorato­ry re­search will in­clude host-pathogen in­ter­ac­tions and the role of the mi­cro­bio­me in dis­ease process­es. The site is sched­uled to open in late 2016.”

The spokesper­son de­clined to spec­i­fy ex­act­ly how many jobs are be­ing cut. “We’re not pro­vid­ing a break­down of the changes or spe­cif­ic num­bers at this time, as it will in­clude sep­a­ra­tions and moves,” she not­ed.

Mer­ck’s move fol­lows a ma­jor trend in bio­phar­ma R&D, as the biggest com­pa­nies con­cen­trate more and more of their work in the big hubs. And vir­tu­al­ly all of the ma­jor play­ers have down­sized at one time or an­oth­er.

Close to three years ago, Mer­ck trig­gered a ma­jor re­or­ga­ni­za­tion in its R&D ranks, as the then new R&D chief Roger Perl­mut­ter set in mo­tion a plan that in­volved 8,500 lay­offs, all of which were piled on a re­struc­tur­ing ef­fort that was an­nounced ear­li­er.

Those lay­offs fol­lowed a years-long gap in sig­nif­i­cant new drug ap­provals and a string of clin­i­cal set­backs. Since then, though, Mer­ck land­ed a land­mark ap­proval of Keytru­da, now the num­ber two check­point in­hibitor on the block­buster can­cer mar­ket, along with an OK ear­ly this year for its hep C com­bo, Zepati­er, which is be­ing sold in a ri­val-in­fest­ed field.

Derek Lowe at In the Pipeline, a close­ly fol­lowed blog that has fre­quent­ly been a leader in flag­ging scut­tle­butt about R&D re­or­ga­ni­za­tions, was the first to spot­light ru­mors of a move. He re­port­ed:

The North Wales, PA site is be­ing closed (the screen­ing op­er­a­tions there are mov­ing to Ke­nil­worth). New Jer­sey dis­cov­ery chem­istry (Ke­nil­worth and Rah­way) is be­ing cut by 20%, and Rah­way’s med-chem is en­tire­ly mov­ing to Ke­nil­worth over the next few months. Dis­ease area bi­ol­o­gy in Ke­nil­worth is shut­ting down (not sure what the ram­i­fi­ca­tions of that one might be). I’m told that some peo­ple will be of­fered a chance to move to the Boston or Bay area sites, and all of these de­ci­sions will be made by the end of Sep­tem­ber. And ap­par­ent­ly they’ve al­so told every­one that more changes will be com­ing in the next few weeks, so I’m sure that’s calmed every­thing down as well.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

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.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.

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.

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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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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