Biotech gains ground in NYC: Sprawl­ing re­search cen­ter planned in $1.6B Mid­town project

Mak­ing good on its promise to inch its way to­ward biotech hub sta­tus, New York City is ded­i­cat­ing a mas­sive space for life sci­ence com­pa­nies to put down roots in a 105-year-old struc­ture in Mid­town.

Com­mer­cial re­al es­tate de­vel­op­ers have been work­ing to make over the old Far­ley Post Of­fice Build­ing, a Ro­man clas­sic struc­ture that spans two city blocks, in­to an elab­o­rate tran­sit hub to be called the Moyni­han Train Hall. Now, the two firms be­hind the $1.6 bil­lion over­haul have hired a bro­ker with ex­ten­sive knowl­edge of Boston’s re­al es­tate mar­ket and have de­vel­oped a brochure for the train hall that mar­kets the struc­ture to the life sci­ence in­dus­try.

David Green­baum

The brochure calls the space “Moyni­han Re­search Cen­ter at Far­ley” and it high­lights po­ten­tial de­signs for lab­o­ra­to­ry and of­fice space. De­vel­op­ers Vor­na­do Re­al­ty Trust and Re­lat­ed Cos, which have a 99-year lease to de­vel­op about 900,000 square feet of of­fice and re­tail space, told the Wall Street Jour­nal that they’re tar­get­ing new in­dus­tries that are rapid­ly grow­ing in the city.

“Just as Google and Face­book have de­cid­ed they need a ma­jor pres­ence in New York, there is the recog­ni­tion by life-sci­ences com­pa­nies that for kids who are the sci­en­tists of the fu­ture, they want to live in ur­ban ar­eas,” David Green­baum, pres­i­dent of Vor­na­do’s New York di­vi­sion, told the WSJ.

This new re­al es­tate project is the lat­est de­vel­op­ment in NYC’s jour­ney to biotech hub sta­tus. The city has seen a boost of life sci­ence ac­tiv­i­ty in re­cent years, thanks to ef­forts made by the state and city to in­cen­tivize biotech to plant roots in New York. The moves ap­pear to be work­ing, with new en­trants set­ting up shop in the city. NYU Lan­gone Med­ical Cen­ter is col­lab­o­rat­ing with Cam­bridge, MA-based Bi­o­Labs to cre­ate a 50,000-square-foot biotech co-work­ing cen­ter on Var­ick Street in Low­er Man­hat­tan. And the Long Is­land City Part­ner­ship is work­ing on a plan for a life sci­ences cen­ter in that Queens dis­trict.

Nan­cy Thorn­ber­ry

And a cou­ple months ago, NYC’s eco­nom­ic de­vel­op­ment group told me it post­ed a “want­ed ad” for an or­ga­ni­za­tion or joint ven­ture to de­vel­op and op­er­ate a life sci­ence R&D cam­pus in the city. New York is putting up $100 mil­lion in city cap­i­tal and city-owned land to spur the project, which has been coined “LifeSci NYC Hub,” the EDC said.

“NYC has proven to be an out­stand­ing place to re­cruit for biotech,” said Kally­ope CEO Nan­cy Thorn­ber­ry, who sits on the ad­vi­so­ry coun­cil for the EDC ef­fort.  “The scene is just be­gin­ning to grow here, and so there’s an un­tapped pool of tal­ent of sci­en­tists from acad­e­mia who are in­ter­est­ed in work­ing in biotech. There’s al­so a num­ber of in­di­vid­u­als want­i­ng to make tran­si­tion from phar­ma to biotech who want to live here in New York.”

Still, Thorn­ber­ry ad­mits the city has had a his­tor­i­cal prob­lem with find­ing space for biotech. WSJ re­ports the city has strug­gled to keep star­tups around as they grow.

New York has on­ly 2.8 mil­lion square feet of rentable lab space, com­pared with New Jer­sey’s 16.2 mil­lion and the 26.8 mil­lion square feet in the greater Boston area, ac­cord­ing to da­ta from the spring of 2017 col­lect­ed by re­al es­tate ser­vices firm JLL.

Im­age: Ren­der­ing of the Far­ley Post Of­fice Build­ing. SOM

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.