Ei­sai is build­ing a be­spoke Cam­bridge re­search cen­ter with a $100M-plus plan to find new ways to tack­le Alzheimer's

With a steady drum­beat of bad news set to the tem­po of doom and gloom in the Alzheimer’s/de­men­tia re­search world play­ing in the back­ground, Ei­sai is cre­at­ing its own $100 mil­lion-plus plan to start fresh and blaze some new re­search trails that go be­yond tau and amy­loid be­ta.

The Japan­ese com­pa­ny is build­ing a 50,000-square-foot re­search home at the Alewife Re­search Cen­ter close to the heart of the hum­ming Cam­bridge, MA biotech hub. Draw­ing on cur­rent staffers from their An­dover site — which is be­ing shut down — and adding some new skill sets, com­pa­ny ex­ecs plan to as­sem­ble a team of more than 80 sci­en­tists at the Ei­sai Cen­ter for Ge­net­ics Guid­ed De­men­tia Dis­cov­ery.

They’re com­mit­ting more than $100 mil­lion to fund op­er­a­tions for the first three years, says the cen­ter’s new pres­i­dent, Nadeem Sar­war. Break­through re­search in­to hu­man ge­net­ics will form a foun­da­tion for this de­men­tia group, he adds, but will go fur­ther in build­ing up ex­per­tise in da­ta sci­ences, im­mun­ode­men­tia, dis­cov­ery tech­nolo­gies and pre­ci­sion chem­istry.

And they’ll be work­ing shoul­der-to-shoul­der. The new cen­ter is be­ing built ac­cord­ing to the de­mands of the cur­rent style: Open. (Even though staffers may not al­ways care for it.)

“Open of­fices, open lab and open style,” is the way Sar­war, who’s join­ing the move­ment cel­e­brat­ing the end of re­search si­los, de­scribes it.

Sar­war says they’re join­ing the mi­gra­tion in­to Cam­bridge in or­der to gain clos­er con­tacts with the full range of aca­d­e­m­ic and in­dus­try re­search groups. He adds that Ei­sai plans to set up col­lab­o­ra­tive deals with a set of new part­ners, rang­ing from the star­tups and spin­outs jump­ing in­to the are­na as well as the more es­tab­lished com­pa­nies and promi­nent aca­d­e­m­ic teams in the hub.

The big idea here is that if you can start with a bet­ter un­der­stand­ing of the dis­ease, and the var­i­ous trig­gers that may be in­volved, you can do a much bet­ter job at de­feat­ing it.

Ei­sai has a con­sid­er­able amount of ex­pe­ri­ence in clin­i­cal de­vel­op­ment in this field. The com­pa­ny is al­lied on a BACE drug with Bio­gen, which has had mixed re­sults. They have al­so been watch­ing care­ful­ly as the two lead piv­otal pro­grams for BACE — at Mer­ck and more re­cent­ly at Eli Lil­ly and As­traZeneca — went down in flames.

Ul­ti­mate­ly, says Sar­war, it’s prob­a­ble that the field will go the way of on­col­o­gy, look­ing for more com­plex com­bi­na­tion ap­proach­es as it strikes the dis­ease at dif­fer­ent stages of de­vel­op­ment. And that won’t come eas­i­ly or quick­ly, which is why they’re com­mit­ting to a decade worth of work.

“We have to keep try­ing, for pa­tients and fam­i­lies,” says Sar­war. “It’s one of the most dev­as­tat­ing ill­ness­es there is.”

Sci­en­tists will be mov­ing in­to the new cen­ter as it is be­ing pre­pared for a grand open­ing next spring.

Im­age: Nadeem Sar­war and Ei­sai’s Cam­bridge site. EI­SAI

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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