Boston-based lab provider to open second Bay Area location

A Boston-based provider of lab space is tripling its foot­print with the ad­di­tion of a West Coast cam­pus.

Smart­Labs, a com­pa­ny with labs in three dif­fer­ent neigh­bor­hoods in the Boston area, will open a new re­search and man­u­fac­tur­ing cen­ter that will be lo­cat­ed in the heart of the South San Fran­cis­co biotech cor­ri­dor. The site will sup­port end-to-end drug de­vel­op­ment and in­clude 500L man­u­fac­tur­ing biore­ac­tors that can sup­port al­lo­gene­ic and au­tol­o­gous cell ther­a­pies.

The ex­pan­sion is part of a larg­er plan to grow the com­pa­ny to 2 mil­lion square feet with­in the next five years. The com­pa­ny of­fers flex­i­ble lab and of­fice spaces that can be cus­tomized to fit com­pa­nies of any size from 10 to 200 peo­ple, and uti­lize R&D space, vi­var­i­ums, pi­lot-scale suites and cGMP man­u­fac­tur­ing ca­pac­i­ty, all un­der the same roof. The com­pa­ny sees it­self as an al­ter­na­tive to the search for lab space and re­al es­tate, which has heat­ed up to an all-time high in 2021.

Boston and Cal­i­for­nia’s Bay Area are at the top of the list of re­gions with boom­ing life sci­ences re­al es­tate surges, along with San Diego, ac­cord­ing to a study from CBRE. But in emerg­ing mar­kets, it can be dif­fi­cult for star­tups to plant roots with­out a new lab space, and while the in­flux of cash from Covid-19-re­lat­ed rev­enue has led to many com­pa­nies ex­pand­ing rapid­ly, those projects can take up to three years to com­plete. A push to grow do­mes­tic pro­duc­tion, rather than re­ly on im­ports, has al­so pushed the de­mand for growth.

The Smart­Labs site at South San Fran­cis­co’s Gate­way of the Pa­cif­ic cam­pus will of­fer 28 prod­uct suites, ca­pa­ble of end-to-end drug de­vel­op­ment. It’s the com­pa­ny’s sixth site, and sec­ond South San Fran­cis­co lo­ca­tion. ‘Our city, as the birth­place of biotech, is the per­fect lo­ca­tion for Smart­Labs to launch their new of­fer­ing,’ South San Fran­cis­co may­or Mark Na­gales said in a state­ment. ‘South San Fran­cis­co’s biotech ecosys­tem is brim­ming with tal­ent and in­no­va­tion, and by tripling their foot­print in the area, Smart­Labs is mak­ing end-to-end drug de­vel­op­ment op­por­tu­ni­ties avail­able in our own back­yard. The con­ve­nience and ex­per­tise of the Smart­Labs of­fer­ing will un­doubt­ed­ly help lo­cal com­pa­nies rapid­ly ad­vance their sci­ence.’

In the­o­ry, a 60-per­son biotech build­ing a 20,000-square-foot cGMP lab would need 18 months to build a new fa­cil­i­ty, and spend, by Smart­Labs’ es­ti­mate, at least $16 mil­lion to get up and run­ning. At a Smart­Labs lo­ca­tion, a com­pa­ny can be good to op­er­ate in just four weeks.

The com­pa­ny has raised $330 mil­lion in the last 21 months, in­clud­ing its Se­ries B an­nounced in Sep­tem­ber that raised $250 mil­lion. Ar­row­Mark Part­ners led that round, and Winslow Cap­i­tal Man­age­ment, Onex Fal­con were new in­vestors in the round, fol­lowed by Con­ver­sion Ven­ture Cap­i­tal and Breed’s Hill Cap­i­tal.

Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.

Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).

When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.

Now Pfizer wants to give the pharma rival a run for its money.

Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.

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As the investments in cell and gene therapy manufacturing continue to grow across the world, Cincinnati Children’s Hospital and CTI Clinical Trial & Consulting Services have entered a $100 million agreement to produce clinical material locally.

The joint venture enables the hospital to work on its Translational Core Laboratory, which manufactures and tests services for cell and gene therapy trials. This will help address the global gene and cell therapy shortage and prevent the lack of capacity from getting in the way of new development. About 15 C&G therapy products have been approved by regulatory agencies across the globe, and a study from the Alliance for Regenerative Medicine predicts another 10 to 20 per year by 2025.

Rob Califf, the famous cardiologist from Duke University, is likely to return to the top of the FDA, this time under the Biden administration.

At his confirmation hearing Tuesday, Democrats and Republicans on the Senate health committee offered their support for Califf, with Chair Patty Murray (D-WA) stressing the need for an experienced leader, like Califf, who can ensure that science comes first.

Aamir Malik, Pfizer chief business innovation officer

Pfizer made a big splash in the M&A space Monday, announcing a $6.7 billion buyout of Arena Pharmaceuticals to chase Bristol Myers Squibb in the S1P race. But company execs suggested the company isn’t finished bringing on new assets.

In an investor call outlining the Arena acquisition, chief business innovation officer Aamir Malik took a moment to discuss Pfizer’s growth plans going forward. The strategy was made up of three pillars: advancing the internal pipeline, continuing to pursue outside opportunities and exploring the combination of technology and data to ‘accelerate’ growth.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Just two months after Moderna announced plans to build a $500 million mRNA vaccine factory in Africa, the biotech giant agreed ‘in principle’ yesterday on a new mRNA vaccine manufacturing facility — but instead of looking in the US, Europe or Africa again, Moderna is going to the land down under.

While the deal is not set in stone, Moderna said that the biotech and the Australian government are committed to finalizing the agreement. As for the financial aspects of the deal, they have not been publicly disclosed.

The drastic difference in efficacy for Merck’s Covid-19 pill between interim and final analyses — from a 50% relative reduction in hospitalizations and deaths at the interim to just 30% in the final results — had some worrying that the Pfizer pill’s early success for adults at high risk of hospitalization might also be more muted in the final results.

But that wasn’t the case early Tuesday as Pfizer said that final data available from the more than 2,200 high-risk patients enrolled in its trial confirmed prior results showing Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo. The company added:

Roche/Genentech CMO Levi Garraway

Breakthroughs in drug development have begun to unlock the potential of antibody-drug conjugates, therapies designed to better target proteins on tumor cells. Genentech’s Polivy has become an early winner in blood cancer, and now the drugmaker is revealing promising results in getting into patients even sooner.

A combination of Roche’s Polivy, an ADC targeting the CD79b protein on tumor cells, with Rituxan and the chemotherapy regimen R-CHOP cut the risk of disease progression or death over Rituxan-chemo alone by 27% in patients with first-line diffuse large B cell lymphoma, according to late-breaking data presented Tuesday at #ASH21.

Sanofi head of development Dietmar Berger

Sanofi’s fitusiran has had a rough road in hemophilia, weathering clinical holds and program halts tied to its lingering safety woes. Now, the drug is nearing the finish line with late-stage data in hand, but will those same safety concerns slam the brakes on the program despite its deliriously effective results?

Fitusiran, an RNAi drug designed to silence the gene that overproduces a protein responsible for clotting suppression, significantly reduced the annualized rate of bleeding over on-demand factor therapy in hemophilia A/B patients without preexisting factor inhibitors in the blood, according to late-breaking data presented Tuesday at #ASH21.
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