Boom­ing rare dis­ease play­er Shire adding a trendy new R&D hub in Kendall Square for 1,000-plus

Shire CEO Flem­ming Orn­skov

Shire CEO Flem­ming Orn­skov has al­ready made it clear that he in­tends to make the com­pa­ny a lead­ing force in rare dis­ease drug de­vel­op­ment and mar­ket­ing. Now he’s mov­ing to al­so make it one of the most vis­i­ble play­ers in the field.

Orn­skov has inked a lease for the 343,000-square-foot build­ing at 500 Kendall Street, right next to the 650 Kendall Street ad­dress it al­ready owns. The plan is to turn Gen­zyme’s old fa­cil­i­ty in­to a rare dis­ease in­no­va­tion hub with more than 1,000 staffers. And it plans to move in cross-dis­ci­pli­nary teams in­volved in re­search, clin­i­cal de­vel­op­ment, med­ical af­fairs, busi­ness de­vel­op­ment and more.

A Shire spokesman notes that the new hub will like­ly house more than 1,000 staffers, with 350 al­ready on site in Kendall Square and room for more than 900 staffers in the soon-to-be-for­mer Gen­zyme cen­ter.

Shire is still keep­ing its big cam­pus in Lex­ing­ton, MA, where it’s been pulling in work­ers from var­i­ous satel­lite fa­cil­i­ties since Orn­skov took the helm. The com­pa­ny added 750 new jobs last year and has an­oth­er 400 open in Mass­a­chu­setts. It’s al­so un­der­tak­ing a strate­gic re­view to con­sid­er where every­one be­longs.

Kendall Square in Cam­bridge has be­come ground ze­ro in the biotech world for in­no­va­tion and new re­search over the past few years. Close to MIT and Har­vard, phar­ma com­pa­nies like Pfiz­er have been mi­grat­ing in­to the neigh­bor­hood, adding new fa­cil­i­ties and gleam­ing new labs to il­lus­trate their com­mit­ment to the lat­est tech­nolo­gies. When George Scan­gos took over Bio­gen 6 years ago, he made the point of mov­ing in­to Cam­bridge, where the re­search was, re­vers­ing the sub­ur­ban shift trig­gered by his pre­de­ces­sor at the com­pa­ny.

For Shire, it’s a chance to glean more in­fo while spot­light­ing its tal­ent and busi­ness strat­e­gy. Shire ac­quired a pres­ence in Cam­bridge with its buy­out of Bax­al­ta.

Staffers will start mov­ing in in about two years.

Orn­skov had this to say in a state­ment:

“By ex­pand­ing our pres­ence in Cam­bridge, with its close prox­im­i­ty to best-in-class hos­pi­tals, re­search in­sti­tu­tions, uni­ver­si­ties and a thriv­ing biotech­nol­o­gy com­mu­ni­ty, we will strength­en our ties with the ear­ly in­no­va­tors around us to shape the next gen­er­a­tion of break­through ther­a­pies for pa­tients with high un­met needs. These plans sig­ni­fy our con­tin­ued growth and our deep and en­dur­ing com­mit­ment to serv­ing pa­tients, fam­i­lies and care­givers across the globe who are af­fect­ed by rare dis­eases and high­ly spe­cial­ized con­di­tions.”

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Mil­li­pore­Sig­ma to build new $20 mil­lion, 12,000-square-foot lab in Switzer­land

On the heels of opening a new laboratory in Shanghai last week, MilliporeSigma is continuing its construction push.

The Merck KGgA life science subsidiary announced Wednesday its intentions to build a new $20 million lab in Buchs, Switzerland to support its reference materials business. It’s estimated that the new facility will be completed in December 2021 and open in early 2022 and is expected to be 12,000 square feet.

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

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Ludwig Hantson, Alexion CEO

Why pay $4B for a steady di­et of dis­ap­point­ment? Porges turns thumbs down on Alex­ion’s M&A strat­e­gy, of­fers some point­ers

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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