Af­ter un­ex­pect­ed tie, Am­s­ter­dam wins 'coin toss' for new EMA HQ

Well, that was un­ex­pect­ed. The EU’s third and fi­nal vote on the new lo­ca­tion of the Eu­ro­pean Med­i­cine Agency tied be­tween Mi­lan and Am­s­ter­dam, with Am­s­ter­dam win­ning the prover­bial coin toss tie-break­er (EU of­fi­cials drew the city’s name out of a bowl).

The re­sults may sur­prise those fol­low­ing the first two vot­ing rounds close­ly, as Mi­lan came in the lead on the pre­vi­ous ses­sions. Both cities ranked ex­tra­or­di­nar­i­ly well on the EMA’s score­card, with the lo­ca­tions es­pe­cial­ly pop­u­lar with the agency’s 900-per­son staff. The EMA said ear­li­er this month that 65% or more of its staff would be will­ing to re­lo­cate to both Mi­lan and Am­s­ter­dam. Ac­cord­ing to a staff sur­vey in Sep­tem­ber, Am­s­ter­dam would woo the most EMA staffers to re­lo­cate, while Mi­lan ranked fourth.

Staffers like­ly breathed a sigh of re­lief that oth­er top-ranked cities like Bratisla­va and Bucharest did not end up in the top three. Less than 30% of staffers were will­ing to move to those cities, which would have put the EMA in a tough po­si­tion — un­der­staffed and on­ly able to work on top pri­or­i­ty ef­forts.

The EMA has called Lon­don home since 1995, when it was first es­tab­lished. From there, it mon­i­tors and ap­proves drugs across 28 Eu­ro­pean Union mem­ber states and 500 mil­lion peo­ple. Fol­low­ing the Unit­ed King­dom’s vote to ex­it the EU in 2019, the EMA has been scram­bling to choose a site that will meet all of its (many) needs. The re­lo­ca­tion caused a fren­zy of bids from ma­jor cities through­out Eu­rope, first to­tal­ing 19 prospec­tive cities but with three drop­ping out ear­ly this morn­ing: Mal­ta, Za­greb, and Dublin.

The EU’s top cri­te­ria for the EMA’s new home city is ac­ces­si­bil­i­ty to in­ter­na­tion­al trav­el and bilin­gual ed­u­ca­tion for the staffer’s chil­dren. The EMA’s staff has been a ma­jor con­cern, as an ex­o­dus of em­ploy­ees would mean a slow down of process­es. The EMA warned last month that, worst-case sce­nario, its re­lo­ca­tion from Lon­don could per­ma­nent­ly dam­age the med­i­cines reg­u­la­to­ry sys­tem, trig­ger­ing a pub­lic health cri­sis.

If it can’t com­pen­sate for large staff loss­es fol­low­ing its re­lo­ca­tion, it would be forced to in­voke its Brex­it pre­pared­ness busi­ness con­ti­nu­ity plan. The plan has the EMA de­creas­ing its ac­tiv­i­ties to on­ly in­clude those with high pri­or­i­ty. Ac­tiv­i­ties such as cor­po­rate gov­er­nance, au­dits and con­fer­ences are list­ed as the low­est pri­or­i­ties. The top pri­or­i­ties in­clude the as­sess­ment and safe­ty mon­i­tor­ing of med­i­cines and ac­tiv­i­ties vi­tal for main­tain­ing the in­fra­struc­ture of the Eu­ro­pean med­i­cines reg­u­la­to­ry net­work.

To con­tin­ue car­ry­ing out its high­ly pri­or­i­tized ac­tiv­i­ties, the EMA says it needs 462 full time equiv­a­lent (FTE) staff — close to 50% of its cur­rent staff. It needs an­oth­er 140 to car­ry out medi­um pri­or­i­ty work and a fur­ther 110 to con­tin­ue to per­form its low­est pri­or­i­ty ac­tiv­i­ties.

Am­s­ter­dam has a num­ber of things go­ing for it, ac­cord­ing to the EMA’s score­card. It has good flight con­nec­tiv­i­ty to oth­er Eu­ro­pean Eco­nom­ic Area cap­i­tal cities and in­ter­na­tion­al lo­ca­tions. It has ex­cel­lent pub­lic trans­port be­tween the air­port and the pro­posed premis­es of the EMA. It al­so has lots of hous­ing and “high qual­i­ty ac­com­mo­da­tion” with­in walk­ing dis­tance to the pro­posed HQ site. And there’s lots of Eu­ro­pean-ori­ent­ed schools.

Mi­lan had many of the same things go­ing for it, ex­cept the city al­so in­clud­ed de­tails on cur­rent and fu­ture school ca­pac­i­ty for the staffer’s chil­dren, which may have eased wor­ry about putting hun­dreds of new stu­dents in­to lo­cal schools.

Now, the EMA has plen­ty on its plate. The agency has to take up new op­er­a­tions at the Am­s­ter­dam site by March 2019. Fit­ting out the new head­quar­ters alone will take 12-15 months, the agency es­ti­mates. Build­ing one in time will re­quire fast ac­tion and a hur­ry-up con­struc­tion sched­ule.

Re­ac­tions

Here’s Steve Bates, CEO of the UK’s BioIn­dus­try As­so­ci­a­tion:

“Lon­don’s loss is Am­s­ter­dam’s gain. To­day’s de­ci­sion on the lo­ca­tion of the Eu­ro­pean Med­i­cines Agency means a 1000 high qual­i­ty jobs leav­ing the UK, dis­rupt­ing a thou­sand fam­i­lies as a di­rect re­sult of Brex­it, with im­pli­ca­tions for thou­sands more. Busi­ness­es now need cer­tain­ty. The best way to do this is by an ear­ly agree­ment to a tran­si­tion time­frame and con­tin­ued close reg­u­la­to­ry co-op­er­a­tion. We must now en­sure Brex­it does not dis­rupt the safe sup­ply of vi­tal med­i­cines to tens of mil­lions of fam­i­lies in the EU 27 and the UK.”


Mar­tine Dehlinger-Kre­mer, VP of Glob­al Med­ical and Reg­u­la­to­ry Af­fairs at in­ter­na­tion­al CRO Syn­ter­ac­tHCR, says Am­s­ter­dam has all the cri­te­ria to be a suc­cess­ful move:

Am­s­ter­dam is a very dy­nam­ic city and an in­ter­na­tion­al­ly ori­ent­ed city. The Nether­lands of­fers all the fa­cil­i­ties nec­es­sary for the agency to re­lo­cate quick­ly and ef­fi­cient­ly. Am­s­ter­dam will be able to pro­vide good hous­ing, in­ter­na­tion­al schools and health­care for the EMA em­ploy­ees as well as ac­cess to the labour mar­ket for their part­ners. Am­s­ter­dam is well recog­nised med­ical and sci­ence in­dus­try. Am­s­ter­dam has even been nom­i­nat­ed as the Eu­ro­pean Cap­i­tal of In­no­va­tion by the Eu­ro­pean Union. Am­s­ter­dam of­fers one of Eu­rope’s biggest air­ports which will al­low easy and fast ac­cess to the EMA vis­i­tors.”


And Pier­lui­gi Parac­chi, CEO of Italy’s Genen­ta:


Im­age: Am­s­ter­dam Shut­ter­stock

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

An un­ortho­dox pro­pos­al for Bio­gen's Medicare-man­dat­ed Aduhelm tri­al

Biogen has gone full blitz since Medicare announced it would only cover its new Alzheimer’s drug when used in clinical trials, accusing the agency of discriminating against Alzheimer’s patients and trying to get physicians to change regulators’ minds.  Critics, meanwhile, cheered what they see as a necessary wall protecting payers and patients from an unproven and unsafe drug.

Far less attention, though, has gone to what a Medicare-funded clinical trial would actually look like. Biogen has operated as if it would be a standard late-stage Alzheimer’s trial, enrolling a couple thousand patients and giving half placebo.

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