Just how much would no-deal Brex­it harm bio­med­ical sci­ence? Re­searchers speak out

As Con­ser­v­a­tive Par­ty lead­ers face off in a bid to be­come the UK’s next Prime Min­is­ter, sci­en­tists from a range of spe­cial­ties — from can­cer to cli­mate — are sound­ing loud­er alarms about the threats of a loom­ing no-deal Brex­it for their re­search work.

Pamela Kearns Birm­ing­ham

Cit­ing an analy­sis by the Uni­ver­si­ty Col­lege Lon­don of the lat­est EU re­search fund­ing da­ta, the Guardian re­port­ed that UCL and eight oth­er Rus­sell Group uni­ver­si­ties ran on­ly 20 big Eu­ro­pean re­search col­lab­o­ra­tions in 2018, a steep drop from around 50 in 2016. And in­di­vid­ual re­searchers are feel­ing the cloud of un­cer­tain­ty snuff­ing out prospects.

While the British gov­ern­ment un­der There­sa May had out­lined a co­op­er­a­tive frame­work to nur­ture sci­ence and in­no­va­tion, it all be­came moot when she failed mul­ti­ple at­tempts to get the deal she ne­go­ti­at­ed with the EU through the Par­lia­ment. That murky fu­ture has dri­ven po­ten­tial col­lab­o­ra­tors away, Pamela Kearns, di­rec­tor of Can­cer Re­search UK’s na­tion­al clin­i­cal tri­als unit, told the news­pa­per.

“In one re­cent dis­cus­sion about a fund­ing bid with very long­stand­ing Eu­ro­pean part­ners, it was de­cid­ed they wouldn’t have a UK part­ner on the project as it would be too great a risk,” Kearns, who cur­rent­ly over­sees 16 tri­als across 21 Eu­ro­pean coun­tries, said.

She is al­so wor­ried that UK sci­en­tists will lose ac­cess to Hori­zon Eu­rope, a €100 bil­lion (£89.9 bil­lion) fund­ing pro­gram that fea­tures can­cer as one of its key mis­sions, if it crash­es out of the EU on Oc­to­ber 31 with­out a deal.

Her con­cerns echo those of many oth­ers, in­clud­ing No­bel Prize-win­ning cell bi­ol­o­gist Paul Nurse, who com­pared the fund to the Cham­pi­on’s League. Drop­ping out of it, the Fran­cis Crick di­rec­tor warned, would rep­re­sent a ma­jor blow to UK sci­ence.

Paul Work­man ICR

Paul Work­man of the In­sti­tute of Can­cer Re­search al­so chimed in:

I am con­cerned that it could very well be­come much more dif­fi­cult for UK sci­en­tists to work with their col­leagues in Eu­rope if they can no longer join Eu­ro­pean con­sor­tia or ac­cess EU in­for­ma­tion re­sources that al­low sci­en­tists to find po­ten­tial col­lab­o­ra­tors in fu­ture. In­deed I al­ready hear many sto­ries where our UK sci­en­tists are be­ing dis­cour­aged from join­ing Eu­ro­pean ini­tia­tives – just based on the un­cer­tain­ty.

At the very least, Work­man added, the gov­ern­ment should reaf­firm its com­mit­ment to R&D and work to en­sure a stream of pub­lic and pri­vate in­vest­ments in the long term.

Days ago, 11 groups — in­clud­ing the CRUK, the Acad­e­my of Med­ical Sci­ences and the As­so­ci­a­tion of Med­ical Re­search Char­i­ties — made the same call to the PM hope­fuls, Boris John­son and Je­re­my Hunt:

The next Prime Min­is­ter must set out a long-term plan for re­search and in­no­va­tion in­vest­ment up to 2030. This should build on the Gov­ern­ment tar­get to boost over­all R&D in­vest­ment ini­tial­ly to 2.4% of GDP by 2027 – and the longer-term aim of 3% of GDP. But words and tar­gets will not be enough, the UK needs a co­her­ent long-term plan to build our po­si­tion as the glob­al hub for new world-lead­ing tech­nolo­gies, to draw on our strengths across mul­ti­ple dis­ci­plines, to at­tract tal­ent from around the world and to pro­mote British en­tre­pre­neur­ship.

The 160,000 To­ries tasked with se­lect­ing the coun­try’s next leader will be­gin vot­ing next week, with re­sults ex­pect­ed on Ju­ly 23.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: Chi­na's BeiGene scores first-ever FDA ap­proval — but can they carve up J&J's block­buster fran­chise?

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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Carson Block. Muddy Waters via YouTube

Shorts ga­lore: Mud­dy Wa­ters sees slide for Pep­tiDream, tweets con­cerns about Fi­bro­Gen's new da­ta

The short seller Muddy Waters is taking aim at Japan’s most profitable biotech, projecting a slide for a company that has skyrocketed over the last four years. Meanwhile, the firm tweeted out an analysis accusing FibroGen of manipulating data to obscure safety concerns in their latest reveal, although some investors seem satisfied by the biotech’s explanation.

Muddy Waters shorted PeptiDream, a Japanese biotech-for-hire that leveraged its peptide library into partnerships with some of the world’s largest pharmaceutical companies, a 50% profit margin and $6 billion valuation. The firm noted that despite its esteem, PeptiDream has failed to bring a drug to market 13 years after its 2006 launch (although this is not especially rare for biotech).

Pin­cer move­ment: Cal­i­for­nia biotech gets $35M to suf­fo­cate can­cer in co­or­di­nat­ed at­tack

Having served in Afghanistan, the navy veteran leading California-based EpicentRx wants to leave no patient behind with his arsenal of anti-cancer drugs. On Thursday, the company was given a $35 million boost to further its mission.

The injection of funds will be used to shepherd its late-stage CD47 drug, RRx-001, to the FDA for marketing, and its oncolytic virus program into the clinic.

RRx-001, engineered as an agent that makes tumor cells more sensitive to therapy, is in a Phase III trial in combination with chemotherapy for use in third-line and beyond small cell lung cancer (SCLC). The drug has been granted orphan drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma.