Lady Eliza Manningham-Buller. Imperial College London

Well­come Trust joins warn­ing for no-deal Brex­it, calls on Boris John­son to cast R&D vi­sion

Boris John­son may have pledged to con­tin­ue build­ing on Britain’s “enor­mous strengths” in life sci­ence as he blazes a path to­ward Brex­it, but one of the coun­try’s top fun­ders of bio­med­ical re­search is de­mand­ing more.

In a let­ter to the UK’s new Prime Min­is­ter, Well­come Trust warned that “the fi­nal months of 2019 could be a tip­ping point for UK sci­ence” and leav­ing the EU with­out a deal is a threat to the thriv­ing sec­tor. La­dy Eliza Man­ning­ham-Buller, who chairs the char­i­ty, urged John­son to make a sig­nif­i­cant state­ment on sci­ence to lay out his vi­sion in the face of glob­al health emer­gen­cies and the loom­ing loss of ac­cess to col­lab­o­ra­tion with Eu­ro­pean peers.

But David Grainger of Medicxi, a Lon­don-based VC firm known for its as­set-cen­tric plays around Eu­rope, dis­missed Well­come Trust’s let­ter as “more scare­mon­ger­ing” and as­sert­ed “UK as a place to do sci­ence will be un­af­fect­ed” by Brex­it.

One of John­son’s key promis­es to the par­ty mem­bers who elect­ed him was that he will ex­e­cute the UK’s de­par­ture from the EU by Oc­to­ber 31, come what may.

The con­cerns are hard­ly new. While John­son was still vy­ing for the lead­er­ship role against fel­low Con­ser­v­a­tive Par­ty MP Je­re­my Hunt, re­searcher or­ga­ni­za­tions in­clud­ing Can­cer Re­search UK have sound­ed sim­i­lar alarms. The un­cer­tain­ty around the fu­ture re­la­tion­ship be­tween the UK and oth­er coun­tries in Eu­rope has al­ready jeop­ar­dized re­searchers’ par­tic­i­pa­tion in con­ti­nen­tal re­search pacts, they said.

Man­ning­ham-Buller echoes that “some dam­age has al­ready been done, with loss of re­searchers, and in­flu­ence.” And like Pamela Kearns of CRUK, she raised con­cerns about se­cur­ing mem­ber­ship in Hori­zon Eu­rope, a €100 bil­lion (£89.9 bil­lion) fund­ing pro­gram that fea­tures can­cer as one of its key mis­sions.

“While sci­ence pro­motes glob­al col­lab­o­ra­tion, the bar­ri­ers to suc­cess need to be min­i­mized, in­clud­ing with Eu­rope where our clos­est and most ex­ten­sive sci­ence re­la­tion­ships are,” the let­ter read. “That means ne­go­ti­at­ing as­so­ci­at­ed coun­try sta­tus in the EU’s ‘Hori­zon Eu­rope’ re­search pro­gramme, even if we in­tend to cre­ate our own sys­tems in the years ahead.”

It is up to John­son’s gov­ern­ment to seize the op­por­tu­ni­ty and “spend the sort of mon­ey our com­peti­tors are do­ing” — such as Ger­many — Man­ning­ham-Buller told the BBC.

“The key to this will be to en­sure that in­creased pub­lic in­vest­ment leads to an even greater pri­vate sec­tor con­tri­bu­tion to­wards the de­vel­op­ment and use of new tech­nolo­gies, in­clud­ing through pa­tient cap­i­tal,” she wrote in her let­ter.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Frank Zhang (AP Images)

Plot thick­ens around Leg­end Biotech, Gen­Script with founder Frank Zhang's ar­rest

Two months after Legend Biotech made the startling disclosure that founder and then-CEO Frank Zhang was placed under “residential surveillance,” its parent company revealed that he’s been formally arrested.

Zhang — who, since founding GenScript 18 years ago, has taken the CRO public and groomed Legend Biotech in-house until the J&J-partnered CAR-T player was mature enough for its own Nasdaq listing — is severing his final ties with both. He is resigning as board chair/non-executive director of GenScript and director of Legend.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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