No clear an­swers: Yes, re­cent ac­tions against Chi­nese Amer­i­can sci­en­tists do pose a threat — but maybe those of­fi­cial con­cerns about es­pi­onage are valid too

Ear­li­er this week we asked our read­ers to chime in on a con­ver­sa­tion in­spired by for­mer NIH di­rec­tor and Sanofi R&D chief Elias Zer­houni, who was con­cerned that re­cent purges of Chi­nese Amer­i­can sci­en­tists at top bio­med­ical in­sti­tu­tions could spell trou­ble for the sci­en­tif­ic com­mu­ni­ty. While ground­ed in na­tion­al se­cu­ri­ty rea­sons, he ar­gues, the US risks los­ing valu­able tal­ent and col­lab­o­ra­tions if it doesn’t han­dle the sit­u­a­tion prop­er­ly.

The re­sults to our snap poll, which gath­ered 220 re­spons­es, re­flects a lack of con­sen­sus on the three key ques­tions: How se­ri­ous is the prob­lem of aca­d­e­m­ic es­pi­onage? In try­ing to fix that is­sue, are we hurt­ing Chi­nese Amer­i­can sci­en­tists? And what, if any­thing, should be done about it?

More re­spon­dents be­lieve that wor­ries about aca­d­e­m­ic es­pi­onage are at least “some­what” well-found­ed, con­sti­tut­ing al­most 60%. On the oth­er side, 30% say “not re­al­ly” or “ab­solute­ly not,” with 10% stand­ing in the mid­dle.

“Ma­jor­i­ty of aca­d­e­m­ic find­ings are of no val­ue,” one read­er com­ments.

An­oth­er raised the con­cern that aca­d­e­mics don’t al­ways know where the line is be­tween friend­ly shar­ing of in­for­ma­tion and IP theft:

In­sti­tu­tions don’t al­ways train their fac­ul­ty and staff on ac­cept­able/un­ac­cept­able col­lab­o­ra­tion poli­cies, and there’s a fast-and-loose cul­ture in acad­e­mia on many top­ics (da­ta re­pro­ducibil­i­ty, HR, lab safe­ty, IP) that goes be­yond so-called aca­d­e­m­ic es­pi­onage.

But even for those con­cerned with some lev­el of es­pi­onage, there is a di­vide as to whether it’s a sys­temic ef­fort com­ing specif­i­cal­ly from Chi­na or bad ac­tors that are bound to pop up, re­gard­less of na­tion­al­i­ty.

A slight ma­jor­i­ty agrees that the dis­missals at MD An­der­son and Emory threat­en the en­tire Chi­nese Amer­i­can sci­en­tif­ic com­mu­ni­ty in the US — in par­tic­u­lar, the bio­med­ical re­search field, not least be­cause it shapes the pub­lic dis­course about sci­en­tists with roots in Chi­na.

Com­bine the cur­rent ad­min­is­tra­tion’s an­ti-im­mi­grant stance with these re­cent events and even Amer­i­can born Chi­nese sci­en­tists like me feel threat­ened. It adds to a cli­mate of fear – who’s look­ing over our shoul­ders and mis­in­ter­pret­ing our ac­tions?

Those who hold the op­po­site view, though, say iso­lat­ed cas­es — in which in­di­vid­u­als were al­leged­ly pun­ished for shar­ing con­fi­den­tial in­for­ma­tion and vi­o­lat­ing con­flict of in­ter­est poli­cies — don’t make a con­spir­a­cy against an en­tire eth­nic group.

Along the same lines, while 60% of re­spon­dents say they share an ur­gency to ad­dress the fears of Chi­nese Amer­i­can sci­en­tists, 20% do not and the rest are ei­ther neu­tral or haven’t formed an opin­ion.

Many in sup­port wor­ry about a re­verse brain drain, es­pe­cial­ly as they have had a pos­i­tive ex­pe­ri­ence work­ing with Chi­nese-born col­leagues: “In the ab­sence of pos­i­tive in­for­ma­tion, in­di­vid­u­als will make there own de­ci­sions, and well-fund­ed Chi­nese com­pa­nies are push­ing hard for tal­ent al­ready.”

Oth­ers main­tain the prob­lem is overblown.

“It should be clear to all that there is noth­ing to be con­cerned about if sci­en­tists are not par­tic­i­pat­ing in ques­tion­able part­ner­ships with for­eign gov­ern­men­tal agen­cies or com­pa­nies, etc. It seems crazy to sug­gest that sci­en­tists who work with­in the nor­mal con­fines of acad­e­mia or in­dus­try would be at risk with­out ad­di­tion­al ac­tion.”

What about Zer­houni’s pro­pos­al to set up a blue-rib­bon com­mit­tee to draft a new set of clear­ly de­fined rules to gov­ern for­eign sci­en­tif­ic en­gage­ment?

The idea is clear­ly still in its in­fan­cy, with more than half re­spond­ing “neu­tral” or “no opin­ion” and some pro­fess­ing lack of un­der­stand­ing as to what that en­tails. Sup­port and dis­agree­ment are split right down the mid­dle.

Go­ing back to the ex­pul­sions that trig­gered the con­ver­sa­tion, a re­spon­dent sug­gests the so­lu­tion will be more in­for­ma­tion.

The best way for­ward is for the gov­ern­ment to spell out ex­act­ly what the ev­i­dence against these in­di­vid­u­als was. If it is con­vinc­ing to sci­en­tists that their in­ten­tions re­al­ly were to hurt Amer­i­can sci­ence and ben­e­fit Chi­nese, the ac­tions will be ac­cept­ed and will serve as a warn­ing to oth­ers per­haps con­sid­er­ing sim­i­lar ad­ven­tures. On the oth­er hand, if the ev­i­dence is weak or they mis­in­ter­pret­ed the in­tent of the ac­tions of these peo­ple, then wide­spread pan­ic will en­sue, with or with­out a “blue rib­bon pan­el”.

So­cial im­age: Shut­ter­stock

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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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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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

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