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

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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