‘I was shocked’: Con­tro­ver­sy brews at Emory af­ter promi­nent Chi­nese neu­ro­sci­en­tists are oust­ed over dis­clo­sure is­sues

It’s what Chi­nese sci­en­tists work­ing in the US have been dread­ing since MD An­der­son oust­ed three of its Asian fac­ul­ty mem­bers fol­low­ing NIH-di­rect­ed in­ves­ti­ga­tions: A sec­ond pres­ti­gious in­sti­tu­tion has closed down a promi­nent lab and ter­mi­nat­ed the two Chi­na-born re­searchers head­ing the lab.

The news, com­ing out of Emory Uni­ver­si­ty, is once again stir­ring up in­dig­na­tion, be­wil­der­ment and anx­i­ety among Chi­nese aca­d­e­mics and ne­ti­zens alike, not least be­cause the oust­ed pro­fes­sors have gone pub­lic with their side of the sto­ry, ques­tion­ing how the school han­dled the fir­ing, dis­put­ing ac­cu­sa­tions and ex­press­ing their wor­ry. As a con­se­quence, sev­er­al post­docs from Chi­na work­ing in their lab have al­so been asked to leave the coun­try.

Xi­ao­jiang Li Emory

Xi­ao­jiang Li and Shi­hua Li were 23-year vet­er­ans of Emory and not­ed neu­ro­sci­en­tists spe­cial­iz­ing in Hunt­ing­ton’s dis­ease. The mar­ried cou­ple, who are now US cit­i­zens, joint­ly ran a lab at Emory that re­cent­ly cre­at­ed a pig mod­el for the ge­net­ic ail­ment that they say rep­re­sents bet­ter test­ing grounds for new treat­ments. Last April, they pub­lished this find­ing in Cell in col­lab­o­ra­tion with Ji­nan Uni­ver­si­ty and the Chi­nese Acad­e­my of Sci­ences in Guangzhou.

Xi­ao­jiang Li was giv­ing a speech at Ji­nan, where he is a part-time pro­fes­sor, when The At­lanta Jour­nal-Con­sti­tu­tion re­port­ed on May 23 that Emory has fired two re­searchers for fail­ing to dis­close fund­ing from and re­search ties with Chi­nese en­ti­ties.

The no­ti­fi­ca­tion ar­rived one week ear­li­er, he told the Chi­nese blog Zhishifen­zi, and on the same day, his lab was shut down. The grad­u­ate stu­dents and post­docs at the scene were de­mand­ed to stop their ex­per­i­ments, va­cate the lab and at­tend in­ter­views with “strangers in suits,” Zhishifen­zi re­port­ed based on con­ver­sa­tions with wit­ness­es.

On May 24, Xi­ao­jiang Li bat back at Emory through a state­ment to Sci­ence, in which he claimed to have dis­closed his Chi­nese re­search ac­tiv­i­ty to the uni­ver­si­ty since 2012 when he be­gan work­ing on non-hu­man pri­mate re­search in Chi­na and co­op­er­at­ed with its in­ves­ti­ga­tion dat­ing back to No­vem­ber 2018.

Shi­hua Li Emory

“I was shocked that Emory Uni­ver­si­ty would ter­mi­nate a tenured pro­fes­sor in such an un­usu­al and abrupt fash­ion and close our com­bined lab con­sist­ing of a num­ber of grad­u­ates and post­doc­tor­al trainees with­out giv­ing me spe­cif­ic de­tails for the rea­sons be­hind my ter­mi­na­tion,” he said, adding he’s re­quest­ed a copy of the in­ves­ti­ga­tion.

As in the case with MD An­der­son, Emory said it ini­ti­at­ed its own in­ves­ti­ga­tions af­ter the NIH brought sus­pi­cion of mis­con­duct to their at­ten­tion.

The probe at the pres­ti­gious Hous­ton re­search hos­pi­tal in­volved a to­tal of five re­searchers, with con­cerns span­ning vi­o­la­tions of peer re­view con­fi­den­tial­i­ty as well as fail­ure to dis­close for­eign sources of fund­ing and po­ten­tial con­flicts of in­ter­est. Au­thor­i­ties made the call to purge three of them, cleared an­oth­er of sanc­tions, and are still look­ing in­to the last.

Amid a trade war with Chi­na and in­creased na­tion­al vig­i­lance re­gard­ing aca­d­e­m­ic es­pi­onage, the NIH be­gan warn­ing grantee in­sti­tu­tions about sci­en­tists with for­eign ties in 2018, prompt­ing at least 55 to launch their own probes.

“(W)e re­mind uni­ver­si­ties to look close­ly at their or­ga­ni­za­tions to mit­i­gate un­scrupu­lous prac­tices by for­eign en­ti­ties that aim to cap­i­tal­ize on the col­lab­o­ra­tive na­ture of the U.S. bio­med­ical en­ter­prise,” an NIH spokesper­son told End­points News in the wake of MD An­der­son’s ac­tions, which marked the pub­lic in­stance of a US bio­med­ical in­sti­tu­tion sanc­tion­ing its own re­searchers for al­leged threats of for­eign in­flu­ence.

The fate of Xi­ao­jiang Li’s six NIH-fund­ed projects re­mains un­known, as does those of his post­doc re­searchers be­ing force­ful­ly repa­tri­at­ed (one of whom is preg­nant), Xi­ao­jiang Li said to Sci­ence. The pres­i­dent of Ji­nan has pub­licly pledged to host the Li’s en­tire team and pro­vide them with the fa­cil­i­ties and equip­ment to con­tin­ue their work.


Im­age: Emory Uni­ver­si­ty. Shut­ter­stock

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.