Charles Lieber (Charles Krupa, AP)

Har­vard's Charles Lieber in­dict­ed for ly­ing to the feds, bring­ing US re­searcher­s' Chi­na ties back to the spot­light

Five months af­ter his shock­ing ar­rest, Charles Lieber has been in­dict­ed by a fed­er­al grand ju­ry for ly­ing to au­thor­i­ties about his in­volve­ment in Chi­na’s Thou­sand Tal­ents Pro­gram.

The 61-year-old sci­en­tist — who chaired Har­vard’s chem­istry de­part­ment and led a lab spe­cial­iz­ing in nanoscience be­fore he was ar­rest­ed and placed on ad­min­is­tra­tive leave in late Jan­u­ary — is fac­ing two counts of mak­ing false state­ments. He will be ar­raigned in fed­er­al court at a lat­er date, and is ex­pect­ed to con­test the charges.

While Lieber was not the first Amer­i­can sci­en­tist not of Chi­nese eth­nic­i­ty to be swept up in the FBI’s probe in­to aca­d­e­m­ic es­pi­onage, his case stood out be­cause of his high pro­file and the sever­i­ty of the po­ten­tial con­se­quences. From a DOJ re­lease:

The charge of mak­ing false state­ments pro­vides for a sen­tence of up to five years in prison, three years of su­per­vised re­lease and a fine of $250,000.

Amid some re­newed ten­sion in US-Chi­na re­la­tions — with Pres­i­dent Don­ald Trump point­ing fin­gers at Chi­na’s ini­tial han­dling of the coro­n­avirus out­break, and Xi Jin­ping es­sen­tial­ly dar­ing the US by im­pos­ing a na­tion­al se­cu­ri­ty law on Hong Kong — Amer­i­can of­fi­cials are said to be con­sid­er­ing fur­ther re­stric­tions on the en­try of Chi­nese stu­dents as re­tal­i­a­tion. The re­ports sparked new de­bates around the Trump ad­min­is­tra­tion’s ac­cu­sa­tions that Chi­na has been steal­ing sci­en­tif­ic se­crets by in­fil­trat­ing top or­ga­ni­za­tions. With­in the bio­med­ical en­ter­prise, aca­d­e­m­ic es­pi­onage is an ac­knowl­edged prob­lem, al­though sci­en­tists are di­vid­ed on what counts as spy­ing, how per­va­sive it is and whether the gov­ern­ment is throw­ing out the ba­by with the bath wa­ter.

As an in­ter­nal in­ves­ti­ga­tion by the Mof­fitt Can­cer Cen­ter high­light­ed, col­lab­o­rat­ing with or even re­ceiv­ing funds from Chi­nese uni­ver­si­ties aren’t an of­fense in the gov­ern­ment and re­search in­sti­tu­tions’ eyes. It on­ly be­comes an is­sue when re­searchers hide their af­fil­i­a­tion — time com­mit­ment as well as pay­ments — even when no se­crets are ap­par­ent­ly di­vulged.

At Mof­fitt, the fail­ure to re­port cost six top of­fi­cials their job, in­clud­ing its for­mer CEO and ac­claimed hema­tol­o­gist Alan List.

Lieber’s ties to Chi­na al­leged­ly be­gan in 2011 when he, “un­be­knownst to Har­vard Uni­ver­si­ty,” be­came a strate­gic sci­en­tist at Wuhan Uni­ver­si­ty of Tech­nol­o­gy. For the next three years, he would sign on­to the Thou­sand Tal­ents Plan, which is de­signed to re­cruit top brains like him­self.

Un­der that con­tract, the DOJ said he was paid a salary of $50,000 per month, liv­ing ex­pens­es of up to ap­prox­i­mate­ly $158,000 USD, and award­ed more than $1.5 mil­lion to es­tab­lish a re­search lab at the uni­ver­si­ty. In re­turn, he al­leged­ly agreed to no less than nine months of work per year.

All of that came in on top of the $15 mil­lion in grants Lieber has re­ceived from the NIH over the years.

But when the feds came knock­ing in April 2018, he told in­ves­ti­ga­tors that he was nev­er asked to par­tic­i­pate in Thou­sand Tal­ents, ac­cord­ing to the com­plaint. Har­vard, al­leged­ly tak­ing him by his word, al­so told the NIH he had no for­mal as­so­ci­a­tion with WUT af­ter 2012 and that the Wuhan in­sti­tu­tion was false­ly ex­ag­ger­at­ing his role there.

His lawyer, Marc Mukasey, told the Har­vard Crim­son that the gov­ern­ment has it wrong, and that Lieber is the vic­tim, not the per­pe­tra­tor.

“Pro­fes­sor Lieber has ded­i­cat­ed his life to sci­ence and to his stu­dents,” Mukasey wrote. “Not mon­ey, not fame, just his sci­ence and his stu­dents. […] “When jus­tice is done, Char­lie’s good name will be re­stored and the sci­en­tif­ic com­mu­ni­ty again will be able to ben­e­fit from his in­tel­lect and pas­sion.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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