Viravuth Yin (MDI Biological Laboratory)

Biotech co-founder set­tles ma­jor re­search mis­con­duct al­le­ga­tions with HHS

In one life, Vi­ravuth Yin is an in­ter­na­tion­al­ly-rec­og­nized ex­pert in re­gen­er­a­tive bi­ol­o­gy who pi­o­neered the use of the ze­brafish as a drug screen­ing plat­form, dis­cov­ered a po­ten­tial new re­gen­er­a­tive heart drug and spun that dis­cov­ery in­to a new biotech start­up known as No­vo Bio­sciences, where he now serves as co-founder and CSO.

But in an­oth­er life, a life that he’s try­ing to move past with an HHS set­tle­ment on Wednes­day, Yin is al­leged to have com­mit­ted ma­jor re­search mis­con­duct, in­clud­ing “know­ing­ly, in­ten­tion­al­ly, and/or reck­less­ly fal­si­fy­ing and/or fab­ri­cat­ing da­ta” on three pub­lished pa­pers and two man­u­scripts. Those three pub­lished pa­pers, two of which were pub­lished in iScience, will now be re­tract­ed, at Yin’s re­quest, ac­cord­ing to the set­tle­ment.

The set­tle­ment al­so ef­fec­tive­ly means that Yin, who was in­ves­ti­gat­ed be­cause of his NIH grant fund­ing, does not ad­mit nor de­ny those find­ings of re­search mis­con­duct, and it’s not an ad­mis­sion of li­a­bil­i­ty. But the set­tle­ment al­so means that Yin has agreed to al­low a com­mit­tee of two to three se­nior fac­ul­ty mem­bers at an aca­d­e­m­ic in­sti­tu­tion who are fa­mil­iar with his field of re­search, but not in­clud­ing his su­per­vi­sor or col­lab­o­ra­tors, to pro­vide over­sight and guid­ance to him for two years.

How that stip­u­la­tion will play out in the re­al world re­mains un­known as Yin no longer works at the Mount Desert Is­land Bi­o­log­i­cal Lab­o­ra­to­ry where the mis­con­duct al­leged­ly oc­curred.

It was the re­search Yin did at MDI­BL that al­lowed him to move over and co-found No­vo Bio­sciences along­side Kevin Strange, who stepped down as pres­i­dent of the MDI­BL in Ju­ly 2018 to work as the oth­er No­vo co-founder.

NIH’s grants data­base notes that Yin was the project leader for one grant worth more than $82,000 on com­par­a­tive an­i­mal mod­els at MDI­BL. The data­base notes, “This re­search in turn re­sult­ed in mul­ti­ple firsts for the MDI­BL in­clud­ing the dis­cov­ery of three lead small mol­e­cules for re­gen­er­a­tive med­i­cine ap­pli­ca­tions, six U.S. and in­ter­na­tion­al patent ap­pli­ca­tions, one is­sued U.S. patent and the launch of the spin­off com­pa­ny No­vo Bio­sciences.”

The Maine-based biotech No­vo has since re­ceived a two-year, $1.5 mil­lion re­search grant from the NIH for the fur­ther de­vel­op­ment of its po­ten­tial new heart treat­ment, as well as an­oth­er $4 mil­lion in funds raised for the com­pa­ny’s first hu­man tri­als.

Whether or not this re­search mis­con­duct, which HHS said in­clud­ed “re­port­ing re­search meth­ods and sta­tis­tics that were not per­formed” in at least five ex­per­i­men­tal re­sults, catch­es up with No­vo Bio­sciences re­mains to be seen.

Strange told Re­trac­tion Watch: “We are ful­ly con­fi­dent that the stud­ies cit­ed by ORI [Of­fice of Re­search In­tegri­ty] have no re­la­tion­ship to nor do they pro­vide any sci­en­tif­ic foun­da­tions for our pre­vi­ous and on­go­ing work. Dr. Yin re­mains a valu­able mem­ber of the No­vo Bio­sciences team.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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