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.”

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,200+ biopharma pros reading Endpoints daily — and it's free.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,200+ biopharma pros reading Endpoints daily — and it's free.

Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.