UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Flori­da woman has been in­dict­ed as part of a clin­i­cal tri­al fraud scheme over a Glax­o­SmithK­line pe­di­atric asth­ma study, the Jus­tice De­part­ment an­nounced Tues­day, the lat­est de­vel­op­ment in a case where three in­di­vid­u­als have al­ready plead­ed guilty.

Jes­si­ca Pala­cio was charged with par­tic­i­pat­ing in a plot to fal­si­fy med­ical records, giv­ing off the ap­pear­ance that tri­al par­tic­i­pants were mak­ing their sched­uled vis­its to a Mi­a­mi CRO and tak­ing an ex­per­i­men­tal asth­ma med­ica­tion as re­quired. Pala­cio was al­so charged with ly­ing to FDA in­ves­ti­ga­tors about her con­duct.

The FDA Of­fice of Crim­i­nal In­ves­ti­ga­tions is con­tin­u­ing to in­ves­ti­gate the case, which was launched last Au­gust.

“Re­li­able and ac­cu­rate da­ta from clin­i­cal tri­als is the cor­ner­stone of FDA’s eval­u­a­tion of a new drug,” said Justin Field­er, spe­cial agent at the Mi­a­mi branch of the FDA’s Of­fice of Crim­i­nal In­ves­ti­ga­tions, in a state­ment. “We will con­tin­ue to mon­i­tor, in­ves­ti­gate and bring to jus­tice those whose ac­tions may sub­vert the FDA ap­proval process and en­dan­ger the pub­lic health.”

Pala­cio and three oth­ers work­ing for the CRO known as Un­lim­it­ed Med­ical Re­search fab­ri­cat­ed par­tic­i­pa­tion of pa­tients in the study be­tween 2013 and 2016, the DOJ said. The pur­port­ed mas­ter­mind of the scheme, a woman named Yvelice Vil­la­man-Ben­cosme, plead­ed guilty to con­spir­a­cy to com­mit wire fraud in Jan­u­ary and was sen­tenced to 63 months in prison. As part of her plea agree­ment, Vil­la­man-Ben­cosme was or­dered to for­feit $174,000.

In that agree­ment, Vil­la­man-Ben­cosme ad­mit­ted that she at­tempt­ed to de­fraud GSK by us­ing pa­tients’ per­son­al in­for­ma­tion from her pri­vate med­ical prac­tice to cre­ate false in­for­ma­tion to be en­tered in­to case his­to­ries. The four made it ap­pear as though pa­tients sat­is­fied el­i­gi­bil­i­ty cri­te­ria, re­ceived phys­i­cal ex­ams, took the study drug and re­ceived pay­ment for clin­i­cal tri­al vis­its.

The plea deal list­ed one ex­am­ple of a pa­tient known on­ly as D.H., who Vil­la­man-Ben­cosme had said was “do­ing well” and rec­om­mend­ed the con­tin­ued use of med­ica­tion af­ter a vis­it in April 2015. None of Vil­la­man-Ben­cosme’s record­ed state­ments in the check­up were true, as D.H. was not par­tic­i­pat­ing in the study.

Vil­la­man-Ben­cosme fal­si­fied case his­to­ries for at least 11 in­di­vid­u­als and ad­mit­ted to par­tic­i­pat­ing in the scheme be­tween around Sep­tem­ber 2013 and June 2016.

The clin­i­cal tri­al in ques­tion was the GSK-spon­sored study dubbed VESTRI, ac­cord­ing to court doc­u­ments from last Au­gust. Re­searchers had aimed to mea­sure the long-term safe­ty of Ad­vair Diskus, an in­haled asth­ma med­ica­tion, in pa­tients aged 4 to 11 years old. Re­sults from the study were re­port­ed in March 2016 and pub­lished in the New Eng­land Jour­nal of Med­i­cine that Sep­tem­ber.

Asked for com­ment, GSK said it com­mis­sioned Un­lim­it­ed Med­ical Re­search as one of the sites to con­duct the VESTRI study and ful­ly co­op­er­at­ed with the DoJ probe, a spokesper­son con­firmed to End­points News.

“As soon as we be­came aware of pos­si­ble clin­i­cal tri­al fraud we con­duct­ed an in­ter­nal in­ves­ti­ga­tion; ex­clud­ed the da­ta from the stud­ies and re­ports; and re­port­ed the po­ten­tial fraud to the FDA and the In­sti­tu­tion­al Re­view Boards,” the spokesper­son told End­points in an email.

Phone calls to Un­lim­it­ed Med­ical Re­search went unan­swered. The CRO gi­ant Parex­el was al­so list­ed as a study col­lab­o­ra­tor on the gov­ern­ment’s clin­i­cal tri­als web­site, and Parex­el told End­points ear­ly Thurs­day that the com­pa­ny has “no af­fil­i­a­tion” with Un­lim­it­ed Med­ical Re­search.

Two oth­er in­di­vid­u­als in the case have plead­ed guilty to con­spir­a­cy to com­mit wire fraud. Lisett Raven­tos was sen­tenced to 30 months in prison in March, and May­tee Lle­do was sched­uled to be sen­tenced in April. Pala­cio was the on­ly mem­ber of the group to al­so be charged with mak­ing false state­ments on a signed af­fi­davit.

This sto­ry has been up­dat­ed with com­ment from Glax­o­SmithK­line and Parex­el.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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Richard Pazdur (via AACR)

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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