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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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