Scripps reach­es $10M set­tle­ment with gov­ern­ment over al­le­ga­tions NIH grants weren't prop­er­ly ac­count­ed for

Scripps Re­search In­sti­tute has set­tled a case with the Jus­tice De­part­ment al­leg­ing claims of mis­ap­pro­pri­at­ed funds, the US at­tor­ney for the dis­trict of Mary­land an­nounced late last week.

Pros­e­cu­tors said the in­sti­tute im­prop­er­ly used NIH-fund­ed re­search grants for non-grant re­lat­ed ac­tiv­i­ties, in­clud­ing work­ing on new grant ap­pli­ca­tions, teach­ing ac­tiv­i­ties and oth­er ad­min­is­tra­tive tasks. As part of the set­tle­ment, Scripps has agreed to pay $10 mil­lion.

Pros­e­cu­tors not­ed that no de­ter­mi­na­tion of li­a­bil­i­ty had been made in the case.

“The NIH has fi­nite re­sources to sup­port im­por­tant re­search across the na­tion,” said gov­ern­ment lawyer Jef­frey Clark in a state­ment on Sept. 11. “To­day’s set­tle­ment demon­strates our com­mit­ment to pro­tect those re­sources by en­sur­ing that NIH grants funds are used for the pur­pos­es for which they were in­tend­ed.”

Ac­cord­ing to the an­nounce­ment, Scripps re­ceives mil­lions of dol­lars in NIH grant fund­ing every year, and the set­tle­ment re­solves al­le­ga­tions that oc­curred be­tween 2008 and 2016. Scripps al­leged­ly did not pro­vide a prop­er ac­count­ing sys­tem for its re­searchers to keep track of time spent on non-grant projects. As such, the in­sti­tute charged the time to the gov­ern­ment rather than al­lo­cate it as in­di­rect costs.

The al­leged in­ci­dents were orig­i­nal­ly brought to light through a whistle­blow­er claim from a for­mer Scripps em­ploy­ee, who will re­ceive $1.75 mil­lion as part of the agree­ment. While at Scripps, their salary was al­leged­ly 100% charged to the gov­ern­ment for at least two years, ac­cord­ing to re­port­ing by the Palm Beach Post. 

A spokesper­son for Scripps told End­points News that the charges stemmed from an “ac­count­ing dis­crep­an­cy that av­er­aged less than half of one per­cent per year of the in­sti­tute’s an­nu­al fed­er­al grant fund­ing.”

The in­sti­tute’s state­ment con­tin­ued:

Through­out the course of the in­quiry the In­sti­tute ful­ly co­op­er­at­ed with the fed­er­al gov­ern­ment, pro­vid­ing all re­quest­ed doc­u­men­ta­tion and as­sist­ing gov­ern­ment in­ves­ti­ga­tors. No ques­tions were raised con­cern­ing the qual­i­ty or con­duct of our re­search or the con­tri­bu­tions of our fac­ul­ty to sci­ence, in­no­va­tion, and the im­prove­ment of hu­man health.

Scripps Re­search tremen­dous­ly val­ues the in­vest­ment the fed­er­al gov­ern­ment makes in sci­en­tif­ic re­search, and we are deeply com­mit­ted to us­ing this sup­port to its ut­most to make dis­cov­er­ies and in­no­va­tions that im­prove hu­man health.

Scripps is one of the most promi­nent sci­en­tif­ic in­sti­tu­tions in the bio­med­ical are­na, with lo­ca­tions in La Jol­la, CA and Jupiter, FL. Dur­ing the Covid-19 pan­dem­ic, Scripps ex­ec­u­tive vice pres­i­dent Er­ic Topol has been one of the staunchest pro­po­nents of in­dus­try trans­paren­cy, pub­licly push­ing for vac­cine mak­ers to di­vulge in­for­ma­tion about their tri­als. Mod­er­na, Pfiz­er and As­traZeneca, the three com­pa­nies con­duct­ing Phase III stud­ies in the US, each re­leased their safe­ty blue­prints with­in the last four days.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Kimberly Smith, ViiV R&D chief (ViiV Healthcare)

Af­ter sting­ing FDA set­back, Glax­o­SmithK­line's Vi­iV fi­nal­ly notch­es US ap­proval for long-act­ing HIV in­jec­tion

GlaxoSmithKline’s HIV unit ViiV was dealt a stinging loss back in late 2019 when the FDA slammed the brakes on its application for a once-monthly injection based on manufacturing issues. Now, with that roadblock in the rearview, ViiV has finally made good on its promise to change the HIV game.

The FDA on Thursday approved ViiV’s Cabenuva (cabotegravir and rilpivirine) as a long acting, once-monthly therapy for HIV-positive adults who are virologically suppressed and on a stable antiviral regimen.