Jorge Gomez, former Moderna CFO

Mod­er­na blind­sided by in­ves­ti­ga­tion in­to for­mer CFO Jorge Gomez, com­pa­ny says

It’s been days since Mod­er­na sent its new CFO Jorge Gomez pack­ing — af­ter just one day on the job — over an in­ves­ti­ga­tion launched by his for­mer em­ploy­er. Al­though that probe was ini­ti­at­ed back in March, Mod­er­na says it had no idea un­til last week.

Mod­er­na told End­points News on Mon­day that it was un­aware of Dentsply’s in­ves­ti­ga­tion in­volv­ing Gomez un­til it was pub­licly dis­closed on May 10. The news, first re­port­ed by the Wall Street Jour­nal, comes just five days af­ter Dentsply an­nounced an in­ves­ti­ga­tion in­to “cer­tain fi­nan­cial re­port­ing mat­ters” re­lat­ed to Gomez’s time at the den­tal equip­ment com­pa­ny.

In­ves­ti­ga­tors are dig­ging in­to the “use of in­cen­tives to sell prod­ucts to dis­trib­u­tors in the third and fourth quar­ters of 2021, and whether those in­cen­tives were ap­pro­pri­ate­ly ac­count­ed for and the im­pact of those sales was ad­e­quate­ly dis­closed in the Com­pa­ny’s pe­ri­od­ic re­ports filed with the Se­cu­ri­ties and Ex­change Com­mis­sion,” ac­cord­ing to a Dentsply SEC fil­ing.

The com­pa­ny is al­so as­sess­ing whether “cer­tain for­mer and cur­rent mem­bers of se­nior man­age­ment” used in­cen­tives and oth­er ac­tions to achieve ex­ec­u­tive com­pen­sa­tion tar­gets last year, the fil­ing said.

With­in an hour of learn­ing about the probe, Mod­er­na CEO Stéphane Ban­cel met with the com­pa­ny’s chief le­gal of­fi­cer, chair­man of the board, and ex­ter­nal coun­sel to dis­cuss and sched­ule a meet­ing with the full board, the biotech told End­points.

“Up­on meet­ing, the Board made the de­ter­mi­na­tion that it was ap­pro­pri­ate to sep­a­rate Mr. Gomez from Mod­er­na,” a com­pa­ny spokesper­son said. “Mr. Gomez was im­me­di­ate­ly in­formed of that de­ci­sion.”

The next day, Mod­er­na an­nounced that Gomez was leav­ing the com­pa­ny, ef­fec­tive im­me­di­ate­ly. David Meline, Gomez’s pre­de­ces­sor, will step back in­to the CFO role while Mod­er­na restarts its hunt for a new re­place­ment, Mod­er­na said.

De­spite the end re­sult, Mod­er­na de­fend­ed its de­ci­sion to hire Gomez and its swift ac­tion to let him go. The com­pa­ny an­nounced back in April that it was bring­ing Gomez on­to the team, just hours af­ter its Covid-19 vac­cine ri­val Pfiz­er named its own new CFO.

“The May 11, 2022 an­nounce­ment and de­par­ture of Jorge Gomez from Mod­er­na strong­ly re­flects the se­ri­ous­ness with which Mod­er­na takes cor­po­rate gov­er­nance,” a spokesper­son said. “We are con­fi­dent that Mod­er­na con­duct­ed all ap­pro­pri­ate due dili­gence on this mat­ter pri­or to the hir­ing of Mr. Gomez, based on avail­able in­for­ma­tion.”

Gomez is leav­ing with $700,000 in sev­er­ance pay, which is equal to a year’s salary. How­ev­er, Mod­er­na could ter­mi­nate or sus­pend his sev­er­ance ben­e­fits and seek re­pay­ment if the Dentsply in­ves­ti­ga­tion finds him guilty of any wrong­do­ing, ac­cord­ing to an SEC fil­ing.

The for­mer CFO has not re­spond­ed to a re­quest for com­ment.

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.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.