Jeff Elton, ConcertAI CEO (via MassBio)

Con­cer­tAI sings a uni­corn tune as the FDA-part­nered clin­i­cal tri­als soft­ware up­start ex­pands

The crescen­do is build­ing at Con­cer­tAI as the ar­ti­fi­cial in­tel­li­gence life sci­ences start­up reels in its en­sem­ble to boost clin­i­cal study di­ver­si­ty, ex­pand de­cen­tral­ized clin­i­cal tri­als and pile on the re­al-world da­ta for can­cer treat­ments.

The FDA-part­nered up­start raised a $150 mil­lion Se­ries C, soar­ing in­to uni­corn sta­tus to a $1.9 bil­lion val­u­a­tion, to take its tech on a world­wide tour. The cur­rent set list of 45 bio­phar­ma and con­tract re­search or­ga­ni­za­tion cus­tomers is not enough for the five-year-old Cam­bridge, MA, com­pa­ny.

“While we start­ed off as a da­ta-cen­tric or­ga­ni­za­tion, we’ve re­al­ly been ad­vanc­ing as much more of a tech­nol­o­gy-cen­tric or­ga­ni­za­tion,” CEO Jeff El­ton told End­points News. A for­mer Ac­cen­ture glob­al man­ag­ing di­rec­tor and North Amer­i­ca life sci­ences leader, El­ton is a board mem­ber of the Mass­a­chu­setts Biotech­nol­o­gy Coun­cil.

A Bris­tol My­ers Squibb tie-up, an FDA part­ner­ship on re­al-world out­comes of on­col­o­gy treat­ments, an ex­pand­ed mul­ti-year col­lab­o­ra­tion with J&J’s Janssen — to in­crease tri­al di­ver­si­ty and ramp up wider ac­cess to tri­als — and an ac­qui­si­tion of Ter­aRecon, which serves 1,300 clin­i­cal tri­al sites world­wide, were all ma­jor mile­stones in 2021 that paved the route for a ma­jor cap­i­tal haul this year. Ex­pect more deal flow as Con­cer­tAI aims to be a “pos­i­tive, strong ac­quir­er,” El­ton said.

The com­pa­ny brought in new in­vestor Sixth Street be­cause of its soft­ware-as-a-ser­vice and life sci­ences ex­per­tise, El­ton said. One no­table group that Con­cer­tAI hasn’t tar­get­ed for in­vest­ment: bio­phar­mas and di­ag­nos­tics com­pa­nies.

“We’ve re­al­ly tried to main­tain our­selves as neu­tral, and when you’re do­ing work be­tween providers and bio­phar­ma, that neu­tral­i­ty ac­tu­al­ly means trust and that neu­tral­i­ty means you can play a more im­por­tant role as you go for­ward, and that’s not true of a lot of the groups that we tend to see in our ecosys­tem,” El­ton said.

Con­cer­tAI says its soft­ware has been in­volved in about 40 new prod­uct launch­es; in­creased pa­tients’ time on ther­a­py by 10%; and shrunk time for study de­sign and clin­i­cal tri­al ex­e­cu­tion by up to 25%. The 1,000-em­ploy­ee com­pa­ny has been grow­ing on av­er­age “a lit­tle north of 40%” per year, El­ton said.

As the start­up ma­tures, El­ton said Con­cer­tAI will build out its com­mer­cial team while re­main­ing a sci­ence- and clin­i­cal ex­per­tise-led com­pa­ny.

Aside from the FDA, phar­mas and CROs, Con­cer­tAI’s tools are al­so de­ployed at med­ical so­ci­eties and oth­er reg­u­la­tors across Eu­rope and Japan, too. Growth will come in Asia-Pa­cif­ic and Latin Amer­i­ca next, El­ton said. Its tech is used on both piv­otal and post-ap­proval tri­als.

“Over the past two years, we’ve fo­cused on nov­el clin­i­cal re­search so­lu­tions with the po­ten­tial to ac­cel­er­ate the time from study ini­ti­a­tion to reg­u­la­to­ry de­ci­sion, in­creas­ing our over­all in­no­va­tion ca­pac­i­ty. This will al­low us to reach more pa­tients and ac­cel­er­ate life-chang­ing can­cer ther­a­pies to ben­e­fit pa­tients glob­al­ly,” said Marisa Co, VP of R&D busi­ness in­sights and an­a­lyt­ics at Bris­tol My­ers, in the news re­lease.

JPM 2020 was the last time the start­up boast­ed of a fund­ing round, se­cur­ing $150 mil­lion in fi­nanc­ing in the months lead­ing up to the pan­dem­ic. Fol­low­ing the lat­est fi­nanc­ing, in­vestors in­clude Sixth Street, De­c­la­ra­tion Part­ners, Mav­er­ick Ven­tures, Al­liance­Bern­stein PCI, SAIGroup and oth­ers.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Iya Khalil, Merck VP and head of data, AI and genome sciences (Novartis)

Mer­ck-No­var­tis re­volv­ing door spins again as AI leader Iya Khalil switch­es phar­mas

As talk of AI this-and-that gobbles up headline after headline, one Big Pharma is losing its AI leader as she transitions to another drug giant: Iya Khalil will trade in her hat as Novartis’ go-to expert and leader in the space for Merck as VP and head of data, AI and genome sciences next week.

After nearly three years leading the artificial intelligence team at Novartis — as Big Pharma and biotechs alike latch onto the ripening AI-for-drug-discovery mode of operation — Khalil will switch employers to head up a similar post at Merck, where she’ll work out of Cambridge, MA beginning Feb. 13, the company tells Endpoints News.

Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”