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.

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.

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.

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 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.”