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.

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Almost a year after the FDA gave the green light to LA-based Aadi Bioscience’s first drug, the biotech is looking to private investors to keep itself going.

The oncology player announced Thursday that it has engaged with both new and existing investors in a PIPE financing — selling 3.3 million shares at $12.50 a share, the biotech’s closing price at Nasdaq on Wednesday. The company is also selling off pre-funded warrants to purchase over 2.4 million more shares at $12.4999 per pre-funded warrant.