The field of off-the-shelf cell ther­a­peu­tics is grow­ing, with the promise of quick­er, cheap­er, and eas­i­er to man­u­fac­ture ther­a­pies than the first gen­er­a­tion of au­tol­o­gous CAR-Ts that im­pressed with their po­ten­cy but fell short on adop­tion due to man­u­fac­tur­ing wob­bles. And Pre­ci­sion Bio­Sciences — which is us­ing its gene edit­ing tech­nol­o­gy to de­vel­op cell based im­munother­a­pies de­rived from healthy donors in­stead of the pa­tient — is plan­ning ahead. On Thurs­day, the com­pa­ny un­veiled a new Durham, NC fa­cil­i­ty ded­i­cat­ed to mak­ing its off-the-shelf CAR-T prod­ucts.

No­var­tis’ pi­o­neer­ing CAR-T drug — Kym­ri­ah — was ap­proved by the FDA amidst great fan­fare in 2017, but adop­tion was ham­pered by man­u­fac­tur­ing woes. No­var­tis lat­er added ca­pac­i­ty, hav­ing bought cell and gene ther­a­py man­u­fac­tur­er Cell­for­Cure. These prod­ucts re­quire enor­mous man­u­fac­tur­ing heft — mak­ers first iso­late cells from the pa­tient, ma­nip­u­late them in the lab by adding chimeric anti­gen re­cep­tors to di­rect T cells to snuff out can­cer cells and then re-in­fuse them back in­to the pa­tient.

Durham, North Car­oli­na-based Pre­ci­sion is hard­ly the first drug de­vel­op­er that has tak­en note of these chal­lenges. Take­da, for in­stance, which plans to take its off-the-shelf CAR-Ts in­to the clin­ic in 2021, is in the fi­nal stages of com­plet­ing its in-house man­u­fac­tur­ing fa­cil­i­ty in the Boston area, which is armed with the ca­pac­i­ty to sup­ply a range of clin­i­cal tri­als.

For Pre­ci­sion $DTIL, this new plant is part of a larg­er in­vest­ment in its can­cer im­munother­a­py plat­form and fa­cil­i­ties ex­pan­sions in North Car­oli­na this year.

“(W)e’ve known from the be­gin­ning that it was crit­i­cal for us to ad­dress the need for scal­able man­u­fac­tur­ing of cell-ther­a­py prod­ucts…” not­ed co-founder and chief Matt Kane in a state­ment.

“[The plant] al­so has the po­ten­tial to be a com­mer­cial launch fa­cil­i­ty with the ca­pac­i­ty to gen­er­ate up to 10,000 dos­es of CAR T cell ther­a­pies and 4,000 dos­es of gene ther­a­pies per year,” he added.

The drug de­vel­op­er is aim­ing to have its cer­ti­fi­ca­tions in place to be­gin man­u­fac­tur­ing in the fourth quar­ter — and plans to use the fa­cil­i­ty to cre­ate drug in­gre­di­ents for Phase I/II clin­i­cal tri­als sched­uled to be­gin next year.

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll