At the JP Morgan Healthcare Conference, while addressing the state of the company in 2025, experts from Gilead Sciences touted the company’s manufacturing infrastructure as one of its key advantages in cell therapy production.
Stacey Ma, executive vice president of pharmaceutical development and manufacturing at Gilead spoke about the company’s chimeric antigen receptor (CAR)-T portfolio and how the company is working to ensure faster and more convenient treatment for patients. She said the company is working with accreditation bodies to ensure that medical centers can receive CAR-T accreditation. And that also means gaining support from national payers.
“We want to build off of what we're seeing in our leadership with Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel),” Ma said, citing two US Food and Drug Administration (FDA) approved autologous CAR-T therapies developed by Gilead’s subsidiary Kite Pharma.
With the company anticipating commercialization of its anitocabtagene autoleucel (anito-cel) therapy for multiple myeloma in 2026, Ma emphasized Gilead’s excitement toward “shaping that market further to enable more centers to be able to deliver these therapies closer to home.”
Ma said that in clinical trials, Gilead has delivered anito-cel to patients at turnaround times that are on par with the company’s commercially available CAR-T therapies, which according to the company is about 14 days after the FDA approved a manufacturing change that improved median turnaround time from 16 days in January 2024.
What we're seeing in some of the products that are on market is turnaround time is not there,” Ma said, adding that out-of-spec rates are also a problem for some marketed drugs.
“Our manufacturing is going to be something that's hugely additive in addition to the safety and efficacy that we're seeing.”
“We’re very enthusiastic about this,” said Daniel O’Day, CEO of Gilead in reference to anito-cel. “We believe that this is a potentially best-in-class cell therapy with a differentiated safety profile.”
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