Bancel: Moderna's Cancer Therapy Will Be Approved via Process BLA
“As you mentioned, CAR-T, CAR-T was also approved in the same way as we believe Intesmiran will be, which is as a process BLA not a product BLA.”
Dave Ricks: CAR-T and gene therapies are difficult to scale to millions
“Those two techniques, CAR T and gene therapy, it's hard to think of like super scaled millions of people benefiting.”
Gimenez: Carl June cured pediatric ALL with CAR-T in 2012 breakthrough
“Carl June had his first paper come out showing that he was able to cure a pediatric oncology patient in ALL with a CAR T, which was like 30 years of effort, but that was such a big deal.”
Friedberg: CAR-T will be harnessed for autoimmune conditions beyond cancer
“So CAR-T can in the long run be harnessed, not just for cancer, but autoimmunity and potentially other pathogens in the body in a really targeted way.”
Klausner: Juno Engineered CAR T Therapies Administered to Outpatients
“With Juno, we were able to make these CAR T cells where almost everyone is treated as an outpatient. They don't even have to go into the hospital.”
Hamilton: CAR-T trial achieved an 83% pediatric leukemia remission rate
“We were involved in the CART T clinical a couple of years back for pediatric leukemia, and in this kind of nationwide CART T clinical, 83% of the kids who had recurring leukemia went into remission. And so before, I mean, fewer than 50% lived a couple of years…”
Conde: FDA advisory panels passed gene therapy and CAR-T unanimously 13-0
“Gene therapy, an area that historically has been considered to be very risky, has been shown to be so effective in this form of treating inheritable form of blindness, That that passed the FDA panel recommendation unanimously, a 13 to zero vote. CAR T similarl…”