Feature|Videos|January 2, 2025
FDA Regulations for CAR T-cell Therapy
Examining hurdles surrounding FDA approval and how to streamline the process
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Episodes in this series
The regulatory landscape for CAR T-cell therapies is constantly evolving with the FDA establishing their own guidelines needed for approval. Often, the approval can be long and difficult to obtain. Panelists examine their own strategies that have increased collaboration and support from the FDA.
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FDA reportedly shelves its Commissioner’s National Priority Voucher program, Eli Lilly breaks ground on a $3.5 billion Pennsylvania manufacturing site for next-generation obesity treatments, and Parexel’s Stacy Hurt on how small protocol decisions can become enrollment and retention barriers.
FDA Commissioner’s National Priority Voucher program reportedly in limbo for expedited drug reviews.
Eli Lilly breaks ground on a $3.5 billion manufacturing facility in Pennsylvania to produce next-generation obesity treatments like retatrutide.
Every protocol decision affects patients, and only those with lived disease experience can identify true burden — from invasive biopsies to daily trial demands.
Moderna lays out an oncology-driven growth plan at its 2026 Analyst Day, Pfizer and Blackstone sign a co-funding deal worth up to $1.5 billion for berobenatide, and Parexel’s Stacy Hurt on how patients’ use of AI is reshaping sponsor communication.
Moderna used its 2026 Analyst Day to outline an oncology-driven growth strategy anchored by intismeran and other cancer antigen therapies.
Pfizer and Blackstone Life Sciences sign a co-funding deal in which Blackstone is set to provide up to $1.5 billion through 2028 to advance berobenatide.
With 60% of Americans using AI health tools, patient advocates are encouraging collaborative use of AI alongside healthcare teams for better outcomes.
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