Feature|Videos|January 2, 2025
The Future of Regulatory Processes in Cell and Gene Therapy
Transferring knowledge and continuing to work together with regulatory agencies will lead to changes in approval going forward.
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Episodes in this series
Regulatory agencies are open to changes within the review process which means the uptake of CAR T-cell therapy will change the landscape itself. This is especially true with large-scale commercialization. Information sharing between global agencies will also be helpful in advancing the science forward.
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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.
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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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