Last Updated: 09/26/2026
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Found 24 publications
Statistical analysis plan considerations for autologous cell and cell-based gene therapy clinical trials.
Journal: Journal of biopharmaceutical statistics
Published: July 16, 2026
Pivotal trial design considerations for new and next generation cell and gene therapies.
Journal: Journal of biopharmaceutical statistics
Published: June 05, 2026
Real-world data and evidence in the development of cell and gene therapies.
Journal: Journal of biopharmaceutical statistics
Published: March 30, 2026
Advancing cell and gene therapy: Application of AI/ML in clinical development and patient management.
Journal: Journal of biopharmaceutical statistics
Published: March 12, 2026
FDA Approval Summary: Idecabtagene Vicleucel for the Treatment of Triple-Class-Exposed, Relapsed or Refractory Multiple Myeloma.
Journal: Clinical cancer research : an official journal of the American Association for Cancer Research
Published: January 17, 2025
FDA Approval Summary: Nadofaragene Firadenovec-vncg for Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer.
Journal: Clinical cancer research : an official journal of the American Association for Cancer Research
Published: August 28, 2024
Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical Perspective.
Journal: Therapeutic innovation & regulatory science
Published: January 23, 2024
FDA Approval Summary: Lisocabtagene Maraleucel for Second-Line Treatment of Large B-Cell Lymphoma.
Journal: Clinical cancer research : an official journal of the American Association for Cancer Research
Published: October 11, 2023
FDA Approval Summary: Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma.
Journal: Clinical cancer research : an official journal of the American Association for Cancer Research
Published: March 06, 2023
FDA Approval Summary: Brexucabtagene Autoleucel for Treatment of Adults With Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia.
Journal: The oncologist
Published: April 26, 2022
Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker-Selected Populations in Oncology Confirmatory Trials.
Journal: Therapeutic innovation & regulatory science
Published: November 18, 2021
FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma.
Journal: The oncologist
Published: November 05, 2021
Last Updated: 09/26/2026