In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.
News|Podcasts|December 8, 2025
ACT Brief: AI-Driven Repurposing Advances, GCP Adoption Challenges, and New CAR-T Milestone
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we look at how AI and in-silico methods are reshaping drug repurposing, why staggered ICH GCP rollouts are creating new operational pressure points, and the FDA’s latest CAR-T approval expanding treatment options in B-cell malignancies.
This is the Applied Clinical Trials Brief—your fast track to the latest developments shaping clinical operations and drug development.
- A new ACT
feature article highlights how AI-enabled repurposing, EHR-based real-world evidence, and synthetic patient modeling are accelerating the reuse of existing therapies, with major pharma now integrating computational approaches directly into discovery and development. These tools are shortening timelines, supporting regulatory submissions, and enabling broader therapeutic expansion as agencies grow more receptive to in-silico evidence. - In the final
segment of our conversation with Citeline’s Heidi Chen, she explains that sponsors are navigating a moving target as new ICH GCP guidelines take effect on different schedules worldwide. While the updates increase responsibilities for both sponsors and CROs, Chen expects innovation to remain strong as organizations work to integrate the requirements without slowing the pace of development, especially in fast-moving areas like CAR-T and GLP-1s. - And FDA has
approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma, making it the first and only CAR-T therapy authorized for five different cancer types. The decision strengthens Breyanzi’s position across B-cell malignancies and adds a new option for patients who have cycled through multiple prior therapies.
That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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