October 7, 2024

Accelerating CAR T-cell therapy clinical trial timelines with comprehensive biomarker-driven strategies

Chimeric antigen receptor (CAR) T-cell therapy is one of the fastest-growing sectors within oncology therapeutic development. This advanced form of immunotherapy can deliver “designer” T-cells to specifically recognize, and attack, cancer based on unique tumor-associated antigens, offering a highly targeted and personalized approach. Recently, adoptive cell therapy (ACT) has received considerable attention due to the success of CAR T-cell therapy in treating hematological malignancies. This article focuses on CAR T-cell therapies in cancer and discusses how biopharmaceutical companies can leverage a comprehensive biomarker strategy for their drug development programs to accelerate clinical trial timelines and better predict clinical outcomes.
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October 7, 2024

Six recommendations on NAMs by FDA

Summary

Continued research and collaboration on NAMs-driven safety assessment will need to continue as part of FDA for years to come. This is best achieved by leveraging an adaptive design model which will support the ongoing evolution of new NAMs while keeping abreast of continuing technological advancements.

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<span>Three ways to strengthen the immune system</span>
October 7, 2024

Three ways to strengthen the immune system

What if instead of referring to the next few months as flu season, we reframed our perspective and referred to this time as immune system empowerment season? While it doesn’t necessarily roll off the tongue, it certainly represents a more proactive and action-oriented approach in fighting off many of the illnesses associated with fall weather. 
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