With a staggering 28.4 million new cancer cases projected by 2024, the urgency for improved treatments has never been greater.

While the rapid advancement of personalized treatments has transformed oncology, it has brought with it a host of new considerations, complexities, and challenges that sponsors must overcome.

This free ebook shines a light on how adopting agile, flexible solutions such as adaptive trial designs and customizable assays can support oncology trials

Key Takeaways:

Insights into the importance of customization :

An agile approach for oncology trials :

Leveraging laboratory services providers’ capabilities:

Although it is an important biomarker in oncology (mostly in breast and prostate), Ki-67 immunohistochemistry (IHC) analysis has yet to be standardized. Working groups have provided guidelines for Ki-67 scoring in different cancer types to limit pathologist’s variability.

Digital analysis solutions to assist scoring with image analysis or artificial intelligence (AI) have recently emerged in the evaluation of Ki-67 as rapid and robust solutions. In this context, we compared the results of Ki-67 scoring performed with Aiforia Platform ® (AI platform) and Halo ® (image analysis supervised software) against three independent pathologists on various solid tumors.

Discover more about this in the case study.

For the detection and monitoring of CAR T cells in patients, two main techniques are employed: PCR and flow cytometry. Flow cytometry, however, stands out for its ability to determine the phenotype of CAR T cells. This feature of flow cytometry is vital for assessing the expansion and persistence of CAR T cells in patients, aligning with the FDA’s draft guidance recommendations. The role of flow cytometry extends beyond detection to playing a pivotal role in monitoring CAR T cells during clinical trials. It enables investigators to gain deeper insights into the behavior of CAR T cells post-infusion and their interaction with the patient’s endogenous immune system. Understanding these dynamics is crucial for evaluating the efficacy and safety of CAR T cell therapies.

In summary, flow cytometry is not just a tool for detection; it is a critical component in the advancement and monitoring of CAR T cell therapies, offering invaluable insights into the therapeutic potential and interaction of these engineered cells within the patient’s immune system.

In this poster, first presented at ESCCA 2023, discover how Cerba Research has implemented both autologous and allogenic CAR T assays.

Addressing a significant gap in the market, this collaboration aimed to overcome the limitations posed by the scarcity of Ki-67 expressing cells in standard biological samples. The synergy between Cerba Research’s expertise in clinical trial services and Slingshot Biosciences’ cutting-edge technology led to the creation of a custom-made Ki-67 cell mimic.

This solution not only met but exceeded the expectations in assay validation, showcasing a leap forward in flow cytometry techniques. This case study highlights the transformative impact of this project, marking a milestone in assay validation and flow cytometry applications in clinical research.