2023 - Global Clinical Sample Challenges — New Strategies for Molecular Testing & Flow Cytometry Panel Development

Join this webinar to hear the featured speakers address global clinical sample challenges, with a focus on logistical considerations, new strategies for molecular testing and flow cytometry panel development.
Logistical/Operational Considerations:
Clinical trials and investigational products are becoming more complex, such as within the field of cell and gene therapy, and so is the bioanalytical testing of patient samples. For example, clinical sample analysis plans evaluating safety and efficacy of allogeneic gene-modified cell therapies may encompass over 25 bioanalytical assessments on patient samples, mainly falling within the following categories:
PK
PD
Tumor burden
Safety
Immunogenicity
Such complex sample analysis plans necessitate diligent sample management and processing procedures, as well as careful selection of the most appropriate downstream testing methods and platforms especially considering that patient samples are limited. For example, components of one whole blood sample may be needed for multiple bioanalytical assessments at different laboratories. This single sample’s collection tube, transport conditions and processing procedure must all meet the requirements for each downstream analysis. LabConnects’ sample processing, sample tracking and scientific support services work cross-functionally with partner labs around the world to ensure samples meet all testing requirements.
Flow Challenges:
Flow cytometry is a powerful tool in drug development. The complexity of these assays will continue to evolve as new instrumentation and data analysis packages become available. In clinical trials, flow cytometry analyses provide deep interrogation of cell populations. Therefore, it is critical to develop highly adaptable panels to meet the unique challenges of global trials. When developing a panel, thought must be given to potential trial locations, clinical sample matrices and volume, logistical considerations, CRO (Contract Research Organizations) constraints and level of development and/or validation required. Highly flexible panels that consist of a validated backbone in multiple matrices and adaptable add-on packages to interrogate specific populations of interest are an efficient and cost-effective method that will provide quality, consistent and comparable reportable readouts across drug development programs.
Molecular Testing:
Molecular testing is another powerful tool often utilized across many clinical sample types to help drive clinical research. While sample processing is important for these analyses, so too is selection of the downstream technology itself. Next-generation sequencing (NGS), RNA-sequencing (RNA-seq) using NGS, quantitative polymerase chain reaction (qPCR) and digital droplet PCR (ddPCR) are frequently used to evaluate impacts of investigational products and measure endpoints in clinical trials. Each technology’s benefits and limitations must be considered along with the data that will be generated when deciding which is most appropriate for a specific molecular analysis. LabConnects’ technical experts work with scientists at partner labs when evaluating approaches to ensure the needs of study sponsors are met.