Cell and gene therapy (CGT) products sit at the forefront of current drug development innovation providing a novel personalised mechanism to treat conditions that previously had few options. This drug class holds enormous potential for society and the number of conditions that will be treatable with this drug class will undoubtedly continue to grow.
During this webinar we will discuss factors to consider when executing CGT trials, illustrating how specialty molecular and flow cytometry approaches translate into best practices to support the unique patient, product, site, data and regulatory journeys.
What will you learn?
- How to navigate through the nuances of CGT trials that require a different approach from traditional models
- Assay design considerations for Droplet Digital PCR and Quantitative PCR when monitoring vector copy number, replication-competent lentivirus and replication competent retrovirus, including:
- Appropriate applications for ddPCR and qPCR across various sample types
- How to account for low cellularity samples and reduced mass inputs
- Determinations of LoD and LoQ and getting the most data out of your samples
- How the use of flow cytometry can monitor humoral immunogenicity and the enumeration of CAR(T) cells
Speakers:
Cindy Spittle
With over 30 years of experience in translational and clinical oncology biomarker research, diagnostic assay development and biomarker strategy for clinical drug development. Cindy provides strategic scientific leadership related to the evaluation and implementation of new technologies and laboratory testing services.
Tamie Joeckel
Certified in production and inventory management, she has over 30 years of commercialisation and clinical trial experience and has focused exclusively on CGT for the last 8 years. Considered an expert in strategies for the complex CGT supply chain, Tamie will provide insights into the nuances of operationalising CGT trials throughout the lifecycle of the program.
Sara Botto
Sara's background is in Microbiology and Immunology. After receiving her PhD focused on Virology, she performed research on vaccine development at the Vaccine and Gene Therapy Institute (OHSU). In 2020 she joined ICON and applies her expertise to designing molecular assays aimed at supporting the growing number of cell and gene therapy clinical trials.
Henko Tadema
After completing his Ph.D. studies in the field of Immunology at the University of Groningen, he joined ICON in 2011, just after the implementation of flow cytometry capabilities. Since then, the demand for cellular analysis in clinical studies has kept increasing, and next to the characterisation of cell subsets, or determination of target engagement, even more complex methods have been required in support of cell and gene therapy studies.