Best practices for laboratory solutions relating to cell and gene therapy clinical trials
Cell and gene therapy (CGT) products sit at the forefront of current drug development innovation, providing a novel, personalized mechanism to treat conditions that previously had few ameliorative options. CGT holds enormous potential for society, which will only increase as the number of treatable conditions undoubtedly continues 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:
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- 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
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- How the use of flow cytometry can monitor humoral immunogenicity and the enumeration of CAR(T) cells.
Who may this interest?
- Clinical trial managers
- Biomarker scientists
- Cell and gene therapy bioanalysts
Speakers
Cindy Spittle
VP Scientific Affairs
ICON Laboratory Services Inc. (PA, USA)
Cindy Spittle is VP Scientific Affairs at ICON Laboratory Services. She has 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
Global Business Lead
ICON’s Cell and Gene Therapy Centre (TX, USA)
Tamie Joeckel is the Global Business Lead of ICON’s Cell and Gene Therapy Centre. Certified in production and inventory management, she has over 30 years of commercialization 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 operationalizing CGT trials throughout the lifecycle of the program.
Sara Botto
Research Scientist
ICON Laboratory Services (OR, USA)
Sara Botto is a Research Scientist at ICON Laboratory Services in Portland, Oregan. Her 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 at Orgeon Health and Sciences University (OR, USA). In 2020, she joined ICON and applies her expertise to designing molecular assays aimed at supporting the growing number of CGT clinical trials.
Henko Tadema
Associate Director of bioanalytical science
ICON Bioanalytical Laboratory (Assen, Netherlands)
Henko Tadema is an Associate Director of bioanalytical science at the ICON Bioanalytical Laboratory in the Netherlands, specializing in flow cytometry. Over the last 10 years, demand for cellular analyses in clinical studies has rapidly increased; next to subset characterisation and determination of target engagement, even more complex methods have been implemented in support of CGT studies.
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