Expert Discussion: Innovative Molecular Assays through Revolutionizing Genomic Analysis in Cell Therapy Development
Time: 2:30 pm
day: Track C - Molecular Assay (Day One - Afternoon)
Details:
- Harnessing the power of next-generation sequencing for comprehensive genomic profiling, enabling precise characterization of genetic variations, gene expression profiles, and molecular pathways relevant to cell therapy efficacy and safety.
- Exploring the applications of digital PCR in quantitative nucleic acid analysis, offering enhanced sensitivity, accuracy, and reproducibility for detecting rare mutaons, monitoring gene expression levels, and assessing viral vector integration sites.
- Discuss the regulatory landscape for CRISPR-based gene therapy, exploring potential risks, recent FDA guidance, and the ethical balance between stringent regulations and patient autonomy.
