GCT Track
- Requirements in bringing drugs to market
- Vector serotypes to produce more durable gene expression
- Vector Design and Development for Gene and Cell Therapies
- Current challenges and future of gene therapy technical development
- Lessons learnt from commercial products/ late-stage products
- The complexity of vector development and production
- Investors perspective of gene therapy development
- Reducing timelines for cell and gene therapy drug development
- CMC strategies for rare diseases
- Qualifying starting materials/intermediary materials
- Developing novel vectors to reduce immunogenicity
- Successful strategies to accelerate CGT process development from preclinical to manufacturing and commercialisation
- Efficient enabling novel technologies and resources
- Defining optimal regulatory pathways
- Critical elements of establishing a robust CMC strategy
- Identifying and measuring of CQAs and determining CPPs
- Crucial factors in easing the complexity of vector development and production
- Achieving technical, regulatory, and cost efficiency for manufacturing safe gene and cell therapy products
- Critical aspects of establishing an efficient, consistent, and flexible CMC strategy
- Controlling a product’s CQAs by controlling the process’ CPPs
- Emerging technologies improving effectiveness and CGTPs manufacturing processes and production
- Crucial components of controlling and scaling manufacturing process and operations for CGTPs
- Development of Pediatric Gene Therapy Using Nuclease-Free Genomic Editing Technology
