Navigating the Regulatory Route and Challenges for Gene Therapies Targeting Common Diseases
Time: 1:30 pm
day: Conference Day One
Details:
- Overview of regulatory challenges and strategies for gene therapies targeting common disease
- Establishing long-term safety and efficacy of gene therapies to overcome safety concerns in larger patient cohort over extended periods
- Identifying new approaches to upscale manufacturing to serve a larger market
- Confirming additional requirements on clinical data and post-marketing surveillance that would be required in a common disease setting compared to rare disease
