Understanding the Regulatory Framework for CNS Gene Therapies
Time: 1:00 pm
day: Pre-Conf Workshop Track B PM
Details:
- Understanding the importance of acknowledging the regulatory framework for gene therapies early in development
- Discussing the advantages and disadvantages of seamless clinical trials and standard clinical trials for rare neurological conditions
- Diving into the difference in requirements for setting up clinical trials for gene therapies in different countries
- Rethinking regulatory framework when developing a CNS-directed gene therapy for a larger patient population
- Tackling the regulatory views of the development of novel BBB-penetrant capsids
