Navigating Preclinical to Clinical Translation of AXV-101 to Accelerate Gene Therapy Development
Time: 2:30 pm
day: Conference Day One
Details:
- Selecting optimal animal models and securing regulatory approval to establish robust preclinical foundations across FDA and MHRA requirements
- Conducting dose-ranging studies achieving therapeutic windows comparable to other therapies to ensure safe and effective human translation
- Overcoming mouse-to-human dosing challenges and regulatory hurdles to successfully initiate clinical trials with promising early safety data
