Fireside Chat: Navigating the Regulatory Landscape: Considerations for Oncolytic Viruses
Time: 12:00 pm
day: Pre-Conference Day
Details:
- Development of guidelines and requirements for pre-clinical safety and toxicity studies specific to oncolytic viruses in the CMC field
- Addressing translational challenges when transitioning from animal models to human patients
- Establishing effective collaboration with regulatory authorities to ensure successful initiation of clinical trials
- Guidance for determining the distribution of each transgene in toxicity studies for more complex oncolytic viruses entering the clinic
- Understanding and navigating the differences in regulatory requirements across various regions and jurisdictions for oncolytic viruses
- Overcoming challenges associated with the regulatory pathway for approval and market authorization of oncolytic viruses in the CMC domain
