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

Speakers: