1) Cohort Planning and Dose Selection in First-in-Human (FIH) Studies: a. Overview of cohort planning and key considerations for dose selection in FIH studies. b. Discussion on main objectives and endpoints for FIH studies. 2) Progressing into Early Patient Studies: Considerations, Advantages, and Limitations: a. Insights into the considerations involved when transitioning from FIH to early patient studies. b. Exploration of the advantages and limitations associated with this progression. 3) Timeline Considerations and Regulatory Environment Across Regions: a. Examination of timelines for early clinical development. b. Insights based on ICON's experience, highlighting regional variations in regulatory processes.
Brought to you by:
This event is sponsored by an ASCPT Partner organization. The content of the session is provided for informational purposes only and does not constitute or imply ASCPT's endorsement, recommendation, or approval of a specific institution, service, employer, or content.
