First-in-human (FIH) oncology trials serve as a pivotal transition from preclinical research to patient care, marking the first step in validating the safety and biological activity of a novel therapeutic in humans. These early-phase studies generate essential data on dosing, pharmacokinetics, and preliminary efficacy signals, setting the stage for subsequent clinical development.
This webinar will highlight key considerations and best practices for designing and executing FIH oncology trials, offering practical solutions to help sponsors navigate the regulatory, operational, and clinical hurdles inherent to these studies.
Led by experts Bin Pan, PhD, Executive Director of Operational Strategy, Juliet Moritz, Senior Vice President of Strategic Solutions & Patient Centricity, this webinar explores best practices such as regulatory preparation, site initiation, cohort management and safety monitoring for designing and executing first-in-human oncology trials.
Key Takeaways Include:
- Essential considerations for designing and executing first-in-human (FIH) oncology trials
- Best practices for preparing a robust IND package to streamline regulatory approval
- Strategies for effective dose escalation planning and patient safety monitoring
- Practical approaches to site initiation, patient recruitment, and cohort management
- Insights into overcoming operational and regulatory challenges in early-phase oncology trials
Expert Speakers
