Webinar times:
10am Japan & Korea Feb 20th
9am China Feb 20th
8pm US ET Feb 19th
Navigating early drug development is critical to ensuring the long-term success of therapeutic candidates. This webinar explores key strategies to overcome common challenges, with expert insights from APAC and US perspectives.
We will begin by addressing the importance of understanding therapeutic potential, emphasizing the early selection of biomarkers to validate mechanisms of action and support dose-response relationships. Insights into biomarker incorporation during First-in-Human (FIH) study design will highlight their role in decision-making and regulatory support.
Learn how to effectively prepare an IND package for submission to the FDA by integrating Model-Informed Drug Development (MIDD) approaches, especially for novel modalities. Discover how biomarker-driven strategies can accelerate drug development timelines while increasing confidence in advancing through clinical phases.
Whether you’re navigating the FDA, EMA or other regulatory landscapes, this session will provide actionable guidance for global regulatory success in early drug development.
Key Learnings:
- Understanding Therapeutic Potential: Emphasizing the early selection of biomarkers to validate mechanisms of action and support clinical development.
- Regulatory Strategy Development: Highlighting the importance of formulating a robust regulatory strategy early in the development process to ensure global success.
- Overcoming Common Challenges: Providing expert insights into common hurdles in early drug development and offering strategies to overcome them.