Navigating What's Next For Global Drug Development: What Sponsors Need To Know

The shifting regulatory expectations in the clinical trial landscape create a need for a smarter, earlier approach to development. In this discussion with Novotech experts, we explore how early-stage sponsors can adapt to these dynamic changes, including new FDA initiatives such as AI-driven reviews and user fee changes. The conversation highlights the importance of designing trials with a global perspective from the start to navigate accelerated pathways for faster market entry.

This episode also details how contract research organizations (CROs) are evolving to help sponsors prioritize markets and build regulatory flexibility into their programs. For anyone planning trials in 2025 and beyond, this conversation provides valuable insights to prepare for what's next and position a program for long-term success.