Early Planning To De-Risk Development: Nonclinical Strategy And Study Design

Having completed drug discovery and identified your lead asset, it's time to commence IND-enabling activities, bringing you closer to the clinical deployment stage. Because only a fraction of nonclinical lead assets progresses to the clinic, the significance of your nonclinical program cannot be overstated. It is pivotal in determining whether your program advances to Phase 1 and influences the timeline for reaching that milestone.

Although you may not have control over all variables, focusing on the ones within your control can help mitigate avoidable risks and maximize the likelihood of your product reaching the clinical stage. Implementing effective strategies in nonclinical development involves the strategic design and meticulous planning to identify appropriate studies and create an optimized roadmap that minimizes risk during critical early-stage milestones. By prioritizing intelligent decision-making and proactive planning, you can enhance the chances of success for your product in the nonclinical phase.

Whether you are a researcher, scientist, or industry professional, these resources will equip you with the knowledge and tools to successfully navigate the nonclinical development process.