Phase I development is not a one-size-fits-all process. The scientific, regulatory and operational choices made before and during first-in-human development can influence not only how quickly a study starts, but also the quality and usefulness of the evidence generated for the next stage of an asset’s development.

This webinar will explore how sponsors can build a Phase I strategy around the decisions they ultimately need to make, from translating nonclinical evidence into a first-in-human approach and selecting an appropriate regulatory pathway, to designing flexibility into protocols and identifying activities that can be progressed in parallel.

Using practical development scenarios, the discussion will consider how early clinical pharmacology can help sponsors generate the right evidence at the right time, while avoiding unnecessary rework later in development

Key learnings:

• Define the evidence needed from Phase I to support the asset’s next scientific, regulatory or business development decision. Identify the two highest-ROI levers for reducing operating costs
• Evaluate where regulatory, protocol and operational flexibility can accelerate early development without compromising the longer-term development programme.
• Identify how clinical pharmacology, bioanalytical, PK, IMP and operational planning can contribute to a more complete, decision-ready evidence package from Phase I.
• Apply Phase I evidence to inform proof of concept, funding, partnering or progression into Phase II.