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Early Planning to De-risk Development: Nonclinical Strategy and Study Design

With drug discovery completed and your lead asset identified, it’s time to initiate IND-enabling activities, moving one step closer to clinical deployment. Because a very small percentage of nonclinical lead assets move into the clinic, your nonclinical program plays a critical role in whether your program advances to Phase 1 and how long it takes to get there.

While not all variables are within your control, getting it right with the variables you do control can minimize unnecessary risk and give your product the best chance to reach the clinic. Successful nonclinical strategies leverage smart design and planning to identify the right studies and outline an optimized plan to de-risk critical early-stage milestones.

We’ll answer questions like:

  • When is the transition into the clinic most successful?
  • How can you determine which nonclinical studies are right for your program?
  • How can you prioritize studies to de-risk your program?
  • What is the goal of good laboratory practice (GLP) requirements for nonclinical studies?

Download the Guide