Why is this Important? You want to make certain your product is based on sound science and that it works as intended.
|Key Actions||Things to Consider||Tool Kit|
|Demonstrate biologic activity of the product and its mechanism of action in small laboratory models||Is the biological rationale solid?
Is the therapeutic concept technically achievable when you take into account bioavailability, route of administration, and other pharmacokinetic considerations?
While it is valuable to solicit independent and expert assessments of the market/business plan, it is just as important to vet the early science because everything ultimately will rest on this foundation.
|Evaluate safety and therapeutic index in non-GLP animal studies||What are the potential safety concerns and what is the plan to address them?
Consider both on- and off-target effects
|Make sure your provisional patents cover the lead product candidate|