Proof of Concept, POC (Phase 1-2)
In Proof of Concept, the project team strives to: Phase 1 – determine safety in normal healthy volunteers, starting with minimal dose, escalating to desired dose; Phase 2 – evaluate drug in patient population, determine efficacy (proof of concept). Increasingly, patients are included in Phase 1 to seek proof of concept early. Antiinfective agents achieve POC in Phase 1.
While these are the goals for each of these Stages of Development, the work that must be accomplished for each project may vary signficantly, depending upon the therapy area, and corporate strategy. Some work may be deferred to later stages, e.g. see the section POC at Chorus (Lilly) and Flexion Therapeutics.