I have frequently worked as the clinical representative in Sponsor teams when preparing for Pre-IND Meetings, encouraging my clients to present their Pre-IND submission at the soonest possible opportunity. By proactively engaging the FDA early on in the regulatory process, my clients are well informed about the FDA’s preclinical and clinical expectations prior to making major investments in their clinical programs, invariably resulting in significant cost savings.

The FDA is very helpful when a Sponsor is well-prepared and asks the right questions. They are gracious enough to meet with the Sponsor ahead of IND submission, which facilitates a smooth review process and sets the stage for a productive, long-term relationship that is centered on mutual respect. I have mastered the art of Pre-IND activities in this regard.