Pre-IND Team Player

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.

FDA Representation 

Presenting and defending cutting-edge clinical strategy at the FDA, I have attended over 30 CBER meetings in the last 25 years. I have played a key role in an array of successful Pre-IND, End-of-Phase II, and IDE meetings within the various centers of the FDA, providing me with a unique advantage in advising and representing my clients. With a proven track record, I have managed a wide range of successful IND and BLA submissions, and I have also supported the process by producing clinical sections of multiple regulatory documents and drafting numerous clinical protocols in various therapeutic areas, including Orphan Drug Designations and approvals.