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.