I did lol.

https://www.linkedin.com/in/barry-calvarese-13a5418/

I develop and manage product and indication-specific global regulatory/clinical strategies that enable the most efficient registration pathway(s) and yield a high probability of approval success. I utilize expertise in preclinical; chemistry, manufacturing and controls (CMC); and clinical and commercial development to build strategies that meet the demands of a dynamic regulatory environment. Examples include expediting Proof of Concept Clinical studies in the US and international settings, drug re-purposing 505(b)(2) strategies, negotiating preclinical/clinical requirements with FDA, successful strategy/writing waivers for Carcinogenicity and TQT studies, eCTD submissions.

Breakthrough Therapy Designation. Recently initiated and managed approval of BTD for first in class cardiovascular drug, only second CV drug to gain FDA BTD status.