As the Laboratory Director at ZEO ScientifiX, I have led the research, development, and manufacturing of novel biological medicine for the treatment of pulmonary, cardiovascular, and orthopedic degenerative diseases. Our teams’ mission is to advance biological medicine to offer safe and effective solutions to treat diseases. In my academic tenure at the University of Miami’s Interdisciplinary Stem Cell Institute (ISCI), I trained in manufacturing, characterizing, and culturing adult stem cells and extracellular vesicles for research, pre-clinical, and clinical regenerative medicine application. This experience included the application of molecular biology techniques including flow cytometry analysis, protein analysis, genetic sequencing, and fluorescence microscopy. I led the processing validation tasks required for ISCI’s onsite cGMP stem cell manufacturing facility, while my independent research focused on the manipulation of in vitro culture systems intended to enhance cell or exosome product potency. At ZEO, my research has evolved into the development of novel allogenic and autologous biologics for use in regenerative medicine and aesthetic applications. I have spearheaded my team’s effort to be the first group to fully characterize amniotic fluid derived extracellular vesicles and gain FDA approval for use as a therapeutic drugs in clinical trial testing. The data I have collected at ZEO was critical to the submission and approval of 4 IND applications for ZEO’s initial phase I/II and 1 phase 2 clinical trial investigating our lead extracellular vesicle biologic, Zofin. I am actively managing both the research and manufacturing arms of our organization while focusing on the clinical manufacturing of Zofin for our FDA approved single patient, expanded access, and clinical trial programs. We are currently focused on completing our phase II clinical trials for Zofin while advancing the development of Zofin to prepare for later stage clinical trial testing.