Olen Stephens Food and Drug Administration

Olen Stephens joined the Office of New Drug Quality Assessment (ONDQA) in 2008 and has served as a chemistry reviewer, CMC lead for the Division of Anesthesia, Analgesia, and Addiction Products, and is currently an acting branch chief. For the past four years he has been a member of the ONDQA QbD Liaison's, an internal group of CMC reviewers who facilitate review of QbD-containing applications. Olen's background in bio-organic and bio-physical chemistry includes work on proteins that bind double stranded RNA and beta-amino acid peptides designed to mimic alpha helices that served as scaffolds for protein binding epitopes. Prior to joining the FDA, he was a chemistry/biochemistry professor at a small liberal arts college where his research employed cation-pi interactions to stabilize peptides into a desired stable secondary structure. Current interests include applications of nanotechnology in pharmaceutical products and risk factors for glass lamellae formation and high soluble silicate concentrations in parenteral products.