Meet The Team

Dr. Smith joined Pharmalytical Consulting LLC in January 2009. Previously, she served as Executive Director, Product Development at Amylin Pharmaceuticals, Inc. and while there was responsible for all CMC development activities. During her tenure there, Dr. Smith served in pivotal roles developing two successfully launched first-in-class products, namely Symlin®(pramlintide acetate injection) and Byetta® (exenatide injection). Additionally, Dr. Smith is a co-inventor for the recently filed once-weekly sustained formulation for exenatide. Prior to Amylin, she worked at Ligand Pharmaceuticals, Inc. on a small molecule formulation, which is commercialized as Targretin® (bexarotene) capsules.

Dr. Smith has experience leading all aspects of API and drug product development through all development stages from pre-clinical to IND, through proof-of-concept, Phase 3, NDA filing and approval and onto commercialization. She has had hands-on experience with all aspects of CMC including formulation, process, methods, regulatory strategy, quality control, validation, and technical writing. She has experience working with peptides, proteins, small-molecules, parenterals, non-conventional formulations, and drug-device combination products. 

Stewart Smith, the founder of Pharmalytical Consulting LLC, is a 25-year veteran of the pharmaceutical/biotechnology industry.  Mr Smith's career has extended from the bench into management and has ranged from start-up biotechs to large pharma.  He has experience with projects ranging from the pre-IND stage up to commercial overseas manufacturing and has worked with compounds ranging from small molecules to peptides to biologics.  

Mr Smith blends an in-depth knowledge of the technical aspects of pharmaceutical analysis with a strong understanding of the necessary guidance and regulations to achieve cost effective workable solutions.