Russell Wesdyk

Russell Wesdyk has had the privilege of serving patients for over 30 years. For approximately 25 of those years, Mr. Wesdyk worked in a variety of technical and business roles in the generic, biotech, and branded pharmaceutical industry. Subsequent to working at BMS, Lupin, and Genvec, his last industry role was as EVP of Corporate Development at Cempra Pharmaceuticals. He now works at FDA, serving as the Acting Director for OPQ’s Office of Surveillance.

Mr. Wesdyk received a BS in Chemistry from Seton Hall University and an MBA from Fairleigh Dickinson. On the technical side, Russ has experience across a range of CMC areas with a focus in Quality Assurance, Formulation, Manufacturing and Scale-Up. On the business side, Mr. Wesdyk’s background includes corporate development, strategic planning, and life cycle management. Mr. Wesdyk has published actively in the areas of quality, and formulation and manufacturing of controlled release dosage forms. More recently as a regulator, Russ served as CDER’s lead negotiator in the GDUFA I process and is presently championing and leading CDER’s surveillance and quality metrics initiative.