Russell Wesdyk

  PhotoRussell Wesdyk has over 25 years of experience in the pharmaceutical industry including the generic, biotech, and branded segments. Mr. Wesdyk received his BS in Chemistry from Seton Hall University before pursuing his MBA, thus marrying both technical and business components, a theme carried throughout his career. On the technical side, Russ has experience across a range of CMC areas with focus in Regulatory Affairs, Quality, Formulation, Manufacturing and Scale-Up. On the business side, Mr. Wesdyk’s background includes corporate development, strategic planning, and life cycle management. His industry career has taken him through branded companies like Bristol Myers Squibb, and generic companies like Apothecon and Lupin. During those roles Russ had responsibilities resulting in the successful domestic and international formulation, scale-up and technology transfer of a number of marketed products and served as a technical advisor to pharmaceutical equipment manufacturers as well as a reviewer for various industrial-pharmaceutics journals. Mr. Wesdyk has published actively in the areas of quality and formulation and manufacturing of controlled release dosage forms. His business accomplishments include serving as lead negotiator in transactions totaling in excess of $10 Billion. Prior to joining FDA, Mr. Wesdyk's last role in Industry was as Executive Vice President of Business Development for Cempra Pharmaceuticals, a recently IPOed bio-pharmaceutics firm focused on anti-infective therapies. Russ is currently Scientific Coordinator for FDA's Office of Pharmaceutical Science, where he had responsibility for leading development and implementation of a quality system for the CMC review function and served as CDER’s lead negotiator in the GDUFA process. <--October 2013, MTB-->