Mary Ellis Bogden, BS
Senior CMC Regulatory Consultant
Mary Ellis Bogden joined Whitsell Innovations (WI) in 2011 to grow and develop the Chemistry, Manufacturing and Controls (CMC) group, focusing on CMC regulatory writing and review, consultation, and dossier strategy. The CMC group at WI is composed of industry professionals across various functional areas providing regulatory and technical expertise to meet our clients’ needs. Ms. Ellis Bogden's industry experience includes more than 20 years spanning small to mid-size pharmaceutical companies, contract services, and generic sectors.
Prior to joining WI, Ms. Ellis Bogden worked at Inspire Pharmaceuticals for 11 years in both pharmaceutical development and CMC operations. She authored many CMC documents supporting development activities from pre-Investigational New Drug (IND) through Phase 3 and regulatory submissions across regions. She has extensive experience in managing cross-functional teams in the CMC environment for drug product through all phases of research and development. Ms. Ellis Bogden’s breadth of laboratory experience includes various research and development roles in analytical and bioanalytical development at the former Magellan Laboratories (now Catalent Pharma Solutions) and Mylan Pharmaceuticals. Her firsthand knowledge of the pharmaceutical development process combined with her regulatory background provides WI with expertise in the areas of CMC regulatory writing and dossier strategy, product development, project management, and vendor alliance.
Ms. Ellis Bogden has a degree in liberal arts with an emphasis in life sciences from West Virginia University in Morgantown, WV. Mary is a member of the American Association of Pharmaceutical Sciences (AAPS).