Medical Writing Manager
Mary Ellis Bogden, BS, 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 different functional areas providing regulatory and technical expertise to meet our clients’ needs. Ms. Bogden’s industry experience includes more than 25 years spanning small to mid-size pharmaceutical companies, contract services, and generic sectors.
Prior to joining WI, Ms. 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 through all phases of research and drug development. Ms. Bogden’s breadth of laboratory experience includes various roles in analytical and bioanalytical research and 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. Bogden is a member of the American Association of Pharmaceutical Scientists (AAPS).
Ms. Bogden has a degree in liberal arts with an emphasis in life sciences from West Virginia University in Morgantown, WV. Ms. Bogden is an avid equestrian; in her spare time, she rides and trains in hunters and jumpers. She is a long-standing board member of the Ridge Riders Interscholastic Equestrian Association for middle school and high school students.