Sr. Writer and Manager
Mary Ellis Bogden joined Whitsell Innovations (WI) in 2011, bringing expertise in the area of Chemistry, Manufacturing, and Controls (CMC). Her regulatory background includes CMC submission strategy, planning, and writing in support of investigational and marketing applications to global health authorities (US Food and Drug Administration, European Medicines Association, Health Canada, and others).
Ms. Ellis Bogden’s areas of expertise include inhalation and nasal aerosols, modified-release tablets, and ophthalmic solutions. In addition to CMC regulatory documents, Ms. Ellis Bogden authors structural characterization and elucidation, formulation and manufacturing development, and ICH-compliant analytical and stability reports supporting the development and post marketing life cycle of pharmaceutical products.
Ms. Ellis Bogden’s industry experience includes 30 years spanning small- to mid-size pharmaceutical companies, contract services, and generic sectors working in CMC regulatory, pharmaceutical and manufacturing development, analytical research and development, and bioanalytical support. She has extensive experience in managing cross-functional teams in the CMC environment through all phases of drug development. 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 holds a Bachelor of Arts in liberal arts with an emphasis in life sciences from West Virginia University. She is a member of the American Medical Writers Association (AMWA) and the Healthcare Businesswomen’s Association (HBA).
Mary is an avid equestrian, and she rides and trains in hunters and jumpers in her spare time.