Lucy Owen provides strategic advice to clients, with a focus on the issues management process in the context of Rx-to-OTC switch. She specializes in development and execution of science-based regulatory and commercial strategies, including:
- Developing the public health benefit/risk case for an Rx-to-OTC switch
- Developing product labeling through an iterative development process including qualitative and quantitative testing with consumers and advising on behavioral and other studies/data needed to support the switch
- Preparing for regulatory submissions, FDA interactions and Advisory Committee meetings
Lucy joined PinneyAssociates in 1998 and directed PinneyAssociates’ Issues Management Team for over 10 years before becoming Vice President of Program Operations and Rx-to-OTC Switch, and in 2018, Senior Vice President. Her responsibilities have included the management of a wide variety of projects involving support for Rx-to-OTC switch programs, as well as support for approved OTC products, prescription medications and vaccines, and non-profit public health advocacy organizations.
Lucy has advised clients on a wide array of treatments for conditions including, among others, allergy, cholesterol lowering, dermatological conditions, gastrointestinal conditions, insomnia, migraine, infectious disease, pain, problem drinking, women’s health conditions, as well as reproductive health and family planning, smoking cessation/tobacco control, and vaccines for childhood diseases and bioterror agents.
- Completed graduate work in the History of Medicine at Oxford University
- Graduated with High Distinction and High Honors from the University of Michigan