Lucy Owen provides strategic advice to clients, with a focus on the issues management process in the context of Rx-to-OTC switch. She helps clients to develop and execute science-based regulatory and commercial strategies to address the concerns of regulators and other key stakeholders in order to facilitate regulatory approval for new products and to maximize product acceptance. Lucy manages the development of the research base to build the benefit/risk case for Rx-to-OTC switch candidates.
Lucy directed PinneyAssociates’ Issues Management Team for over 10 years before becoming Vice President of Program Operations and Rx-to-OTC Switch. Her responsibilities have included the management of a wide variety of projects involving support for Rx-to-OTC switch programs, as well as support of OTC products, prescription medications and vaccines, and non-profit public health advocacy organizations.
In the area of Rx-to-OTC switch, Lucy provides critical support to companies from the earliest stages of assessing the feasibility of a switch, including helping sponsors to identify and manage issues typical of all switches and unique to particular switch candidates; to develop the public health case for the switch; to develop labeling through an iterative development process including qualitative and quantitative testing with consumers; to design consumer studies (including label comprehension, self-selection and actual use trials); to develop supporting materials; and to prepare for regulatory submissions, FDA interactions and Advisory Committee meetings.
Lucy has advised clients on a wide array of treatments for public health issues including, among many others, allergy, cholesterol lowering, dermatological conditions, gastrointestinal conditions, insomnia, migraine, treatment of infectious disease, pain management, problem drinking, women’s health conditions including reproductive health and family planning, smoking cessation/tobacco control, and vaccines for childhood diseases and bioterror agents.
Lucy Owen joined PinneyAssociates in 1998 after completing her graduate work in the history of medicine at Oxford University. Before attending Oxford University, Lucy graduated from the University of Michigan with High Distinction and High Honors.