Rx-to-OTC switch is a complex process with numerous parallel workstreams; the goal of the process is regulatory approval of a commercially viable OTC product that will benefit the public health.
In this second of two webinars, the presenters will focus on the commercial issues and milestones that characterize a successful switch. The presenters will flag the critical points for regulatory involvement, though the regulatory process will have been covered in detail in the first webinar of the series.
Successful Rx-to-OTC switches have been defined by:
- Thoughtful selection of switch candidates through regulatory and commercial feasibility assessments
- Development of a sound Drug Facts Label allowing for viable claims for consumer marketing
- Using data to address issues and gaps
- Strong leadership and project management linking regulatory, clinical, medical and commercial strategies and workstreams over the life of the project to ensure regulatory and commercial success
- Planning for an OTC launch
Christine Sweeney, Ph.D., MPH, Director, Issues Management, PinneyAssociates
Christine has supported a range of Rx and OTC clients in therapeutic areas including, pain management, smoking cessation, weight loss, cholesterol lowering, allergic rhinitis, women’s reproductive health and men’s health. She assists clients in the development of labeling and the design of consumer studies (label comprehension, self-selection, actual use), as well as the drafting of regulatory submissions in support of Rx-to-OTC switch programs. For nearly two decades, Christine has applied her expertise in behavioral and public health to supported clients’ efforts to gain approval and expand the market for pharmaceutical and consumer healthcare products with a focus on building the benefit/risk case for a switch and managing the issues raised by switch.
George Quesnelle, Senior Strategic Advisor, OTC Commercialization and Optimization, PinneyAssociates
George Quesnelle has nearly 30 years of Rx-to-OTC switch experience, with commercial responsibility for some of the most successful switches in the industry, including Nicorette and NicoDerm CQ. He advises clients on the commercialization process for the switch, including OTC switch candidate identification, forecasting OTC switch volume, helping to develop or evaluate marketing plans as well as consumer and trade promotions and sales strategies. George helps clients evaluate manufacturing and distribution scenarios to minimize risk and maximize launch success. From 2004 to 2008, George was President of GSK Consumer Healthcare North America. In 2014, the Consumer Healthcare Products Association awarded him the Ivan D. Combe Lifetime Achievement Award for his contributions to the industry, especially his pioneering work in OTC switch and directly improving self-care for consumers in the US.
Who Should Attend?
Mid and senior level professionals responsible for identifying Rx-to-OTC switch candidates and supporting Rx-to-OTC switches.
Relevant areas of expertise include:
- Regulatory affairs
- Project management
- Clinical research
PinneyAssociates helps our pharmaceutical and consumer healthcare clients to reduce their regulatory risk and enhance the commercial value of their life sciences products. PinneyAssociates understands that Rx-to-OTC switches are complex initiatives that raise regulatory, scientific/medical, policy and commercial issues involving sometimes conflicting interests of multiple stakeholders. We have over 20 years of experience in providing strategic regulatory insights for OTC switches, direct-to-OTC approvals, and existing OTC products, which enables us to provide comprehensive science-based support to sponsors throughout the product lifecycle.