- Discuss the different levels of financial and team support switches require with various levels of commercial, regulatory, clinical, and operational involvement
- Develop and manage a team that’s right for your switch
- Lessons learned from an active Switch by a non-profit organization (naloxone)
Leveraging the marketing power of Rx to OTC Switch through:
• Identifying key market research insights on category indications, consumer use, and differentiative claims driving trial
• Building positioning and branding around product essence and executing across marketing vehicles
• Understanding the role of health care professionals in influencing purchase decisions
• Addressing consumer barriers to advance availability, access, and adoption
In order to have a drug approved for OTC use, sufficient data has to be submitted to the FDA demonstrating that consumers will understand how to use the product safely. This data is collected though consumer behavior studies.
- Defining success
- Standard studies
- Nothing is standard – our responsibility as sponsors
- Successful label, program, and study design
- Discovery Driven Planning in Behavior Program
Artificial intelligence (AI) is an emerging field. It allows a machine to make decision based on data, environment or inputs. AI can be of particular use in efficient process validations. It can learn complex interdependencies among numerous inputs and use this learning in validating the outcome of a process with very high efficiency and precision. Process validation is critical for both Rx and OTC drugs.
Rx companies with switchable prescription assets can achieve long-term life cycle value by pursuing an Rx to OTC switch. Driving success with OTC drugs requires different capabilities than driving success with Rx drugs, however, and therefore a strategic assessment of whether to build, borrow, or buy those capabilities is a critical part of the Rx to OTC switch process.
• Discuss how Rx and OTC capabilities differ
• Analyze the options that should be considered to ensure that OTC capabilities are established for the switch
• Consider partner selection if you choose to partner with an OTC company