This week, I presented views on “Navigating Regulatory Expectations” from my role as a brand innovator. The first part I shared was the basis for commercialization strategies that I’ve seen pharma and medical device companies use. Then I shared lessons learned from seven relevant cases.
I’ve chosen this illustration of an Idaho river and some rafters to illustrate the idea of navigating regulatory guidelines, because I believe that there are ups and downs and there are some calm waters and there are some choppy, white waters all through the process. If you learn to navigate them then you can have a successful promotional experience.
My view as a brand innovator comes from developing and working on brand strategies for over 100 product launches and re-launches. I’ve worked in a wide range of categories on pharma, biotech, devices, and diagnostics. During that time, I facilitated cross-functional teams that have very often included the medical, regulatory, and legal representatives of the team, in addition, of course, to the marketing, advertising, and sales teams. I’ve also personally negotiated promotional claims with DDMAC and now OPDP on behalf of my clients. The cases are from my own firsthand experience.
Now I’ll start with explaining the commercialization strategies. These are usually based on what’s known as a target product profile or, abbreviated, TPP. This becomes the foundation for hoped-for clinical claims. The TPP is developed long before the clinical trials have even begun. It often is developed based on market needs and competitive gaps that are highlighted in market research and industry reports. This TPP is regularly used as a benchmark as clinical and market development continues and as market research reports come in.
This TPP then becomes a promotional driver for the launch of a product. It will spell out the superiority claims in efficacy and/or safety, the hoped-for differentiation of the product, especially in crowded categories that are so common in pharma, medical devices, diagnostics, and other med tech industries. The product positioning will be based on this all along the brand’s life cycle, from launch to growth to maintenance and even through down-cycling. Overall, this is the context for my lessons learned that I’ll share with you in promotional regulatory guidance. Essentially, the TPP becomes the driver.
The seven cases that I’ll share with you and the key learnings are from varying avenues. For all of these relevant cases, I’ll illustrate some of the key claims, as well as the regulatory lessons that we learned.