Fierce competition in nearly every therapeutic class paired with consistent investor pressure has pharmaceutical companies scrambling to find points of divergence within their product profiles. We as an industry repeatedly fall into the habit of creating a box of limitations to think within, literally creating a “battle for marginal differentiation”.
In our years crafting strategic brand positions we may as well have had this conversation a million times:
Rx Client: That is a stupendous idea, it would really shake things up! But…
OptiBrand: What are we waiting for?
Rx Client: We don’t have the right end-point data to confidently support that
OptiBrand: Well, can we get the right data?
Rx Client: Technically yes, but we don’t have the time or money…
We know that physicians are not likely to change their usage behavior and comfort zones over minimal data differences (in many cases), so we ultimately allow these ideas to die prematurely. We’d need to borrow the hands and toes of a full room just to count the number of missed, potential home run, opportunities.
But what if there was another way? Why must we always fall into the same trap just because this is the model majority that our industry has adopted?
The solution is actually quite logical. Start thinking of where to position earlier. Not necessarily a full-fleshed statement, but rather where the strongest opportunities lie. Back these hypotheses up with a few customer interviews, and most importantly understand exactly what data would be needed to make the claim motivating enough to shift behavior.
Build what’s learned into the Phase III trial design in the form of secondary end-points, measurement types, and measurement intervals.
For example: your proposed product is to be indicated for anemia, a disease state where one therapeutic goal is to return red blood cell (RBC) counts to normal as soon as possible. Standard protocol for the class is to measure blood levels at two weeks to claim efficacy. If speed is a high-value opportunity then why not design a Ph. III trial to measure blood levels daily to potentially support a claim of earlier clinical success? Such a claim would differentiate your product and create a significant clinical and commercial advantage.
Or, if data for your compound showed comparable efficacy to the market leader, but differed in mode of action, metabolism or route of excretion – any one of these could prove to be a clinical and commercial advantage. Further, any of these could pose a strong competitive barrier to entry once you begin to claim your stake. But you need to determine the nature, cost and value of the data needed to pursue your proposed claim.
You don’t want to discover at launch that you can’t make a game-changing claim because the right supportive data isn’t in place. Too many have made that mistake already!
Traditionally, the conversation of brand positioning is initiated upon or near the availability of Phase III data. Starting this process so late will limit your opportunities to the data that you’ve collected, which in most cases is the same data as competitive brands A, B, and C. This is not always an issue, but it is certainly not always that your product is leaps & bounds ahead of what is available and what is to come.
The pre-positioning process we recommend in Phase II includes conducting a market evaluation, developing areas of opportunity and drafting concepts for positioning. Once we receive Phase III results, positioning concepts can be modified and the most promising selected for both qualitative and quantitative testing. Therefore we are not conducting a full brand positioning exercise twice. Rather, the objective is to prepare for a highly successful launch.
Many pharmaceutical manufacturers start early to prepare for launch this way. However, some hesitate to initiate pre-positioning activities before Phase III because of the ‘cost.’ That’s looking at cost from the wrong perspective. The true cost of not pursing pre-positioning may be the commercial failure of the brand.