Commercialization and the Risks of Missing a Step

By Susan Nemetz

In our work with emerging biopharma companies, we frequently encourage leaders to build a plan (roadmap) to define their asset’s path to market so they don’t miss a step. We infer that missing a step can slow them down, cost them more, and potentially change their ability to reach their destination, the market where they hope to serve patients.

We use the metaphor of “missing a step” in hopes that this image will help paint the picture (another metaphor) of the downside risks of not building a full and robust commercialization plan.

So, let me add a personal connection to this missing-a-step scenario and belabor this metaphor to make the point. My story involves a physical fall due to literally missing a step, but the relevance to navigating the path to the market for a biopharma product is remarkably consistent.

Missing a step is never expected or planned, otherwise it would be called skipping a step. (Much like it’s a car accident, not a car on purpose.) The unexpected nature of missing a step means that you also must deal with an unpleasant surprise, unfortunate implications, and often a range of emotions. Missing a step in literal terms can mean embarrassingly picking yourself up off the floor and trying not to cry in front of your neighbors and friends. Missing a step in commercialization planning could have far-reaching implications.

Missed step examples in commercialization include:

• Not developing an overall commercialization plan timeline in early Phase 2, resulting in key commercialization insights (market, customer, payer, patient) not being developed in a timely fashion with input into the clinical development program design or clinical trial endpoints
• Lack of early cross-functional alignment on the Target Product Profile (TPP) resulting in suboptimal product value proposition
• Insufficient or inadequate competitive intelligence resulting in a surprise competitor or unexpected endpoint
• Not completing a scientific platform resulting in conflicting external communications

Once it is clear (if it is even clear to the team) that you missed a step in commercialization planning, weighing the risks and implications for the program becomes critical. This is where the literal and metaphorical can be dramatically different because, in the literal case, you immediately feel the pain, but in the metaphorical missed step in commercialization, the pain will likely come later; however, it is just a matter of how profoundly you or your company will feel it. Another important difference is that the pain of a literal missed step will most likely heal in the following weeks, but the impact of missed steps in commercialization planning may not be fixable later. Sometimes, there is no going back to salvage the launch; the implications may be detrimental and irreversible.

For example:

• If you miss a step in developing a strategic commercialization plan and budget aligned to the projected market opportunity for your asset, the pain may be suboptimal outcomes in business development, potential partnership and investor fund raising discussions
• If you miss a step in appropriate market development, the pain may be slow adoption of the product in the market- especially in the case of a new therapeutic area where disease education and establishment of clinical care pathways prior to product introduction is critical
• If you miss a step in publication planning, the pain may be significant as the data needed to explain to clinicians how to treat the disease may not be available
• If you miss a step in HEOR, the pain may be your inability to demonstrate the value proposition of your treatment to payers so they will reimburse the cost for patients
• If you miss a step in the state licensing process, you will not be able to market your drug in all/many states, which will be incredibly painful for the patients who won’t receive the medicine and the company who won’t generate revenues

The list of potential pain points for missed steps along the commercialization path that will slow you down or change the trajectory of your path to the market is exhaustive. (Even worse than using crutches—which is no fun!) It is important to remember that with proper planning early in development, biopharma leaders see all the steps, where they are along the path, and what it will take to ensure they are addressed. Building a commercialization roadmap reduces the grief of finding out too late that an important step was missed earlier, which will slow you down or change the trajectory of your path to the market

In my case, the missed step meant multiple interactions with the healthcare system, crutches that had other consequences, forfeited social opportunities, and an inconvenient impact on myself and my family members.

What would a missed step mean in your world?

Coming back full circle (another metaphor), our commitment to illuminating the path to market has been central to our work in building Corval, our novel commercialization planning platform. We know the complex, fragmented, months-long commercialization planning process can challenge biopharma companies.

What if instead of the risk of missing a step, you were empowered to…

• See the full picture—understand all the activities, timing, hiring, and other resources needed
• Streamline the process—build your plan in days instead of months
• Take a deep breath—have peace of mind that everything will get done

Visit How It Works to see how Corval can illuminate your path to success so you don’t miss a step!

How are you planning ahead for your asset? Even the best of us can stumble once in a while.