We write and speak a great deal about commercialization. It’s central to the work of our clients and, therefore, to ours as well.
And so, in a recent panel, we brought together three experts from The NemetzGroup — Colleen Moore, Liz Tufo, and Tracey Sacco — to share their perspectives on the topic.
Over the past ten years or so, the term “commercialization” emerged in the industry to include multiple disciplines and insights required to guide the asset plans from the earliest stages of drug development to the market. This term became especially relevant as R&D teams recognized the need for “commercialization perspectives” as part of the cross-functional program team.
In our view — and one increasingly shared across innovative biopharma companies — commercialization is much more strategic than just the commercial functions responsible for delivering an asset to market (marketing, sales, national accounts, etc.). That’s essential, of course. But we believe commercialization is broader and deeper. It’s a mindset, an ethos — something that pervades the organization from the outset. It is a clear understanding that to ensure patients benefit from our innovative therapies, we must navigate the complex commercialization path successfully.
Developing a commercialization mindset comes down to three interconnected factors:
- Executive buy-in. Establishing the mindset throughout the organization and acting as the role model for this way of thinking.
- Education. Ensuring that across the organization, in all corners and at all levels, there is an awareness and deep understanding of this mindset and how it relates to the company vision and values.
- Application. Ensuring everyone involved in implementing the company vision understands how this ethos applies to their individual role and area of function.
Maintaining this mindset can be challenging because it requires thinking about an uncertain future end-state and working backward from there to the present. That can be difficult since so many people in the organization are (understandably) focused on achieving the next short-term milestone. At that early stage, the capabilities in the company are centered around the science.
Some ideas to keep in mind…
Leadership Alignment Is a Critical Success Factor
It is important that there are numerous internal conversations to reinforce the messages repeatedly and cross-functionally. At times it can feel like overkill. But it is well known that consistency in the way a strategy is talked about is critical.
Leadership needs to remain flexible, always paying close attention to the decisions that must be made, the key factors driving them, and the resources required over time so that investment remains calibrated with the current need.
For example, if there is commercialization expertise required that is not available from an internal source, leadership must be aware of this need and recognize that outside resources may be necessary. This provides both additional proficiency and flexibility for the organization.
Further, at many early-stage companies, we have worked with the leadership teams to consider non-traditional options, such as “hybrid roles,” which span what might otherwise be two or three roles within a larger organization.This allows a smaller company to remain nimble while also attracting talent with a broad skill set and providing the opportunity to grow with the company over time.
It Is Never Too Early to Adopt a Commercialization Mindset
We worry when we see companies believe that commercialization comes at the end of drug development, with the science alone driving efforts in the early years. We know many additional factors need to be considered early on, which can have profound implications for patients and a drug’s success in the market. These may include robust competitive intelligence, publications planning, Health Economic Outcomes Research (HEOR) endpoints, selecting Quality of Life (QOL) measures, packaging, and storage and handling considerations. Money can’t always solve critical errors made early on, many of which can compound further down the road when there is no time remaining to address them.
So, it’s not just about clinical feasibility. Consider the example of indication selection, where having a market perspective is critical to understanding the current and future unmet needs, prioritizing the opportunity, and anticipating market hurdles.
One example that Tracey mentioned occurred in a company where she pushed the team to bring in a patient advisory board pre-Phase 2. People thought it was crazy at that point. But as she explained, it is not only important to engage those patient groups early, there is also much to learn from different patient perspectives, such as: How best to design a trial? What challenges might there be? What additional considerations may exist?
Keep in mind as well — and this goes back to the earlier point about senior leadership and alignment — that a company and its leadership can do everything right and at the right time, but if everyone is not onboard and committed to doing things in lockstep, it’s not going to have the desired effect. It’s critical to keep an eye on this throughout the organization.
Commercialization Should Be Fit-For-Purpose
Over-hiring; doing lots of research that is not necessary to answer the question or make a decision; bad or inaccurate market insight negatively informing clinical trial endpoints; investing too much too early or too little too late — these are just a few common errors that can occur and can have a substantial negative impact. We believe that a company must be efficient about where and when it deploys resources and raises the questions that need to be asked and answered.
Commercialization insights should be incorporated along the way but with the right cadence and investment. Consider the asset and where it is in the development stage. For example, if a company is preclinical and invests in paid research soliciting feedback on the target profile, the results will often generate a generic answer. We believe this is wasted time and money — at this point, the company has yet to articulate clarity on the target product profile and the likely competitive differentiation. The research will need to be conducted again as data impacts the profile of the product. In contrast, that same company should invest in understanding the market landscape and gain an appreciation for the unmet needs and how it could differentiate its product from the existing competition.
All that said, we are very pragmatic about when and how a company needs to gain these understandings. An early-stage company needs to right-size its commercialization capabilities and should not necessarily build out an organization. This build can be stage-gated based upon different milestones, financing realities, or the phase of the clinical program.
We suggest companies start by having a plan and mapping out when the right time is to ramp up and acquire the needed insights, whether from an internal team or outside domain experts.
Conclusion
Ultimately, commercialization aims to optimize the asset’s value for both patients and the company. To achieve this, commercialization needs to be viewed and understood as covering the entire vision for an asset — it is not just another word for “launch.”
When thinking of a company in the R&D stages, we always want to add a “C” (R&D&C) to represent the equally important role that commercialization plays in shaping the product across its development continuum.