Is it just me, or has commercialization, as a term, taken on more prominence in our biopharma world of late? It seems that every day we read more about it, hear more about it, and yes, talk more about it than ever before.

But what does the term really mean? Does it create a “stigma,” with its implicit emphasis on the money side of our industry vs. the purer science focus? Maybe if the term were not also viewed as a “function,” it would cause less angst. More important, how does commercialization’s fuzzy definition impact the way we bring medicines to market?

In many people’s minds, commercialization is seen as a transition point; a time when a drug moves from development by the scientists to a treatment that is marketed and sold by the business people. If not quite a discrete point in time in the gestation of a drug, it has certainly represented a noticeable shift in attention from R&D to the marketplace.

As a result of this abrupt transition point of view, we see many companies ignore strategy and try to build commercialization capability in a “just in time” manner. Org charts are created, and certain positions are hired when they are perceived to be needed. Strategies for marketing, medical affairs, and selling are developed as launch appears on the horizon.

To some degree, this seems logical. By only creating the functions and spending time on what you need today, you can keep your spending low and reasonably manage risk. After all, why develop a go-to-market plan for a drug whose probability for success is still uncertain, or for a company that may be swallowed up by a larger entity or struggle with financing before it reaches the finish line? (I recognize that all of this describes most of our early-stage companies.)

But our world has changed. And with it, this sequential, “we will get to it when the time is right” approach, no longer works.

With each passing day, the science becomes more complicated, the regulations more numerous, the competition more fierce, and the stakes — both the risks and the rewards — more consequential. Indeed, the entire process of bringing a drug to market only continues to get more complex,with multiple stakeholders and strategies needed to address clinical data, value propositions, differentiated claims, and global audiences. Add to this the 24/7 nature of our digital world and there is little room to breathe, let alone make mistakes.

For these reasons (and others described below), I define commercialization not as a function performed by one segment of the organization, or as a process that only begins post-approval. Rather, I like to think of it as a “mindset”: something present from the very beginning of drug development that is baked into the entire organization, in concert with the overall corporate strategy.

The benefits of a commercialization mindset:

Not to overstate it, but I see commercialization as our reason for being. (Does it surprise you that I think this way?) If you work in an enterprise that develops drugs, your purpose is to get them out into the world and into the bodies of the people who need them: to enable them to live better, longer, healthier lives.

Today, successful commercialization requires a company-wide focus on cross-functional collaboration and customer-centered strategies. And it needs to start early and be woven into the fabric of the culture. Regardless of where a given drug may end up, we want to have a commercialization strategy and plan that gets us to the goal (i.e., helping the patient). There are key principles supporting this mindset:

Commercialization engages everyone in the company in a broader, long-term vision.

It’s not just about financial return; it’s an inclusive process, one in which we all value making a difference in the lives of those who might benefit from our work. It’s about figuring out how we are going to connect our science to the market. It is about purpose!

The very act of commercialization drives value.

In today’s companies, value creation is increasingly represented by intangible drivers like innovation, people, ideas, and brand.

A broader (earlier) and innovative end-to-end focus on brand vision, market insights, customer relationships, medical strategy, and wise resource deployment results in direct value creation by tying the product development to the market needs and, ultimately, driving revenues. This, in turn, funds future research which increases value to patients and so on.

Commercialization aligns the product strategy with the corporate strategy and market needs.

Presuming your company has a corporate strategy, it probably says something about curing disease and making a difference in patients’ lives. Commercialization is the path to get there. It helps ensure that drugs will be accessible to patients, will be reimbursed, medically understood, adopted appropriately, and labeled and promoted effectively.

All of these points are determined way back in the earliest stages of defining the target product profile, which informs the clinical trial strategy, that will result in a differentiated, reimbursable label.

A commercialization mindset helps all functions contribute to success, whether that’s Finance building systems that embrace the future commercial entity; IT enabling the compliant customer-facing systems; HR challenging leaders to create a vision for their function to ensure they attract the right talent to enable team success; or other function(s) whose actions can likewise contribute as part of a coordinated whole.

In short, it ensures that every leader in every function is focused on the end game — the market, the customer, the patient, and how their work contributes to the success of the company.


Fundamentally, commercialization is a mindset – an overarching culture that the company embraces. To view it as merely a “marketing and sales function” is to miss the tremendous opportunity that has been put in front of us — for the drug in question, the company as a whole, and the patients we serve!