Guest Column | May 16, 2025

Innovative Strategies In Early Commercialization: A Leader's Perspective

By John Harlow

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They say the mark of intelligence is making the complex simple.

By that standard, navigating early commercialization in the pharmaceutical industry is one of the toughest challenges, especially for smaller companies without deep resources.

In my experience, the two biggest hurdles for smaller companies in early commercialization are financial constraints and team experience. Many companies, prior to product approval, are often singularly focused on progressing through clinical development, regulatory submissions, and final approvals. Given their financial realities, they understandably hesitate to invest heavily in early commercialization work — and more often than not, that’s a critical error that can undermine long-term success.

Many of these companies are led by exceptional scientists or founders with deep expertise in their area of study, but with limited commercial experience. Their challenge isn’t just getting a product approved; it’s ensuring it is well-positioned in the market to achieve commercial success. This requires early and strategic preparation of the brand, the organization, and the market.

Unlike large pharmaceutical giants, smaller companies must operate differently. They can’t rely on vast budgets and extensive support teams. Instead, success depends on innovative strategies, creative problem-solving, resourcefulness, and prioritization.

Let me share a few ways we’ve tackled these challenges in the past:

Building Relationships And Alignment

One of the most overlooked but essential strategies in early commercialization is building strong internal alignment and relationships across the organization. This goes beyond the typical sales approach; it’s about genuinely engaging with the regulatory and clinical development pathways and understanding the broader goals of the entire organization.

At one of my previous companies, I was the second commercial hire, stepping into a team that was entirely focused on clinical development. It wasn’t until our first board meeting that the reality sank in — we were significantly behind in our launch preparations. The clinical and regulatory teams had done incredible work, but there was no commercial foundation in place.

We spent the next year playing catch-up, working closely with our internal cross-functional partners, such as finance, regulatory, medical, and legal, to refine our positioning and secure alignment across the company. That experience reinforced a critical lesson for me: smaller companies don’t have the luxury of time. If commercialization efforts don’t start early, you’ll spend valuable months scrambling to build a strategy instead of executing one. It’s not easy, but this alignment is essential for laying a strong foundation for success.

Leveraging Limited Resources

When resources are constrained, innovation becomes essential. But hasn’t necessity always been the mother of invention?

At Melinta, we operate in a highly competitive space with seven commercial products and a lean team and resources. Traditional Big Pharma commercialization models weren’t feasible. Instead, we focused on making our promotional spend feel bigger than it actually was.

By leveraging a mix of digital strategies, carefully deploying personnel, and maximizing high-impact promotional tactics, we amplified our reach without dramatically increasing costs. This approach forced us to differentiate between high-impact investments and “nice-to-haves.”

A key lesson? In small companies, although you often don’t have control over every aspect of the business, you have the ability to impact the entire business. Building strong relationships and finding ways to contribute to areas like regulatory or clinical development — even when they fall outside of your formal role — can help you make a meaningful impact.

Prioritizing For Maximum Impact

In the early commercialization period, everything can feel urgent. But not all priorities are created equal.

Early in my transition from large to small pharma, I had a defining moment when I asked, “Who handles this?” only to be met with, “You do.” From that moment on, I realized that if you don’t know the answer, the answer is “you.”

That really changed my perspective on how to prioritize effectively. Not every problem needs a full-time hire or a massive budget. Sometimes, the answer is a strategic consultant, a targeted digital tool, or a phased approach.

I break down priorities into three areas:

  • Preparing the Product: Ensuring the right messaging, clinical positioning, and market access strategy.
  • Preparing the Market: Engaging KOLs, payers, and decision makers early.
  • Preparing the Organization: Ensuring you have great people who are aligned, trained, and ready to execute.

By ranking priorities based on short-term and long-term value, we ensure that every dollar and decision moves us forward strategically.

The Importance Of Cross-Functional Collaboration

Cross-functional collaboration is a cornerstone of successful early commercialization.

At Melinta Therapeutics, we adopted a “One Melinta” mindset. Instead of marketing, sales, market access, and medical affairs working in silos, we built a fully integrated, appropriately compliant, go-to-market approach. That meant going beyond typical cross-functional meetings. We created shared objectives and encouraged an open-door policy where teams could raise concerns or suggestions at any point in the process. The result was a more agile, cohesive launch effort where each function understood their role but also knew how to step into adjacent spaces when needed.

It starts with building strong relationships and trust within your team and across the organization. In a small company, your team is essentially the entire organization, so fostering a culture where everyone feels supported and valued is essential. Whether in person or virtually, investing time in these relationships can pay dividends when it comes to launching a product successfully.

More Than A Strategy

Early commercialization is more than just strategy — it’s building a foundation of trust, alignment, and creativity that allows your team to overcome obstacles and achieve success. It’s about being comfortable making decisions without perfect information and knowing that agility and execution are more valuable than waiting for a perfect plan. The ability to pivot and problem-solve in real-time has been one of the most valuable lessons of my career. For me, it’s about building the plane while flying it. And if you have the right people and build the right culture, strategy, and alignment, you’ll land exactly where you need to be.

About the Author:

John Harlow is the Chief Commercial Officer of Melinta Therapeutics. He has a successful 20+ year history in healthcare working across multiple disciplines and therapeutic areas at large, midsize and start-up pharma and biotech companies including Novartis, Alpharma, Shionogi, J&J, Pfizer, and now Melinta Therapeutics.