by Allison Murphy
For all its promise, a new biopharma asset is incredibly challenging, costly, and time-consuming to launch. So why jeopardize your success if you don’t have to? Let’s explore common mistakes in pharma launch strategy, why these missteps can derail your efforts, and how to avoid them.
Downplaying crucial aspects of successful launches leads to ineffective launches or expensive last-minute scrambles. Here are a few common mistakes biopharma companies should avoid:
Bringing your product to market starts well before you launch—with a strong commercialization strategy. Effective commercialization prepares both the market and your company to deliver your product to patients and optimize value for all stakeholders. Commercialization is much broader than launch. It’s an ethos that spans every stage of drug development and market strategy.
Don’t make the mistake of treating commercialization strategy as an afterthought to complete in a mad rush 18 months before your launch. In fact, commercialization planning should run parallel with and inform clinical development. Launch planning is the execution phase of all the work for commercialization that, ideally, your team will have done all along the way.
The adage “If you build it, they will come” doesn’t apply to biopharma. Yet many biopharma companies fall into the trap of assuming that strong science alone is sufficient for successful market entry. They believe that if they meet the endpoints of their clinical trials and secure regulatory approval, market success is all but guaranteed. They decide not to bother with “commercial stuff.” After all, the science is beautiful and novel.
But the truth is that everyone on the team should be concerned with commercialization from the outset. Neglecting early commercialization planning can lead to serious pitfalls—even if the asset is based on legitimate science and achieves regulatory approval.
Let’s consider an example that occurs far too often. A groundbreaking drug hits the market. But the biopharma company can’t prove any incremental benefit for patients versus the current standard of care. As a result, payers don’t see the value proposition for covering this drug regardless of the cost. So, they refuse to pay for it. Without reimbursement, no healthcare provider will prescribe it, and no patient can afford it out of pocket. The drug fails in the market.
What went wrong? The team that designed the clinical studies was focused on proving the science for approval. But they should have also considered collecting data that payers could plug into their financial models to demonstrate a patient benefit and health economic benefit. By the time the team realizes this mistake years later, it’s too late to generate new data. The patients don't get the intended benefit, and the biopharma company doesn't get the forecasted revenue.
Moral of the story: Don't miss any critical steps that could enhance your product profile and boost your chance of delivering patient benefits and commercial success. Launching a pharmaceutical product demands meticulous commercialization planning from the start. With proper planning, your team can develop a stronger product profile that meets the needs of everyone involved: patients, doctors, the scientific community and payers.
Market assessment is the work of describing, defining, and characterizing a market or specific indication within a larger market. A proper market assessment includes the market size, target patient audience, disease awareness, diagnosis and treatment rates, and treatment guidelines.
Market assessment is a critically important input to developing your target product profile (TPP), ensuring that clinical studies are designed to deliver a product that will meet market needs, and forecasting your product’s market potential. Critically, market assessment extends far beyond today’s status quo. You also need to spot emerging trends that will impact the market by the time the product launches.
Competitor intelligence is another key input to forecasting the product’s market potential and developing a successful go-to-market strategy. Without enough focus on this area, you’re likely to develop and launch a product that lacks strong positioning against competitors.
To differentiate your asset from other options on the market, you should assess the competitive landscape for a disease, target, therapeutic or indication; track your competition over time; and communicate the implications to all internal stakeholders. Since clinical trials take so long, it is likely the standard of care will change by the time your drug is approved, so considering the future landscape is critical.
Your team must understand all aspects of the competitive environment: competitor capabilities, assets and profiles, pipelines, clinical studies, current and future data and indications, clinical development and regulatory timelines. Continual monitoring is important, because the standard of care changes rapidly as new entrants launch.
Timing is critical, too. Without an early investment in competitive intelligence, you may be forced to adjust complex clinical trial programs, creating costly delays. That means your commercial opportunity is limited, the investment in clinical development programs is not maximized, and valuable resources are wasted.
Your team, and the tools they use to support their work, can spell the difference between success and failure. Clinical trials are like moving a large boat: everyone must row in the same direction. Without proactive planning, you run the risk of confusion and miscommunication.
Early in the commercialization process, you should determine the essential internal stakeholders who will have input into the commercialization plan—and outline each person’s responsibilities. Starting this discipline early will ensure that in the intense focus of launch, everyone knows their role, is skilled at anticipating the needs, and provides essential updates to their colleagues. This is especially true when the team includes external resources such as consultants and agencies.
No matter how dedicated and organized your team is, you should anticipate changes along the way. Internal team members may leave, external engagements come to an end, and the trial itself may require adjustments. With that reality in mind, continuity of systems and tools is key to keeping the team on track. By identifying the strategic planning platform that will remain even as people come and go, you can foster strong collaboration, allow for dynamic adjustments in real time, and mitigate the risk of critical tasks falling through the cracks.
Early commercialization planning addresses many of these mistakes before they cost you time and money. By focusing on early planning and strategic resource allocation, you’ll improve your chance of an impactful launch.
Creating a commercialization map early:
Leveraging the right tools makes this effort more effective and easier for your team. Corval is a strategic planning platform that enables teams to quickly create a customized, multi-year commercialization roadmap with a companion budget and resource plan. Corval brings decades of expertise and 75,000+ data points into an elegant interface that provides a single source of truth and multi-user access. Our robust platform helps you confidently address the high-stakes challenges of bringing your product to market.
Final Thoughts
Infusing commercialization thinking into your study planning and execution is invaluable, even if you choose to sell your asset to a pharma company or engage an industry partner to bring it to market. With effective commercialization, you can paint a picture of a product that's not only scientifically sound, but also on track for financial success—potentially increasing your asset’s worth by millions of dollars. In the grand scheme of clinical trial development and execution, early commercialization planning is one of the most powerful and cost-effective ways to mitigate risks and give your asset the best chance in the market.
Questions on how Corval can dramatically reduce the time, effort, and resources it takes to bring your asset to life? Reach out to us today.